Expiration date: 12/2025
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.
