Description

COMPOSITION
Each capsule contains:
Gabapentin (300 mg)

PHARMACOLOGY
Gabapentin is structural related to the neurotransmitter-aminobutyric acid
(GABA) but its mechanism of action is different from that of several drugs that interact with GABA synapses, eg. valproat,
barbiturat, GABA transminase inhibitor, GABA uptake inhibitor, GABA agonist, GABA prodrugs.

PHARMACOKINETICS
Gabapentine does not bind to plasma protein. Its volume of distribution is
57,7 L. In epileptic patients, concentration of Gabapentin in CSF is about 20% of its steady-state plasma concentration,
excreted via the renal route only. Gabapentine does not induce oxidase enzymes which influences drug metabolism.

PRODUCT INFORMATION
In the elderly patients with renal dysfunction, plasma clearance of gabapentine is decreased, elimination rate is constant and
plasma and renal clearance is compared directly with creatinine clearance. Gabapentine can be removed from plasma by
hemodialysis. Dosage adjustment is recommended in patients with renal dysfunction or those undergoing hemodialysis (see
dosage).

INDICATIONS
As add-on therapy antiepileptic drug for partial seizures and for partial seizures with secondary generalization in patients who
have not achieved satisfactory control to standard anticonvulsants used alone or in combination. or who are intolerant to
therapeutic doses of these drugs.

DOSAGE AND ADMINISTRATION
Adults and children > 12 years :
Gabapentine is given orally without meals.
The effective dose is 900-1800 mg/day. Titration to an effective dose can progress rapidly and can be accomplished over few
days by administering 300 mg once a day 1; 300 mg twice a day on day 2; and 300 mg 3 times a day on day 3. Thereafter,
the dose can be increased to 1200 mg/day given in 3 equally divided doses and if necessary, further titration can occur using
increment of 300 mg/day given in 3 equally divided doses up to a maximum of 2400 mg/day.
The maximum time between doses in a 3 times daily schedule should not exceed
12 hours. If gabapentine is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be
done gradually over a minimum of 1 week.
Patients with compromised renal function or those undergoing haemodialysis :
Dosage adjustment is recommended (see table).

Table. Maintenance Dosage of Gabapentine in Adults with Reduced Renal Function.

Renal Function Creatinine Clearance (ml/min)        Total Daily Dosea (mg/day) NORMAL DOSAGE

≥ 80                                                 900         1200         2400
50 – 79                                             600          600         1200
30 – 49                                             300          300           600
15 – 29                                             150          300           300
< 15                                                 150b        150b        150b
Haemodialysis                                       –                       200-300d

Total daily dose should be administered as three times a day (in the morning, at noon and in the evening