Gabapentin Oral Solution, 250 mg / 5 mL, RX ONLY

/Gabapentin Oral Solution, 250 mg / 5 mL, RX ONLY
Gabapentin Oral Solution, 250 mg / 5 mL, RX ONLY2018-09-06T09:12:40+00:00

Prescription Drug Name:

Gabapentin Oral Solution, 250 mg / 5 mL, RX ONLY

ID:

ce4a0985-fac9-4688-9a48-0f2943bf6434

Code:

34391-3

DESCRIPTION


id: 56d8911c-2e2f-4be4-8ce2-6c60c997fd7e
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Gabapentin oral solution is supplied as an oral solution containing 250 mg/5 mL of gabapentin. The inactive ingredients for the oral solution are anise flavor, artificial strawberry flavor, glycerin, hydrochloric acid, purified water, sodium hydroxide and xylitol. 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.

CONTRAINDICATIONS


id: cb6cbe7c-eb78-424b-9df0-3cc9b6117e73
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Gabapentin oral solution is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

DRUG ABUSE AND DEPENDENCE


id: 7f811bcc-659e-4561-825c-8b1998e9f2ef
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

The abuse and dependence potential of gabapentin oral solution has not been evaluated in human studies.

OVERDOSAGE


id: be666251-7d0b-45a2-b484-359ad0cee8de
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 ADMlNlSTRATION


id: 24330299-d549-4c8e-ac9c-982762c4ff1d
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Gabapentin oral solution is given orally with or without food. If gabapentin oral solution 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).

HOW SUPPLIED


id: 3c2112c7-5059-4360-b11d-ba15ca396881
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Gabapentin Oral Solution is supplied as follows: 250 mg/5 mL oral solution; clear colorless to slightly yellow solution; each 5 mL of oral solution contains 250 mg of gabapentin; available in: Bottles containing 470 mL (NDC 59063-127-47).