Rasagiline

Generic Name: rasagiline

Over-the-Counter (OTC)

Brand Names:

Rasagiline

11 DESCRIPTION Rasagiline tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson's disease. Rasagiline mesylate is designated chemically as: 1H-Inden-1-amine, 2, 3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate. The empirical formula of rasagiline mesylate is C 12 H 13 N∙CH 4 SO 3 and its molecular weight is 267.34.

Overview

Uses

1 INDICATIONS AND USAGE Rasagiline tablets are indicated for the treatment of Parkinson's disease (PD). Rasagiline Tablets, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson's disease ( 1 )

Dosage

2 DOSAGE AND ADMINISTRATION Monotherapy: Rasagiline Tablets 1 mg once daily (2.1) As adjunct without levodopa: Rasagiline Tablets 1 mg once daily (2.1) As adjunct to levodopa: Rasagiline Tablets 0.5 mg once daily. Increase dose to 1 mg daily as needed for sufficient clinical response (2.1) Patients taking ciprofloxacin or other CYP1A2 inhibitors: Rasagiline Tablets 0.5 mg once daily (2.2, 5.4) Patients with mild hepatic impairment: Rasagiline Tablets 0.5 mg once daily.

Side Effects

6 ADVERSE REACTIONS The following adverse reactions are described in more detail in the Warnings and Precautions section of the label: Hypertension [ see Warnings and Precautions (5.1) ] Serotonin Syndrome [ see Warnings and Precautions (5.2) ] Falling Asleep During Activities of Daily Living and Somnolence [ see Warnings and Precautions (5.3) ] Hypotension / Orthostatic Hypotension [ see Warnings and Precautions (5.6) ] Dyskinesia [ see Warnings and Precautions (5.7) ] Hallucinations / Psychotic-Like Behavior [ see Warnings and Precautions (5.8) ] Impulse Control /Compulsive Behaviors [ see Warnings and Precautions (5.9) ] Withdrawal-Emergent Hyperpyrexia and Confusion [ see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence 3% or greater than placebo): Rasagiline...

Interactions

7 DRUG INTERACTIONS Meperidine: Risk of serotonin syndrome (4, 7.1) Dextromethorphan: Risk of psychosis or bizarre behavior (4, 7.2) MAO inhibitors: Risk of non-selective MAO inhibition and hypertensive crisis (4, 7.3) 7.1 Meperidine Serious, sometimes fatal reactions have been precipitated with concomitant use of meperidine (e.g., Demerol and other tradenames) and MAO inhibitors including selective MAO-B inhibitors [see Contraindications (4)] . 7.2 Dextromethorphan The concomitant use of rasagiline tablets and dextromethorphan was not allowed in clinical studies. The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior.

Warnings

5 WARNINGS AND PRECAUTIONS May cause hypertension (including severe hypertensive syndromes) at recommended doses (5.1) May cause serotonin syndrome when used with antidepressants (5.2) May cause falling asleep during activities of daily living, daytime drowsiness, and somnolence (5.3) May cause hypotension, especially orthostatic (5.6) May cause or exacerbate dyskinesia. Decreasing the levodopa dose may lessen or eliminate this side effect (5.7) May cause hallucinations and psychotic-like behavior (5.8) May cause impulse control/compulsive behaviors (5.9) May cause withdrawal-emergent hyperpyrexia and confusion (5.10) 5.1 Hypertension Exacerbation of hypertension may occur during treatment with rasagiline tablets. 4 CONTRAINDICATIONS Rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors, because of risk of serotonin syndrome [See Warnings and Precautions (5.2)] . At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications.

Storage

16 HOW SUPPLIED/STORAGE AND HANDLING Rasagiline Tablets 0.5 mg: White to off white round shaped flat faced, beveled uncoated tablets debossed with '47' on one side and plain on other side.

Frequently Asked Questions

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.