displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Gabapentin tablets USP are supplied as oval shaped, film-coated, biconvex scored tablets containing 600 mg and 800 mg of gabapentin USP.
The inactive ingredients for the tablets are corn starch, copovidone, poloxamer 407, magnesium stearate, polyethylene glycol, talc, hypromellose, titanium dioxide, macrogol, polysorbate 80 and purified water.
Gabapentin USP is described as 1-(aminomethyl) cyclohexaneacetic acid with a molecular formula of C H NO and a molecular weight of 171.24. The structural formula of gabapentin is:
Gabapentin USP is a white to off-white crystalline solid with a pK of 3.7 and a pK 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: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Gabapentin tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
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 USP 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 tablets USP 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
NDC:64725-0126-1 in a BOTTLE of 100 TABLETS