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A3879-22/24 SPINAL 22G QUINCKE/24G EUROPEAN PENCIL POINT - regional anesthesia kit

Smiths Medical ASD, Inc.

EPINEPHRINE injection, USP

1:1000 (1 mg/mL)

Ampul
Protect from light until ready to use.

Rx only

Description
Epinephrine Injection, USP 1:1000 is a sterile, nonpyrogenic solution.
Each mL contains epinephrine 1 mg; sodium chloride 9 mg; sodium
metabisulfite 0.9 mg added. May contain
hydrochloric acid for pH
adjustment. The solution contains no bacteriostat or antimicrobial
agent. It is administered by the following routes: intravenous,
intracardiac (left ventricular chamber), via endotracheal tube into the
bronchial tree, subcutaneous or intramuscular. Epinephrine, USP is a
sympathomimetic (adrenergic) agent designated chemically as
4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white,
microcrystalline powder. It has the following structural formula:

Sodium Chloride, USP is chemically designated NaCl, a white, crystalline compound freely soluble in water.

Clinical Pharmacology
The actions of epinephrine resemble the effects of
stimulation of adrenergic nerves. To a variable degree it acts on both
alpha and beta receptor sites of sympathetic effector cells. Its most
prominent actions are on the beta receptors of the heart, vascular and
other smooth muscle. When given by rapid intravenous injection, it
produces a rapid rise in blood pressure, mainly systolic, by (1) direct
stimulation of cardiac muscle which increases the strength of
ventricular contraction, (2) increasing the heart rate and (3)
constriction of the arterioles in the skin, mucosa and splanchnic areas
of the circulation. When given by slow intravenous injection epinephrine
 usually produces only a moderate rise in systolic and a fall in
diastolic pressure. Although some increase in pulse pressure occurs,
there is usually no great elevation in mean blood pressure. Accordingly,
 the compensatory reflex mechanisms that come into play with a
pronounced increase in blood pressure do not antagonize the direct
cardiac actions of epinephrine as much as with catecholamines that have a
 predominant action on alpha receptors.
Total peripheral resistance
decreases by action of epinephrine on beta receptors of the skeletal
muscle vasculature and blood flow is thereby enhanced. Usually this
vasodilator effect of the drug on the circulation predominates so that
the modest rise in systolic pressure which follows slow injection or
absorption is mainly the result of direct cardiac stimulation and
increase in cardiac output. In some instances peripheral resistance is
not altered or may even rise owing to a greater ratio of alpha to beta
activity in different vascular areas. Epinephrine relaxes the smooth
muscles of the bronchi and iris and is a physiologic antagonist of
histamine. The drug also produces an increase in blood sugar and
glycogenolysis in the liver. Intravenous injection produces an immediate
 and intensified response. Following intravenous injection epinephrine
disappears rapidly from the blood stream. Epinephrine is rapidly
inactivated in the body and is degraded by enzymes in the liver and
other tissues. The large portion of injection doses is excreted in the
urine as inactivated compounds. The remainder is excreted in the urine
as unchanged or conjugated compounds.

Indications and Usage
Epinephrine is used to relieve respiratory distress due
 to bronchospasm, to provide rapid relief of hypersensitivity reactions
to drugs and other allergens, and to prolong the action of anesthetics.
Its cardiac effects may be of use in restoring cardiac rhythm in cardiac
 arrest due to various causes, but it is not used in cardiac failure or
in hemorrhagic, traumatic, or cardiogenic shock. Epinephrine is used as a
 hemostatic agent. It is also used in treating mucosal congestion of hay
 fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic
paroxysms; in syncope due to complete heart block or carotid sinus
hypersensitivity; for symptomatic relief of serum sickness, urticaria,
angioneurotic edema; for resuscitation in cardiac arrest following
anesthetic accidents; in simple (open angle) glaucoma; for relaxation of
 uterine musculature and to inhibit uterine contractions. Epinephrine
Injection can be utilized to prolong the action of anesthetics used in
local and regional anesthesia.

Contraindications
Epinephrine is contraindicated in patients with known
hypersensitivity to sympathomimetic amines, in patients with angle
closure glaucoma, and patients in shock (nonanaphylactic). It should
not
 be used in patients anesthetized with agents such as cyclopropane or
halothane as these may sensitize the heart to the arrhythmic action of
sympathomimetic drugs. Addition of epinephrine to local anesthetics for
injection of certain areas (e.g., fingers, toes, ears, etc.) is
contraindicated because of danger that vasoconstriction may result in
sloughing of tissue.
Except as diluted for admixture with local
anesthetics to reduce absorption and prolong action, epinephrine should
not ordinarily be used in those cases where vasopressor drugs may be
contraindicated,
 e.g., in thyrotoxicosis, diabetes, in obstetrics when maternal blood
pressure is in excess of 130/80 and in hypertension and other
cardiovascular disorders.

Warnings
Inadvertently induced high arterial blood pressure may
result in angina pectoris, aortic rupture or cerebral hemorrhage.
Epinephrine may induce potentially serious cardiac arrhythmias in
patients not suffering from heart disease and in patients with organic
heart disease or who are receiving drugs that sensitize the myocardium.
Parenterally administered epinephrine initially may produce constriction
 of renal blood vessels and decrease urine formation. Epinephrine
Injection, USP is subject to oxidation and should be protected against
exposure to light and stored in light-resistant containers. Epinephrine
is the preferred treatment for serious allergic or other emergency
situations even though this product contains sodium metabisulfite, a
sulfite that may in other products cause allergic-type reactions
including anaphylactic symptoms or life-threatening or less severe
asthmatic episodes in certain susceptible persons. The alternatives to
using epinephrine in a life-threatening situation may not be
satisfactory. The presence of a sulfite in this product should not deter
 administration of the drug for treatment of serious allergic or other
emergency situations.

Precautions
Do not use the Injection if its color is pinkish or
darker than slightly yellow or if it contains a precipitate. Do not
administer unless solution is clear and container is intact. Discard
unused portion. Although epinephrine can produce ventricular
fibrillation, its actions in restoring electrical activity in asystole
and in enhancing defibrillation of the fibrillating ventricle are well
documented. The drug, however, should be used with caution in patients
with ventricular fibrillation. Epinephrine should be used cautiously in
patients with hyperthyroidism, hypertension and
cardiac arrhythmias.
All vasopressors should be used cautiously in patients taking monoamine
oxidase (MAO) inhibitors. Epinephrine should not be administered
concomitantly with other sympathomimetic drugs (such as isoproterenol)
because of possible additive effects and increased toxicity. Combined
effects may induce serious cardiac arrhythmias. They may be administered
 alternately when the preceding effect of other such drugs has subsided.
 Administration of epinephrine to patients receiving cyclopropane or
halogenated hydrocarbon general anesthetics such as halothane which
sensitize the myocardium, may induce cardiac arrhythmia. (See
CONTRAINDICATIONS.) When encountered, such arrhythmias may respond to
administration of a beta-adrenergic blocking drug. Epinephrine also
should be used cautiously with other drugs (e.g., digitalis glycosides)
that sensitize the myocardium to the actions of
sympathomimetic
agents. Diuretic agents may decrease vascular response to pressor drugs
such as epinephrine. Epinephrine may antagonize the neuron blockade
produced by guanethidine resulting in decreased antihypertensive effect
and requiring increased dosage of the latter.

Pregnancy Category C. Animal reproduction
studies have not been conducted with epinephrine. It is also not known
whether epinephrine can cause fetal harm when administered to a
pregnant woman or can affect reproduction capacity. Epinephrine should be given to a pregnant woman only if clearly needed.

Labor and Delivery. Parenteral
administration of epinephrine if used to support blood pressure during
low or other spinal anesthesia for delivery can cause acceleration of
fetal heart rate and
should not be used in obstetrics when maternal blood pressure exceeds 130/80. (See CONTRAINDICATIONS.)

Adverse Reactions
Transient and minor side effects of anxiety, headache,
fear and palpitations occur only with systemic therapeutic doses,
especially in hyperthyroid individuals. Adverse effects such as cardiac
arrhythmias and excessive rise in blood pressure may occur with systemic
 therapeutic doses or with inadvertent overdosage. Other adverse
reactions include cerebral hemorrhage, hemiplegia, subarachnoid
hemorrhage, anginal pain in patients with angina pectoris, anxiety,
restlessness, headache, tremor, weakness, dizziness, pallor and
respiratory difficulty. Such reactions are unlikely when epinephrine is
diluted to 1:200,000 for injection with local anesthetic agents.

Overdosage
Erroneous administration of large doses of epinephrine
may lead to precordial distress, vomiting, headache, dyspnea, as well as
 unusually elevated blood pressure. (See WARNINGS.) Toxic effects of
overdosage can be counteracted by injection of an alpha-adrenergic
blocker and a betaadrenergic blocker. In the event of a sharp rise in
blood pressure, rapid-acting vasodilators such as the nitrites, or
alpha-adrenergic blocking agents can be given to counteract the marked
pressor effect of large doses of epinephrine.

Dosage and Administration
Subcutaneously or intramuscularly – 0.2 to 1 mL (mg). Start with a small dose and increase if required.
Note: The subcutaneous is the preferred route
of administration. If given intramuscularly, injection into the buttocks
 should be avoided.

Hypersensitivity Reactions
For bronchial asthma and certain allergic manifestations, e.g.,
angioedema, urticaria, serum sickness, anaphylactic shock, use
epinephrine subcutaneously. The adult intravenous dose for
hypersensitivity
 reactions or to relieve bronchospasm usually ranges from 0.1 to 0.25 mg
 injected slowly. Neonates may be given a dose of 0.01 mg per kg of body
 weight; for the infant 0.05 mg is an adequate initial dose and this may
 be repeated at 20 to 30 minute intervals in the management of asthma
attacks.
Cardiac Resuscitation
A dose of 0.5 mL (0.5 mg) diluted to 10 mL with sodium chloride
injection can be administered intravenously or intracardially to restore
 myocardial contractility. Intracardiac injection should only be
administered by personnel well trained in the technique, if there has
not been sufficient time to establish an intravenous route. External
cardiac massage should follow intracardial administration to permit the
drug to enter coronary circulation. The drug should be used secondarily
to unsuccessful attempts with physical or electromechanical methods.
Ophthalmologic Use
Ophthalmologic use (for producing conjunctival decongestion, to
control hemorrhage, produce mydriasis and reduce intraocular pressure) –
 use a concentration of 1:10,000 (0.1 mg/mL) to
1:1000 (1 mg/mL).
Regional Anesthesia
A final concentration of 1:200,000 of epinephrine injection is
recommended for infiltration injection, nerve block, caudal or other
epidural blocks. From 0.3 to 0.4 mg of epinephrine (0.3 to
0.4 mL of
1:1000 solution) may be mixed with spinal anesthetic agents. Parenteral
drug products should be inspected visually for particulate matter and
discoloration prior to administration. (See PRECAUTIONS.)

How SuppliedEpinephrine Injection, USP 1:1000 (1 mg/mL) is supplied in a 1 mL ampul single-dose container (NDC 0409-7241-61).

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Revised: October, 2008

Printed in USA EN-1927

Hospira, Inc., Lake Forest, IL 60045 USA

Epinephrine Pack Label

LIDOCAINE HYDROCHLORIDE
	    (lidocaine hydrochloride anhydrous)
	 injection, solution

AQUEOUS SOLUTIONS FOR INFILTRATION

AND NERVE BLOCK

Ampul

Plastic Multiple-dose Fliptop Vial

Glass Teartop Vial

Rx only

DESCRIPTION
Lidocaine Hydrochloride Injection, USP is a sterile,
nonpyrogenic solution of lidocaine hydrochloride in water for injection
for parenteral administration in various concentrations with
characteristics as follows:

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Concentration

0.5%

1%

1.5%

2%

mg/mL lidocaine HCl (anhyd.)

5

10

15

20

mg/mL sodium chloride

8

7

6.5

6

Multiple-dose vials contain 0.1% of methylparaben added as
preservative. May contain sodium hydroxide and/or hydrochloric acid for
pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIED section for various sizes and strengths.

Lidocaine is a local anesthetic of the amide type.

Lidocaine Hydrochloride, USP is chemically designated
2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride
monohydrate, a white powder freely soluble in water. The molecular
weight is 288.82. It has the following structural formula:

The semi-rigid vial used for the plastic vials is fabricated from a
specially formulated polyolefin. It is a copolymer of ethylene and
propylene. The safety of the plastic has been confirmed by tests in
animals according to USP biological standards for plastic containers.
The container requires no vapor barrier to maintain the proper drug
concentration.

CLINICAL PHARMACOLOGY
Mechanism of action:
 Lidocaine stabilizes the        neuronal membrane by inhibiting the
ionic fluxes required for the initiation and conduction        of
impulses, thereby effecting local anesthetic action.

