Packager: Aphena Pharma Solutions - Tennessee, LLC
These highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN.
GABAPENTIN capsules, for oral use
Capsules : 100 mg, 300 mg and 400 mg (3)
Tablets (functional scored): 600 mg, and 800 mg (3)
To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Pregnancy: Based on animal data, may cause fetal harm (8.1)
Sudden and Unexplained Death in Patients with Epilepsy [see Warnings and Precautions (5.9)]
The most common adverse reactions with gabapentin in combination with other antiepileptic drugs in patients >12 years of age, not seen at an equivalent frequency among placebo-treated patients, were somnolence, dizziness, ataxia, fatigue, and nystagmus. The most common adverse reactions with gabapentin in combination with other antiepileptic drugs in pediatric patients 3 to 12 years of age, not seen at an equal frequency among placebo-treated patients, were viral infection, fever, nausea and/or vomiting, somnolence, and hostility [see Warnings and Precautions (5.7)].
When pregnant mice received oral doses of gabapentin (500 mg/kg/day, 1,000 mg/kg/day, or 3,000 mg/kg/day) during the period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. The no-effect dose for embryofetal developmental toxicity in mice (500 mg/kg/day) is less than the maximum recommended human dose (MRHD) of 3,600 mg/kg on a body surface area (mg/m2) basis.
In studies in which rats received oral doses of gabapentin (500 mg/kg/day to 2,000 mg/kg/day) during pregnancy, adverse effect on offspring development (increased incidences of hydroureter and/or hydronephrosis) were observed at all doses. The lowest dose tested is similar to the MRHD on a mg/m2 basis.
When pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in embryofetal mortality was observed at all doses tested (60 mg/kg, 300 mg/kg, or 1,500 mg/kg). The lowest dose tested is less than the MRHD on a mg/m2 basis.
The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is:
Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72±0.10 and a pKa2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature.
Gabapentin bioavailability is not dose proportional; i.e., as dose is increased, bioavailability decreases. Bioavailability of gabapentin is approximately 60%, 47%, 34%, 33%, and 27% following 900 mg/day, 1,200 mg/day, 2,400 mg/day, 3,600 mg/day, and 4,800 mg/day given in 3 divided doses, respectively. Food has only a slight effect on the rate and extent of absorption of gabapentin (14% increase in AUC and Cmax).
In a study in anuric adult subjects (N=11), the apparent elimination half-life of gabapentin on nondialysis days was about 132 hours; during dialysis the apparent half-life of gabapentin was reduced to 3.8 hours. Hemodialysis thus has a significant effect on gabapentin elimination in anuric subjects. [see Dosage and Administration (2.3) and Use in Specific Populations (8.6)].
In vitro studies were conducted to investigate the potential of gabapentin to inhibit the major cytochrome P450 enzymes (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4) that mediate drug and xenobiotic metabolism using isoform selective marker substrates and human liver microsomal preparations. Only at the highest concentration tested (171 mcg/mL; 1 mM) was a slight degree of inhibition (14% to 30%) of isoform CYP2A6 observed. No inhibition of any of the other isoforms tested was observed at gabapentin concentrations up to 171 mcg/mL (approximately 15 times the Cmax at 3,600 mg/day).
Coadministration of gabapentin (125 mg to 500 mg; N=48) decreases hydrocodone (10 mg; N=50) Cmax and AUC values in a dose-dependent manner relative to administration of hydrocodone alone; Cmax and AUC values are 3% to 4% lower, respectively, after administration of 125 mg gabapentin and 21% to 22% lower, respectively, after administration of 500 mg gabapentin. The mechanism for this interaction is unknown. Hydrocodone increases gabapentin AUC values by 14%. The magnitude of interaction at other doses is not known.
Antacid (Maalox®) (aluminum hydroxide, magnesium hydroxide)
Dizziness and Somnolence and Effects on Driving and Operating Heavy Machinery Advise patients that gabapentin may cause dizziness, somnolence, and other symptoms and signs of CNS depression. Other drugs with sedative properties may increase these symptoms. Accordingly, although patients' ability to determine their level of impairment can be unreliable, advise them neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on gabapentin to gauge whether or not it affects their mental and/or motor performance adversely. Inform patients that it is not known how long this effect lasts [see Warnings and Precautions (5.3) and Warnings and Precautions (5.4)].
MEDICATION GUIDEGabapentin Capsules, USPGabapentin Tablets, USP(gab'' a pen' tin)
Gabapentin tablets can be taken with or without food. If you take an antacid containing aluminum and magnesium, such as Maalox®, Mylanta®, Gelusil®, Gaviscon®, or Di-Gel®, you should wait at least 2 hours before taking your next dose of gabapentin.
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Count 800 mg
45 71610-432-45
120 71610-432-70
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
20200612JH
PRINCIPAL DISPLAY PANEL - 800 mg
NDC 71610-432 - Gabapentin, USP 800 mg Tablets - Rx Only
NDC:71610-432-45 45 in 1 BOTTLE; Type 0: Not a Combination Product 06/10/2020 09/23/2022
NDC:71610-432-70 120 in 1 BOTTLE; Type 0: Not a Combination Product 06/10/2020 09/23/2022
ANDA ANDA205101 11/20/2016 09/23/2022
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(71610-432)
https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=489a9c65-9a43-48d0-a35d-ec7b18e1d7d5