Presentation

Pregaben 25: Each capsule contains Pregabalin INN 25 mg.

Pregaben 50: Each capsule contains Pregabalin INN 50 mg.

Pregaben 75: Each capsule contains Pregabalin INN 75 mg.

Pregaben 150: Each capsule contains Pregabalin INN 150 mg.

Description

Pregabalin is a structural derivative of gamma-amino-butyric acid (GABA). It does not bind directly to GABAA, GABAB, or benzodiazepine receptors. It binds with high affinity to the alpha 2-delta site (an auxilliary subunit of voltage-gated calcium channels) in central nervous system tissues. Oral bioavailability of Pregabalin is 90%. Pregabalin is eliminated largely by renal excretion, and has an elimination half-life of about 6 hours. Pregabalin can be taken with or without food.

Indications

Neuralgia: (a) pain from diabetic neuropathy, (b) post herpetic neuralgia

Partial seizure / epilepsy: Pregabalin is also indicated as adjunctive therapy for adult patients with partial onset seizures.

Dosage & Administration

Diabetic neuropathic pain:

The maximum recommended dose of Pregabalin is 100 mg three times a day in patients with creatinine clearance of at least 60 mL/min. Dosing should begin at 50 mg three times a day and may be increased to 300 mg/day within 1 week based on efficacy and tolerability.

Post therapeutic neuralgia:

The recommended dose of Pregabalin is 75 to 150 mg two times a day, or 50 to 100 mg three times a day in patients with creatinine clearance of at least 60 mL/min. Dosing should begin at 75 mg two times a day, or 50 mg three times a day and may be increased to 300 mg/day within 1 week based on efficacy and tolerability.

Epilepsy:

The recommended dose of Pregabalin is 150 to 600 mg/day as adjunctive therapy in the treatment of partial onset seizures in adults.

Side Effects

Pregabalin is well tolerated but a few side effects like dizziness, somnolence and blurred vision may occur.

Precautions

Abrupt or rapid discontinuation of Pregabalin may produce some symptoms including insomnia, nausea, headache and diarrhoea. So Pregabalin should be tapered gradually over a minimum of 1 week rather than discontinued abruptly. Pregabalin treatment may associate with creatine kinase elevations. It should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.

Use in Pregnancy & Lactation

Pregnancy: Pregabalin is a pregnancy category-C drug. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Pregabalin may be secreted through the breast milk like other drugs, so it should be used in nursing women only if the benefits clearly overweigh the risks.

Pediatric Use

The safety and efficacy of Pregabalin in pediatric patients have not been established.

Drug Interaction

The extent of Pregabalin absorption is unaffected by gabapentin co-administration. It does not interact with other antiepileptic agents or oral contraceptive preparations.

Over Dose

Overdosage of up to 8000 mg has been reported. The symptoms consist of dizziness, somnolence, blurred vision and mild diarrhoea. Pregabalin can be removed by emesis or gastric lavage.

Commercial Pack

Pregaben 25: Box containing 3 blister strips of 10 capsules.

Pregaben 50: Box containing 3 blister strips of 10 capsules.

Pregaben 75: Box containing 3 blister strips of 10 capsules.

Pregaben 150: Box containing 2 blister strips of 10 capsules.