Hemodynamics:
Excessive blood levels may cause        changes in cardiac output, total
 peripheral resistance, and mean arterial pressure. With        central
neural blockade these changes may be attributable to block of autonomic
fibers, a        direct depressant effect of the local anesthetic agent
on various components of the        cardiovascular system and/or the
beta-adrenergic receptor stimulating action of epinephrine        when
present. The net effect is normally a modest hypotension when the
recommended dosages        are not exceeded.

Pharmacokinetics and metabolism:
 Information        derived from diverse formulations, concentrations
and usages reveals that lidocaine is        completely absorbed
following parenteral administration, its rate of absorption depending,
      for example, upon various factors such as the site of
administration and the presence or        absence of a vasoconstrictor
agent. Except for intravascular administration, the highest        blood
 levels are obtained following intercostal nerve block and the lowest
after subcutaneous        administration.

The plasma binding of lidocaine is dependent on drug concentration,
and the        fraction bound decreases with increasing concentration.
At concentrations of 1 to 4 mcg of        free base per mL, 60 to 80
percent of lidocaine is protein bound. Binding is also dependent
on the plasma concentration of the alpha-1-acid glycoprotein.

Lidocaine crosses the blood-brain and placental barriers, presumably by passive        diffusion.

Lidocaine is metabolized rapidly by the liver, and metabolites and
unchanged drug        are excreted by the kidneys. Biotransformation
includes oxidative N-dealkylation, ring        hydroxylation, cleavage
of the amide linkage, and conjugation. N-dealkylation, a major
pathway of biotransformation, yields the metabolites
monoethylglycinexylidide and        glycinexylidide. The
pharmacological/toxicological actions of these metabolites are similar
      to, but less potent than, those of lidocaine. Approximately 90% of
 lidocaine administered is        excreted in the form of various
metabolites, and less than 10% is excreted unchanged. The        primary
 metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline.

The elimination half-life of lidocaine following an intravenous bolus
 injection is        typically 1.5 to 2.0 hours. Because of the rapid
rate at which lidocaine is metabolized, any        condition that
affects liver function may alter lidocaine kinetics. The half-life may
be        prolonged two-fold or more in patients with liver dysfunction.
 Renal dysfunction does not        affect lidocaine kinetics but may
increase the accumulation of metabolites.

Factors such as acidosis and the use of CNS stimulants and
depressants affect the        CNS levels of lidocaine required to
produce overt systemic effects. Objective adverse        manifestations
become increasingly apparent with increasing venous plasma levels above
6.0        mcg free base per mL. In the rhesus monkey arterial blood
levels of 18-21 mcg/mL have been        shown to be threshold for
convulsive activity.

INDICATIONS AND USAGE
Lidocaine Hydrochloride Injection, USP is indicated for
 production of local or        regional anesthesia by infiltration
techniques such as percutaneous injection and intravenous
regional anesthesia by peripheral nerve block techniques such as
brachial plexus and        intercostal and by central neural techniques
such as lumbar and caudal epidural blocks, when        the accepted
procedures for these techniques as described in standard textbooks are
     observed.

CONTRAINDICATIONS
Lidocaine is contraindicated in patients with a known history of hypersensitivity        to local anesthetics of the amide type.

WARNINGS
LIDOCAINE HYDROCHLORIDE INJECTION, FOR INFILTRATION AND
 NERVE BLOCK, SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED
IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE
EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY
 AFTER ENSURING THE IMMEDIATE
 AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY
EQUIPMENT, AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC
REACTIONS AND RELATED EMERGENCIES (See also ADVERSE REACTIONS and PRECAUTIONS).
 DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION
FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF
 ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.

Intra-articular infusions of local anesthetics following arthroscopic
 and other surgical procedures is an unapproved use, and there have been
 post-marketing reports of chondrolysis in patients receiving such
infusions. The majority of reported cases of chondrolysis have involved
the shoulder joint; cases of gleno-humeral chondrolysis have been
described in pediatric and adult patients following intra-articular
infusions of local anesthetics with and without epinephrine for periods
of 48 to 72 hours. There is insufficient information to determine
whether shorter infusion periods are not associated with these findings.
 The time of onset of symptoms, such as joint pain, stiffness and loss
of motion can be variable, but may begin as early as the 2nd month after
 surgery. Currently, there is no effective treatment for chondrolysis;
patients who experienced chondrolysis have required additional
diagnostic and therapeutic procedures and some required arthroplasty or
shoulder replacement.

To avoid intravascular injection, aspiration should be performed
before the local anesthetic solution is injected. The needle must be
repositioned until no return of blood can be elicited by aspiration.
Note, however, that the absence of blood in the syringe does not
guarantee that intravascular injection has been avoided.

Local anesthetic solutions containing antimicrobial preservatives
(e.g., methylparaben) should not be used for epidural or spinal
anesthesia because the safety of these agents has not been established
with regard to intrathecal injection, either intentional or accidental.

PRECAUTIONSGeneral:
The safety and effectiveness of lidocaine depend on
proper dosage, correct          technique, adequate precautions, and
readiness for emergencies. Standard textbooks should          be
consulted for specific techniques and precautions for various regional
anesthetic          procedures.

Resuscitative equipment, oxygen, and other resuscitative drugs should be          available for immediate use. (See WARNINGS and ADVERSE REACTIONS).
 The lowest dosage that results in effective anesthesia should be used
to avoid          high plasma levels and serious adverse effects.
Syringe aspirations should also be          performed before and during
each supplemental injection when using indwelling catheter
techniques. During the administration of epidural anesthesia, it is
recommended that a test          dose be administered initially and that
 the patient be monitored for central nervous system          toxicity
and cardiovascular toxicity, as well as for signs of unintended
intrathecal          administration before proceeding. When clinical
conditions permit, consideration should be          given to employing
local anesthetic solutions that contain epinephrine for the test dose
       because circulatory changes compatible with epinephrine may also
serve as a warning sign of          unintended intravascular injection.
An intravascular injection is still possible even if
aspirations for blood are negative. Repeated doses of lidocaine may
cause significant          increases in blood levels with each repeated
dose because of slow accumulation of the drug          or its
metabolites. Tolerance to elevated blood levels varies with the status
of the          patient. Debilitated, elderly patients, acutely ill
patients and children should be given          reduced doses
commensurate with their age and physical condition. Lidocaine should
also be          used with caution in patients with severe shock or
heart block. Lumbar and caudal epidural          anesthesia should be
used with extreme caution in persons with the following conditions:
     existing neurological disease, spinal deformities, septicemia and
severe hypertension.

Local anesthetic solutions containing a vasoconstrictor should be
used cautiously          and in carefully circumscribed quantities in
areas of the body supplied by end arteries or          having otherwise
compromised blood supply. Patients with peripheral vascular disease and
         those with hypertensive vascular disease may exhibit
exaggerated vasoconstrictor response.          Ischemic injury or
necrosis may result. Preparations containing a vasoconstrictor should be
          used with caution in patients during or following the
administration of potent general          anesthetic agents, since
cardiac arrhythmias may occur under such conditions.

Careful and constant monitoring of cardiovascular and respiratory
(adequacy of          ventilation) vital signs and the patient's state
of consciousness should be          accomplished after each local
anesthetic injection. It should be kept in mind at such times
that restlessness, anxiety, tinnitus, dizziness, blurred vision,
tremors, depression or          drowsiness may be early warning signs of
 central nervous system toxicity.

Since amide-type local anesthetics are metabolized by the liver,
lidocaine should          be used with caution in patients with hepatic
disease. Patients with severe hepatic          disease, because of their
 inability to metabolize local anesthetics normally, are at
greater risk of developing toxic plasma concentrations. Lidocaine should
 also be used with          caution in patients with impaired
cardiovascular function since they may be less able to
compensate for functional changes associated with the prolongation of
A-V conduction          produced by these drugs. Many drugs used during
the conduct of anesthesia are considered          potential triggering
agents for familial malignant hyperthermia. Since it is not known
   whether amide-type local anesthetics may trigger this reaction and
since the need for          supplemental general anesthesia cannot be
predicted in advance, it is suggested that a          standard protocol
for the management of malignant hyperthermia should be available. Early
         unexplained signs of tachycardia, tachypnea, labile blood
pressure and metabolic acidosis          may precede temperature
elevation. Successful outcome is dependent on early diagnosis,
prompt discontinuance of the suspect triggering agent(s) and institution
 of treatment,          including oxygen therapy, indicated supportive
measures and dantrolene (consult dantrolene          sodium intravenous
package insert before using).

Proper tourniquet technique, as described in publications and
standard textbooks,          is essential in the performance of
intravenous regional anesthesia. Solutions containing
epinephrine or other vasoconstrictors should not be used for this
technique.

Lidocaine should be used with caution in persons with known drug
sensitivities.          Patients allergic to para-aminobenzoic acid
derivatives (procaine, tetracaine, benzocaine,          etc.) have not
shown cross sensitivity to lidocaine.

Use in the Head and Neck Area:
 Small doses of          local anesthetics injected into the head and
neck area, including retrobulbar, dental and          stellate ganglion
blocks, may produce adverse reactions similar to systemic toxicity seen
         with unintentional intravascular injections of larger doses.
Confusion, convulsions,          respiratory depression and/or
respiratory arrest and cardiovascular stimulation or          depression
 have been reported. These reactions may be due to intra-arterial
injections of          the local anesthetic with retrograde flow to the
cerebral circulation. Patients receiving          these blocks should
have their circulation and respiration monitored and be constantly
    observed. Resuscitative equipment and personnel for treating adverse
 reactions should be          immediately available. Dosage
recommendations should not be exceeded. (See DOSAGE AND ADMINISTRATION).

Information for Patients:
When appropriate, patients should be informed in
advance that they may experience          temporary loss of sensation
and motor activity, usually in the lower half of the body
following proper administration of epidural anesthesia.

Clinically Significant Drug Interactions:
The administration of local anesthetic solutions
containing epinephrine or          norepinephrine to patients receiving
monoamine oxidase inhibitors or tricyclic          antidepressants may
produce severe prolonged hypertension.

Phenothiazines and butyrophenones may reduce or reverse the pressor effect of          epinephrine.

Concurrent use of these agents should generally be avoided. In
situations when          concurrent therapy is necessary, careful
patient monitoring is essential.

Concurrent administration of vasopressor drugs (for the treatment of
hypotension          related to obstetric blocks) and ergot-type
oxytoxic drugs may cause severe persistent          hypertension or
cerebrovascular accidents.

Drug Laboratory Test Interactions:
The intramuscular injection of lidocaine may result in
an increase in creatine          phosphokinase levels. Thus, the use of
this enzyme determination without isoenzyme          separation as a
diagnostic test for the presence of acute myocardial infarction may be
        compromised by the intramuscular injection of lidocaine.

Carcinogenesis, Mutagenesis, Impairment of Fertility:
Studies of lidocaine in animals to evaluate the
carcinogenic and mutagenic          potential or the effect on fertility
 have not been conducted.

Pregnancy:
Teratogenic Effects. Pregnancy Category B.
          Reproduction studies have been performed in rats at doses up
to 6.6 times the human dose          and have revealed no evidence of
harm to the fetus caused by lidocaine. There are, however,          no
adequate and well-controlled studies in pregnant women. Animal
reproduction studies are          not always predictive of human
response. General consideration should be given to this fact
before administering lidocaine to women of childbearing potential,
especially during early          pregnancy when maximum organogenesis
takes place.

Labor and Delivery:
Local anesthetics rapidly cross the placenta and when
used for epidural,          paracervical, pudendal or caudal block
anesthesia, can cause varying degrees of maternal,          fetal and
neonatal toxicity (See CLINICAL PHARMACOLOGY—Pharmacokinetics).
 The potential          for toxicity depends upon the procedure
performed, the type and amount of drug used, and          the technique
of drug administration. Adverse reactions in the parturient, fetus and
        neonate involve alterations of the central nervous system
peripheral vascular tone and          cardiac function.

Maternal hypotension has resulted from regional anesthesia. Local
anesthetics          produce vasodilation by blocking sympathetic
nerves. Elevating the patient's          legs and positioning her on her
 left side will help prevent decreases in blood pressure.          The
fetal heart rate also should be monitored continuously, and electronic
fetal monitoring          is highly advisable.

Epidural, spinal, paracervical, or pudendal anesthesia may alter the
forces of          parturition through changes in uterine contractility
or maternal expulsive efforts. In one          study, paracervical block
 anesthesia was associated with a decrease in the mean duration of
    first stage labor and facilitation of cervical dilation. However,
spinal and epidural          anesthesia have also been reported to
prolong the second stage of labor by removing the          parturient's
reflex urge to bear down or by interfering with motor function. The
     use of obstetrical anesthesia may increase the need for forceps
assistance.

