Venpa

Venpa® 25 mg capsule: Each capsule contains Pregabalin USP 25 mg.

Venpa® 50 mg capsule: Each capsule contains Pregabalin USP 50 mg.

Venpa® 75 mg capsule: Each capsule contains Pregabalin USP 75 mg.

Pregabalin is a structural derivative of gamma-amino-butyric acid (GABA). It does not bind directly to GABAA, GABAB & benzodiazepine receptors. It binds with high affinity to the alpha-2-delta 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.

1. Neuralgia:

                ● Pain from diabetic neuropathy

                ● Postherpetic neuralgia

2. Partial seizure/epilepsy:

                ● Pregabalin is also indicated as adjunctive therapy for adult patients with partial-onset seizures

3. Can be used for the management of Fibromyalgia & Neuropathic pain associated with spinal cord injury.

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.

Postherpetic 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.

Management of Fibromyalgia: The recommended dose of Pregabalin for Fibromyalgia is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day) and may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day 450 mg/day).

Neuropathic pain associated with spinal cord injury: The recommended dose range is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after treatment with 300 mg/day and who tolerate Pregabalin may be treated with up to 300 mg two times a day. Venpa® Capsules can be taken without regards to meals.

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

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.

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.

Store at temperature not exceeding 30º C in a dry place. Protect from light.

Venpa® 25 mg capsule: Each box contains 30 (3X10's) capsules in Alu-Alu blister strips.

Venpa® 50 mg capsule: Each box contains 30 (3X10's) capsules in Alu-Alu blister strips.

Venpa® 75 mg capsule: Each box contains 30 (3X10's) capsules in Alu-Alu blister strips.