PG 50

Generic

Pregabalin

 

Indications

Pregabalin is prescribed to treat neuropathic pain caused by :

• diabetic peripheral neuropathy.
• Post-herpetic neuralgia treatment
• Adult patients with partial onset seizures may benefit from adjunctive treatment.
• Fibromyalgia is treated in a variety of ways.
• Neuropathic pain is a type of pain that occurs after a spinal cord injury.

 

Pharmacology

Pregabalin is a structural derivative of gamma-amino butyric acid, an inhibitory neurotransmitter (GABA). It has no direct GABAA, GABAB, or benzodiazepine receptor binding. In central nervous system tissues, pregabalin binds to the alpha-2-delta site (an auxiliary subunit of voltage-gated calcium channels) with a high affinity. Pregabalin has a 90% oral bioavailability that is dose-independent. It is largely excreted from the systemic circulation as an unaltered medication by the kidneys, having a 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

There are no significant interactions between Pregabalin with other antiepileptic drugs & oral contraceptive. Pregabalin may potentiate the effects of ethanol and lorazepam.

 

Contraindications

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

 

Side Effect

Dizziness, somnolence, dry mouth, edema, impaired vision, weight gain, and aberrant thinking are the most prevalent adverse effects.

 

Pregnancy & Lactation

Pregabalin has a pregnancy category of C. As a result, it should only be taken if the potential benefit outweighs the dangers to the fetus.

Pregabalin, like other medications, can pass into the breast milk, therefore it should only be used in nursing mothers if the benefits clearly outweigh the risks.

 

Precautions & Warnings

Pregabalin withdrawal without tapering might cause sleeplessness, nausea, headaches, and diarrhea. As a result, rather than stopping suddenly, it should be tapered gradually over a minimum of one week. If you use Pregabalin, your creatinine kinase level may rise. If myopathy is detected or suspected, or if creatinine kinase levels are abnormally high, it should be stopped immediately.

 

Therapeutic Class

Adjunct anti-epileptic drugs

 

Storage Conditions

Keep away from light and moisture in a cool, dry area (below 30° C). Keep out of children's reach.

 

Pharmaceutical Name

Eskayef Pharmaceuticals Ltd.