The use of some local anesthetic drug products during labor and
delivery may be          followed by diminished muscle strength and tone
 for the first day or two of life. The          long-term significance
of these observations is unknown. Fetal bradycardia may occur in 20
     to 30 percent of patients receiving paracervical nerve block
anesthesia with the amide-type          local anesthetics and may be
associated with fetal acidosis. Fetal heart rate should always
be monitored during paracervical anesthesia. The physician should weigh
the possible          advantages against risks when considering
paracervical block in prematurity, toxemia of          pregnancy and
fetal distress. Careful adherence to recommended dosage is of the utmost
          importance in obstetrical paracervical block. Failure to
achieve adequate analgesia with          recommended doses should arouse
 suspicion of intravascular or fetal intracranial injection.
Cases compatible with unintended fetal intracranial injection of local
anesthetic solution          have been reported following intended
paracervical or pudendal block or both. Babies so          affected
present with unexplained neonatal depression at birth, which correlates
with high          local anesthetic serum levels, and often manifest
seizures within six hours. Prompt use of          supportive measures
combined with forced urinary excretion of the local anesthetic has been
         used successfully to manage this complication.

Case reports of maternal convulsions and cardiovascular collapse
following use of          some local anesthetics for paracervical block
in early pregnancy (as anesthesia for          elective abortion)
suggest that systemic absorption under these circumstances may be rapid.
          The recommended maximum dose of each drug should not be
exceeded. Injection should be made          slowly and with frequent
aspiration. Allow a 5-minute interval between sides.

Nursing Mothers:
It is not known whether this drug is excreted in human
milk. Because many drugs          are excreted in human milk, caution
should be exercised when lidocaine is administered to a          nursing
 woman.

Pediatric Use:
Dosages in pediatric patients should be reduced, commensurate with age, body          weight and physical condition. See DOSAGE AND ADMINISTRATION.

ADVERSE REACTIONS
Systemic:
Adverse experiences following the        administration of lidocaine are
 similar in nature to those observed with other amide local
anesthetic agents. These adverse experiences are, in general,
dose-related and may result        from high plasma levels caused by
excessive dosage, rapid absorption or inadvertent        intravascular
injection, or may result from a hypersensitivity, idiosyncrasy or
diminished        tolerance on the part of the patient. Serious adverse
experiences are generally systemic in        nature. The following types
 are those most commonly reported:

Central Nervous System:
 CNS manifestations are        excitatory and/or depressant and may be
characterized by lightheadedness, nervousness,        apprehension,
euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double
vision,        vomiting, sensations of heat, cold or numbness,
twitching, tremors, convulsions,        unconsciousness, respiratory
depression and arrest. The excitatory manifestations may be very
brief or may not occur at all, in which case the first manifestation of
toxicity may be        drowsiness merging into unconsciousness and
respiratory arrest.

Drowsiness following the administration of lidocaine is usually an
early sign of a        high blood level of the drug and may occur as a
consequence of rapid absorption.

Cardiovascular System:
 Cardiovascular        manifestations are usually depressant and are
characterized by bradycardia, hypotension, and        cardiovascular
collapse, which may lead to cardiac arrest.

Allergic:
Allergic reactions are characterized        by cutaneous lesions,
urticaria, edema or anaphylactoid reactions. Allergic reactions may
   occur as a result of sensitivity either to local anesthetic agents or
 to the methylparaben        used as a preservative in multiple dose
vials. Allergic reactions as a result of sensitivity        to lidocaine
 are extremely rare and, if they occur, should be managed by
conventional means.        The detection of sensitivity by skin testing
is of doubtful value.

Neurologic: The
incidences of adverse reactions        associated with the use of local
anesthetics may be related to the total dose of local        anesthetic
administered and are also dependent upon the particular drug used, the
route of        administration and the physical status of the patient.
In a prospective review of 10,440        patients who received lidocaine
 for spinal anesthesia, the incidences of adverse reactions        were
reported to be about 3 percent each for positional headaches,
hypotension and backache;        2 percent for shivering; and less than 1
 percent each for peripheral nerve symptoms, nausea,        respiratory
inadequacy and double vision. Many of these observations may be related
to local        anesthetic techniques, with or without a contribution
from the local anesthetic.

In the practice of caudal or lumbar epidural block, occasional
unintentional        penetration of the subarachnoid space by the
catheter may occur. Subsequent adverse effects        may depend
partially on the amount of drug administered subdurally.

These may include spinal block of varying magnitude (including total
spinal block),        hypotension secondary to spinal block, loss of
bladder and bowel control, and loss of        perineal sensation and
sexual function. Persistent motor, sensory and/or autonomic (sphincter
      control) deficit of some lower spinal segments with slow recovery
(several months) or        incomplete recovery have been reported in
rare instances when caudal or lumbar epidural block        has been
attempted. Backache and headache have also been noted following use of
these        anesthetic procedures.

There have been reported cases of permanent injury to extraocular
muscles requiring        surgical repair following retrobulbar
administration.

OVERDOSAGE
Acute emergencies from local anesthetics are generally
related to high plasma levels encountered during therapeutic use of
local anesthetics or to unintended subarachnoid injection of local
anesthetic solution (see ADVERSE REACTIONS, WARNINGS and PRECAUTIONS).

Management of Local Anesthetic Emergencies:
 The first consideration is prevention, best accomplished by careful
monitoring of cardiovascular and respiratory vital signs and the
patient's state of consciousness after each local anesthetic injection.
At the first sign of change, oxygen should be administered.

The first step in the management of convulsions, as well as
underventilation or apnea due to unintended subarachnoid injection of
drug solution, consists of immediate attention to the maintenance of a
patent airway and assisted or controlled ventilation with oxygen and a
delivery system capable of permitting immediate positive airway pressure
 by mask. Immediately after the institution of these ventilatory
measures, the adequacy of the circulation should be evaluated, keeping
in mind that drugs used to treat convulsions sometimes depress the
circulation when administered intravenously. Should convulsions persist
despite adequate respiratory support, and if the status of the
circulation permits, small increments of an ultra-short acting
barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such
as diazepam) may be administered intravenously. The clinician should be
familiar, prior to use of local anesthetics, with these anticonvulsant
drugs. Supportive treatment of circulatory depression may require
administration of intravenous fluids and, when appropriate, a
vasopressor as directed by the clinical situation (e.g., ephedrine).

If not treated immediately, both convulsions and cardiovascular
depression can result in hypoxia, acidosis, bradycardia, arrhythmias and
 cardiac arrest. Underventilation or apnea due to unintentional
subarachnoid injection of local anesthetic solution may produce these
same signs and also lead to cardiac arrest if ventilatory support is not
 instituted. If cardiac arrest should occur standard cardiopulmonary
resuscitative measures should be instituted.

Endotracheal intubation, employing drugs and techniques familiar to
the clinician, may be indicated, after initial administration of oxygen
by mask, if difficulty is encountered in the maintenance of a patent
airway or if prolonged ventilatory support (assisted or controlled) is
indicated.

Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.

The oral LD50 of lidocaine HCl in non-fasted
 female rats is 459 (346−773) mg/kg (as the salt) and 214 (159−324)
mg/kg (as the salt) in fasted female rats.

DOSAGE AND ADMINISTRATION
Table 1 (Recommended Dosages) summarizes the
recommended volumes and concentrations of Lidocaine Hydrochloride
Injection, USP for various types of anesthetic procedures. The dosages
suggested in this table are for normal healthy adults and refer to the
use of epinephrine-free solutions. When larger volumes are required only
 solutions containing epinephrine should be used, except in those cases
where vasopressor drugs may be contraindicated.

There have been adverse event reports of chondrolysis in patients
receiving intra-articular infusions of local anesthetics following
arthroscopic and other surgical procedures.  Lidocaine is not approved
for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

These recommended doses serve only as a guide to the amount of
anesthetic required for most routine procedures. The actual volumes and
concentrations to be used depend on a number of factors such as type and
 extent of surgical procedure, depth of anesthesia and degree of
muscular relaxation required, duration of anesthesia required, and the
physical condition of the patient. In all cases the lowest concentration
 and smallest dose that will produce the desired result should be given.
 Dosages should be reduced for children and for elderly and debilitated
patients and patients with cardiac and/or liver disease.

The onset of anesthesia, the duration of anesthesia and the degree of
 muscular relaxation are proportional to the volume and concentration
(i.e., total dose) of local anesthetic used. Thus, an increase in volume
 and concentration of Lidocaine Hydrochloride Injection will decrease
the onset of anesthesia, prolong the duration of anesthesia, provide a
greater degree of muscular relaxation and increase the segmental spread
of anesthesia. However, increasing the volume and concentration of
Lidocaine Hydrochloride Injection may result in a more profound fall in
blood pressure when used in epidural anesthesia. Although the incidence
of side effects with lidocaine is quite low, caution should be exercised
 when employing large volumes and concentrations, since the incidence of
 side effects is directly proportional to the total dose of local
anesthetic agent injected.

For intravenous regional anesthesia, only the 50 mL single-dose vial
containing 0.5% Lidocaine Hydrochloride Injection, USP should be used.

Epidural Anesthesia

For epidural anesthesia, only the following available specific products of Lidocaine Hydrochloride Injection by Hospira are recommended:

1%. . . . . . . . . . . . . . . . . . . . 30 mL single-dose teartop vials

1.5%. . . . . . . . . . . . . . . . . . . . . . . 20 mL single-dose ampuls

2%. . . . . . . . . . . . . . . . . . . . . . . . . 10 mL single-dose ampuls

Although these solutions are intended specifically for epidural
anesthesia, they may also be used for infiltration and peripheral nerve
block provided they are employed as single dose units. These solutions
contain no bacteriostatic agent. In epidural anesthesia, the dosage
varies with the number of dermatomes to be anesthetized (generally 2−3
mL of the indicated concentration per dermatome).

Caudal and Lumbar Epidural Block:
 As a precaution against the adverse experiences sometimes observed
following unintentional penetration of the subarachnoid space, a test
dose such as 2−3 mL of 1.5% lidocaine hydrochloride should be
administered at least 5 minutes prior to injecting the total volume
required for a lumbar or caudal epidural block. The test dose should be
repeated if the patient is moved in a manner that may have displaced the
 catheter. Epinephrine, if contained in the test dose (10−15 mcg have
been suggested), may serve as a warning of unintentional intravascular
injection. If injected into a blood vessel, this amount of epinephrine
is likely to produce a transient "epinephrine response" within 45
seconds, consisting of an increase in heart rate and systolic blood
pressure, circumoral pallor, palpitations and nervousness in the
unsedated patient. The sedated patient may exhibit only a pulse rate
increase of 20 or more beats per minute for 15 or more seconds. Patients
 on beta-blockers may not manifest changes in heart rate, but blood
pressure monitoring can detect an evanescent rise in systolic blood
pressure. Adequate time should be allowed for onset of anesthesia after
administration of each test dose. The rapid injection of a large volume
of Lidocaine Hydrochloride Injection through the catheter should be
avoided, and, when feasible, fractional doses should be administered.

In the event of the known injection of a large volume of local
anesthetic solutions into the subarachnoid space, after suitable
resuscitation and if the catheter is in place, consider attempting the
recovery of drug by draining a moderate amount of cerebrospinal fluid
(such as 10 mL) through the epidural catheter.

Maximum Recommended Dosages

NOTE: The products accompanying this insert do not contain epinephrine.

Adults: For
normal healthy adults, the individual maximum recommended dose of
lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of
body weight and in general it is recommended that the maximum total dose
 not exceed 500 mg. When used without epinephrine, the maximum
individual dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight and
 in general it is recommended that the maximum total dose does not
exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum
 recommended dosage should not be administered at intervals of less than
 90 minutes. When continuous lumbar or caudal epidural anesthesia is
used for non-obstetrical procedures, more drug may be administered if
required to produce adequate anesthesia.

The maximum recommended dose per 90 minute period of lidocaine
hydrochloride for paracervical block in obstetrical patients and
non-obstetrical patients is 200 mg total. One-half of the total dose is
usually administered to each side. Inject slowly five minutes between
sides. (See also discussion of paracervical block in PRECAUTIONS).

For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults.

Children: It is
difficult to recommend a maximum dose of any drug for children, since
this varies as a function of age and weight. For children over 3 years
of age who have a normal lean body mass and normal body development, the
 maximum dose is determined by the child's age and weight. For example,
in a child of 5 years weighing 50 lbs., the dose of lidocaine HCl should
 not exceed 75 — 100 mg (1.5 — 2 mg/lb). The use of even more dilute
solutions (i.e., 0.25 — 0.5%) and total dosages not to exceed 3 mg/kg
(1.4 mg/lb) are recommended for induction of intravenous regional
anesthesia in children.

In order to guard against systemic toxicity, the lowest effective
concentration and lowest effective dose should be used at all times. In
some cases it will be necessary to dilute available concentrations with
0.9% sodium chloride injection in order to obtain the required final
concentration.

Parenteral drug products should be inspected visually for particulate
 matter and discoloration prior to administration whenever the solution
and container permit. Solutions that are discolored and/or contain
particulate matter should not be used.

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Table 1

Recommended Dosages of Lidocaine Hydrochloride Injection, USP for Various Anesthetic

Procedures in Normal Healthy Adults

Lidocaine Hydrochloride Injection, USP (without Epinephrine)

Procedure

Conc. (%)

Vol. (mL)

Total Dose (mg)

Infiltration

Percutaneous

0.5 or 1.0

1−60

5−300

Intravenous Regional

0.5

10−60

50−300

Peripheral Nerve Blocks, e.g.

