Epiven Dosage/Direction for Use



Novell Pharma


Averroes Pharma
Full Prescribing Info
Dosage/Direction for Use
General: Gabapentin is given orally with or without food.
When in the judgment of the clinician there is a need for dose reduction, discontinuation, or substitution with an alternative medication, this should be done gradually over a minimum of one week.
Epilepsy: Adults and pediatric patients over 12 years of age: The effective dosing range was 900 to 3600 mg/day. Therapy may be initiated by administering 300 mg three times a day (TID) on Day 1, or by titrating the dose as described in Table 1. Thereafter, the dose can be increased in three equally divided doses up to a maximum dose of 3600 mg/day. Dosages up to 4800 mg/day have been well tolerated in long-term open-label clinical studies. The maximum time between doses in the three times a day (TID) schedule should not exceed 12 hours to prevent breakthrough convulsions. (See Table 1.)

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Pediatric patients age 3-12 years: The starting dose should range from 10 to 15 mg/kg/day given in equally divided doses (three times a day), and the effective dose reached by upward titration over a period of approximately three days. The effective dose of gabapentin in pediatric patients age 5 years and older is 25 to 35 mg/kg/day given in equally divided doses (three times a day). The effective dose in pediatric patients ages 3 to less than 5 years is 40 mg/kg/day given in equally divided doses (three times a day). 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.
It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, gabapentin may be used in combination with other antiepileptic drugs without concern for alteration of the plasma concentrations of gabapentin or serum concentrations of other antiepileptic drugs.
Neuropathic pain in adults: The starting dose is 900 mg/day given as three equally divided doses, and increased if necessary, based on response, up to a maximum dose of 3600 mg/day. Therapy should be initiated by titrating the dose as described in Table 1.
Dosage adjustment in impaired renal function for patients with neuropathic pain or epilepsy: Dosage adjustment is recommended in patients with compromised renal function as described in Table 2 and/or those undergoing hemodialysis. (See Table 2.)

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Dosage adjustment in patients undergoing hemodialysis: For patients undergoing hemodialysis who have never received gabapentin, a loading dose of 300 to 400 mg is recommended, then 200 to 300 mg of gabapentin following each 4 hours of hemodialysis.
Epiven Capsule is available in strength of 300mg. It is not able to deliver all approved dose regimens of gabapentin; other approved dosage forms and strengths of gabapentin should be used in such cases.
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