Gaban 600 mg – Film-Coated Tablets

Composition

Each film-coated tablet contains :  

• Gabapentin: 600 mg.
• Excipients: S.Q. for one film-coated tablet.

Indications

• Postherpetic Neuralgia: Gaban (gabapentin) is indicated for the management of postherpetic neuralgia in adults.
• Epilepsy: Gaban (gabapentin) is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. GABAN is indicated also as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.

Dosage & Administration

Postherpetic Neuralgia:

In adults with postherpetic neuralgia, Gaban therapy may be initiated as a single 300-mg dose on day 1, 600 mg/day on day 2 (divided BID), and 900 mg/day on day 3 (divided TID).

The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800mg (divided TID).

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.

Additional benefit of using doses greater than 1800 mg/day was not demonstrated.

Epilepsy:

Gaban is recommended for add-on therapy in patients 3 years of age and older.

Patients > 12 years of age:

The effective dose of Gaban is 900 to 1800 mg / day and given in divided doses (three times a day) using 300 mg or 400 mg capsules or 600 or 800 mg tablets.

If necessary the dose may be increased using 300 or 400 mg capsules or 600 or 800 mg tablets, three times a day up to 1800 mg/day.

Dosages up to 2400 mg/ day have been well tolerated, doses of 3600 mg /day have also been administered for a short duration and have been well tolerated.

The maximum time between doses in the three times a day schedule should not exceed 12 hours.

Pediatric patients age 3 – 12 years:

The starting dose should range from 10 – 15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin for patients 5 years of age and older is 25 – 35 mg/ kg/ day and given in divided doses (three times a day).

Dosages up to 50 mg/ kg/ day have been well-tolerated and the maximum time interval between doses should not exceed 12 hours.

If Gaban  is discontinued and / or an alternate anticonvulsants medication is added to the therapy, this should be done gradually over a minimum of 1 week.

Dosage in renal impairment:

In patients with stable renal functions creatinine clearance can be reasonably well estimated.

Dosage adjustment in patients ≥ 12 years of age with compromised renal functions or undergoing hemodialysis is recommended as follows in Table (1):

For patients with creatinine clearance < 15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with creatinine clearance of 7.5mL/min should receive one half the daily dose that patients with a creatinine clearance of 15 mL/min receive).

Table ( 2 )

Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the table (1) and supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the table (2 )

Dosage in Elderly:

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and should be adjusted based on creatinine clearance values in these patients.