Brachial

1.5

15−20

225−300

Dental

2.0

1−5

20−100

Intercostal

1.0

3

30

Paravertebral

1.0

3−5

30−50

Pudendal (each side)

1.0

10

100

Paracervical

Obstetrical Analgesia

(each side)

1.0

10

100

Sympathetic Nerve Blocks, e.g.

Cervical (stellate ganglion)

1.0

5

50

Lumbar

1.0

5−10

50−100

Central Neural Blocks

Epidural*

Thoracic

1.0

20−30

200−300

Lumbar

Analgesia

1.0

25−30

250−300

Anesthesia

1.5

15−20

225−300

2.0

10−15

200−300

Caudal

Obstetrical Analgesia

1.0

20−30

200−300

Surgical Anesthesia

1.5

15−20

225−300

*Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome).

THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE.
 OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM
 RECOMMENDED DOSE IS NOT EXCEEDED.

Sterilization, Storage and Technical Procedures:
 Disinfecting agents containing heavy metals, which cause release of
respective ions (mercury, zinc, copper, etc.) should not be used for
skin or mucous membrane disinfection as they have been related to
incidence of swelling and edema. When chemical disinfection of
multi-dose vials is desired, either isopropyl alcohol (91%) or 70% ethyl
 alcohol is recommended. Many commercially available brands of rubbing
alcohol, as well as solutions of ethyl alcohol not of USP grade, contain
 denaturants which are injurious to rubber and, therefore, are not to be
 used. It is recommended that chemical disinfection be accomplished by
wiping the vial stopper thoroughly with cotton or gauze that has been
moistened with the recommended alcohol just prior to use.

HOW SUPPLIED
Lidocaine Hydrochloride Injection, USP is supplied as follows:

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NDC

Container

Concentration

Size

Total (mg)

Single-dose:

0409-4278-01

Glass Teartop Vial

0.5% (5 mg/mL)

50 mL

250

0409-4713-01

Glass Ampul

1% (10 mg/mL)

2 mL (bulk – 400 units)

20

0409-4713-02

Glass Ampul

1% (10 mg/mL)

5 mL

50

0409-4713-05

Glass Ampul

1% (10 mg/mL)

5 mL (bulk – 400 units)

50

0409-4713-20

Glass Ampul

1% (10 mg/mL)

20 mL

200

0409-4713-32

Glass Ampul

1% (10 mg/mL)

2 mL

20

0409-4713-62

Glass Ampul

1% (10 mg/mL)

2 mL (bulk – 800 units)

20

0409-4713-65

Glass Ampul

1% (10 mg/mL)

5 mL (bulk – 800 units)

50

0409-4279-02

Glass Teartop Vial

1% (10 mg/mL)

30 mL

300

0409-4270-01

Sterile Glass Teartop Vial

1% (10 mg/mL)

30 mL

300

0409-4776-01

Glass Ampul

1.5% (15 mg/mL)

20 mL

300

0409-4056-01

Sterile Glass Ampul

1.5% (15 mg/mL)

20 mL

300

0409-4282-01

Glass Ampul

2% (20 mg/mL)

2 mL

40

0409-4282-02

Glass Ampul

2% (20 mg/mL)

10 mL

200

Multiple-dose:

0409-4275-01

Plastic Fliptop Vial

0.5% (5 mg/mL)

50 mL

250

0409-4276-01

Plastic Fliptop Vial

1% (10 mg/mL)

20 mL

200

0409-4276-02

Plastic Fliptop Vial

1% (10 mg/mL)

50 mL

500

0409-4277-01

Plastic Fliptop Vial

2% (20 mg/mL)

20 mL

400

0409-4277-02

Plastic Fliptop Vial

2% (20 mg/mL)

50 mL

1000

Single-dose products are preservative-free.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls
and glass teartop vials may be autoclaved one time only. Autoclave at 15
 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS.

Revised: February, 2010

Printed in USA                            EN-2421

Hospira, Inc., Lake Forest, IL 60045 USA

Lidocaine Pack Label

BUPIVACAINE
	    (bupivacaine hydrochloride)
	 injection, solution
 [Hospira, Inc.]

Bupivacaine HCl 0.75% in Dextrose

8.25% Injection

Sterile Hyperbaric Solution for

Spinal Anesthesia

Rx only

DESCRIPTION
Bupivacaine hydrochloride is 1-Butyl-2΄
6΄-pipecoloxylidide monochloride, monohydrate, a white crystalline
powder that is freely soluble in 95 percent ethanol, soluble in water,
and slightly soluble in chloroform or acetone. It has the following
structural formula:

Dextrose is D-glucopyranose monohydrate and has the following structural formula:

Bupivacaine Spinal (Bupivacaine in Dextrose Injection, USP) is
available in sterile, hyperbaric solution for subarachnoid injection
(spinal block).

Bupivacaine hydrochloride is related chemically and pharmacologically
 to the aminoacyl local anesthetics. It is a homologue of mepivacaine
and is chemically related to lidocaine. All three of these anesthetics
contain an amide linkage between the aromatic nucleus and the amino or
piperidine group. They differ in this respect from the procaine-type
local anesthetics, which have an ester linkage.

Each 1 mL of Bupivacaine Spinal contains 7.5 mg bupivacaine
hydrochloride, anhydrous and 82.5 mg dextrose, anhydrous. The pH of this
 solution is adjusted to 5.5 (4.0 to 6.5) with sodium hydroxide and/or
hydrochloric acid.

The specific gravity of Bupivacaine Spinal is between 1.030 and 1.035 at 25°C and 1.03 at 37°C.

Bupivacaine Spinal does not contain any preservatives.

Solutions of bupivacaine hydrochloride may be autoclaved if they do not contain epinephrine.

CLINICAL PHARMACOLOGY
Local anesthetics block the generation and the
conduction of nerve impulses, presumably by increasing the threshold for
 electrical excitation in the nerve, by slowing the propagation of the
nerve impulse and by reducing the rate of rise of the action potential.
In general, the progression of anesthesia is related to the diameter,
myelination and conduction velocity of affected nerve fibers.
Clinically, the order of loss of nerve function is as follows: (1) pain,
 (2) temperature, (3) touch, (4) proprioception and (5) skeletal muscle
tone.

Systemic absorption of local anesthetics produces effects on the
cardiovascular and central nervous system (CNS). At blood concentrations
 achieved with normal therapeutic doses, changes in cardiac conduction,
excitability, refractoriness, contractility, and peripheral vascular
resistance are minimal. However, toxic blood concentrations depress
cardiac conduction and excitability, which may lead to atrioventricular
block, ventricular arrhythmias and cardiac arrest, sometimes resulting
in fatalities. In addition, myocardial contractility is depressed and
peripheral vasodilation occurs, leading to decreased cardiac output and
arterial blood pressure. Recent clinical reports and animal research
suggest that these cardiovascular changes are more likely to occur after
 unintended direct intravascular injection of bupivacaine. Therefore,
when epidural anesthesia with bupivacaine is considered, incremental
dosing is necessary.

Following systemic absorption, local anesthetics can produce central
nervous system stimulation, depression or both. Apparent central
stimulation is manifested as restlessness, tremors and shivering,
progressing to convulsions, followed by depression and coma progressing
ultimately to respiratory arrest. However, the local anesthetics have a
primary depressant effect on the medulla and on higher centers. The
depressed stage may occur without a prior excited stage.

Pharmacokinetics:
 The rate of systemic absorption of local anesthetics is dependent upon
the total dose and concentration of drug administered, the route of
administration, the vascularity of the administration site, and the
presence or absence of epinephrine in the anesthetic solution. A dilute
concentration of epinephrine (1:200,000 or 5 μg/mL) usually reduces the
rate of absorption and peak plasma concentration of bupivacaine,
permitting the use of moderately larger total doses and sometimes
prolonging the duration of action.

The onset of action with bupivacaine is rapid and anesthesia is
long-lasting. The duration of anesthesia is significantly longer with
bupivacaine than with any other commonly used local anesthetic. It has
also been noted that there is a period of analgesia that persists after
the return of sensation, during which time the need for strong
analgesics is reduced.

The onset of sensory blockade following spinal block with Bupivacaine
 Spinal (bupivacaine in dextrose injection, USP) is very rapid (within
one minute), maximum motor blockade and maximum dermatome level are
achieved within 15 minutes in most cases. Duration of sensory blockade
(time to return of complete sensation in the operative site or
regression of two dermatomes) following a 12 mg dose averages 2 hours
with or without 0.2 mg epinephrine. The time to return of complete motor
 ability with 12 mg Bupivacaine Spinal (bupivacaine in dextrose
injection, USP) averages 3½ hours without the addition of epinephrine
and 4½ hours if 0.2 mg epinephrine is added. When compared to equal
milligram doses of hyperbaric tetracaine, the duration of sensory
blockade was the same but the time to complete motor recovery was
significantly longer for tetracaine. Addition of 0.2 mg epinephrine
significantly prolongs the motor blockade and time to first
postoperative narcotic with Bupivacaine Spinal (bupivacaine in dextrose
injection, USP).

Local anesthetics appear to cross the placenta by passive diffusion.
The rate and degree of diffusion is governed by (1) the degree of plasma
 protein binding, (2) the degree of ionization, and (3) the degree of
lipid solubility. Fetal/maternal ratios of local anesthetics appear to
be inversely related to the degree of plasma protein binding, because
only the free, unbound drug is available for placental transfer.
Bupivacaine with a high protein binding capacity (95%) has a low
fetal/maternal ratio (0.2 to 0.4). The extent of placental transfer is
also determined by the degree of ionization and lipid solubility of the
drug. Lipid soluble, nonionized drugs readily enter the fetal blood from
 the maternal circulation.

Depending upon the route of administration, local anesthetics are
distributed to some extent to all body tissues, with high concentrations
 found in highly perfused organs such as the liver, lungs, heart and
brain.

Pharmacokinetic studies on the plasma profiles of bupivacaine after
direct intravenous injection suggest a three-compartment open model. The
 first compartment is represented by the rapid intravascular
distribution of the drug. The second compartment represents the
equilibration of the drug throughout the highly perfused organs such as
the brain, myocardium, lungs, kidneys and liver. The third compartment
represents an equilibration of the drug with poorly perfused tissues,
such as muscle and fat. The elimination of drug from tissue distribution
 depends largely upon the ability of binding sites in the circulation to
 carry it to the liver where it is metabolized.

Various pharmacokinetic parameters of the local anesthetics can be
significantly altered by the presence of hepatic or renal disease,
addition of epinephrine, factors affecting urinary pH, renal blood flow,
 the route of drug administration, and the age of the patient. The
half-life of bupivacaine in adults is 3.5 ± 2 hours and in neonates 8.1
hours.

Amide-type local anesthetics such as bupivacaine are metabolized
primarily in the liver via conjugation with glucuronic acid. Patients
with hepatic disease, especially those with severe hepatic disease, may
be more susceptible to the potential toxicities of the amide-type local
anesthetics. Pipecoloxylidine is the major metabolite of bupivacaine.

The kidney is the main excretory organ for most local anesthetics and
 their metabolites. Urinary excretion is affected by renal perfusion and
 factors affecting urinary pH. Only 5% of bupivacaine is excreted
unchanged in the urine.

When administered in recommended doses and concentrations,
bupivacaine does not ordinarily produce irritation or tissue damage and
does not cause methemoglobinemia.

INDICATIONS AND USAGE
Bupivacaine Spinal is indicated for the production of subarachnoid block (spinal anesthesia).

Standard textbooks should be consulted to determine the accepted
procedures and techniques for the administration of spinal anesthesia.

CONTRAINDICATIONS
Bupivacaine Spinal (Bupivacaine in Dextrose Injection,
USP) is contraindicated in patients with a known hypersensitivity to it
or to any local anesthetic agent of the amide-type.

The following conditions preclude the use of spinal anesthesia:

Severe hemorrhage, severe hypotension or shock and
arrhythmias, such as complete heart block, which severely restrict
cardiac output.

Local infection at the site of proposed lumbar puncture.

Septicemia.

WARNINGS
LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED BY CLINICIANS
 WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED
TOXICITY AND OTHER ACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO
 BE EMPLOYED, AND THEN ONLY AFTER INSURING THE IMMEDIATE
 AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY
RESUSCITATIVE EQUIPMENT, AND THE PERSONNEL RESOURCES NEEDED FOR PROPER
MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES. (See also ADVERSE REACTIONS, PRECAUTIONS and OVERDOSAGE.)
 DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION
FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF
 ACIDOSIS, CARDIAC ARREST, AND, POSSIBLY, DEATH.

