Expiration date: 04/2026

Structure and Composition:

The capsules. One capsule contains Gabapentin 100, 300 or 400 mg

Excipients: lactose, corn starch, talc

in blisters of 10 pieces. a stack of cardboard 2, 5 or 10 packages.

Dosage and administration:

Inside, regardless of meals or with food.

Epilepsy. Adults and children over 12 years: the effective dose - 900-3600 mg / day. Therapy can be started with a dose of 300 mg three times a day for the first day or dose titration as described below. Subsequently the dose may be increased to a maximum of 3600 mg / day (equal to 3 admission). In the long-term open-label clinical studies tolerated at doses up to 4800 mg / day was good. The maximum interval between doses at three receiving the drug should not exceed 12 hours in order to avoid the appearance of seizures.

Initial dose titration
Dose	Day 1	Day2	day 3
900 mg	300 mg 1 time a day	300 mg 2 times a day	300 mg 3 times a day

Children 3-12 years: effective dose - 25-35 mg / kg / day in 3 equal doses doses (see table.). Begin to titrate the dose may be effective for 3 days: 10 mg / kg / day on the first day, 20 mg / kg / day on the second day and 30 mg / kg / day on the third day (see table.). subsequently the dose can be increased to a maximum - 35 mg / kg / day in 3 equal doses reception. The extended clinical study tolerability at doses of 40-50 mg / kg / day was good.

.

Dosages of gabapentin in children aged 3-12 years
Body Weight in kg	The daily dose, mg / day
17-25	600
26-36	900
37-50	1200
51-72	1800

Initial dose titration in children
Body Weight in kg	Dose	Day 1	Day 2	Day 3
17-25	600 mg	200 mg 1 time a day	200 mg 2 times a day	200 mg 3 times a day
³26	900 mg	300 mg 1 time a day	300 mg 2 times a day	300 mg 3 times a day

Gabapentin may be used in combination with other antiepileptic drugs, without fear of changes in concentrations of gabapentin in the plasma and serum concentrations of other anti-epileptic drugs. Cancelling gabapentin and / or add to the treatment of other anticonvulsants should be phased in over at least 1 week.

Neuropathic pain in adults. Initial dose - 900 mg / day in 3 divided doses equal doses as necessary, depending on the effect of gradually increasing the dose until a maximum of 3600 mg / day. Initiate therapy on the selection of doses should be as described in the first table.

Patients with impaired renal function or patients undergoing hemodialysis, dose reduction is recommended (see. Table).

Dosages of gabapentin in adult kidney function given
Cl creatinine, ml / min	The daily dosea, mg / day
³80	900-3600
50-79	600-1800
30-49	300-900
15-29	150b-600
<15	150b-300

a) daily dose should be administered in 3 doses. In patients with normal renal function (Cl creatinine> 80 ml / min), the dose ranges from 900 to 3600 mg / day. Patients with impaired kidney (Cl creatinine <79 ml / min), the dose should be reduced.

b) Assign to 300 mg a day.

Patients receiving hemodialysis who have not previously received gabapentin, a drug is recommended to be administered in a dose of 300-400 mg of shock, and then apply it to 200-300 mg every 4 hours of hemodialysis.