Rasagiline Mesylate
Generic Name: rasagiline mesylate
Brand Names:
Rasagiline Mesylate
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
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.
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
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 place...
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 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. 4 CONTRAINDICATIONS Rasagiline tablets are 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 tablets and initiation of treatment with these medications.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of rasagiline in pregnant women. In animal studies, oral administration of rasagiline to rats during gestation and lactation resulted in decreased survival and reduced body weight in the offspring at doses similar to those used clinically. When administrated to pregnant animals in combination with levodopa/carbidopa, there were increased incidences of fetal skeletal variations in rats and increases in embryofetal death and cardiovascular abnormalities in rabbits [see Data] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Rasagiline tablets 0.5 mg: White to off-white, round, flat, beveled tablets, debossed with “31” on one side and “I” on the other side. Supplied as bottles of 30 tablets with child-resistant cap (NDC 23155-746-03). Rasagiline tablets 1 mg: White to off-white, round, flat, beveled tablets, debossed with “32” on one side and “I” on the other side.
Frequently Asked Questions
What is Rasagiline Mesylate used for?▼
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
What are the side effects of Rasagiline Mesylate?▼
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 place...
Can I take Rasagiline Mesylate during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of rasagiline in pregnant women. In animal studies, oral administration of rasagiline to rats during gestation and lactation resulted in decreased survival and reduced body weight in the offspring at doses similar to those used clinically. When administrated to pregnant animals in combination with levodopa/carbidopa, there were increased incidences of fetal skeletal variations in rats and increases in embryofetal death and cardiovascular abnormalities in rabbits [see Data] .
What are the important warnings for Rasagiline Mesylate?▼
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. 4 CONTRAINDICATIONS Rasagiline tablets are 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 tablets and initiation of treatment with these medications.
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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.