Intra-articular infusions of local anesthetics following arthroscopic
 and other surgical procedures is an unapproved use, and there have been
 post-marketing reports of chondrolysis in patients receiving such
infusions. The majority of reported cases of chondrolysis have involved
the shoulder joint; cases of gleno-humeral chondrolysis have been
described in pediatric and adult patients following intra-articular
infusions of local anesthetics with and without epinephrine for periods
of 48 to 72 hours. There is insufficient information to determine
whether shorter infusion periods are not associated with these findings.
 The time of onset of symptoms, such as joint pain, stiffness and loss
of motion can be variable, but may begin as early as the 2nd month after
 surgery. Currently, there is no effective treatment for chondrolysis;
patients who experienced chondrolysis have required additional
diagnostic and therapeutic procedures and some required arthroplasty or
shoulder replacement.

Spinal anesthetics should not be injected during uterine
contractions, because spinal fluid current may carry the drug further
cephalad than desired.

A free flow of cerebrospinal fluid during the performance of spinal
anesthesia is indicative of entry into the subarachnoid space. However,
aspiration should be performed before the anesthetic solution is
injected to confirm entry into the subarachnoid space and to avoid
intravascular injection.

Bupivacaine solutions containing epinephrine or other vasopressors
should not be used concomitantly with ergot-type oxytocic drugs, because
 a severe persistent hypertension may occur. Likewise, solutions of
bupivacaine containing a vasoconstrictor, such as epinephrine, should be
 used with extreme caution in patients receiving monoamine oxidase
inhibitors (MAOI) or antidepressants of the triptyline or imipramine
types, because severe prolonged hypertension may result.

Until further experience is gained in patients younger than 18 years,
 administration of bupivacaine in this age group is not recommended.

Mixing or the prior or intercurrent use of any other local anesthetic
 with bupivacaine cannot be recommended because of insufficient data on
the clinical use of such mixtures.

PRECAUTIONSGeneral:
The safety and effectiveness of spinal anesthetics
depend on proper dosage, correct technique, adequate precautions and
readiness for emergencies. Resuscitative equipment, oxygen and other
resuscitative drugs should be available for immediate use. (See WARNINGS, ADVERSE REACTIONS and OVERDOSAGE.)
 The patient should have I.V. fluids running via an indwelling catheter
to assure a functioning intravenous pathway. The lowest dosage of local
anesthetic that results in effective anesthesia should be used.
Aspiration for blood should be performed before injection and injection
should be made slowly. Tolerance varies with the status of the patient.
Debilitated, elderly patients and acutely ill patients may require
reduced doses. Reduced doses may also be indicated in patients with
increased intra-abdominal pressure (including obstetrical patients), if
otherwise suitable for spinal anesthesia.

There should be careful and constant monitoring of cardiovascular and
 respiratory (adequacy of ventilation) vital signs and the patient's
state of consciousness after local anesthetic injection. Restlessness,
anxiety, incoherent speech, lightheadedness, numbness and tingling of
the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision,
 tremors, depression or drowsiness may be early warning signs of central
 nervous system toxicity.

Spinal anesthetics should be used with caution in patients with severe disturbances of cardiac rhythm, shock, or heart block.

Sympathetic blockade occurring during spinal anesthesia may result in
 peripheral vasodilation and hypotension, the extent depending on the
number of dermatomes blocked. Blood pressure should, therefore, be
carefully monitored especially in the early phases of anesthesia.
Hypotension may be controlled by vasoconstrictors in dosages depending
on the severity of hypotension and response of treatment. The level of
anesthesia should be carefully monitored because it is not always
controllable in spinal techniques.

Because amide-type local anesthetics such as bupivacaine are
metabolized by the liver, these drugs, especially repeat doses, should
be used cautiously in patients with hepatic disease. Patients with
severe hepatic disease, because of their inability to metabolize local
anesthetics normally, are at a greater risk of developing toxic plasma
concentrations. Local anesthetics should also be used with caution in
patients with impaired cardiovascular function because they may be less
able to compensate for functional changes associated with the
prolongation of AV conduction produced by these drugs. However, dosage
recommendations for spinal anesthesia are much lower than dosage
recommendations for other major blocks and most experience regarding
hepatic and cardiovascular disease dose-related toxicity is derived from
 these other major blocks.

Serious dose-related cardiac arrhythmias may occur if preparations
containing a vasoconstrictor such as epinephrine are employed in
patients during or following the administration of potent inhalation
agents. In deciding whether to use these products concurrently in the
same patient, the combined action of both agents upon the myocardium,
the concentration and volume of vasoconstrictor used, and the time since
 injection, when applicable, should be taken into account.

Many drugs used during the conduct of anesthesia are considered
potential triggering agents for familial malignant hyperthermia. Because
 it is not known whether amide-type local anesthetics may trigger this
reaction and because the need for supplemental general anesthesia cannot
 be predicted in advance, it is suggested that a standard protocol for
management should be available. Early unexplained signs of tachycardia,
tachypnea, labile blood pressure, and metabolic acidosis may precede
temperature elevation. Successful outcome is dependent on early
diagnosis, prompt discontinuance of the suspect triggering agent(s) and
prompt institution of treatment, including oxygen therapy, indicated
supportive measures, and dantrolene. (Consult dantrolene sodium
intravenous package insert before using.)

The following conditions may preclude the use of spinal anesthesia,
depending upon the physician's evaluation of the situation and ability
to deal with the complications or complaints which may occur:

Pre-existing diseases of the central nervous system,
such as those attributable to pernicious anemia, poliomyelitis,
syphilis, or tumor.

Hematological disorders predisposing to coagulopathies
or patients on anticoagulant therapy. Trauma to a blood vessel during
the conduct of spinal anesthesia may, in some instances, result in
uncontrollable central nervous system hemorrhage or soft tissue
hemorrhage.

Chronic backache and preoperative headache.

Hypotension and hypertension.

Technical problems (persistent paresthesias, persistent bloody tap).

Arthritis or spinal deformity.

Extremes of age.

Psychosis or other causes of poor cooperation by the patient.

Information for Patients:
When appropriate, patients should be informed in
advance that they may experience temporary loss of sensation and motor
activity, usually in the lower half of the body, following proper
administration of spinal anesthesia. Also, when appropriate, the
physician should discuss other information including adverse reactions
in the Bupivacaine Spinal (Bupivacaine in Dextrose Injection, USP)
package insert.

Clinically Significant Drug Interactions:
The administration of local anesthetic solutions
containing epinephrine or norepinephrine to patients receiving monoamine
 oxidase inhibitors or tricyclic antidepressants may produce severe,
prolonged hypertension. Concurrent use of these agents should generally
be avoided. In situations when concurrent therapy is necessary, careful
patient monitoring is essential.

Concurrent administration of vasopressor drugs and of ergot-type
oxytocic drugs may cause severe persistent hypertension or
cerebrovascular accidents.

Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.

Carcinogenesis, Mutagenesis and Impairment of Fertility:
Long-term studies in animals of most local anesthetics
including bupivacaine to evaluate the carcinogenic potential have not
been conducted. Mutagenic potential or the effect on fertility have not
been determined. There is no evidence from human data that Bupivacaine
Spinal (Bupivacaine in Dextrose Injection, USP) may be carcinogenic or
mutagenic or that it impairs fertility.

Pregnancy Category C:
Decreased pup survival in rats and an embryocidal
effect in rabbits have been observed when bupivacaine hydrochloride was
administered to these species in doses comparable to 230 and 130 times
respectively the maximum recommended human spinal dose. There are no
adequate and well-controlled studies in pregnant women of the effect of
bupivacaine on the developing fetus. Bupivacaine hydrochloride should be
 used during pregnancy only if the potential benefit justifies the
potential risk to the fetus. This does not exclude the use of
Bupivacaine Spinal at term for obstetrical anesthesia. (See Labor and Delivery.)

Labor and Delivery:
Spinal anesthesia has a recognized use during labor and
 delivery. Bupivacaine hydrochloride, when administered properly, via
the epidural route in doses 10 to 12 times the amount used in spinal
anesthesia has been used for obstetrical analgesia and anesthesia
without evidence of adverse effects on the fetus.

Maternal hypotension has resulted from regional anesthesia. Local
anesthetics produce vasodilation by blocking sympathetic nerves.
Elevating the patient's legs and positioning her on her left side will
help prevent decreases in blood pressure. The fetal heart rate also
should be monitored continuously and electronic fetal monitoring is
highly advisable.

It is extremely important to avoid aortocaval compression by the
gravid uterus during administration of regional block to parturients. To
 do this, the patient must be maintained in the left lateral decubitus
position or a blanket roll or sandbag may be placed beneath the right
hip and the gravid uterus displaced to the left.

Spinal anesthesia may alter the forces of parturition through changes
 in uterine contractility or maternal expulsive efforts. Spinal
anesthesia has also been reported to prolong the second stage of labor
by removing the parturient's reflex urge to bear down or by interfering
with motor function. The use of obstetrical anesthesia may increase the
need for forceps assistance.

The use of some local anesthetic drug products during labor and
delivery may be followed by diminished muscle strength and tone for the
first day or two of life. This has not been reported with bupivacaine.

There have been reports of cardiac arrest during use of bupivacaine
hydrochloride 0.75% solution for epidural anesthesia in obstetrical
patients. The package insert for bupivacaine hydrochloride for epidural,
 nerve block, etc. has a more complete discussion of preparation for,
and management of, this problem. These cases are compatible with
systemic toxicity following unintended intravascular injection of the
much larger dose recommended for epidural anesthesia and have not
occurred within the dose range of bupivacaine hydrochloride 0.75%
recommended for spinal anesthesia in obstetrics. The 0.75% concentration
 of bupivacaine hydrochloride is therefore not recommended for
obstetrical epidural anesthesia. Bupivacaine Spinal (bupivacaine in
dextrose injection, USP) is recommended for spinal anesthesia in
obstetrics.

Nursing Mothers:
It is not known whether local anesthetic drugs are
excreted in human milk. Because many drugs are excreted in human milk,
caution should be exercised when local anesthetic drugs are administered
 to a nursing woman.

Pediatric Use:
Until further experience is gained in patients younger
than 18 years, administration of Bupivacaine Spinal in this age group is
 not recommended.

ADVERSE REACTIONS
Reactions to bupivacaine are characteristic of those associated with other amide-type local anesthetics.

The most commonly encountered acute adverse experiences which demand
immediate countermeasures following the administration of spinal
anesthesia are hypotension due to loss of sympathetic tone and
respiratory paralysis or underventilation due to cephalad extension of
the motor level of anesthesia. These may lead to cardiac arrest if
untreated. In addition, dose-related convulsions and cardiovascular
collapse may result from diminished tolerance, rapid absorption from the
 injection site or from unintentional intravascular injection of a local
 anesthetic solution. Factors influencing plasma protein binding, such
as acidosis, systemic diseases which alter protein production, or
competition of other drugs for protein binding sites, may diminish
individual tolerance.

Respiratory System:
 Respiratory paralysis or underventilation may be noted as a result of
upward extension of the level of spinal anesthesia and may lead to
secondary hypoxic cardiac arrest if untreated. Preanesthetic medication,
 intraoperative analgesics and sedatives, as well as surgical
manipulation, may contribute to underventilation. This will usually be
noted within minutes of the injection of spinal anesthetic solution, but
 because of differing surgical maximal onset times, differing
intercurrent drug usage and differing manipulation, it may occur at any
time during surgery or the immediate recovery period.

Cardiovascular System:
 Hypotension due to loss of sympathetic tone is a commonly encountered
extension of the clinical pharmacology of spinal anesthesia. This is
more commonly observed in patients with shrunken blood volume, shrunken
interstitial fluid volume, cephalad spread of the local anesthetic,
and/or mechanical obstruction of venous return. Nausea and vomiting are
frequently associated with hypotensive episodes following the
administration of spinal anesthesia. High doses, or inadvertent
intravascular injection, may lead to high plasma levels and related
depression of the myocardium, decreased cardiac output, bradycardia,
heart block, ventricular arrhythmias, and, possibly, cardiac arrest.
(See WARNINGS, PRECAUTIONS, and OVERDOSAGE sections.)

Central Nervous System: Respiratory paralysis or underventilation secondary to cephalad spread of the level of spinal anesthesia (see Respiratory System) and hypotension for the same reason (see Cardiovascular System)
 are the two most commonly encountered central nervous system-related
adverse observations which demand immediate countermeasures.

High doses or inadvertent intravascular injection may lead to high
plasma levels and related central nervous system toxicity characterized
by excitement and/or depression. Restlessness, anxiety, dizziness,
tinnitus, blurred vision or tremors may occur, possibly proceeding to
convulsions. However, excitement may be transient or absent, with
depression being the first manifestation of an adverse reaction. This
may quickly be followed by drowsiness merging into unconsciousness and
respiratory arrest.

Neurologic:
 The incidences of adverse neurologic reactions associated with the use
of local anesthetics may be related to the total dose of local
anesthetic administered and are also dependent upon the particular drug
used, the route of administration and the physical status of the
patient. Many of these effects may be related to local anesthetic
techniques, with or without a contribution from the drug.

