GABACOR Capsule, hard Ref.[50338] Active ingredients: Gabapentin

Dosage

Epilepsy Dosage for Adults and Children older than 12 Years of Age

Initiation of treatment should be as add-on therapy. Gabapentin can be given orally with or without food.

In controlled clinical trials, the effective dose range was 900 mg/day to 1800 mg/day given in divided doses (three times a day).

Therapy may be initiated by administering 300 mg of gabapentin three times a day on Day 1, as 300 mg capsules, or by titrating the dose as described below.

Titration to an effective dose can take place rapidly, over a few days, giving 300 mg gabapentin on Day 1, 300 mg gabapentin twice a day on Day 2, 300 mg gabapentin three times a day on Day 3, as 300 mg capsules. Titration may be preferable for patients with renal impairment, patients with encephalopathy, patients on more than 2 other anti-epileptic drugs and patients with multiple other medical problems.

To minimise potential side effects, especially somnolence, dizziness, fatigue and ataxia, the first dose on Day 1 may be administered at bedtime. If necessary, the dose may be increased using 300 or 400 mg capsules three times a day up to 2400 mg/day. Dosages up to 2400 mg/day have been well tolerated in long-term open-label clinical studies.

The maximum time between doses in the three times a day schedule should not exceed 12 hours.

Neuropathic Pain in Adults older than 18 Years of Age

The starting dose is 900 mg/day given as three daily divided doses, and titrated if necessary, based on response, up to a maximum dose of 3600 mg/day.

Dosage for Children Aged 3 to 12 Years of Age

The effective dose of gabapentin is 25 to 35 mg/kg/day given in three divided doses (3 times a day). Titration to an effective dose can take place over 3 days by giving 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2, and 30 mg/kg/day on Day 3. Dosages up to 40 to 50 mg/kg/day have been well tolerated in a long-term clinical study. Doses of 60 mg/kg/day have also been administered to a small number of children.

Dosage Adjustment

Dose Adjustment in Impaired Renal Function in Patients with Neuropathic Pain or Epilepsy

Dose adjustment is recommended in patients with compromised renal function and/or those undergoing haemodialysis (see Table 1).

Table 1. Maintenance Dosage of Gabapentin in Adults with Reduced Renal Function:

^a Total daily dose should be administered as a divided TID regimen. Doses used to treat patients with normal renal function (creatinine clearance >80 mL/min) range from 900 mg/day to 3600 mg/day. Reduced dosages are for patients with renal impairment (creatinine clearance <79 mL/min).
^b To be administered as 300 mg every other day.

For patients undergoing haemodialysis who have never received gabapentin, a loading dose of 300 mg to 400 mg is recommended, and then 200 mg to 300 mg of gabapentin following each 4 hours of haemodialysis.

Unlike other agents in this class, it is not necessary to monitor gabapentin plasma concentrations to optimise gabapentin therapy. Further, gabapentin may be used in combination with other anti-epileptic drugs without concern for alteration of the plasma concentrations of gabapentin or serum concentrations of other anti-epileptic drugs.

Discontinuation of Gabapentin

If gabapentin is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of one week.(see Section 4.4 Special warnings and precautions for use: Discontinuation).

Signs and Symptoms

Symptoms of an overdose included somnolence, ataxia, dizziness, double vision, nystagmus, slurred speech, drowsiness, loss of consciousness, lethargy, mild hypotension and gastrointestinal symptoms including diarrhoea. Gabapentin overdose alone has not been reported to produce significant cardiotoxicity.

Overdoses as high as 108 g have been reported with full recovery following symptomatic therapy. Reduced absorption of gabapentin at higher doses may limit drug absorption at the time of overdosing and, hence, minimise toxicity from overdoses.

Treatment of Overdosage

There is no specific antidote for gabapentin; treatment is symptomatic. The patient should be monitored closely and given supportive care where necessary to maintain vital functions. Overdoses may involve other concurrent medications and should be treated accordingly.

Activated charcoal may reduce absorption of the drug if given within one hour after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected.

Gabapentin can be removed by haemodialysis. Although haemodialysis has not been performed in the few overdose cases reported, it may be indicated by the patient’s clinical state or in patients with significant renal impairment.

Ipecac-induced emesis is not recommended because of the potential for CNS depression.

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

Store below 25°C.

GABACOR 100 mg capsules are available in blister packs of 100 capsules.
GABACOR 300 mg capsules are available in blister packs of 4, 20 & 100 capsules.
GABACOR 400 mg capsules are available in blister packs of 100 capsules.

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.