Rasagiline mesylate .5 mg/1
Rasagiline mesylate · TABLET · Florida Pharmaceutical Products, LLC
Rasagiline mesylate is a tablet containing rasagiline mesylate at .5 mg/1, taken oral. Manufactured by Florida Pharmaceutical Products, LLC.
Key Facts
- Brand Name
- Rasagiline mesylate
- Generic Name
- Rasagiline mesylate
- NDC Code (Product)
71921-407- Manufacturer
- Florida Pharmaceutical Products, LLC
- Strength
- .5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA206153
- Marketing Start
- 04/14/2026
Recall History
Aidapak Services, LLC
Labeling:Label Mixup; RASAGILINE MESYLATE, Tablet, 0.5 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002690, EXP: 6/5/2014.
Ascend Laboratories, LLC
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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. Rasagiline tablets should not be used in patients with moderate or severe hepatic impairment ( 2.3 , 5.5 ) 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 recommended dose of 1 mg administered orally once daily. In patients taking levodopa, with or without other PD drugs (e.g., dopamine agonist, amantadine, anticholinergics), the recommended initial dose of rasagiline tablets 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 tablets are us…
Contraindications
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. Rasagiline tablets are contraindicated for use with St. John’s wort and with cyclobenzaprine. Rasagiline tablets are contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. Concomitant use of meperidine, tramadol, methadone, propoxyphene dextromethorphan, St. John’s wort, cyclobenzaprine, or another (selective or non-selective) MAO inhibitor
Drug 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. Therefore, in view of rasagiline's MAO inhibitory activity, dextromethorphan is contraindicated for use with rasagiline [see Contraindications ( 4 )]. 7.3 MAO Inhibitors Rasagiline is contraindicated for use with other MAO inhibitors because of the increased risk of nonselective MAO inhibition that may lead to a hypertensive crisis [see Contraindications ( 4 )] . 7.4 Sympathomimetic Medications The concomitant use of rasagiline and sympathomimetic medications was not allowed in clinical stud…
Adverse Reactions
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 tablets monotherapy: flu syndrome, arthralgia, depression, dyspepsia ( 6.1 ) Rasagiline tablets used as adjunct without levodopa: peripheral edema, fall, arthralgia, cough, and insomnia ( 6.1 ) Rasagiline tablets used as adjunct to levodopa: dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnor…
Frequently Asked Questions
What is Rasagiline mesylate used for?
Rasagiline mesylate contains Rasagiline mesylate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Rasagiline mesylate a controlled substance?
Rasagiline mesylate is not classified as a controlled substance by the DEA.
What is the generic name for Rasagiline mesylate?
The generic name for Rasagiline mesylate is Rasagiline mesylate. There are 8 other brand versions of Rasagiline mesylate.
What is the NDC code for Rasagiline mesylate .5 mg/1?
The NDC (National Drug Code) for Rasagiline mesylate .5 mg/1 is 71921-407, listed by Florida Pharmaceutical Products, LLC.