Neurologic effects following spinal anesthesia may include loss of
perineal sensation and sexual function, persistent anesthesia,
paresthesia, weakness and paralysis of the lower extremities, and loss
of sphincter control all of which may have slow, incomplete, or no
recovery, hypotension, high or total spinal block, urinary retention,
headache, backache, septic meningitis, meningismus, arachnoiditis,
slowing of labor, increased incidence of forceps delivery, shivering,
cranial nerve palsies due to traction on nerves from loss of
cerebrospinal fluid, and fecal and urinary incontinence.

Allergic: Allergic-type
 reactions are rare and may occur as a result of sensitivity to the
local anesthetic. These reactions are characterized by signs such as
urticaria, pruritus, erythema, angioneurotic edema (including laryngeal
edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope,
excessive sweating, elevated temperature, and, possibly,
anaphylactoid-like symptomatology (including severe hypotension). Cross
sensitivity among members of the amide-type local anesthetic group has
been reported. The usefulness of screening for sensitivity has not been
definitely established.

Other: Nausea and vomiting may occur during spinal anesthesia.

OVERDOSAGE
Acute emergencies from local anesthetics are generally
related to high plasma levels encountered during therapeutic use or to
underventilation (and perhaps apnea) secondary to upward extension of
spinal anesthesia. Hypotension is commonly encountered during the
conduct of spinal anesthesia due to relaxation of sympathetic tone, and
sometimes, contributory mechanical obstruction of venous return.

Management of Local Anesthetic Emergencies:
 The first consideration is prevention, best accomplished by careful and
 constant monitoring of cardiovascular and respiratory vital signs and
the patient's state of consciousness after each local anesthetic
injection. At the first sign of change, oxygen should be administered.

The first step in the
management of systemic toxic reactions, as well as underventilation or
apnea due to a high or total spinal, consists of immediate
 attention to the establishment and maintenance of a patent airway and
effective assisted or controlled ventilation with 100% oxygen with a
delivery system capable of permitting immediate positive airway pressure
 by mask. This may prevent convulsions if they have not already occurred.

If necessary, use drugs to control the convulsions. A 50 mg to 100 mg
 bolus I.V. injection of succinylcholine will paralyze the patient
without depressing the central nervous or cardiovascular systems and
facilitate ventilation. A bolus I.V. dose of 5 mg to 10 mg of diazepam
or 50 mg to 100 mg of thiopental will permit ventilation and counteract
central nervous system stimulation, but these drugs also depress central
 nervous system, respiratory and cardiac function, add to postictal
depression and may result in apnea. Intravenous barbiturates,
anticonvulsant agents, or muscle relaxants should only be administered
by those familiar with their use. Immediately after the institution of
these ventilatory measures, the adequacy of the circulation should be
evaluated. Supportive treatment of circulatory depression may require
administration of intravenous fluids, and, when appropriate, a
vasopressor dictated by the clinical situation (such as ephedrine or
epinephrine to enhance myocardial contractile force).

Hypotension due to sympathetic relaxation may be managed by giving
intravenous fluids (such as Sodium Chloride Injection 0.9% or Lactated
Ringer's Injection), in an attempt to relieve mechanical obstruction of
venous return, or by using vasopressors (such as ephedrine which
increases the force of myocardial contractions) and, if indicated, by
giving plasma expanders or whole blood.

Endotracheal intubation, employing drugs and techniques familiar to
the clinician, may be indicated, after initial administration of oxygen
by mask if difficulty is encountered in the maintenance of a patent
airway, or if prolonged ventilatory support (assisted or controlled) is
indicated.

Recent clinical data from patients experiencing local
anesthetic-induced convulsions demonstrated rapid development of
hypoxia, hypercarbia, and acidosis with bupivacaine within a minute of
the onset of convulsions. These observations suggest that oxygen
consumption and carbon dioxide production are greatly increased during
local anesthetic convulsions and emphasize the importance of immediate
and effective ventilation with oxygen which may avoid cardiac arrest.

If not treated immediately, convulsions with simultaneous hypoxia,
hypercarbia and acidosis plus myocardial depression from the direct
effects of the local anesthetic may result in cardiac arrhythmias,
bradycardia, asystole, ventricular fibrillation, or cardiac arrest.
Respiratory abnormalities, including apnea, may occur. Underventilation
or apnea due to a high or total spinal may produce these same signs and
also lead to cardiac arrest if ventilatory support is not instituted. If
 cardiac arrest should occur, standard cardiopulmonary resuscitative
measures should be instituted and maintained for a prolonged period if
necessary. Recovery has been reported after prolonged resuscitative
efforts.

The supine position is dangerous in pregnant women at term because of
 aortocaval compression by the gravid uterus. Therefore during treatment
 of systemic toxicity, maternal hypotension or fetal bradycardia
following regional block, the parturient should be maintained in the
left lateral decubitus position if possible, or manual displacement of
the uterus off the great vessels be accomplished.

The mean seizure dosage of bupivacaine in rhesus monkeys was found to
 be 4.4 mg/kg with mean arterial plasma concentration of 4.5 µg/mL. The
intravenous and subcutaneous LD50 in mice is 6 mg/kg to 8 mg/kg and 38 mg/kg to 54 mg/kg, respectively.

DOSAGE AND ADMINISTRATION
The dose of any local anesthetic administered varies
with the anesthetic procedure, the area to be anesthetized, the
vascularity of the tissues, the number of neuronal segments to be
blocked, the depth of anesthesia and degree of muscle relaxation
required, the duration of anesthesia desired, individual tolerance, and
the physical condition of the patient. The smallest dose and
concentration required to produce the desired result should be
administered. Dosages of Bupivacaine Spinal (Bupivacaine in Dextrose
Injection, USP) should be reduced for elderly and debilitated patients
and patients with cardiac and/or liver disease.

For specific techniques and procedures, refer to standard textbooks.

There have been adverse event reports of chondrolysis in patients
receiving intra-articular infusions of local anesthetics following
arthroscopic and other surgical procedures. Bupivacaine Spinal is not
approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

The extent and degree of spinal anesthesia depends upon several
factors including dosage, specific gravity of the anesthetic solution,
volume of solution used, force of injection, level of puncture, and
position of the patient during and immediately after injection.

Seven and one-half mg (7.5 mg or 1.0 mL) Bupivacaine Spinal has
generally proven satisfactory for spinal anesthesia for lower extremity
and perineal procedures including TURP and vaginal hysterectomy. Twelve
mg (12 mg or 1.6 mL) has been used for lower abdominal procedures such
as abdominal hysterectomy, tubal ligation, and appendectomy. These doses
 are recommended as a guide for use in the average adult and may be
reduced for elderly or debilitated patients. Because experience with
Bupivacaine Spinal is limited in patients below the age of 18 years,
dosage recommendations in this age group cannot be made.

Obstetrical Use:
 Doses as low as 6 mg bupivacaine hydrochloride have been used for
vaginal delivery under spinal anesthesia. The dose range of 7.5 mg to
10.5 mg (1 mL to 1.4 mL) bupivacaine hydrochloride has been used for
Cesarean section under spinal anesthesia.

In recommended doses, Bupivacaine Spinal produces complete motor and sensory block.

Unused portions of solutions should be discarded following initial use.

Bupivacaine Spinal should be inspected visually for discoloration and
 particulate matter prior to administration; solutions which are
discolored or which contain particulate matter should not be
administered.

Bupivacaine Spinal may be
autoclaved once at 15 pounds pressure, 121°C (250°F) for 15 minutes. Do
not administer any solution which is discolored or contains particulate
matter.

HOW SUPPLIED
Bupivacaine Spinal (Bupivacaine in Dextrose Injection,
USP) is supplied in 2 mL ampuls (15 mg bupivacaine hydrochloride with
165 mg dextrose anhydrous) packaged in cartons of 10 (NDC
No. 0409-3613-01).

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Revised: February, 2010

Printed in USA                            EN-2403

Hospira, Inc., Lake Forest, IL 60045 USA

Package Label Display Panel

LIDOCAINE HYDROCHLORIDE AND DEXTROSE
	    (lidocaine hydrochloride anhydrous and dextrose monohydrate)
	 injection, solution
 [Hospira, Inc.]

Ampul

Single-dose Container

Rx only

DESCRIPTION
5% Lidocaine Hydrochloride and 7.5% Dextrose Injection,
 USP is a sterile, nonpyrogenic, hyperbaric solution for use in spinal
anesthesia.

5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP contains
lidocaine HCl, which is chemically designated as
2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride,
monohydrate and Dextrose (D-Glucose monohydrate) which have the
following structural formulas:

Lidocaine Hydrochloride (monohydrate)

Dextrose (hydrous)

5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP contains 50
mg/mL of lidocaine hydrochloride, anhydrous with 75 mg/mL of dextrose,
hydrous in water for injection. May contain sodium hydroxide and/or
hydrochloric acid for pH adjustment. pH 6.5 (6.0 to 7.0). The osmolar
concentration is 0.75 mOsmol/mL (calc.). The specific gravity is 1.030
to 1.035.

CLINICAL PHARMACOLOGY
Mechanism of action:
 Lidocaine stabilizes the neuronal membrane by inhibiting the ionic
fluxes required for the initiation and conduction of impulses, thereby
effecting local anesthetic action.

Onset and duration of anesthesia:
 The onset of action is rapid. The duration of perineal anesthesia
provided by 1 mL (50 mg) 5% Lidocaine Hydrochloride and 7.5% Dextrose
Injection, USP averages 100 minutes, with analgesia continuing for an
additional 40 minutes. The duration of surgical anesthesia provided by
1.5 to 2 mL (75 to 100 mg) of this agent is approximately two hours.

Hemodynamics:
Excessive blood levels may cause changes in cardiac output, total
peripheral resistance, and mean arterial pressure. With central neural
blockade these changes may be attributable to block of autonomic fibers,
 or a direct depressant effect of the local anesthetic agent on various
components of the cardiovascular system. The net effect is normally a
modest hypotension when the recommended dosages are not exceeded.

Pharmacokinetics and metabolism:
 Information derived from diverse formulations, concentrations and
usages reveals that lidocaine is completely absorbed following
parenteral administration, its rate of absorption depending, for
example, upon various factors such as the site of administration and the
 presence or absence of a vasoconstrictor agent. Except for
intravascular administration, the highest blood levels are obtained
following intercostal nerve block and the lowest after subcutaneous
administration.

The plasma binding of lidocaine is dependent on drug concentration,
and the fraction bound decreases with increasing concentration. At
concentrations of 1 to 4 mcg of free base per mL, 60 to 80 percent of
lidocaine is protein bound. Binding is also dependent on the plasma
concentration of the alpha-1-acid glycoprotein.

Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion.

Lidocaine is metabolized rapidly by the liver, and metabolites and
unchanged drug are excreted by the kidneys. Biotransformation includes
oxidative N-dealkylation, ring hydroxylation, cleavage of the amide
linkage, and conjugation. N-dealkylation, a major pathway of
biotransformation, yields the metabolites monoethylglycinexylidide and
glycinexylidide. The pharmacological/toxicological actions of these
metabolites are similar to, but less potent than, those of lidocaine.
Approximately 90% of lidocaine administered is excreted in the form of
various metabolites, and less than 10% is excreted unchanged. The
primary metabolite in urine is a conjugate of
4-hydroxy-2,6-dimethylaniline.

The elimination half-life of lidocaine following an intravenous bolus
 injection is typically 1.5 to 2 hours. Because of the rapid rate at
which lidocaine is metabolized, any condition that affects liver
function may alter lidocaine kinetics. The half-life may be prolonged
two-fold or more in patients with liver dysfunction. Renal dysfunction
does not affect lidocaine kinetics but may increase the accumulation of
metabolites.

Factors such as acidosis and the use of CNS stimulants and
depressants affect the CNS levels of lidocaine required to produce overt
 systemic effects. Objective adverse manifestations become increasingly
apparent with increasing venous plasma levels above 6.0 mcg free base
per mL. In the rhesus monkey arterial blood levels of 18 to 21 mcg/mL
have been shown to be threshold for convulsive activity.

INDICATIONS AND USAGE
5% Lidocaine Hydrochloride and 7.5% Dextrose Injection,
 USP is indicated for the production of spinal anesthesia when the
accepted procedures for this technique as described in standard
textbooks are observed.

CONTRAINDICATIONS
Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

The following conditions preclude the use of spinal anesthesia:

Severe hemorrhage, shock or heart block

Local infection at the site of proposed puncture

Septicemia

Known sensitivity to the local anesthetic agent.

WARNINGS
5% LIDOCAINE HYDROCHLORIDE AND 7.5% DEXTROSE INJECTION,
 USP FOR SPINAL ANESTHESIA SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE
 WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND
OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM SPINAL ANESTHESIA AND THEN
 ONLY AFTER ENSURING THE IMMEDIATE
 AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY
EQUIPMENT, AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC
REACTIONS AND RELATED EMERGENCIES (See also ADVERSE REACTIONS and PRECAUTIONS).
 DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION
FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF
 ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.

