Prelica 50

Generic

Pregabalin

 

Indications

Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy and management of post herpetic neuralgia. It is also indicated for the adjunctive therapy for partial onset seizures in patients 1 month of age and older. It can be used for the management of fibromyalgia & neuropathic pain associated with spinal cord injury.

 

Pharmacology

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-amino butyric acid (GABA). It does not bind directly to GABAA, GABAB, 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.

 

Dosage & Administration

Neuropathic pain associated with diabetic peripheral neuropathy: In patients with a creatinine clearance of at least 60 mL/min, the maximum recommended dose of Pregabalin is 100 mg three times per day (300 mg/day). Dosage should be started at 50 mg three times a day (150 mg/day) and raised to 300 mg/day within one week based on efficacy and tolerability.

Pregabalin is indicated for post-herpetic neuralgia at a dosage of 75 to 150 mg twice day, or 50 to 100 mg three times daily (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Dosing should start at 75 mg twice a day, or 50 mg three times a day (150 mg/day), and can be raised to 300 mg/day after one week based on efficacy and tolerability.

Adjunctive therapy for adult patients with partial-onset seizures: In general, patients should be started on a total daily dosage of no more than 150 mg/day (75 mg two times a day, or 50 mg three times a day). The dose may be raised to a maximum of 600 mg/day based on individual patient response and tolerability.

Fibromyalgia Management: The suggested dose of Pregabalin for fibromyalgia is 300 to 450 mg/day. Dosing should start at 75 mg twice day (150 mg/day) and be raised to 150 mg twice daily (300 mg/day) within 1 week based on efficacy and tolerability.

Neuropathic pain caused by a spinal cord injury: 150 to 600 mg/day is the suggested dosage range. The suggested beginning dose is 75 mg twice day (150 mg per day). Based on efficacy and tolerance, the dose may be raised to 150 mg twice day (300 mg/day) within one week.

Pregabalin pills can be taken with or without food.

 

Interaction

Pregabalin has no notable interactions with other antiepileptic medicines or oral contraceptives. Pregabalin has the potential to enhance the effects of ethanol and lorazepam.

 

Contraindications

Pregabalin is not recommended for individuals who have a history of hypersensitivity to Pregabalin or any of its components.

 

Side Effects

Common: Dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and abnormal thinking.

Rare: Muscle weakness, muscle pain, breathing problem, diarrhea etc.

 

Pregnancy & Lactation

Pregnancy: May cause fetal harm

Lactation: Breastfeeding is not recommended

 

Precautions & Warnings

Discontinuation of Pregabalin without tapering may produce insomnia, nausea, headache and diarrhea. So it should be tapered gradually over a minimum of 1 week rather than discontinued abruptly. Creatinine kinase may be elevated if treated with Pregabalin. It should be discontinued rapidly if myopathy is diagnosed or suspected or if creatinine kinase is elevated markedly.

 

Therapeutic Class

Anti-epileptic medications taken in addition

 

Storage Condition

Do not store above 300C, protect from light & moisture Keep out of the reach of children

 

Pharmaceutical Name

Radiant Pharmaceuticals Ltd.