Slower titration of gabapentin dosage may be appropriate for individual patients. 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. Alternatively, the starting dose is 900 mg/day given as three equally divided doses. The therapy may be initiated by titrating the dose as described in Table 1. Further, gabapentin may be used in combination with other antiepileptic medicinal products without concern for alteration of the plasma concentrations of gabapentin or serum concentrations of other antiepileptic medicinal products. It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. The total daily dose should be divided in three single doses, the maximum time interval between doses should not exceed 12 hours. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The effective dose of gabapentin in children aged 6 years and older is 25 to 35 mg/kg/day. The starting dose should range from 10 to 15 mg/kg/day and the effective dose is reached by upward titration over a period of approximately three days. 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. Dosages up to 4800 mg/day have been well tolerated in long-term open-label clinical studies. 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.
Therapy may be initiated by titrating the dose as described in Table 1 or by administering 300 mg three times a day (TID) on Day 1. In clinical trials, the effective dosing range was 900 to 3600 mg/day. Dosage is determined by the treating physician according to individual tolerance and efficacy. 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.Įpilepsy typically requires long-term therapy. Date of first authorisation/renewal of the authorisation
4.7 Effects on ability to drive and use machines.4.5 Interaction with other medicinal products and other forms of interaction.
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