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Gabafion

Gabapentin

Short Description

Gabafion with Gabapentin as active ingredient, available in capsule 300 mg.

Indications

Epilepsy :

Gabafion is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children

age 3 years and above.

Neuropathic pain :

Gabafion is indicated for the treatment of neuropathic pain in adults age 18 years and above.

Specification

General :

Gabapentin is given orally with or without food. When in the judgement of the clinician there is a need for dose reduction, discontinuation, or

substitution with an alternative medication, this should be done gradually over a minimum of one week.


Epilepsy :

Adults and pediatric patients over 12 years of age :

The effective dosing range was 900 to 1800 mg/day. Therapy may be initiated by  ministering 300 mg (TID) on day 1, or by titrating the dose as described below :


DOSING CHART – INITIAL TITRATION

Dose : 900 mg

Day-1 : 300 mg QD (Once a day (in the evening))

Day-2 : 300 mg BIDb (Two times a day (in the morning and evening))

Day-3 : 300 mg TIDc (Three times a day (in the morning, at noon and in the evening))


Thereafter, the dose can be increased in three equally divided doses up to a maximum dose of 2400 mg/day. The maximum time between

doses in the three times a day (TID) schedule should not exceed 12 hours to prevent breakthrough convulsions.


Pediatric patients age 3 – 12 years :

The starting dose should range from 10 to 15 mg/kg/day given in equally divided doses (three times a day), and the effective dose reached by upward

titration over a period of approximately three days. The effective dose of Gabapentin in pediatric patients age 5 years and older is 25 to 35 mg/kg/day

given in equally divided doses (three times a day). The effective dose in pediatric patients ages 3 to less than 5 years is 40 mg/kg/day given in equally

divided doses (three times a day). The maximum time interval between doses should not exceed 12 hours.

It is not necessary to monitor Gabapentin plasma concentrations to optimize Gabapentin therapy. Further, Gabapentin may be used in combination

with other antiepileptic drugs without concern for alteration of the plasma concentrations of Gabapentin or other antiepileptic drugs.


Neuropathic pain in adults :

Gabafion should be titrated to a maximum dose of 1800 mg per day. Titration to an effective dose can be progress rapidly and can be accomplished

over a few days by administering 300 mg once a day on day 1, 300 mg twice a day on day 2 and 300 mg three times a day on day 3, as described in TABLE 1.

Thereafter, the dose can be increased using increments of 300 mg per day given in three devided doses to a maximum of 1800 mg per day.

Dosage adjustment in impaired renal function for patients with neuropathic pain or epilepsy :

Dosage adjustment is recommended in patients with compromised renal function as described in the insert and/or those undergoing hemodialysis.


Dosage adjustment in patients undergoing hemodialysis :

For patients undergoing hemodialysis who have never received Gabapentin, a loading dose of 300 to 400 mg is recommended, then 200 to 300

mg of Gabapentin following each 4 hours of hemodialysis. On dialysis-free days there should be no treatment with Gabapentin. If Gabapentin

discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.


Route and duration of administration :

Gabapentin capsules should be swallowed whole with sufficient fluid intake. Administration may be made during or between meals. In threetimes

daily administration, care should be taken that the interval between two single doses does not exceed 12 hours.

Whether a missed dose of Gabapentin (this means more than 12 hours passed since the last administration) should be made up for by taking

an additional dose of Gabapentin later or not is at the physician’s direction.

In concurrent treatment with Magnesium or Aluminium containing antacids, Gabapentin should be taken at least 2 hours after administration of

the antacid. This largely avoids a reduction in Gabapentin bioavailability.

The duration of administration depends on the clinical requirements. In the treatment epilepsy, usually, long term therapy is required.

If therapy with Gabapentin capsules should be discontinued, the dose reduced, or switched to another drug, this should be done gradually over

a minimum of one week, although there is no evidence of a rebound phenomenon (increased occurance of epileptic seizures following abrupt

withdrawal of therapy).

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Central Nervous System Product