For this blog article, I'm presenting another excerpt from my new book, Hacking the Out of Body Experience, which is still unpublished. Due to its size, I've broken this chapter into two articles. This is the first half.
Can we use science to transform ourselves into ideal (or at least better) candidates for OBEs? I believe the answer is yes. We start by examining what scientists know about the people who are predisposed to OBEs. Then we change our habits to "reprogram" our brains for OBE using a concept neuroscientists called neuroplasticity: the brain's ability to rewire itself.
There are two kinds of OBE habits we can develop: habits that make OBEs more likely to occur (which I'll talk about throughout the entire book), and habits to make you a better candidate for OBEs, which I'll cover now. There are also bad habits you should break (like watching too much television) but we'll get into those later.
The first way to become a better candidate for OBEs is to meditate daily. There are literally hundreds of meditation techniques, and all of them can make you a better candidate for OBEs.
While it's important to practice OBE techniques, that's not what I mean here. Here I want to talk about "normal" meditation; the kind where you just sit quietly, clear your mind and still your thoughts. For example, one of the most simple and powerful meditation techniques is "mindfulness meditation" in which you simply sit and cultivate a focused awareness on the present moment, and extend a loving awareness toward others.
I usually meditate twice a day: A fifteen-to-twenty minute silent "mindfulness" meditation early in the morning after I wake up, and a "binaural beat" meditation under headphones in the evening. I'll go into more details about binaural beats and other sound technologies in chapter 65.
Can that make you a better candidate for OBEs? Everything I know about OBEs says yes. Of course, that doesn't guarantee that you'll have OBEs. Renown skeptic Dr. Susan Blackmore has meditated every day for more than 30 years, and she claims it hasn't helped her induce any OBEs. So think of meditation as just one piece of the puzzle.
Another thing science tells us is that OBEs happen more often to creative people, people who use their imaginations. In other words, people who focus on "inner events" more than "outer events." In terms of brain science, they spend a lot of time on "task negative" brain events (mind-wandering, daydreaming) and less time on "task positive" brain events (focused tasks). In terms of neuroscience, this means they exercise, or even over-use, the "default mode network" (DMN) which I'll cover in more detail in chapter 71.
A lot of people tell me, "I used to have OBEs when I was a child, but then they stopped." So what changed? Why do children have more OBEs? I believe it's because they use their active imagination more than adults. Kids use their active imagination constantly. I once read an article about a 9-year-old girl who could self-induce OBEs. Someone asked her how she did it. She said something like, "It's easy. Just pretend you're on a roller-coaster, then try to move but don't really move. Eventually, you'll start to get faster and faster, and you'll actually feel like you're shaking. At some point, you'll just pop out of your body." She figured out that using her active imagination while she's relaxed is a key factor. Her instruction to "move but don't really move" sounds very much like an OBE technique I developed called the "Almost Move Technique" which I explain in chapter 30.
As we get older, our brains and belief systems tend to, for lack of a better word, "solidify" and become more rigid. Our brains develop habitual patterns (think of them as ruts) and we use our active imagination less. So the first step is to break out of these ruts.
The more you use your active imagination, the easier it will be to achieve OBEs. In my first book, I have an exercise called "Pretend Day."2 The whole point was to get you to use your active imagination as much as you can by pretending weird things happen. For example, imagine you pull out a gun and shoot a stoplight that's holding you back. Or pretend there are purple dragons circling in the sky above you, or balls of light encircling your head. It doesn't matter what you fantasize about; just that you do fantasize.
So to become a better candidate for OBEs, make every day "pretend day." Learn to actively engage in playful fantasy. Don't consider this a waste of time; consider it a necessary part of rewiring your brain for OBEs.
Science tells us one of the most important attributes of OBE-susceptible people is absorption.3 I wrote about this in my second book.4 Absorption is commonly measured by the Tellegen Absorption Scale (TAS) by psychologists to test how absorbed people get in their own mental imagery, or how focused they are on inner events. According to scientists, people who rate high on the TAS also tend to be more easily hypnotized. They're also typically better at an important OBE skill: visualization. Absorption is also strongly correlated with openness to experience. (This may suggest drugs used to treat ADD might help you focus more on OBEs.) So another way to rewire your brain for OBEs is to develop absorption.
Many scientists seem to treat absorption and suggestibility as a static and unchanging trait, but I know of at least two ways to develop absorption. The first is to read (or write) fiction stories and books. I especially favor science fiction and fantasy novels that conjure up images of strange new worlds and the creatures that inhabit them, like elves, trolls and gnomes. You can lose yourself and become absorbed in a television show or a movie, but they don't have the same effect because they feed your brain with both visual and auditory data: there's not much creativity left for the viewer. They lead you by the nose and tell you exactly what to think and feel. When you read fiction, you do something different: you create a mental image of the events occurring in the story.
As you read, try to imagine the faces of the people in the story. Try to visualize the circumstances they're in. Try to become absorbed into the story's plot to the exclusion of everything else in the outside world. Again, this is not a waste of time; it's a technique to rewire your brain.
The second way to develop absorption is to listen to music. I'm not talking about background music; that's actually counterproductive. Listen intently, under headphones. Don't combine it with anything else. Put your phone down and give it your full attention. Try to get totally lost in the music. Focus on its ups and downs, and how the music makes you feel. It's better to listen to instrumental songs rather than songs with lyrics. Some genres of music are more conducive to this process than others. For example, as appealing as they might be to you, Country and Folk music might be poor choices for this because they tend to emphasize stories conveyed in words, using the music only to emphasize the story. Classical / Baroque music emphasizes the music only, which is better for this purpose. It's is highly creative and can drag you up and down in wonderful ways. Unfortunately, I find most Classical music boring, so I tend to favor music with some lyrics, but where the music overpowers the lyrics, and not the other way around. I like long progressive rock songs by Yes that are heavy on music, with lyrics that are nothing more than poetry (like "Close To The Edge"), or the earlier, more progressive songs by Pink Floyd (like "Echoes.") I also listen to progressive metal that's music-heavy (like Dream Theater), and symphonic metal (like Epica). Bands that are "trippy" like "Dead Can Dance" are also good for getting entranced. I'll talk more about OBE music in chapter 53.
2 Out of Body Experiences, Robert Peterson, Hampton Roads Publishing, 1997, pg. 40.
3 Seeing Myself, Susan Blackmore, Robinson, 2017, pg. 117.
4 Lessons Out of the Body, Robert Peterson, Hampton Roads Publishing, 2001, pg. 221.
5 How Enlightenment Changes Your Brain, Andrew Newberg and Mark Robert Waldman, Penguin Random House, 2016, pg. 124.
It's been a long time since I've done a book review for my blog. That's probably because I was so busy last summer that I hardly took any time to read. I always read more in the winter months.
