SB-Gabalin 25Capsule

Generic

Pregabalin

Indications

Pregabalin is indicated for:

• Management of neuropathic pain associated with diabetic peripheral neuropathy
• Management of post-herpetic neuralgia
• Adjunctive therapy for adult patients with partial onset seizures
• Management of fibromyalgia
• Neuropathic pain associated with spinal cord injury.

Pharmacology

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid (GABA). It does not bind directly to the GABAA, GABAB, or benzodiazepine receptors. Pregabalin binds to the alpha2delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissue with high affinity. The oral bioavailability of pregabalin is ≥90% and is independent of dose. It is primarily eliminated from the systemic circulation as a prototype drug through renal excretion, 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: 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.

Interactions

There is no significant interaction between pregabalin and other anti-epileptic drugs and oral contraceptives. Pregabalin can enhance the effects of ethanol and lorazepam.

Contraindications

Patients known to be allergic to pregabalin or any of its ingredients should not use pregabalin.

Side Effects

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

Pregnancy & Lactation

The pregabalin pregnancy category is C. Therefore, it should only be used if the potential benefit justifies the potential risk to the fetus. 
 Pregabalin can be secreted through human milk like other drugs, so it should only be used in breastfeeding women if the benefits clearly outweigh the risks.

Precautions & Warnings

Stopping pregabalin without reducing pregabalin can cause insomnia, nausea, headache, and diarrhea. Therefore, it should be gradually reduced for at least 1 week, rather than stopped suddenly. If treated with pregabalin, creatinine kinase may increase. If myopathy is diagnosed or suspected or the creatinine kinase is significantly elevated, the drug should be discontinued immediately.

Therapeutic Class

Adjunct anti-epileptic drugs

Storage Conditions

Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.

Pharmaceutical Name

Sunman-Birdem Pharma Ltd.