Active Ingredient: Gabapentin
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above.
Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
900 - 4,800 mg
From 300 To 1,600 mg 3 time(s) per day every day
For all indications a titration scheme for the initiation of therapy is described in the following table, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section.
Dosing chart – Initial titration:
| Day 1 | Day 2 | Day 3 |
|---|---|---|
| 300 mg once a day | 300 mg two times a day | 300 mg three times a day |
In accordance with current clinical practice, if gabapentin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication.
Epilepsy typically requires long-term therapy. Dosage is determined by the treating physician according to individual tolerance and efficacy. Adults and adolescents In clinical trials, the effective dosing range was 900 to 3600 mg/day. Therapy may be initiated by titrating the dose as described in the table above or by administering 300 mg three times a day (TID) on Day 1. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day. Slower titration of gabapentin dosage may be appropriate for individual patients. The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600 mg/day is a total of 3 weeks. Dosages up to 4800 mg/day have been well tolerated in long-term open-label clinical studies. The total daily dose should be divided in three single doses, the maximum time interval between the doses should not exceed 12 hours to prevent breakthrough convulsions.
Elderly patients may require dosage adjustment because of declining renal function with age. Somnolence, peripheral oedema and asthenia may be more frequent in elderly patients.
Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid-intake (e.g. a glass of water).
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