Today I'm reviewing The Initiation: A Progressive Spiritual Manual by Tom Llewellyn. The author was kind enough to send me a review copy. While it's not specifically about lucid dreaming, OBEs, or astral projection, the book progresses toward that end. The last couple chapters are about those things.
I really liked this book. It's spiritual, but well grounded. It's practical, meaning it has lots of easy to understand instructions. It's progressive, meaning each chapter builds on the next and the whole book is a step-by-step journey of becoming.
Chapter 9 is "The Path." Llewellyn lists these elements of the path: Fasting, Giving, Discipline, Ethics, Love, Pain, Fear, Persistence and Positive Attitude.
"Once a western disciple came up to him and asked him 'How to meditate.' Initially the Baba told him to go away but as the Westerner was leaving the Baba said "Just meditate like Christ."
"We always hold one jewel in the face of suffering and pain. This jewel, is the way we can respond."
In the "third door" section, Llewellyn has lots of meditation exercises, and he's got a lot of them. He has dynamic energy exercises like Robert Bruce. He has breathing exercises like Bhastrika: Bellows Breath, and Kapalabhati: Cleansing Shining Skull Breath. He has lots of exercises, mostly geared toward different kinds of meditation. They're all very solid, and different from most exercises you find in ordinary OBE books, but he uses a lot of these exercises to supplement his OBE techniques.
In my opinion, lucid dreaming is completely different from shamanic journeying. Lucid dreams occur when the body is completely asleep and inanimate, and your conscious awareness is firmly anchored in the self-created hallucination called the dream. Shamanic journeying is more like Robert Monroe's "Focus Level" experiences in which your conscious awareness remains centered mainly in the physical body, but you observe and even interact using a remote mechanism, much like remote viewing.
I found that confusing, but he does say that as you get more experience with both, lucid dreaming will start to "phase" into the astral projection state.
The last chapter of the book is about astral projection, and he does give some good exercises. For example, he gives a technique called "Pulsing" which is basically the same as Akhena's "The Fire and the Diamond" technique in which you shift your attention from chakra to chakra, but Llewellyn uses multiple chakras whereas Akhena only used two: the root chakra (Fire) and the third eye (Diamond). He also recommends doing hundreds of "perineum mula-bhanda contractions."
Achieving OBEs represents the final door of "The Initiation." There's one more chapter about psychic self-defense (or as they say in the UK, "defence") which is largely based on Robert Bruce's teachings.
I liked this book. The writing is mature and well done. It's 282 pages, so there's a good amount of content, and it's high quality. And there are lots of practical exercises.
My only complaint is that there are a lot of small mistakes. I didn't even notice it in the first half of the book, but by the last third I found a mistake on almost every page. I'm not talking about grammar-Nazi mistakes like spelling or even grammar; things like the wrong word (like physic where he meant psychic), missing words, extra words, etc. Things that a good editor would have caught, but it's easy for authors to miss because they get too close to the work. Still, the content and principles are solid.
I'll give it 4 out of 5 stars.


text:
HYDROCODONE BITARTRATE AND ACETAMINOPHEN- hydrocodone bitartrate, acetaminophen solution
Par Pharmaceutical
Hydrocodone Bitartrate and Acetaminophen Oral Solution
(7.5 mg/325 mg per 15 mL)
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering Hydrocodone Bitartrate and Acetaminophen Oral Solution. Dosing errors due to confusion between mg and mL, and other Hydrocodone Bitartrate and Acetaminophen Oral Solutions of different concentrations can result in accidental overdose and death [see WARNINGS, DOSAGE AND ADMINISTRATION].
Hydrocodone Bitartrate and Acetaminophen Oral Solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing Hydrocodone Bitartrate and Acetaminophen Oral Solution, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].
Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Acetaminophen Oral Solution. Follow patients for signs of respiratory depression, especially during initiation of Hydrocodone Bitartrate and Acetaminophen Oral Solution or following a dose increase [see WARNINGS].
Accidental ingestion of Hydrocodone Bitartrate and Acetaminophen Oral Solution, especially by children, can result in a fatal overdose of Hydrocodone Bitartrate and Acetaminophen Oral Solution [see WARNINGS].
Prolonged use of Hydrocodone Bitartrate and Acetaminophen Oral Solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS].
The concomitant use of Hydrocodone Bitartrate and Acetaminophen Oral Solution with all Cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used Cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Follow patients receiving Hydrocodone Bitartrate and Acetaminophen Oral Solution and any Cytochrome P450 3A4 inhibitor or inducer for signs and symptoms of respiratory depression and sedation [see CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS; Drug Interactions].
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see WARNINGS, OVERDOSAGE].
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS, PRECAUTIONS; Drug Interactions].
Reserve concomitant prescribing of Hydrocodone Bitartrate and Acetaminophen Oral Solution and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation.
Hydrocodone bitartrate and acetaminophen is available in liquid form for oral administration.
Hydrocodone Bitartrate and Acetaminophen Oral Solution contains:
Hydrocodone Bitartrate …………………………… 2.5 mg 7.5 mg
Acetaminophen …………………………………… 108 mg 325 mg
Alcohol ……………………………………………. 7% 7%
In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring.
Hydrocodone is a semi-synthetic opioid agonist with relative selectivity for the mu-opioid (µ) receptor, although it can interact with other opioid receptors at higher doses. Hydrocodone acts as a full agonist, binding to and activating opioid receptors at sites in the peri-aquaductal and peri-ventricular gray matter, the ventro-medial medulla and the spinal cord to produce analgesia. The analgesia, as well as the euphoriant, respiratory depressant and physiologic dependence properties of μ agonist opioids like hydrocodone, result principally from agonist action at the μ receptors.
There is a relationship between increasing hydrocodone plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions [see DOSAGE AND ADMINISTRATION].
Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β-hydroxymetabolites. See OVERDOSAGE for toxicity information.
CYP3A4 mediated N-demethylation to norhydrocodone is the primary metabolic pathway of hydrocodone with a lower contribution from CYP2D6 mediated O-demethylation to hydromorphone. Hydromorphone is formed from the O-demethylation of hydrocodone and may contribute to the total analgesic effect of hydrocodone. Therefore, the formation of these and related metabolites can, in theory, be affected by other drugs [see PRECAUTIONS; Drug Interactions]. N-demethylation of hydrocodone to form norhydrocodone via CYP3A4 while O-demethylation of hydrocodone to hydromorphone is predominantly catalyzed by CYP2D6 and to a lesser extent by an unknown low affinity CYP enzyme. Hydrocodone and its metabolites are eliminated primarily in the kidneys.
Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. A small fraction (10-25%) of acetaminophen is bound to plasma proteins. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Acetaminophen is primarily metabolized in the liver by first-order kinetics and involves three principal separate pathways: conjugation with glucuronide; conjugation with sulfate; and oxidation via the cytochrome, P450-dependent, mixed-function oxidase enzyme pathway to form a reactive intermediate metabolite, which conjugates with glutathione and is then further metabolized to form cysteine and mercapturic acid conjugates. The principal cytochrome P450 isoenzyme involved appears to be CYP2E1, with CYP1A2 and CYP3A4 as additional pathways. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.
Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Oral Solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
Hydrocodone Bitartrate and Acetaminophen Oral Solution is contraindicated in patients with:
Risk of Accidental Overdose and Death due to Medication Errors
Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with Hydrocodone Bitartrate and Acetaminophen Oral Solutions of different concentrations, when prescribing, dispensing, and administering Hydrocodone Bitartrate and Acetaminophen Oral Solution. Ensure that the dose is communicated clearly and dispensed accurately. Always use a calibrated measuring device when administering Hydrocodone Bitartrate and Acetaminophen Oral Solution to ensure the dose is measured and administered accurately.
Hydrocodone Bitartrate and Acetaminophen Oral Solution contains hydrocodone, a Schedule II controlled substance. As an opioid, Hydrocodone Bitartrate and Acetaminophen Oral Solution exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE].
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hydrocodone Bitartrate and Acetaminophen Oral Solution. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing Hydrocodone Bitartrate and Acetaminophen Oral Solution, and monitor all patients receiving Hydrocodone Bitartrate and Acetaminophen Oral Solution for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Hydrocodone Bitartrate and Acetaminophen Oral Solution, but use in such patients necessitates intensive counseling about the risks and proper use of Hydrocodone Bitartrate and Acetaminophen Oral Solution along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Hydrocodone Bitartrate and Acetaminophen Oral Solution. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see PRECAUTIONS; Information for Patients]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 800-503-0784, or log on to www.opioidanalgesicrems.com. The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint.
While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Hydrocodone Bitartrate and Acetaminophen Oral Solution, the risk is greatest during the initiation of therapy or following a dosage increase. Follow patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of Hydrocodone Bitartrate and Acetaminophen Oral Solution.
To reduce the risk of respiratory depression, proper dosing and titration of Hydrocodone Bitartrate and Acetaminophen Oral Solution are essential [see DOSAGE AND ADMINISTRATION]. Overestimating the Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage when converting patients from another opioid product can result in a fatal overdose.
Accidental ingestion of Hydrocodone Bitartrate and Acetaminophen Oral Solution especially by children, can result in respiratory depression and death due to an overdose of Hydrocodone Bitartrate and Acetaminophen Oral Solution.
Prolonged use of Hydrocodone Bitartrate and Acetaminophen Oral Solution during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see PRECAUTIONS; Information for Patients, Pregnancy].
Concomitant use of Hydrocodone Bitartrate and Acetaminophen Oral Solution with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of hydrocodone and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression [see WARNINGS], particularly when an inhibitor is added after a stable dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in Hydrocodone Bitartrate and Acetaminophen Oral Solution-treated patients may increase hydrocodone plasma concentrations and prolong opioid adverse reactions. When using Hydrocodone Bitartrate and Acetaminophen Oral Solution with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in Hydrocodone Bitartrate and Acetaminophen Oral Solution-treated patients, monitor patients closely at frequent intervals and consider dosage reduction of Hydrocodone Bitartrate and Acetaminophen Oral Solution until stable drug effects are achieved [see PRECAUTIONS; Drug Interactions].
Concomitant use of Hydrocodone Bitartrate and Acetaminophen Oral Solution with CYP3A4 inducers or discontinuation of an CYP3A4 inhibitor could decrease hydrocodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to Hydrocodone Bitartrate and Acetaminophen Oral Solution. When using Hydrocodone Bitartrate and Acetaminophen Oral Solution with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, follow patients at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur [see PRECAUTIONS; Drug Interactions].
Advise both patients and caregivers about the risks of respiratory depression and sedation when Hydrocodone Bitartrate and Acetaminophen Oral Solution is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see PRECAUTIONS; Drug Interactions, Information for Patients].
The use of Hydrocodone Bitartrate and Acetaminophen Oral Solution in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
Patients with Chronic Pulmonary Disease: Hydrocodone Bitartrate and Acetaminophen Oral Solution-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of Hydrocodone Bitartrate and Acetaminophen Oral Solution [see WARNINGS; Life-Threatening Respiratory Depression].
Elderly, Cachetic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see WARNINGS; Life-Threatening Respiratory Depression].
Follow such patients closely, particularly when initiating and titrating Hydrocodone Bitartrate and Acetaminophen Oral Solution and when Hydrocodone Bitartrate and Acetaminophen Oral Solution is given concomitantly with other drugs that depress respiration [see WARNINGS; Life-Threatening Respiratory Depression]. Alternatively, consider the use of non-opioid analgesics in these patients.
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Hydrocodone Bitartrate and Acetaminophen Oral Solution may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see PRECAUTIONS; Drug Interactions]. Follow these patients for signs of hypotension after initiating or titrating the dosage of hydrocodone and acetaminophen tablets and oral solution. In patients with circulatory shock hydrocodone and acetaminophen tablets and oral solution may cause vasodilatation that can further reduce cardiac output and blood pressure.
Avoid the use of Hydrocodone Bitartrate and Acetaminophen Oral Solution with circulatory shock.
There have been postmarketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Hydrocodone Bitartrate and Acetaminophen Oral Solution immediately and seek medical care if they experience these symptoms. Do not prescribe Hydrocodone Bitartrate and Acetaminophen Oral Solution for patients with acetaminophen allergy [see PRECAUTIONS; Information for Patients/Caregivers].
In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), hydrocodone and acetaminophen tablets and oral solution may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Follow such patients for signs of sedation and respiratory depression, particularly when initiating therapy with hydrocodone and acetaminophen tablets and oral solution.
Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of hydrocodone and acetaminophen tablets and oral solution in patients with impaired consciousness or coma.
Hydrocodone Bitartrate and Acetaminophen Oral Solution is contraindicated in patients with gastrointestinal obstruction, including paralytic ileus.
