GABAPENTIN- gabapentin solution
Acella Pharmaceuticals, LLC
Gabapentin Oral Solution is indicated for:
- Management of postherpetic neuralgia in adults
- 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
In adults with postherpetic neuralgia, gabapentin may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated.
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 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Gabapentin Oral Solution should be administered three times a day. The maximum time between doses should not exceed 12 hours.
Pediatric Patients Age 3 to 11 yearsThe starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The effective 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. 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):
|TID = Three times a day; BID = Two times a day; QD = Single daily dose|
|Renal Function Creatinine Clearance (mL/min)||Total Daily Dose Range (mg/day)||Dose Regimen (mg)|
|≥ 60||900 to 3600||300 TID||400 TID||600 TID||800 TID||1200 TID|
|>30 to 59||400 to 1400||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 *||100 to 300||100 QD||125 QD||150 QD||200 QD||300 QD|
|Post-Hemodialysis Supplemental Dose (mg) †|
|Hemodialysis||125 †||150 †||200 †||250 †||350 †|
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.
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).
Oral solution: 250 mg per 5 mL (50 mg per mL), clear colorless to slightly yellow solution
Gabapentin Oral Solution 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 Oral Solution should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
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