XIL Capsule

Indications & Uses

Pregabalin is indicated for:

1. Management of neuropathic pain (diabetic neuropathy, postherpetic neuralgia etc.)

2. Management of fibromyalgia

3. Adjunctive therapy for partial onset of seizures/ epilepsy

4. GAD (Generalized anxiety disorder)

Dosage & administration

1. Neuropathic pain, initially 150 mg daily in 2-3 divided doses, increased if necessary after 3-7 days to 300 mg daily in 2-3 divided doses, increased further if necessary after 7 days to max. 600 mg daily in 2-3 divided doses. Child and adolescent under 18 years not recommended.

2. Fibromyalgia, -the recommended dose is 300 to 450 mg daily. Dosing should be begin at 150 mg daily in two divided doses and may be increased to 300 mg daily in two divided doses within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg daily may be further increased 450 mg daily in two divided doses.

3. Epilepsy, initially 150 mg daily in 2-3 divided doses, increased if necessary after 7 days to 300 mg daily in 2-3 divided doses, increased further if necessary after 7 days to max. 600 mg daily in 2-3 divided doses. Child and adolescent under 18 years not recommended.

4. Generalized anxiety disorder, initially 150 mg daily in 2-3 divided doses, increased if necessary at 7 days intervals in steps of 150 mg daily; max. 600 mg daily in 2-3 divided doses. Child and adolescent under 18 years not recommended.

Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin.

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

There are no pharmacokinetic interaction between Pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbitol and topiramate. Important pharmacokinetic interactions would also not be expected to occur between Pregabalin and commonly used antiepileptic drugs.

Use in Pregnancy & Lactation

Pregnancy: Pregabalin is a pregnancy category-C. 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.

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.

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 α2-d site (an auxiliary 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.