The administration of Hydrocodone and Acetaminophen Oral Solution or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
The hydrocodone in Hydrocodone and Acetaminophen Oral Solution may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Follow patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
The hydrocodone in Hydrocodone Bitartrate and Acetaminophen Oral Solution may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Follow patients with a history of seizure disorders for worsened seizure control during Hydrocodone Bitartrate and Acetaminophen Oral Solution therapy.
Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including Hydrocodone Bitartrate and Acetaminophen Oral Solution. In these patients, mixed agonist/antagonist and partial analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms.
When discontinuing Hydrocodone Bitartrate and Acetaminophen Oral Solution, gradually taper the dosage [see DOSAGE AND ADMINISTRATION]. Do not abruptly discontinue Hydrocodone Bitartrate and Acetaminophen Oral Solution in patients who have been using Hydrocodone Bitartrate and Acetaminophen Oral Solution around the clock for more than 5 days [see DRUG ABUSE AND DEPENDENCE].
Hydrocodone Bitartrate and Acetaminophen Oral Solution may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Hydrocodone Bitartrate and Acetaminophen Oral Solution and know how they will react to the medication [see PRECAUTIONS; Information for Patients/Caregivers].
Instruct patients how to measure and take the correct dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution and to always use a calibrated measuring device when administering Hydrocodone Bitartrate and Acetaminophen Oral Solution to ensure the dose is measured and administered accurately [see WARNINGS].
If the prescribed concentration is changed, instruct patients on how to correctly measure the new dose to avoid errors which could result in accidental overdose and death.
Inform patients that the use of Hydrocodone Bitartrate and Acetaminophen Oral Solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS]. Instruct patients not to share Hydrocodone Bitartrate and Acetaminophen Oral Solution with others and to take steps to protect Hydrocodone Bitartrate and Acetaminophen Oral Solution from theft or misuse.
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Hydrocodone Bitartrate and Acetaminophen Oral Solution or when the dosage is increased, and that it can occur even at recommended dosages [see WARNINGS]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS]. Instruct patients to take steps to store securely and to dispose of unused Hydrocodone Bitartrate and Acetaminophen Oral Solution by flushing down the toilet.
Inform patients and caregivers that potentially fatal additive effects may occur if Hydrocodone Bitartrate and Acetaminophen Oral Solution is used with benzodiazepines and other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see WARNINGS, PRECAUTIONS; Drug Interactions].
Inform patients that Hydrocodone Bitartrate and Acetaminophen Oral Solution could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see PRECAUTIONS; Drug Interactions].
Inform patients to avoid taking Hydrocodone Bitartrate and Acetaminophen Oral Solution while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Hydrocodone Bitartrate and Acetaminophen Oral Solution [see PRECAUTIONS; Drug Interactions].
Inform patients that Hydrocodone Bitartrate and Acetaminophen Oral Solution opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see WARNINGS].
Instruct patients how to properly measure and take Hydrocodone Bitartrate and Acetaminophen Oral Solution [see DOSAGE AND ADMINISTRATION, WARNINGS].
Advise patients to always use the enclosed calibrated oral syringe/dosing cup when administering Hydrocodone Bitartrate and Acetaminophen Oral Solution to ensure the dose is measured and administered accurately [see WARNINGS].
Advise patients never to use household teaspoons or tablespoons to measure Hydrocodone Bitartrate and Acetaminophen Oral Solution.
Advise patients not to adjust the dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution without consulting with a physician or other healthcare professional.
If patients have been receiving treatment with Hydrocodone Bitartrate and Acetaminophen Oral Solution for more than a few weeks and cessation of therapy is indicated, counsel them on the importance of safely tapering the dose as abrupt discontinuation of the medication could precipitate withdrawal symptoms. Provide a dose schedule to accomplish a gradual discontinuation of the medication [see DOSAGE AND ADMINISTRATION].
Inform patients to not take more than 4000 milligrams of acetaminophen per day. Advise patients to call their prescriber if they take more than the recommended dose.
Inform patients that Hydrocodone Bitartrate and Acetaminophen Oral Solution may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see WARNINGS].
Inform patients that anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Acetaminophen Oral Solution. Advise patients how to recognize such a reaction and when to seek medical attention [see CONTRAINDICATIONS, ADVERSE REACTIONS].
Inform female patients of reproductive potential that prolonged use of Hydrocodone Bitartrate and Acetaminophen Oral Solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see WARNINGS, PRECAUTIONS; Pregnancy].
Inform female patients of reproductive potential that Hydrocodone Bitartrate and Acetaminophen Oral Solution can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [see PRECAUTIONS; Pregnancy].
Inform patients that Hydrocodone Bitartrate and Acetaminophen Oral Solution may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication [see WARNINGS].
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see ADVERSE REACTIONS, CLINICAL PHARMACOLOGY].
Disposal of Unused Hydrocodone Bitartrate and Acetaminophen Oral Solution
Advise patients to dispose of unused Hydrocodone Bitartrate and Acetaminophen Oral Solution by flushing unused Hydrocodone Bitartrate and Acetaminophen Oral Solution down the toilet.
In patients with severe hepatic or renal disease, effects of therapy should be followed with serial liver and/or renal function tests.
The concomitant use of Hydrocodone Bitartrate and Acetaminophen Oral Solution and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone from Hydrocodone Bitartrate and Acetaminophen Oral Solution, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Hydrocodone Bitartrate and Acetaminophen Oral Solution and both CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution is achieved [see WARNINGS].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, hydrocodone plasma concentration will decrease [see CLINICAL PHARMACOLOGY], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Hydrocodone Bitartrate and Acetaminophen Oral Solution.
If concomitant use is necessary, consider dosage reduction of Hydrocodone Bitartrate and Acetaminophen Oral Solution until stable drug effects are achieved. Follow patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage until stable drug effects are achieved. Follow patients for signs or symptoms of opioid withdrawal.
The concomitant use of Hydrocodone Bitartrate and Acetaminophen Oral Solution and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of hydrocodone [see CLINICAL PHARMACOLOGY], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to Hydrocodone Bitartrate and Acetaminophen Oral Solution [see WARNINGS].
If concomitant use is necessary, consider increasing the Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage until stable drug effects are achieved [see DOSAGE AND ADMINISTRATION]. Follow for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage reduction and monitor for signs of respiratory depression.
Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants such as benzodiazepines and other sedative hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome. [see PRECAUTIONS; Information for Patients].
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Hydrocodone Bitartrate and Acetaminophen Oral Solution if serotonin syndrome is suspected.