Intra-articular infusions of local anesthetics following arthroscopic
 and other surgical procedures is an unapproved use, and there have been
 post-marketing reports of chondrolysis in patients receiving such
infusions. The majority of reported cases of chondrolysis have involved
the shoulder joint; cases of gleno-humeral chondrolysis have been
described in pediatric and adult patients following intra-articular
infusions of local anesthetics with and without epinephrine for periods
of 48 to 72 hours. There is insufficient information to determine
whether shorter infusion periods are not associated with these findings.
 The time of onset of symptoms, such as joint pain, stiffness and loss
of motion can be variable, but may begin as early as the 2nd month after
 surgery. Currently, there is no effective treatment for chondrolysis;
patients who experienced chondrolysis have required additional
diagnostic and therapeutic procedures and some  required arthroplasty or
 shoulder replacement.

To avoid intravascular injection, aspiration should be performed
before the local anesthetic solution is injected. The needle must be
repositioned until no return of blood can be elicited by aspiration.
Note, however, that the absence of blood in the syringe does not
guarantee that intravascular injection has been avoided.

Spinal anesthetics should not be injected during uterine contractions
 since spinal fluid current may carry the drug farther cephalad than
desired.

PRECAUTIONSGeneral:
The safety and effectiveness of lidocaine depend on
proper dosage, correct technique, adequate precautions, and readiness
for emergencies. Standard textbooks should be consulted for specific
techniques and precautions for spinal anesthetic procedures.
Resuscitative equipment, oxygen and other resuscitative drugs should be
available for immediate use. (See WARNINGS and ADVERSE REACTIONS.)
 The lowest dosage that results in effective anesthesia should be used
to avoid high plasma levels and serious adverse effects. Repeated doses
of lidocaine may cause significant increases in blood levels with each
repeated dose because of slow accumulation of the drug or its
metabolites. Tolerance to elevated blood levels varies with the physical
 condition of the patient. Debilitated, elderly patients, acutely ill
patients and children should be given reduced doses commensurate with
their age and physical status. Lidocaine should also be used with
caution in patients with severe shock or heart block.

Neurologic deficits have been reported with the use of small bore
needles and microcatheters for spinal anesthesia. It has been
postulated, based on in vitro
 models, that these deficits were due to pooling and non-uniform
distribution of concentrated local anesthesia within the subarachnoid
space.1Animal studies suggest mixing of 5%
lidocaine hydrochloride with an equal volume of CSF or preservative-free
 0.9% saline solution may reduce the risk of nerve injury due to pooling
 of concentrated local anesthetic.2 (See DOSAGE AND ADMINISTRATION.)

The following conditions may preclude the use of spinal anesthesia,
depending upon the physician's ability to deal with the complications or
 complaints that may occur:

a. Pre-existing diseases of the central nervous system such as those
attributable to poliomyelitis, pernicious anemia, paralysis from nerve
injuries, and syphilis.

b. Disturbance in blood morphology and/or anticoagulant therapy. In
these conditions, trauma to a blood vessel during needle puncture may
result in uncontrollable hemorrhage into the epidural or subarachnoid
space. Also profuse hemorrhage into the soft tissue may occur.

c. Extremes of age.

d. Chronic backache and preoperative headache.

e. Hypotension and hypertension.

f. Arthritis or spinal deformity.

g. Technical problems (persistent paresthesias, persistent bloody tap).

h. Psychotic or uncooperative patients.

CONSULT STANDARD TEXTBOOKS FOR SPECIFIC TECHNIQUES AND PRECAUTIONS FOR SPINAL ANESTHETIC PROCEDURES.

Careful and constant monitoring of cardiovascular and respiratory
(adequacy of ventilation) vital signs and the patient's state of
consciousness should be accomplished after each local anesthetic
injection. It should be kept in mind at such times that restlessness,
anxiety, tinnitus, dizziness, blurred vision, tremors, depression or
drowsiness may be early warning signs of central nervous system
toxicity.

Since amide-type local anesthetics are metabolized by the liver,
lidocaine should be used with caution in patients with hepatic disease.
Patients with severe hepatic disease, because of their inability to
metabolize local anesthetic normally, are a greater risk of developing
toxic plasma concentrations. Lidocaine should also be used with caution
in patients with impaired cardiovascular function since they may be less
 able to compensate for functional changes associated with the
prolongation of A-V conduction produced by these drugs.

Many drugs used during the conduct of anesthesia are considered
potential triggering agents for familial malignant hyperthermia. Since
it is not known whether amide-type local anesthetics may trigger this
reaction and since the need for supplemental general anesthesia cannot
be predicted in advance, it is suggested that a standard protocol for
management should be available. Early unexplained signs of tachycardia,
tachypnea, labile blood pressure and metabolic acidosis may precede
temperature elevation. Successful outcome is dependent on early
diagnosis, prompt discontinuance of the suspect triggering agent(s) and
institution of treatment including oxygen therapy, indicated supportive
measures and dantrolene (consult dantrolene sodium intravenous package
insert before using).

Lidocaine should be used with caution in persons with known drug
sensitivities. Patients allergic to para-aminobenzoic acid derivatives
(procaine, tetracaine, benzocaine, etc.) have not shown cross
sensitivity to lidocaine.

Information for Patients:
When appropriate, patients should be informed in
advance that they may experience temporary loss of sensation and motor
activity, usually in the lower half of the body, following proper
administration of spinal anesthesia.

Clinically significant drug interactions:
The administration of local anesthetic solutions
containing epinephrine or norepinephrine to patients receiving monoamine
 oxidase inhibitors, tricyclic antidepressants or phenothiazines may
produce severe, prolonged hypotension or hypertension. Concurrent use of
 these agents should generally be avoided. In situations when concurrent
 therapy is necessary, careful patient monitoring is essential.

Concurrent administration of vasopressor drugs (for the treatment of
hypotension related to spinal blocks) and ergot-type oxytocic drugs may
cause severe, persistent hypertension or cerebrovascular accidents.

Carcinogenesis, mutagenesis, impairment of fertility:
Studies of lidocaine in animals to evaluate the
carcinogenic and mutagenic potential or the effect on fertility have not
 been conducted.

Use in Pregnancy: Teratogenic Effects. Pregnancy Category B.

Reproduction studies have been performed in rats at doses up to 6.6
times the human dose and have revealed no evidence of harm to the fetus
caused by lidocaine. There are, however, no adequate and well-controlled
 studies in pregnant women. Animal reproduction studies are not always
predictive of human response. General consideration should be given to
this fact before administering lidocaine to women of childbearing
potential, especially during early pregnancy when maximum organogenesis
takes place.

Labor and delivery:
Maternal hypotension has resulted from regional
anesthesia. Local anesthetics produce vasodilation by blocking
sympathetic nerves. Elevating the patient's legs and positioning her on
her left side will help prevent decreases in blood pressure. The fetal
heart rate also should be monitored continuously, and electronic fetal
monitoring is highly advisable.

Spinal anesthesia may alter the forces of parturition through changes
 in uterine contractility or maternal expulsive efforts. However, spinal
 anesthesia has also been reported to prolong the second stage of labor
by removing the parturient's reflex urge to bear down or by interfering
with motor function. The use of obstetrical anesthesia may increase the
need for forceps assistance.

Nursing mothers:
It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when lidocaine is administered to a nursing woman.

Pediatric use:
Safety and effectiveness in  pediatric patients below the age of 16 years have not been established.

ADVERSE REACTIONS
Adverse experiences following the administration of
lidocaine are similar in nature to those observed with other amide local
 anesthetic agents. These adverse experiences are, in general,
dose-related and may result from high plasma levels caused by excessive
dosage, rapid absorption or inadvertent intravascular injection, or may
result from a hypersensitivity, idiosyncrasy or diminished tolerance on
the part of the patient. Serious adverse experiences are generally
systemic in nature. The following types are those most commonly
reported:

Central nervous system:
 CNS manifestations are excitatory and/or depressant and may be
characterized by lightheadedness, nervousness, apprehension, euphoria,
confusion, dizziness, lethargy, slurred speech, drowsiness, tinnitus,
blurred or double vision, vomiting, sensations of heat, cold or
numbness, twitching, tremors, convulsions, unconsciousness, respiratory
depression and arrest. The excitatory manifestations may be very brief
or may not occur at all, in which case the first manifestation of
toxicity may be drowsiness merging into unconsciousness and respiratory
arrest.

Drowsiness following the administration of lidocaine is usually an
early sign of a high blood level of the drug and may occur as a
consequence of rapid absorption.

Cardiovascular system:
 Cardiovascular manifestations are usually depressant and are
characterized by bradycardia, hypotension, and cardiovascular collapse,
which may lead to cardiac arrest.

Allergic:
Allergic reactions are characterized by cutaneous lesions, urticaria,
edema or anaphylactoid reactions. Allergic reactions as a result of
sensitivity to lidocaine are extremely rare and, if they occur, should
be managed by conventional means. The detection of sensitivity by skin
testing is of doubtful value.

Neurologic: The
incidences of adverse reactions associated with the use of local
anesthetics may be related to the total dose of local anesthetic
administered and are also dependent upon the particular drug used, the
route of administration and the physical status of the patient. In a
prospective review of 10,440 patients who received lidocaine for spinal
anesthesia, the incidences of adverse reactions were reported to be
about 3 percent each for positional headaches, hypotension and backache;
 2 percent for shivering; and less than 1 percent each for peripheral
nerve symptoms, nausea, respiratory inadequacy and double vision. Many
of these observations may be related to local anesthetic techniques,
with or without a contribution from the local anesthetic.

Neurologic effects following spinal anesthesia may include loss of
perineal sensation and sexual function; persistent anesthesia,
paresthesia, weakness and paralysis of the lower extremities, and loss
of sphincter control all of which may have slow, incomplete, or no
recovery; hypotension; high or total spinal block; urinary retention;
headache; backache; septic meningitis; meningismus, arachnoiditis;
slowing of labor; increased incidence of forceps delivery; shivering;
cranial nerve palsies due to traction on nerves from loss of
cerebrospinal fluid; and fecal and urinary incontinence.

OVERDOSAGE
Acute emergencies from local anesthetics are generally
related to high plasma levels encountered during therapeutic use of
local anesthetics or to unintended subarachnoid injection of local
anesthetic solution (see ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS).

Management of local anesthetic emergencies:
 The first consideration is prevention, best accomplished by careful and
 constant monitoring of cardiovascular and respiratory vital signs and
the patient's state of consciousness after each local anesthetic
injection. At the first sign of change, oxygen should be administered.

The first step in the management of convulsions, as well as
underventilation or apnea due to excessive cephalad spread of the spinal
 block, consists of immediate attention to the maintenance of a patent
airway and assisted or controlled ventilation with oxygen and a delivery
 system capable of permitting immediate positive airway pressure by
mask. Immediately after the institution of these ventilatory measures,
the adequacy of the circulation should be evaluated, keeping in mind
that drugs used to treat convulsions sometimes depress the circulation
when administered intravenously. Should convulsions persist despite
adequate respiratory support, and if the status of the circulation
permits, small increments of an ultra-short acting barbiturate (such as
thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be
administered intravenously. The clinician should be familiar, prior to
use of local anesthetics, with these anticonvulsant drugs. Supportive
treatment of circulatory depression may require administration of
intravenous fluids and, when appropriate, a vasopressor as directed by
the clinical situation (e.g., ephedrine).

If not treated immediately, both convulsions and cardiovascular
depression can result in hypoxia, acidosis, bradycardia, arrhythmias and
 cardiac arrest. Underventilation or apnea due to excessive cephalad
spread of the spinal block may produce these same signs and also lead to
 cardiac arrest if ventilatory support is not instituted. If cardiac
arrest should occur, standard cardiopulmonary resuscitative measures
should be instituted.

Endotracheal intubation, employing drugs and techniques familiar to
the clinician, may be indicated, after initial administration of oxygen
by mask, if difficulty is encountered in the maintenance of a patent
airway or if prolonged ventilatory support (assisted or controlled) is
indicated.

Dialysis is of negligible value in the treatment of acute overdosage with lidocaine.

The intravenous LD50 of lidocaine HCl in female mice is 26 (21 to 31) mg/kg and subcutaneous LD50 is 264 (203 to 304) mg/kg.

DOSAGE AND ADMINISTRATION
Spinal anesthesia with 5% Lidocaine Hydrochloride and
7.5% Dextrose Injection, USP may be induced in the right or left lateral
 recumbent or the sitting position. Since this is a hyperbaric solution,
 the anesthetic will tend to move in the direction in which the table is
 tilted. After the desired level of anesthesia is obtained and the
anesthetic has become fixed, usually in 5 to 10 minutes with lidocaine,
the patient may be positioned according to the requirement of the
surgeon or obstetrician.

In clinical trials, the safety of hyperbaric lidocaine for single
injection spinal anesthesia was demonstrated using 22 or 25 gauge spinal
 needles. In these studies, free flow of CSF was visible before
injection of lidocaine.

