Gabix is given in titrations that lead to an effective dose. Treatment progresses rapidly and can be accomplished over a few days. The total dose should be divided into 3 doses given at intervals not exceeding 12 hrs.
In patients with poor general health ie, low body weight, after organ transplantation, the dose should be titrated more slowly, either by using smaller dosage strengths or longer intervals between dosage increases.
Epilepsy: Epilepsy typically requires long-term therapy. Dosage is determined by the treating physician according to individual tolerance and efficacy.
Adults and Children >12 years: Effective Dosing Range: 900-3600 mg/day. Therapy may be initiated by titrating the dose (described as follows) or by administrating 300 mg 3 times a day on day 1.
Dose Titration: Day 1: 300 mg once a day. Day 2: 300 mg 2 times a day. Day 3: 300 mg 3 times a day.
Thereafter, based on individual patient response and tolerability, the dose can be further increased in increments of 300 mg/day 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 1 week, to reach 2400 mg/day is a total of 2 weeks and to reach 3600 mg/day is a total of 3 weeks. The total daily dose should be divided in 3 single doses, the maximum time interval between the doses should not exceed 12 hrs to prevent breakthrough convulsions.
Children ≥6 years: Starting Dose: 10-15 mg/kg/day. The effective dose is reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin in children ≥6 years is 25-35 mg/kg/day. Dosages up to 50 mg/kg/day have been well-tolerated. The total daily dose should be divided in 3 single doses, the maximum time interval between doses should not exceed 12 hrs. 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.
Neuropathic Pain: The therapy may be initiated by titrating the dose as follows: Day 1: 300 mg once a day. Day 2: 300 mg 2 times a day. Day 3: 300 mg 3 times a day.
Alternatively, the starting dose is 900 mg/day given as 3 equally divided doses. Thereafter, based on individual patient response and tolerability, the dose can be further increased in increments of 300 mg/day 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 1 week, to reach 2400 mg/day is a total of 2 weeks and to reach 3600 mg/day is a total of 3 weeks.
Patients with Renal Impairment: A dosage adjustment is recommended in renally impaired patients and/or those undergoing hemodialysis.
Creatinine Clearance ≥80 mL/min: Total Daily Dosea: 900-3600 mg/day. 50-79 mL/min: 600-1800 mg/day. 30-49 mL/min: 300-900 mg/day. 15-29 mL/min: 150b-600 mg/day. <15c mL/min: 150b-300 mg/day.
aTotal daily dose should be administered as a 3 times a day regimen. Doses used to treat patients with normal renal function (CrCl >80 mL/min) range from 900-3600 mg/day. Reduced dosages are for patients with renal impairment (CrCl <79 mL/min).
bTo be administered as 300 mg on every other day.
cFor patients with CrCl <15 mL/min, the daily dose should be reduced in proportion to CrCl (eg, patients with CrCl of 7.5 mL/min should receive ½ of the daily dose that patients with CrCl of 15 mL/min receive).
Anuric Patients Undergoing Hemodialysis Who Have Never Received Gabapentin: 300-400 mg loading dose then 200-300 mg of Gabix following each 4 hrs of hemodialysis. On dialysis-free days, there should be no treatment with gabapentin.
Renally Impaired Patients Undergoing Hemodialysis: Maintenance dose of gabapentin should be based on the dosing recommendations mentioned previously. In addition to the maintenance dose, an additional dose of 200-300 mg following each 4-hr hemodialysis treatment is recommended.
Discontinuation of Gabix: If gabapentin has to be discontinued, it is recommended that this should be done gradually over a minimum of 1 week independent of the indication.
Administration: Gabix may be given orally with or without food and should be swallowed whole with sufficient fluid intake (eg, a glass of water).
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