The use of Hydrocodone Bitartrate and Acetaminophen Oral Solution is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of Hydrocodone Bitartrate and Acetaminophen Oral Solution and/or precipitate withdrawal symptoms.
Hydrocodone Bitartrate and Acetaminophen Oral Solution may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
If concomitant use is warranted, follow patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Hydrocodone Bitartrate and Acetaminophen Oral Solution and/or the muscle relaxant as necessary.
If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
If concomitant use is warranted, follow patients for signs of urinary retention or reduced gastric motility when Hydrocodone Bitartrate and Acetaminophen Oral Solution is used concomitantly with anticholinergic drugs.
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleactic acid.
Long-term studies to evaluate the carcinogenic potential of the combination of Hydrocodone Bitartrate and Acetaminophen Oral Solution have not been conducted.
Long-term studies in mice and rats have been completed by the National Toxicology Program to evaluate the carcinogenic potential of acetaminophen. In 2-year feeding studies, F344/N rats and B6C3F1 mice were fed a diet containing acetaminophen up to 6000 ppm. Female rats demonstrated equivocal evidence of carcinogenic activity based on increased incidences of mononuclear cell leukemia at 0.8 times the maximum human daily dose (MHDD) of 4 grams/day, based on a body surface area comparison. In contrast, there was no evidence of carcinogenic activity in male rats that received up to 0.7 times or mice at up to 1.2-1.4 times the MHDD, based on a body surface area comparison.
In studies conducted by the National Toxicology Program, fertility assessments with acetaminophen have been completed in Swiss CD-1 mice via a continuous breeding study. There were no effects on fertility parameters in mice consuming up to 1.7 times the MHDD of acetaminophen, based on a body surface area comparison.
Although there was no effect on sperm motility or sperm density in the epididymis, there was a significant increase in the percentage of abnormal sperm in mice consuming 1.78 times the MHDD (based on a body surface comparison) and there was a reduction in the number of mating pairs producing a fifth litter at this dose, suggesting the potential for cumulative toxicity with chronic administration of acetaminophen near the upper limit of daily dosing.
There are no adequate and well-controlled studies in pregnant women. Hydrocodone Bitartrate and Acetaminophen Oral Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see WARNINGS].
Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Hydrocodone Bitartrate and Acetaminophen Oral Solution is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Oral Solution, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Hydrocodone Bitartrate and Acetaminophen Oral Solution and any potential adverse effects on the breastfed infant from Hydrocodone Bitartrate and Acetaminophen Oral Solution or from the underlying maternal condition.
Infants exposed to Hydrocodone Bitartrate and Acetaminophen Oral Solution through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped.
The safety and effectiveness of Hydrocodone Bitartrate and Acetaminophen Oral Solution in the pediatric population below the age of two years have not been established. Use of Hydrocodone Bitartrate and Acetaminophen Oral Solution in the pediatric patients over the age of 2 years is supported by evidence from adequate and well controlled studies of hydrocodone and acetaminophen combination products in adults, along with additional data which support the development of metabolic pathways in children two years of age and over [see DOSAGE AND ADMINISTRATION] for pediatric dosage information.
Elderly patients (aged 65 years or older) may have increased sensitivity to Hydrocodone Bitartrate and Acetaminophen Oral Solution. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of Hydrocodone Bitartrate and Acetaminophen Oral Solution slowly in geriatric patients and follow closely for signs of central nervous system and respiratory depression [see WARNINGS].
Hydrocodone and acetaminophen are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to follow renal function.
Patients with hepatic impairment may have higher plasma hydrocodone concentrations than those with normal function. Use a low initial dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution in patients with hepatic impairment and follow closely for adverse events such as respiratory depression and sedation.
Patients with renal impairment may have higher plasma hydrocodone concentrations than those with normal function. Use a low initial dose Hydrocodone Bitartrate and Acetaminophen Oral Solution in patients with renal impairment and follow closely for adverse events such as respiratory depression and sedation.
The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets and oral solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. Other adverse reactions include:
Cardio-Renal: Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension.
Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, lightheadedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma.
Endocrine: Hypoglycemic coma.
Gastrointestinal System: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting.
Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention.
Hematologic: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia.
Hypersensitivity: Allergic reactions.
Musculoskeletal: Skeletal muscle flaccidity.
Respiratory Depression: Acute airway obstruction, apnea, dose-related respiratory depression [see OVERDOSAGE], shortness of breath.
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Skin: Cold and clammy skin, diaphoresis, pruritus, rash.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in hydrocodone and acetaminophen tablets.
Hydrocodone Bitartrate and Acetaminophen Oral Solution contains hydrocodone, a Schedule II controlled substance.
Hydrocodone Bitartrate and Acetaminophen Oral Solution contains hydrocodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol, can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS].
Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.
"Drug-seeking" behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated "loss" of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider(s). "Doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.
Hydrocodone Bitartrate and Acetaminophen Oral Solution, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.
Risks Specific to Abuse of Hydrocodone Bitartrate and Acetaminophen Oral Solution
Hydrocodone Bitartrate and Acetaminophen Oral Solution is for oral use only. Abuse of Hydrocodone Bitartrate and Acetaminophen Oral Solution poses a risk of overdose and death. The risk is increased with concurrent abuse of Hydrocodone Bitartrate and Acetaminophen Oral Solution with alcohol and other central nervous system depressants.
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.
Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.
Hydrocodone Bitartrate and Acetaminophen Oral Solution should not be abruptly discontinued in a physically-dependent patient [see DOSAGE AND ADMINISTRATION]. If Hydrocodone Bitartrate and Acetaminophen Oral Solution is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur.
Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see PRECAUTIONS; Pregnancy].
Acute overdosage with Hydrocodone Bitartrate and Acetaminophen Oral Solution can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.
Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to Hydrocodone Bitartrate and Acetaminophen Oral Solution overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to Hydrocodone Bitartrate and Acetaminophen Oral Solution overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone in Hydrocodone Bitartrate and Acetaminophen Oral Solution carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product's prescribing information.
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease absorption if acetaminophen is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose-dependent and occurs in the course of intoxication.
Ensure accuracy when prescribing, dispensing, and administering Hydrocodone Bitartrate and Acetaminophen Oral Solution to avoid dosing errors due to confusion between mg and mL, and with other hydrocodone bitartrate and acetaminophen oral solutions of different concentrations, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.
Always use a calibrated measuring device when administering Hydrocodone Bitartrate and Acetaminophen Oral Solution to ensure the dose is measured and administered accurately. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage.
