Neurega 50

Generic

Pregabalin

 

Indications

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

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

 

Pharmacology

Pregabalin is a structural derivative of gamma-aminobutyric acid, an inhibitory neurotransmitter (GABA). It does not bind to the GABAA, GABAB, or benzodiazepine receptors directly. Pregabalin binds to the alpha-2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues with great affinity. Pregabalin has a 90% oral bioavailability that is dosage independent. It is predominantly removed from the systemic circulation as unaltered drug via renal excretion, with a mean elimination half-life of 6.3 hours in patients with normal renal function.

 

Dosage & Administration

Neuropathic pain associated with diabetic peripheral neuropathy: The maximum recommended dose of Pregabalin 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 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: In general, it is recommended that patients be started on a total daily dose no 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.

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.

Pregabalin capsules can be taken without regards to meals.

 

Interaction

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

 

Contraindications

Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin.

 

Side Effects

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

 

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 overcome the risks.

 

Precautions & Warnings

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,

 

Therapeutic Class

Anti-epileptic medications taken in addition

 

Storage Conditions

Store within 25°C.

 

Phamaceutical Name

Ibn Sina Pharmaceuticals Ltd.