GABAPENTIN- gabapentin tablet, film coated
Megalith Pharmaceuticals Inc
Gabapentin is indicated for:
- Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Patients 12 years of age and above
The starting dose is 300 mg three times a day. The recommended maintenance dose of gabapentin is 300 mg to 600 mg three times a day. Dosages up to 2,400 mg/day have been well tolerated in long-term clinical studies. Doses of 3,600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Administer gabapentin three times a day using 600 mg or 800 mg tablets. The maximum time between doses should not exceed 12 hours.
Pediatric Patients Age 3 to 11 years
The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of gabapentin in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Gabapentin may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.
Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):
|Renal Function Creatinine Clearance (mL/min)||Total Daily Dose Range (mg/day)||Dose Regimen (mg)|
|≥ 60||900 to 3,600||300 TID||400 TID||600 TID||800 TID||1,200 TID|
|> 30 to 59||400 to 1,400||200 BID||300 BID||400 BID||500 BID||700 BID|
|> 15 to 29||200 to 700||200 QD||300 QD||400 QD||500 QD||700 QD|
|15 a||100 to 300||100 QD||125 QD||150 QD||200 QD||300 QD|
|Post-Hemodialysis Supplemental Dose (mg) b|
|Hemodialysis||125 b||150 b||200 b||250 b||350 b|
TID = Three times a day; BID = Two times a day; QD = Single daily dose
a For patients with creatinine clearance < 15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:
The use of gabapentin in patients less than 12 years of age with compromised renal function has not been studied.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients.
Administer gabapentin orally with or without food.
Inform patients that, should they divide the scored 600 mg or 800 mg gabapentin tablet in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within 28 days of dividing the scored tablet should be discarded.
If the 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).
- Gabapentin Tablets USP, 600 mg are white, elliptical, film-coated scored tablets debossed “O|E” on one side and “600” on the other side
- Gabapentin Tablets USP, 800 mg are white, elliptical, film-coated scored tablets debossed “O|E” on one side and “800” on the other side
Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with gabapentin. Some of these reactions have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Gabapentin should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
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