Initiate the dosing regimen for each patient individually; taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS].
Follow patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with Hydrocodone Bitartrate and Acetaminophen Oral Solution and adjust the dosage accordingly [see WARNINGS].
Initiating Treatment with Hydrocodone Bitartrate and Acetaminophen Oral Solution
The usual adult dosage is one tablespoonful (15 mL) every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 6 tablespoonfuls.
The usual dosages for children are given by the table below and, is to be given every 4 to 6 hours as needed for pain. The total daily dosage for children should not exceed 6 doses per day. These dosages correspond to an average individual dose of 0.27 mL/kg of Hydrocodone Bitartrate and Acetaminophen Oral Solution (providing 0.135 mg/kg of hydrocodone bitartrate and 5.85 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.
It is of utmost importance that the dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the variability of the household spoon measure it is strongly recommended that caregivers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage.
BODY WEIGHT APPROXIMATE AGE DOSE every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE (6 doses per day)
12 to 15 kg
27 to 34 lbs. 2 to 3 years ¾ teaspoonful = 3.75 mL 4½ teaspoonfuls = 22.5 mL
35 to 50 lbs. 4 to 6 years 1 teaspoonful = 5 mL 6 teaspoonfuls = 30 mL
51 to 69 lbs. 7 to 9 years 1½ teaspoonfuls = 7.5 mL 9 teaspoonfuls = 45 mL
70 to 100 lbs. 10 to 13 years 2 teaspoonfuls = 10 mL 12 teaspoonfuls = 60 mL
46 kg and up
101 lbs. and up 14 years to adult 1 Tablespoonful = 15 mL 6 Tablespoonfuls = 90 mL
Conversion from Other Opioids to Hydrocodone Bitartrate and Acetaminophen Oral Solution
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of Hydrocodone Bitartrate and Acetaminophen Oral Solution. It is safer to underestimate a patient's 24-hour Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage than to overestimate the 24-hour Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage and manage an adverse reaction due to overdose.
Conversion from Hydrocodone Bitartrate and Acetaminophen Oral Solution to Extended-Release Hydrocodone
The relative bioavailability of hydrocodone from Hydrocodone Bitartrate and Acetaminophen Oral Solution compared to extended-release hydrocodone is unknown, so conversion to extended-release tablets must be accompanied by close observation for signs of excessive sedation and respiratory depression.
Individually titrate Hydrocodone Bitartrate and Acetaminophen Oral Solution to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Hydrocodone Bitartrate and Acetaminophen Oral Solution to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation of Hydrocodone Bitartrate and Acetaminophen Oral Solution
When a patient who has been taking Hydrocodone Bitartrate and Acetaminophen Oral Solution regularly and may be physically dependent no longer requires therapy with Hydrocodone Bitartrate and Acetaminophen Oral Solution, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Hydrocodone Bitartrate and Acetaminophen Oral Solution in a physically-dependent patient [see WARNINGS, DRUG ABUSE AND DEPENDENCE].
Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL) is a red-colored, tropical fruit punch flavored liquid containing hydrocodone bitartrate (WARNING: may be habit-forming) 7.5 mg and acetaminophen 325 mg per 15 mL, with 7% alcohol. It is supplied in a container of 16 oz (473 mL) NDC 64376-640-16 and 4 oz (118 mL) NDC 64376-640-40.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.
Chestnut Ridge, NY 10977
Revised: 07/2018
Hydrocodone Bitartrate (hye'' droe koe' done bye tar' trate) and Acetaminophen (a seet'' a min' oh fen) Oral Solution CII
Hydrocodone Bitartrate and Acetaminophen Oral Solution is:
A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine and for which alternative treatments are inadequate and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
Important information about Hydrocodone Bitartrate and Acetaminophen Oral Solution:
Get emergency help right away if you take too much Hydrocodone Bitartrate and Acetaminophen Oral Solution (overdose). When you first start taking Hydrocodone Bitartrate and Acetaminophen Oral Solution, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
Taking Hydrocodone Bitartrate and Acetaminophen Oral Solution with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
Never give anyone else your Hydrocodone Bitartrate and Acetaminophen Oral Solution. They could die from taking it. Store Hydrocodone Bitartrate and Acetaminophen Oral Solution away from children and in a safe place to prevent stealing or abuse. Selling or giving away Hydrocodone Bitartrate and Acetaminophen Oral Solution is against the law.
Do not take Hydrocodone Bitartrate and Acetaminophen Oral Solution if you have:
known hypersensitivity to hydrocodone or acetaminophen, or any ingredient in Hydrocodone Bitartrate and Acetaminophen Oral Solution.
Before taking Hydrocodone Bitartrate and Acetaminophen Oral Solution, tell your healthcare provider if you have a history of:
pregnant or planning to become pregnant. Prolonged use of Hydrocodone Bitartrate and Acetaminophen Oral Solution during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Hydrocodone Bitartrate and Acetaminophen Oral Solution passes into breast milk and may harm your baby.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Hydrocodone Bitartrate and Acetaminophen Oral Solution with certain other medicines can cause serious side effects that could lead to death.
When taking Hydrocodone Bitartrate and Acetaminophen Oral Solution:
Do not change your dose. Take Hydrocodone Bitartrate and Acetaminophen Oral Solution exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
Always use a calibrated measuring device for Hydrocodone Bitartrate and Acetaminophen Oral Solution to correctly measure your dose. A household teaspoon or tablespoon is not an adequate measuring device. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that caregivers obtain and use a calibrated measuring device.
Take your prescribed dose. The usual adult dosage is one tablespoonful (15 mL) every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablespoonfuls. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
If you have been taking Hydrocodone Bitartrate and Acetaminophen Oral Solution regularly, do not stop taking Hydrocodone Bitartrate and Acetaminophen Oral Solution without talking to your healthcare provider.
After you stop taking Hydrocodone Bitartrate and Acetaminophen Oral Solution, the unused solution should be disposed of by flushing down the toilet.
While taking Hydrocodone Bitartrate and Acetaminophen Oral Solution DO NOT:
Drive or operate heavy machinery, until you know how Hydrocodone Bitartrate and Acetaminophen Oral Solution affects you. Hydrocodone Bitartrate and Acetaminophen Oral Solution can make you sleepy, dizzy, or lightheaded.
Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Hydrocodone Bitartrate and Acetaminophen Oral Solution may cause you to overdose and die.
The possible side effects of Hydrocodone Bitartrate and Acetaminophen Oral Solution:
These are not all the possible side effects of Hydrocodone Bitartrate and Acetaminophen Oral Solution. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.
Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977 1-800-828-9393
Issued: 03/2018
hydrocodone bitartrate, acetaminophen solution
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64376-640
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL
HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7) HYDROCODONE BITARTRATE 7.5 mg in 15 mL
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ETHYL MALTOL (UNII: L6Q8K29L05)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
Color RED Score
Shape Size
Flavor TROPICAL FRUIT PUNCH Imprint Code
NDC:64376-640-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/27/2011 09/30/2021
Labeler - Par Pharmaceutical (170266089)
Halo Pharmaceutical Inc 829609168 MANUFACTURE(64376-640)
Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE(64376-640) , PACK(64376-640)
Vintage Pharmaceuticals, LLC 825839835 ANALYSIS(64376-640) , LABEL(64376-640) , MANUFACTURE(64376-640) , PACK(64376-640)
Document Id: 9489cd5e-ff00-4f92-94ff-1b134bf07b4a
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redpajama_set_name: RedPajamaCommonCrawl


Let me come clean. Every time I visit the Metropolitan Museum, I skip the galleries displaying American art, and until recently, it was the same with the Huntington in San Marino. I would spend most of the time there savoring the world-class collection of English paintings and then finish by looking at a couple of temporary exhibitions. Not any longer. Last week, the Huntington inaugurated the new Virginia Steele Scott Galleries, where for the first time in my life, I had the chance to see classical American art presented with such panache and sophistication that it changed my previous opinion of its relevance in the grand scheme of things.
The refurbished galleries, with their elegant, contemporary design, provide more than 16,000 square feet of exhibition space. Usually we see collections of American art presented in rather crowded rooms, giving off a whiff of provinciality, but here at the Huntington, every object had particular appeal, thanks to the way it was placed, lit, and juxtaposed with the other works of art. When museum curators excel, as is the case here, it allows us to see the familiar in a totally new way; I found myself spending time in front of paintings I had previously ignored and even enjoying the displays of decorative art, which is normally not my cup of tea.
Next year will bring a dramatic change in the presentation of the permanent collection at another local museum, the Los Angeles County Museum of Art. When construction is completed on the new Resnick Pavilion for temporary exhibitions designed by Renzo Piano, the museum will have the opportunity to reorganize its permanent collection and reintroduce it to the public. Let's hope that it will be as successful as last year's reinstallation of the galleries of 20th century art.
One also hopes that this museum, so much a part of our city's identity, will be more forthcoming about its plans to sell artworks from the permanent collection. American museums periodically do sell lesser quality works from their collections in an attempt to raise funds for new acquisitions. However, it's usually done very discreetly and hush-hush, and that's definitely the case now with LACMA's latest decision to sell Old Master paintings by three major 17th century European artists: Rubens, Ter Borch, and Pieter de Hooch.
I didn't know about this until the recent New York Times report of their sale at Sotheby's upcoming auction in New York. Checking out the Sotheby's catalog, I found reproductions of these paintings and thought that they were rather attractive. The question is why the museum didn't consider such a sale as an opportunity to build closer ties with the community, helping us understand how the decision was made and why the curators zeroed in on these three paintings. Was it because they are not first rate, or maybe because they are in poor condition and heavily over painted? In short, I believe the museum missed out on the chance to educate us, its faithful public. Perhaps if the museum organized a special one-day seminar displaying the paintings and discussing their artistic value and the reason for their de-accessioning, then a local collector might be inspired to purchase them, and Los Angeles would be better for it.
And while we're talking about the need for transparency in our museums...I hear rumors that MOCA, in a continuing attempt to sort out its financial mess, not only eliminated the curatorial department for design and architecture, but last week, let go its librarian and even its registrar. It definitely doesn't make sense: a museum without a registrar is like a restaurant without a cook. As of this afternoon, my request for information regarding this matter from the museum press department was left unanswered.


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Jacob Lemieux, MD, DPhil and Artem Rogovskyy, DVM, PhD Named Recipients of Bay Area Lyme Foundation's 2020 Emerging Leader Award
August 11, 2020 August 17, 2020 | News By Bay Area Lyme Foundation
Tara DiMilia, 908-947-0500, tara.dimilia@TMstrat.com
Biobank Samples to Aid 2020 Emerging Leader Award Winners in Discovery of New Rapid and Sensitive Diagnostics for Lyme Disease Testing
PORTOLA VALLEY, Calif., August 11, 2020 — Bay Area Lyme Foundation, a leading sponsor of Lyme disease research in the U.S., announces the recipients of the 2020 Emerging Leader Awards, which are designed to support promising scientists who represent the future of Lyme disease-research leadership. Jacob Lemieux, MD, DPhil of Harvard and Massachusetts General Hospital, and Artem Rogovskyy, DVM, PhD of Texas A&M University will each receive $100,000 toward the development of novel direct-detection diagnostic approaches for Lyme disease. Both researchers will utilize biological samples from the Lyme Disease Biobank, a program of the Bay Area Lyme Foundation, working to accelerate research of Lyme disease and other tick-borne infections. Lyme disease is a potentially disabling infection impacting more than 400,000 Americans each year.
"The value of research proposed by our grant recipients is vital to our mission of making Lyme disease easy to diagnose and simple to cure. In this year of COVID-19, we are pleased to have the opportunity to continue our grant program to fund the important work of these scientists addressing the most crucial requirement for Lyme disease – an accurate diagnostic test," said Linda Giampa, executive director, Bay Area Lyme Foundation.
The research projects of the two 2020 $100,000 Emerging Leader Award recipients both aim to improve the accuracy of Lyme disease tests, and each researcher shares more details about their project on the newly-launched Bay Area Lyme Ticktective™ podcast. Here is an overview of their projects:
Using next-generation and target capture sequencing, Dr. Lemieux, a post-doctoral researcher at Harvard and an infectious disease fellow at Massachusetts General Hospital, will develop a sensitive, direct detection diagnostic for early Lyme disease. His project will also utilize samples from the Lyme Disease Biobank and builds on compelling preliminary data and past research funding by Bay Area Lyme.
Assistant Professor at Texas A&M University, Dr. Rogovskyy is working to develop a unique, robust, rapid diagnostic test for Lyme disease with significant improvements in sensitivity and specificity compared to current options. Utilizing samples from the Lyme Disease Biobank, his research will apply a unique spectroscopic technique to explore ways to diagnose disease.
"These grants enlist and support scientists and clinicians who have novel research concepts that we hope will help us solve the problem of Lyme disease," added Wendy Adams, research grant director, Bay Area Lyme. "The progress, determination and commitment of all our awardees continues to inspire us, and we look forward to the data that will come from their research."
