API

Rasagiline (0.5mg)

Drug classification

Rasagiline is an antiparkinsonian agent; specific subclass: monoamine oxidase-B (MAO-B) inhibitor.

Dosage form

Rasalect 0.5 Tablet is an oral tablet containing rasagiline 0.5 mg.

API strength per dosage

Dose

Rasagiline is typically initiated at 1 mg once daily for adults with Parkinson’s disease; some products may start at 0.5 mg once daily, increasing to 1 mg if needed. Safety and efficacy in paediatric patients are not established. Use with caution in mild hepatic impairment; contraindicated in moderate to severe hepatic impairment. No dose adjustment is needed for renal impairment.

Mechanism of action

Rasagiline selectively and irreversibly inhibits monoamine oxidase-B (MAO-B) in the brain, decreasing the breakdown of dopamine. This increases synaptic dopamine levels, enhancing dopaminergic activity and improving motor symptoms in Parkinson’s disease.

Indications

Treatment of Parkinson's disease

Side effects

Joint pain Insomnia difficulty in sleeping Indigestion Flu like symptoms Depression Cough Peripheral edema

Pregnancy category

Safety of rasagiline in pregnancy is not established; use only if potential benefit justifies potential risk to the fetus. Animal studies show adverse effects.

Precautions

Hepatic impairment, risk of serotonin syndrome with serotonergic drugs, hypertensive crisis with tyramine-rich foods, monitor for dyskinesia, orthostatic hypotension, behavioral changes, melanoma risk, drug interactions (CYP1A2 inhibitors), monitor blood pressure, assess for impulse control disorders, caution in elderly.

Contraindications

Concomitant use with monoamine oxidase inhibitors (MAOIs), pethidine, other opioids (e.g., tramadol, methadone), sympathomimetic medications, St. John's Wort, severe hepatic impairment, known hypersensitivity to rasagiline or excipients.