Gabatin 300mg

Tablet
Gabapentin
Unimed Unihealth MFG. Ltd

Other Strength:

Alternative:
- Gabastar® 300mg
- Gaba 300mg



Gabatin
Presentation
Gabatin-300 tablet: Yellow, caplet shaped, film coated tablet having engraved on one side and scored on the other side; each tablet contains Gabapentin INN 300 mg.

Indications
Postherpetic Neuralgia : Gabapentin (Gabatin) is indicated for the management of postherpetic neuralgia in adults.

Epilepsy: Gabapentin (Gabatin) is an antiepileptic drug indicated as add-on therapy for partial seizures and partial seizures with secondary generalization in patients over 12 years of age with epilepsy. Gabapentin (Gabatin) is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 – 12 years.

Dosage & administration
For oral administration only Postherpetic Neuralgia: In adult with postherpetic neuralgia, Gabapentin (Gabatin) therapy may be indicated as single 300 mg dose on day 1, 600 mg/day on day 2 (divided BID), and 900 mg/day on day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range. Additional benefit of using doses greater than 1800 mg/day was not demonstrated. Epilepsy: The anti-epileptic effect of Gabapentin (Gabatin) generally occurs at 900 – 1200 mg/day. It is not necessary to monitor Gabapentin plasma concentrations to optimise Gabapentin therapy. Titration to an effective dose can 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. Thereafter, the dose can be increased to 1200 mg per day given in three equally divided doses, and if necessary, further titration can occur using increments of 300 mg per day given in three equally divided doses up to a maximum of 2400 mg per day The maximum time between doses in a three times daily schedule should not exceed 12 hours. If Gabapentin (Gabatin) is discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of one week.

Elderly: Elderly patients may require dosage adjustment because of declining renal function with age (see table 1 below). Table 1. Maintenance dosage of Gabapentin (Gabatin) in adults with reduced renal function
a. Loading dose of 300 to 400 mg
b. Maintenance dose of 200 to 300mg Gabapentin following each 4 hours of haemodialysis

Contra-indications, warnings, etc.
Contra-indications: Gabapentin is contra-indicated in patients who are hypersensitive to Gabapentin or to the product’s component.

Warnings: Although there is no evidence of rebound seizures with Gabapentin, abrupt withdrawal of anticonvulsant agents in epileptic patients may precipitate status epilepticus. When in the judgement of the clinician there is a need for dose reduction, discontinuation, or substitution of alternative anticonvulsant medication, this should be done gradually over a minimum of one week. Gabapentin is not generally considered effective in the treatment of absence seizures. Patients with epilepsy can be the subject o mood and behavioural disturbances. Such reports have been noted in patients on Gabapentin although a causal link has not been established.

Drug interactions: 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. There is no interaction between Gabapentin and Phenytoin, Valproic acid, Carbamazepine or Phenobarbital. Gabapentin steady-state pharmacokinetics are similar for healtlw subjects and patients with epilepsy receiving anti-epileptic agents. Co-administration of Gabapentin with oral contraceptives including norethisterone and/or ethinyl estradiol dose not influence the steady-state pharmacokinetics of either component. In a clinical study where Gabapentin and an aluminium and magnesium containing antacid were given at the same time, Gabapentin’s bio-availability was reduced by upto 24%. It is recommended that Gabapentin is taken about two hours following any such antacid administration. Renal excretion of Gabapentin is unaltered by probenecid. Food has no effect on Gabapentin pharmacokinetics.

Use in pregnancy and lactation: Safe use in human pregnancy has not been established. Reproduction studies in mice at doses up to 80 times the human dose and in rats and rabbits at doses up to 40 times the human dose revealed one evidence of impaired fertility or harm to the foetus due to Gabapentin administration. However, because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known if Gabapentin is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Gabapentin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Side-effects: Gabapentin has been evaluated for safety in more than 2000 subjects and patients and was well tolerated. Since Gabapentin was most often administered in combination with other antiepileptic agents, it is not possible to determine which agents, if any, are associated with adverse events. However, based on placebo-controlled, double blind studies, possible side-effects are: somnolence, dizziness, ataxia, fatigue, nystagmus, headache, tremor, diplopia, nausea and/or vomiting, rhinitis and amblyopia. Less common side-effects are: pharyngitis, dysarthria, weight increase, dyspepsia, amnesia, nen/ousness and myalgia.

Overdose: In limited experience with overdoses, dizziness, double vision and slurred speech have been noted. Although Gabapentin can be removed by heamodialysis, it is not usually required. However, in patients with renal impairment, heamodialysis may be indicated.

Pharmaceutical precautions
Store in a cool and dry place, protected from light.

Package quantities
Gabatin-300 tablet: Cartons containing 20 tablets in blister.

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