Previous Emerging Leader Award recipients have come from institutions including Brandeis University, Harvard University, Massachusetts Institute of Technology, Louisiana State University, North Carolina State University, Stanford University School of Medicine, Tulane University, University of California San Francisco and Yale University. Most of these projects were in the early stages of research upon awarding, and the Emerging Leader Award offered a springboard for scientists to explore the concepts that were later recognized with grants from the government and other established entities, increasing the scope of focus on Lyme disease. Some have been accepted for presentation at well-respected scientific forums.
These awards are presented annually and are awarded to promising scientists who have identified a defined approach to improved diagnostics or therapeutics for Lyme disease. Researchers interested in applying for the 2021 Emerging Leader Award or learning about the other grants that Bay Area Lyme Foundation offers throughout the year should visit bayarealyme.org/our-research/grant-process
About Lyme Disease
The most common vector-borne infectious disease in the country, Lyme disease is a potentially disabling infection caused by bacteria transmitted through the bite of an infected tick to people and pets. If caught early, most cases of Lyme disease can be effectively treated, but it is commonly misdiagnosed due to lack of awareness and unreliable diagnostic tests. There are more than 400,000 new cases of Lyme disease each year, according to statistics released in 2018 by the CDC. As a result of the difficulty in diagnosing and treating Lyme disease, more than one million Americans may be suffering from the impact of its debilitating long-term symptoms and complications, according to Bay Area Lyme Foundation estimates.
About Bay Area Lyme Foundation
Bay Area Lyme Foundation, a national organization committed to making Lyme disease easy to diagnose and simple to cure, is a leading public not-for-profit sponsor of innovative Lyme disease research in the U.S. A 501c3 non-profit organization based in Silicon Valley, Bay Area Lyme Foundation collaborates with world-class scientists and institutions to accelerate medical breakthroughs for Lyme disease. It is also dedicated to providing reliable, fact-based information so that prevention and the importance of early treatment are common knowledge. A pivotal donation from The LaureL STEM Fund covers overhead costs and allows for 100% of all donor contributions to Bay Area Lyme Foundation to go directly to research and prevention programs. For more information about Lyme disease or to get involved, visit www.bayarealyme.org or call us at 650-530-2439.
Tags: diagnostic research, Emerging Leader, Emerging Leader Award, Harvard, Harvard Medical Research, Lyme diagnostics, Lyme disease, Lyme disease biobank, Lyme research, Massachusetts General Hospital, medical research, next-gen sequencing, next-generation sequencing, press release, Texas A&M University, tick-borne disease, tick-borne illness, ticks
Lyme Stories


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Do you feel like you're failing as a manager? Don't stress. We all get overwhelmed from time to time. The two reasons managers fail are quite simple: over-delegation and under-delegation.
When your plate gets overloaded, the tendency is to over delegate tasks in order to manage your workload.
Those who over-delegate tend to delegate tasks and then forget about them completely. While this hands-off approach is better for morale than micromanagement, even the most independent workers need periodic check-ins to stay on task.
Imagine you're getting a haircut. Even though your stylist is an expert in hair-cutting technique, they still need some initial direction from you in order to give you what you want. Treat the delegation process in this fashion.
If you're involved early on, you can disengage later. After you explain the haircut you want, you can disengage and let the stylist do their thing.
Under-delegation happens when you stay engaged throughout the entire process. This sets you and your team up for failure.
You'll be stressed and overloaded if you're involved in every single task. Your employees will never take ownership of their work, and this ultimately stunts their professional development.
The proper delegation process starts with being very involved in the direction phase. You then disengage during the task to let employees take ownership of their work.
The level to which you disengage is directly related to the employee's experience in the task.
Finally, you have to have a way to measure the results after the task is done. This is simple in Sales and marketing, but difficult for operational tasks.
The best delegation systems have Key Performance Indicators (KPIs) built in to measure success. Employees put more into a task when they know how to "keep score".
The definition of Management is getting things done through others. This is done through delegation. I'm going to share with you a 4-step delegation process to keep yourself from under-delegating or over-delegating.
Step 1: Before delegating a task, you must clearly understand the task yourself.
Most of us don't delegate tasks until our plates are full and we are feeling overwhelmed.
In reality, this process needs to start before we feel overloaded. You need to have the time to fully understand each task you delegate, and this is impossible when you have a full plate.
Don't just delegate a given task to the first person who comes to your mind. Be strategic.
Each person on your team is a resource, and you want to use your resources as efficiently as possible.
Most people let their mind wander when listening to instructions. It's human nature. Most employees underperform at tasks because they didn't clearly understand the task's objective or purpose.
A good way to check for comprehension is to have your employee repeat the task directions back to you.
The thoroughness of your directions is directly related to the employee's expertise in the task at hand. You can be more hands-off with those who have a lot of experience, while you have to go into each step in detail with newer employees.
Follow this 4 step process and you'll be a better manager.
Do you need help getting the most out of your employees? If so, then sign up for an executive coaching session with Arman today.


OMV endorsed in January 2017 the World Bank Initiative " Zero routine flaring by 2030" to end the routine flaring of associated gas during oil production. OMV's endorsement of the Initiative is a clear commitment to responsible resource management and sustainable business practices linking environmental and economic objectives.
The Initiative was launched in 2015 by World Bank together with the former UN Secretary General Ban Ki Moon. The Initiative aims to eliminate the existing oil industry practice of routinely flaring gas at production sites by 2030, and to ensure new oil fields are developed with associated gas utilization solutions and without routine flaring or venting. According to World Bank flaring at oil production sites around the world causes more than 350 million tons of CO2 emissions every year. If the gas that is flared globally every year were used for power generation, it could provide about 750 billion kWh of electricity, or more than the African continent's current annual electricity consumption.
end the legacy routine flaring and venting at existing operational sites through implementation of all viable solutions, as soon as possible, but no later than 2030.
report its routine flaring data annually to World Bank.
OMV Petrom Upstream consumes the associated by-product gas to produce onsite electricity and heat via gas-to-power (G2P) and combined heat and power (CHP) plants. Until end 2016, 31 projects have been implemented, with a combined installed capacity of 65 MW delivering 318,000 tons of CO2 emission annually and significant OPEX savings.
In Tunisia zero routine flaring in operated assets will be achieved with the OMV South Tunisia Gas Valorisation Project.
In Yemen, OMV plans to implement the Habban field electrification project, where currently flared gas will replace the diesel for on-site electricity.