PRESCRIBING INFORMATION
Presentation:
Prebalin 75: Each capsule contains Pregabalin INN 75 mg.
Prebalin 150: Each capsule contains Pregabalin INN 150 mg.
Pharmacodynamic Properties
The active substance, pregabalin is a gamma-aminobutyric acid analogue. Pregabalin binds to an auxiliary subunit (a2-d protein) of voltage-gated calcium channel in the central nervous system, potently displacing [3H]-gabapentin.
Pharmacokinetic Properties
Pregabalin is rapidly absorbed when administered in the fasted state. Oral bioavailability is 90% and is independent of dose. Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. Mean elimination half-life of Pregabalin is 6.3 hours.
Indications
Prebalin is indicated for the following condition-
# Fibromyalgia
# Neuropathic pain associated with diabetic peripheral neuropathy
# Postherpetic neuralgia
# Generalized Anxiety Disorder (GAD) in adults
# As adjunctive therapy in adults with partial seizures with or without secondary generalization
Dosage & Administration
Prebalin is given orally with or without food. The dose range of Prebalin is 150 to 600 mg per day given in either two or three divided doses. When discontinuing Prebalin, taper gradually over a minimum of 1 week.
Fibromyalgia: Adult over 18 years; The recommended dose 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 up to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability.
Neuropathic pain: Adult over 18 years; Initially 150 mg daily in 2-3 divided doses, increased if necessary after 3-7 days to 300 mg daily in 2-3 divided doses, increased further if necessary after 7 days to maximum 600 mg daily in 2-3 divided doses.
Postherpetic neuralgia: Adult over 18 years; The recommended dose for postherpetic neuralgia is 75 to 150 mg two times daily or 50 to 100 mg three times a day (150 to 300 mg/day). 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.
Generalized Anxiety Disorder: Adult over 18 years; Initially 150 mg daily in 2-3 divided doses, increased if necessary at 7-day intervals in steps of 150 mg daily; maximum 600 mg daily in 2-3 divided doses.
Epilepsy: Adult over 18 years; Initially 25 mg twice daily, increased at 7-day intervals in steps of 50 mg daily to 300 mg daily in 2-3 divided doses, increased further if necessary after 7 days to maximum 600 mg daily in 2-3 divided doses.
Child & Adolescents: Not recommended.
Contraindications
Pregabalin is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients.
Side Effects
Very commonly reported side effects are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain or abnormal thinking.
Precautions
Diabetic patients who gain weight on Pregabalin treatment may need to adjust hypoglycemic medications. Caution should be exercised when prescribing Pregabalin to patients who have had a previous episode of angioedema.
In Hepatic and Renal Impairment
Pregabalin clearance is directly proportional to creatinine clearance, so dosage reduction in patients with compromised renal function must be individualized according to creatinine clearance (CLcr). No dosage adjustment is required for patients with hepatic impairment.
Drug Interactions
Interaction may occur with CNS depressants (eg, alcohol, lorazepam, oxycodone).
Use in Pregnancy and Lactation
Pregnancy category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Breast-feeding is not recommended during treatment with Pregabalin.
Overdose
In overdoses up to 15 g, no unexpected adverse reactions were reported. The most commonly reported adverse events in overdose are somnolence, confusional state, agitation and restlessness.
Storage Condition
Store in cool and dry place, keep away from light and out of the reach of children.
Commercial Pack
Prebalin 75: Each box contains 3 blister packs of 10 capsules.
Prebalin 150: Each box contains 2 blister packs of 10 capsules.
