Rasagiline tablets are indicated as monotherapy or as adjunct therapy for the treatment of Parkinson’s disease (PD).

Rasagiline is an irreversible monoamine oxidase-B (MAO-B) inhibitor used either alone in early Parkinson’s disease or as an add-on therapy in advanced stages. Its therapeutic effect is mainly due to selective inhibition of MAO-B, which leads to increased levels of extracellular dopamine in the striatum. The resulting rise in dopamine concentration enhances dopaminergic activity, which is believed to be responsible for its beneficial effects in motor symptoms associated with Parkinson’s disease.

The recommended dose is 1 mg orally once daily as monotherapy or as adjunct therapy in patients not taking levodopa. In patients taking levodopa, with or without other PD drugs (e.g., dopamine agonist, amantadine, anticholinergics), the recommended initial dose of Rasagiline is 0.5 mg once daily. If the patient tolerates the daily 0.5 mg dose, but a sufficient clinical response is not achieved, the dose may be increased to 1 mg once daily. When Rasagiline is used in combination with levodopa, a reduction of the levodopa dose may be considered, based upon individual response. The recommended dose of Rasagiline should not be exceeded because of risk of hypertension.

Pediatric use: The safety & effectiveness in pediatric patients have not been established.

Geriatric use: There were no significant differences in the safety profile of the geriatric & nongeriatric patients.

Rasagiline is contraindicated with meperidine, tramadol, methadone, propoxyphene, and monoamine oxidase inhibitors (MAOIs), including other selective MAO-B inhibitors, due to the risk of serotonin syndrome.

Common side effects include joint pain, mild headache, low mood, dizziness, vertigo, hair loss, mild skin rash, numbness or tingling sensation, dry mouth, reduced appetite, constipation, diarrhea, abdominal pain or discomfort, vomiting, and weight loss.

Pregnancy Category C. Use in pregnancy should be done with caution. Experimental studies suggest that rasagiline may inhibit prolactin secretion and potentially reduce lactation. It is not known whether rasagiline is excreted in human breast milk. Caution is advised when administered to breastfeeding mothers.

Hypertension: Blood pressure may worsen during treatment. Dose adjustment may be required if sustained hypertension occurs. Routine dietary tyramine restriction is not required at recommended doses; however, foods containing very high levels of tyramine (>150 mg) should be avoided as they may cause severe hypertension.

Serotonin syndrome: Reported with concomitant use of antidepressants (SSRIs, SNRIs, tricyclics, tetracyclics, and other antidepressants) or non-selective MAO inhibitors.

CYP1A2 inhibitors (e.g., ciprofloxacin): Maximum dose should not exceed 0.5 mg once daily.

Hepatic impairment: In mild hepatic impairment, dose should not exceed 0.5 mg once daily. Rasagiline is contraindicated in moderate to severe hepatic impairment.

Drug interactions: Concomitant use with fluoxetine or fluvoxamine should be avoided. A washout period of at least 5 weeks is required after stopping fluoxetine before starting rasagiline, and at least 14 days should pass after stopping rasagiline before starting fluoxetine or fluvoxamine.

Use with dextromethorphan or sympathomimetics (including nasal/oral decongestants containing ephedrine or pseudoephedrine) is not recommended.

Cases of melanoma have been reported; patients should be monitored for suspicious skin lesions and evaluated by a specialist if needed.

Symptoms may include drowsiness, dizziness, irritability, agitation, headache, hallucinations, seizures, trismus, opisthotonos, coma, irregular pulse, blood pressure changes, chest pain, respiratory depression, fever, sweating, and cold clammy skin.

Management: No specific antidote is available. Supportive care should include airway management, oxygen supplementation, and mechanical ventilation if needed. Body temperature and fluid-electrolyte balance should be monitored. Severe cases may require intensive care. Dietary tyramine restriction should be followed for several weeks after overdose. Poison control consultation is recommended.

Antiparkinson drugs

Store below 30°C in a dry place. Protect from light. Keep out of reach of children. To be sold only on the prescription of a registered physician.