Neurologic deficits have been reported with the use of small bore
needles and microcatheters for spinal anesthesia. It has been
postulated, based on in vitro
 models, that these deficits were caused by pooling and non-uniform
distribution of concentrated local anesthetic within the subarachnoid
space.1 Animal studies suggest mixing of 5%
lidocaine hydrochloride with an equal volume of CSF or preservative-free
 0.9% saline solution may reduce the risk of nerve injury due to pooling
 of concentrated local anesthetic.2 (See PRECAUTIONS).

Intrathecal distribution of anesthetic may be facilitated by using a
spinal needle of sufficient gauge to insure adequate withdrawal of CSF
through the needle prior to and after anesthetic administration. If the
technique is properly placed in the subarachnoid space, a separate
injection is seldom necessary.

An incomplete or patchy block not responsive to patient repositioning
 may indicate misplacement or inadequate distribution of drug. To avoid
excessive drug pooling, additional doses of lidocaine should not be
administered with the same needle placement.

INJECTIONS SHOULD BE MADE SLOWLY. Consult standard textbooks for specific techniques for spinal anesthetic procedures.

There have been adverse event reports of chondrolysis in patients
receiving intra-articular infusions of local anesthetics following
arthroscopic and other surgical procedures.  5% Lidocaine Hydrochloride
and 7.5% Dextrose Injection, USP is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).

Recommended dosages

Normal healthy adults: The following recommended dosages are for
normal healthy adults and serve only as a guide to the amount of
anesthetic required for most routine procedures. In all cases, the
smallest dose that will produce the desired result should be given.

If the technique is properly performed, and the needle is properly
placed in the subarachnoid space, it should not be necessary to
administer more than one ampul (100 mg).

Obstetrical low spinal or "saddle block� anesthesia:

The dosage recommended for normal vaginal delivery is approximately 1
 mL (50 mg). For Caesarean section and those deliveries requiring
intrauterine manipulations, 1.5 mL (75 mg) is usually adequate.

Surgical anesthesia:

The dosage recommended for abdominal anesthesia is 1.5 to 2 mL (75 to 100 mg).

Pediatric Patients:

The dosage recommendations in healthy adolescents, 16 years of age
and older, is the same as for normal healthy adults. There is
insufficient data in pediatric patients below the age of 16 years to
make dosage recommendations (see PRECAUTIONS).

Note: Parenteral
 drug products should be inspected visually for particulate matter and
discoloration prior to administration whenever the solution and
container permit. Solutions that are discolored and/or contain
particulate matter should not be used.

Unused portions of solutions should be discarded following initial use.

5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP may be
autoclaved once at 15 pounds pressure, 121°C (250°F) for 15 minutes.
Since this preparation contains dextrose, carmelization may occur under
prolonged heating and, in some instances, prolonged storage. Therefore
this preparation should not be autoclaved more than once, according to
the above instructions, and should not be permitted to remain in the
autoclave any longer than necessary. Do not administer any solution
which is discolored or contains particulate matter.

HOW SUPPLIED
5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP is supplied in a single-dose 2 mL ampul (NDC No. 0409-4712-01).

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Lambert DH and Hurley RJ: Cauda Equina syndrome and continuous spinal anesthesia. Anesth and Analg 72:817-9, 1991.

Ready, LB, et al: Neurotoxicity of local anesthetics in rabbits. Anesthesiology 63:364-70, 1985.

Revised: February, 2010

Printed in USA                            EN-2415

Hospira, Inc., Lake Forest, IL 60045 USA

RL-0674

Package Label Display Panel

Drug Facts

3M DURAPREP SURGICAL
				(iodine povacrylex and isopropyl alcohol)
			solution
 [3M Health Care]

Drug Facts

Active ingredients

Iodine povacrylex (0.7% available iodine)

Isopropyl alcohol, 74% w/w

Purpose

Antiseptic

Antiseptic

Uses

patient preoperative skin preparation:

for preparation of the skin prior to surgery

helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only. Flammable, keep away from fire or flame.

To reduce the risk of fire, PREP CAREFULLY:

do not use 26-mL applicator for head and neck surgery

do not use on an area smaller than 8 in. x 10 in. Use a small applicator instead.

solution contains alcohol and gives off flammable vapors

do not drape or use ignition source (e.g., cautery, laser) until
solution is completely dry (minimum of 3 minutes on hairless skin; up to
 1 hour in hair).

avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.

do not allow solution to pool

remove solution-stained material from prep area

Do not use

on patients with known allergies to iodine or any other ingredients in this product

on open wounds, on mucous membranes, or as a general skin cleanser

in infants less than 2 months old due to the risk of excessive skin irritation and transient hypothyroidism

When using this product

keep out of eyes, ears, and mouth. May cause serious injury if
permitted to enter and remain. If contact occurs, flush with cold water
right away and contact a doctor.

to avoid skin injury, care should be taken when removing drapes, tapes, etc…applied over film

use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn

Stop use and ask a doctor if irritation,
sensitization or allergic reaction occurs. These may be signs of a
serious condition. On rare occasions, use of this product has been
associated with skin blistering.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
(follow all directions for use)

at the end of the prep, discard any portion of the solution which is
 not required to cover the prep area. It is not necessary to use the
entire amount available.

Getting Patient Ready for Solution:

use in well-ventilated area

do not microwave or heat the solution applicator

apply to clean, completely dry, residue-free, intact skin

when hair removal is necessary, use a surgical clipper on the
morning of the surgery. If a wet shave is used, thoroughly remove all
soap residues.

Activating the Applicator:

with sponge face parallel to the floor, press the cap end of the applicator. Solution will begin to flow into the sponge.

wait for fluid level to reach indicator line of applicator barrel

When Applying Solution:

DO NOT SCRUB. Paint a single, uniform application and do not reprep area.

do not allow solution to pool. Use sponge
applicator to absorb excess solution and continue to apply a uniform
coating. If solution accidentally gets outside of prep area, remove
excess with gauze.

clean umbilicus with enclosed swabs when applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.)

tuck prep towels as needed under both sides of the neck to absorb excess solution. Remove towels before draping.

avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.

when prepping skin folds, toes, or fingers, use a sterile-gloved
hand to hold skin apart until completely dry. Otherwise, skin may adhere
 to itself.

After Applying Solution:

to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair).
 Solution will turn from a shiny to a dull appearance on skin alerting
the user that the solution is completely dry and no longer flammable.

While Waiting for Solution to Completely Dry:

do not drape or use ignition source (e.g., cautery, laser)

check for pooled solution. Use sterile gauze to soak up pooled solution.

Do not blot because it may remove solution from skin.

remove solution-stained materials. Replace if necessary.

After Solution is Completely Dry:

to reduce the risk of fire, begin draping and/or using cautery only
after solution is completely dry and all solution-stained materials are
removed

if incise drapes are used, apply directly to dry prep. On completion
 of surgical procedure, removal of incise drape will remove film.

apply dressing following standard practices

Other information

store between 20-25ºC (68-77ºF)

avoid excessive heat above 40ºC (104ºF)

solution is not water soluble and may stain. Therefore, avoid contact with reusable items (basins, instruments).

Inactive ingredients

ethyl alcohol, water

Questions?

call 1-800-228-3957 (Monday to Friday 7AM – 6PM CST). www.3M.com.

Package Label Display Panel

Package Label Display Panel

A3879-22/24 SPINAL 22G QUINCKE/24G EUROPEAN PENCIL POINT

regional anesthesia kit c47916

Product Information

Product Type
MEDICAL DEVICE
Item Code (Source)
NHRIC:51688-6231

Packaging

#
Item Code
Package Description
Marketing Start Date
Marketing End Date

1
NHRIC:51688-6231-2
10  in 1 CASE

1

1  in 1 PACKAGE, COMBINATION

Quantity of Parts

Part #
Package Quantity
Total Product Quantity

Part 1
1 AMPULE
1 mL

Part 2
1 AMPULE
5 mL

Part 3
1 AMPULE
2 mL

Part 4
1 AMPULE
2 mL

Part 5
1 APPLICATOR
6 mL

Part 1 of 5

EPINEPHRINE

epinephrine injection, solution

Product Information

Item Code (Source)
NDC:0409-7241

Route of Administration
INTRAVENOUS, INTRACARDIAC, SUBCUTANEOUS, INTRAMUSCULAR
DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name
Basis of Strength
Strength

EPINEPHRINE (EPINEPHRINE)
EPINEPHRINE
1 mg  in 1 mL

Inactive Ingredients

Ingredient Name
Strength

SODIUM CHLORIDE
9 mg  in 1 mL

SODIUM METABISULFITE

Packaging

#
Item Code
Package Description
Marketing Start Date
Marketing End Date

1
NDC:0409-7241-61
1 mL in 1 AMPULE

Marketing Information

Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date

unapproved drug other

05/03/2010

Part 2 of 5

LIDOCAINE HYDROCHLORIDE

lidocaine hydrochloride anhydrous injection, solution

Product Information

Item Code (Source)
NDC:0409-4713

Route of Administration
INFILTRATION
DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name
Basis of Strength
Strength

LIDOCAINE HYDROCHLORIDE ANHYDROUS (Lidocaine)
LIDOCAINE HYDROCHLORIDE ANHYDROUS
10 mg  in 1 mL

Inactive Ingredients

Ingredient Name
Strength

Sodium Chloride
7 mg  in 1 mL

Water

Sodium Hydroxide

Hydrochloric Acid

Packaging

#
Item Code
Package Description
Marketing Start Date
Marketing End Date

1
NDC:0409-4713-65
5 mL in 1 AMPULE

Marketing Information

Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date

ANDA
ANDA080408
03/30/2010

Part 3 of 5

BUPIVACAINE

bupivacaine hydrochloride injection, solution

Product Information

Item Code (Source)
NDC:0409-3613

Route of Administration
INTRATHECAL, INTRASPINAL
DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name
Basis of Strength
Strength

BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE)
BUPIVACAINE HYDROCHLORIDE
7.5 mg  in 1 mL

Inactive Ingredients

Ingredient Name
Strength

SODIUM HYDROXIDE

HYDROCHLORIC ACID

ANHYDROUS DEXTROSE
82.5 mg  in 1 mL

Packaging

#
Item Code
Package Description
Marketing Start Date
Marketing End Date

1
NDC:0409-3613-01
2 mL in 1 AMPULE

Marketing Information

Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date

ANDA
ANDA071810
03/23/2010

Part 4 of 5

LIDOCAINE HYDROCHLORIDE AND DEXTROSE

lidocaine hydrochloride anhydrous and dextrose monohydrate injection, solution

Product Information

Item Code (Source)
NDC:0409-4712

Route of Administration
INTRATHECAL, INTRASPINAL
DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name
Basis of Strength
Strength

LIDOCAINE HYDROCHLORIDE ANHYDROUS (LIDOCAINE)
LIDOCAINE HYDROCHLORIDE ANHYDROUS
50 mg  in 1 mL

DEXTROSE MONOHYDRATE (DEXTROSE)
DEXTROSE MONOHYDRATE
75 mg  in 1 mL

Inactive Ingredients

Ingredient Name
Strength

WATER

SODIUM HYDROXIDE

HYDROCHLORIC ACID

Packaging

#
Item Code
Package Description
Marketing Start Date
Marketing End Date

1
NDC:0409-4712-01
2 mL in 1 AMPULE

Marketing Information

Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date

ANDA
ANDA083914
03/23/2010

Part 5 of 5

3M DURAPREP SURGICAL

iodine povacrylex and isopropyl alcohol solution

Product Information

Item Code (Source)
NDC:17518-011

Route of Administration
TOPICAL
DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name
Basis of Strength
Strength

Iodine povacrylex (Iodine)
Iodine povacrylex
6.02 mg  in 1 mL

Isopropyl alcohol (Isopropyl alcohol)
Isopropyl alcohol
636.4 mg  in 1 mL

Inactive Ingredients

Ingredient Name
Strength

water

Packaging

#
Item Code
Package Description
Marketing Start Date
Marketing End Date

1
NDC:17518-011-09
6 mL in 1 APPLICATOR

Marketing Information

Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date

NDA
NDA021586
09/29/2006

Marketing Information

Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date

premarket notification
K965017
05/11/2011

Labeler - Smiths Medical ASD, Inc.
							(137835299)

Establishment

Name
Address
ID/FEI
Business Operations

Smiths Medical ASD, Inc.

137835299
relabel, manufacture

Establishment

Name
Address
ID/FEI
Business Operations

Hospira, Inc.

030606222
manufacture

Establishment

Name
Address
ID/FEI
Business Operations

Hospira, Inc.

093132819
manufacture

Establishment

Name
Address
ID/FEI
Business Operations

3M Company

054236443
manufacture

Revised: 4/2012

Document Id: dc98f8d6-be40-4d2a-8f10-906e6dc32b98

Set id: 331f6960-a09d-4513-9e6b-a03527d9131e

Version: 2

Effective Time: 20120425

Smiths Medical ASD, Inc.