PRODUCT DETAILS
Prelica® is a structural derivative of the inhibitory neurotransmitter gamma-amino butyric acid (GABA). Prelica is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, management of post herpetic neuralgia, partial onset seizures, management of fibromyalgia.

Prelica® does not bind directly to GABA A, GABA B, or benzodiazepine receptor. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake. Prelica® binds with high affinity to the alpha 2 -delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Prelica® oral bioavailability is equal or more than 90% and is independent of dose. It is eliminated from the systemic circulation primarily by renal excretion as unchanged drug with a mean elimination half-life of 6.3 hours in subjects with normal renal function.

Presentation:

Prelica® 25 : Each capsule contains Pregabalin INN 25 mg.
Prelica® 50 : Each capsule contains Pregabalin INN 50 mg.
Prelica® 75 : Each capsule contains Pregabalin INN 75 mg.

  Dosage and Administration

Neuropathic pain associated with diabetic peripheral neuropathy: The maximum recommended dose of Pregabalin (Prelica®) is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Dosing should begin at 50 mg three times a day (150 mg/day) and may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Post herpetic neuralgia: The recommended dose of Pregabalin (Prelica®) is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/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 (150 mg/day) and may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Adjunctive therapy for adult patients with partial onset seizures: Pregabalin (Prelica®) at doses of 150 to 600 mg/day has been shown to be effective as adjunctive therapy in the treatment of partial onset seizures in adults. The total daily dose should be divided and given either two or three times daily. In general, it is recommended that patients should be started on a total daily dose not greater than 150 mg/day (75 mg two times-a day, or 50 mg three times a day). Based on individual patient response and tolerability, the dose may be increased to a maximum dose of 600 mg/day. 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).

  Side Effects

The most common side effects include dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and abnormal thinking.

  Contraindications

Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.

  Use in Pregnancy and Lactation

Pregnancy: Pregnancy category C. So it should only use if potential benefit justifies the potential risks to the fetus.
It is not known if pregabalin is excreted in human milk; it is, however, present in the milk of rats. So it should be used in nursing mother only if there is a clear benefit over the risk.

  Drug Interaction

Prelica is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (<2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement.

  Over Dosage

There is limited experience with overdose of Prelica. The highest reported accidental overdose of Prelica during the clinical development program was 8000 mg, and there were no notable clinical consequences.

  Storage

Store in a cool & dry place, protect from light.

  Commercial Pack

Prelica® 25 capsule: Each box contains 30 capsules in Alu-Alu blister pack.
Prelica® 50 capsule: Each box contains 30 capsules in Alu-Alu blister pack.
Prelica® 75 capsule: Each box contains 30 capsules in Alu-Alu blister pack.

  • Prelica