displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Gabapentin tablets, USP are supplied as elliptical film-coated tablets containing 600 mg and 800 mg of gabapentin USP.
The inactive ingredients for the tablets are glyceryl behenate, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium stearate, mannitol, talc, pregelatinized starch and Opadry YS-1-7003 (hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80).
Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with a molecular formula of C9H17NO2 and a molecular weight of 171.24. The structural formula of gabapentin is:
Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
DRUG ABUSE AND DEPENDENCE
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9
The abuse and dependence potential of gabapentin has not been evaluated in human studies.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8000 mg/kg. Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation.
Acute oral overdoses of gabapentin up to 49 grams have been reported. In these cases, double vision, slurred speech, drowsiness, lethargy and diarrhea were observed. All patients recovered with supportive care.
Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient’s clinical state or in patients with significant renal impairment.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Gabapentin tablets are given orally with or without food. Patients should be informed that, should they break the scored 600 or 800 mg tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within several days of breaking the scored tablet should be discarded.
If gabapentin dose is reduced, discontinued or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Gabapentin tablets, USP are supplied as follows:
600 mg tablets;
White to off white, biconvex, oval shape, coated tablet scored on both sides and debossed with “202” on one side, available in:
Bottle of 30: NDC 21695-058-30
Bottle of 42: NDC 21695-058-42
Bottle of 60: NDC 21695-058-60
Bottle of 90: NDC 21695-058-90
Bottle of 100: NDC 21695-058-00
800 mg tablets;
White to off white, biconvex, oval shape, coated tablet scored on both sides and debossed with “204” on one side, available in:
Bottle of 30: NDC 21695-059-30
Bottle of 60: NDC 21695-059-60
Bottle of 90: NDC 21695-059-90
Bottle of 100: NDC 21695-059-00