Generic Name
PregabalinTherapeutic Class: Drugs of Nervous System (Adjunct anti-epileptic drugs)
Indications:
Pregabalin is indicated for:
Pregabalin 25: Each capsule contains Pregabalin INN 25 mg.
Pregabalin 50: Each capsule contains Pregabalin INN 50 mg.
Pregabalin 75: Each capsule contains Pregabalin INN 75 mg.
Pregabalin 150: Each capsule contains Pregabalin INN 150 mg.
Description:
Pregabalin is a structural derivative of gamma-amino-butyric acid (GABA). It does not bind directly to GABAA, GABAB, or benzodiazepine receptors. It binds with high affinity to the alpha 2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. The oral bioavailability of Pregabalin is 90%. Pregabalin is eliminated largely by renal excretion and has an elimination half-life of about 6 hours. Pregabalin can be taken with or without food.
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 regard to meals.
Side Effects:
Pregabalin is well tolerated but a few side effects like dizziness, somnolence, and blurred vision may occur.
Precautions:
Abrupt or rapid discontinuation of Pregabalin may produce some symptoms including insomnia, nausea, headache, and diarrhea. 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.
Use in 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 breast milk like other drugs, so it should be used in nursing women only if the benefits clearly overweigh the risks.
Pediatric Use:
The safety and efficacy of Pregabalin in pediatric patients have not been established.
Interaction:
The extent of Pregabalin absorption is unaffected by gabapentin co-administration. It does not interact with other antiepileptic agents or oral contraceptive preparations.
Overdose:
Overdosage of up to 8000 mg have been reported. The symptoms consist of dizziness, somnolence, blurred vision, and mild diarrhea. Pregabalin can be removed by emesis or gastric lavage.
Storage:
Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.
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.
Pregabalin 25: Each capsule contains Pregabalin INN 25 mg.
Pregabalin 50: Each capsule contains Pregabalin INN 50 mg.
Pregabalin 75: Each capsule contains Pregabalin INN 75 mg.
Pregabalin 150: Each capsule contains Pregabalin INN 150 mg.
Description:
Pregabalin is a structural derivative of gamma-amino-butyric acid (GABA). It does not bind directly to GABAA, GABAB, or benzodiazepine receptors. It binds with high affinity to the alpha 2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. The oral bioavailability of Pregabalin is 90%. Pregabalin is eliminated largely by renal excretion and has an elimination half-life of about 6 hours. Pregabalin can be taken with or without food.
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 regard to meals.
Side Effects:
Pregabalin is well tolerated but a few side effects like dizziness, somnolence, and blurred vision may occur.
Precautions:
Abrupt or rapid discontinuation of Pregabalin may produce some symptoms including insomnia, nausea, headache, and diarrhea. 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.
Use in 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 breast milk like other drugs, so it should be used in nursing women only if the benefits clearly overweigh the risks.
Pediatric Use:
The safety and efficacy of Pregabalin in pediatric patients have not been established.
Interaction:
The extent of Pregabalin absorption is unaffected by gabapentin co-administration. It does not interact with other antiepileptic agents or oral contraceptive preparations.
Overdose:
Overdosage of up to 8000 mg have been reported. The symptoms consist of dizziness, somnolence, blurred vision, and mild diarrhea. Pregabalin can be removed by emesis or gastric lavage.
Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.
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