Label: RASAGILINE- rasagiline mesylate tablet

  • NDC Code(s): 83085-007-10, 83085-007-30, 83085-007-50, 83085-008-10, view more
  • Packager: SKG Pharma Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 4, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use RASAGILINE TABLETS safely and effectively. See full prescribing information for RASAGILINE TABLETS. RASAGILINE tablets, for oral ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Rasagiline tablets are indicated for the treatment of Parkinson’s disease (PD).
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Dosing Recommendations - When rasagiline tablets are prescribed as monotherapy or as adjunct therapy in patients not taking levodopa, patients may start rasagiline tablets at the ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Rasagiline 0.5 mg Tablets: White to off-white, round, flat face, beveled-edge tablets, debossed with “L 0.5” on one side () and plain on the other side. Rasagiline 1 mg Tablets: White to ...
  • 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 ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hypertension - Exacerbation of hypertension may occur during treatment with rasagiline. Medication adjustment may be necessary if elevation of blood pressure is sustained. Monitor patients ...
  • 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 ...
  • 7 DRUG INTERACTIONS
    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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate data on the developmental risks associated with the use of rasagiline in pregnant women. In animal studies, oral administration of rasagiline ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Rasagiline is not a controlled substance. 9.2 Abuse - Studies conducted in mice and rats did not reveal any potential for drug abuse and dependence. Clinical trials ...
  • 10 OVERDOSAGE
    In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg of rasagiline there were three reports of cardiovascular side effects (including hypertension and postural ...
  • 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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Rasagiline is a selective, irreversible MAO-B inhibitor indicated for the treatment of idiopathic Parkinson’s disease. The results of a clinical trial designed to ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Two-year carcinogenicity studies were conducted in mice at oral doses of 0 mg/kg/day, 1 mg/kg/day, 15 mg/kg/day, and ...
  • 14 CLINICAL STUDIES
    The effectiveness of rasagiline for the treatment of Parkinson’s disease was established in four 18-week to 26-week, randomized, placebo-controlled trials, as initial monotherapy or adjunct ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Rasagiline tablets, 0.5 mg: White to off-white, round, flat face, beveled-edge tablets, debossed with “L 0.5” on one side () and plain on the other side. Supplied as: Bottles of 30 tablets with ...
  • 17 PATIENT COUNSELING INFORMATION
    Hypertension - Advise patients that treatment with recommended doses of rasagiline tablets may be associated with elevations of blood pressure. Tell patients who experience elevation of blood ...
  • Package/Label Display Panel
    NDC 83085-007-30 - Rasagiline Tablets - 0.5 mg - Rx only - 30 Tablets
  • Package/Label Display Panel
    NDC 83085-007-50 - Rasagiline Tablets - 0.5 mg - Rx only - 500 Tablets
  • Package/Label Display Panel
    ​NDC 83085-007-10 - Rasagiline Tablets - 0.5 mg - Rx only - 1,000 Tablets
  • Package/Label Display Panel
    NDC 83085-008-30 - Rasagiline Tablets - 1 mg - Rx only - 30 Tablets
  • Package/Label Display Panel
    ​NDC 83085-008-50 - Rasagiline Tablets - 1 mg - Rx only - 500 Tablets
  • Package/Label Display Panel
    NDC 83085-008-10 - Rasagiline Tablets - 1 mg - Rx only - 1,000 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information