RASAGILINE MESYLATE 0.5 MG 30 TAB
Generic: Rasagiline
RASAGILINE MESYLATE 0.5 MG 30 TAB
Sign up to see pricing
Licensed pharmacies, clinics, doctor's offices, and veterinary practices get instant account approval
Sign Up — Instant ApprovalDrug Information
Identification
Rasagiline
RASAGILINE
Micro Labs Limited
HUMAN PRESCRIPTION DRUG
Administration
TABLET
ORAL
ANDA207004
Active Ingredients
| Ingredient | Strength |
|---|---|
| RASAGILINE MESYLATE | .5 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1. INDICATIONS AND USAGE Rasagiline tablets are indicated for the treatment of Parkinson's disease (PD). Rasagiline tablets are monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson's disease ( 1 )
Dosage & Administration
2. DOSAGE AND ADMINISTRATION Monotherapy: Rasagiline tablet 1 mg once daily ( 2.1 ) As adjunct without levodopa: Rasagiline tablet 1 mg once daily ( 2.1 ) As adjunct to levodopa: Rasagiline tablet 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 tablet 0.5 mg once daily ( 2.2 , 5.4 ) Patients with mild hepatic impairment: Rasagiline tablet 0.5 mg once daily. Rasagiline tablet should not be used in patients with moderate or severe hepatic impairment ( 2.3 , 5.5 ) 2.1 General Dosing Recommendations When rasagiline is 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 tablet 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 tablet is used in combination with levodopa, a reduction of the levodopa dose may be considered, based upon individual response. The recommended doses of rasagiline should not be exceeded because of risk of hypertension [see Warnings and Precautions (5.1) ]. 2.2 Patients Taking Ciprofloxacin or Other CYP1A2 Inhibitors Patients taking concomitant ciprofloxacin or other CYP1A2 inhibitors should not exceed a dose of rasagiline tablet 0.5 mg once daily [ see Warnings and Precautions (5.4) , Drug Interactions (7.6) , and Clinical Pharmacology (12.3) ]. 2.3 Patients with Hepatic Impairment Patients with mild hepatic impairment should not exceed a dose of rasagiline tablet 0.5 mg once daily. Rasagiline tablets should not be used in patients with moderate or severe hepatic impairment [see Warnings and Precautions (5.5) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ] .
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 monotherapy: flu syndrome, arthralgia, depression, dyspepsia ( 6.1 ) Rasagiline used as adjunct without levodopa: peripheral edema, fall, arthralgia, cough, and insomnia ( 6.1 ) Rasagiline used as adjunct to levodopa: dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, fall, and tenosynovitis ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug and may not reflect the rates of adverse reactions observed in practice. During the clinical development of rasagiline, Parkinson’s disease patients received rasagiline as initial monotherapy (Study 1) and as adjunct therapy (Study 2, Study 3, Study 4). As the populations in these studies differ, not only in the adjunct use of dopamine agonists or levodopa during rasagiline treatment, but also in the severity and duration of their disease, the adverse reactions are presented separately for each study. Monotherapy Use of Rasagiline In Study 1, approximately 5% of the 149 patients treated with rasagiline discontinued treatment due to adverse reactions compared to 2% of the 151 patients who received placebo. The only adverse reaction that led to the discontinuation of more than one patient was hallucinations. The most commonly observed adverse reactions in Study 1 (incidence in rasagiline-treated patients 3% or greater than the incidence in placebo-treated patients) included flu syndrome, arthralgia, depression, and dyspepsia. Table 1 lists adverse reactions that occurred in 2% or greater of patients receiving rasagiline as monotherapy and were numerically more frequent than in the placebo group in Study 1. Table 1: Adverse Reactions* in Study 1 Rasagiline Tablet 1 mg (N=149) Placebo (N=151) % of Patients % of Patients Headache 14 12 Arthralgia 7 4 Dyspepsia 7 4 Depression 5 2 Fall 5 3 Flu syndrome 5 1 Conjunctivitis 3 1 Fever 3 1 Gastroenteritis 3 1 Rhinitis 3 1 Arthritis 2 1 Ecchymosis 2 0 Malaise 2 0 Neck Pain 2 0 Paresthesia 2 1 Vertigo 2 1 *Incidence 2% or greater in rasagiline tablet 1 mg group and numerically more frequent than in placebo group There were no significant differences in the safety profile based on age or gender. Adjunct Use of Rasagiline Rasagiline was studied as an adjunct therapy without levodopa (Study 2), or as an adjunct therapy to levodopa, with some patients also taking dopamine agonists, COMT inhibitors, anticholinergics, or amantadine (Study 3 and Study 4). In Study 2, approximately 8% of the 162 patients treated with rasagiline discontinued treatment due to adverse reactions compared to 4% of the 164 patients who received placebo. Adverse reactions that led to the discontinuation of more than one patient were nausea and dizziness. The most commonly observed adverse reactions in Study 2 (incidence in rasagiline-treated patients 3% or greater than incidence in placebo-treated patients) included peripheral edema, fall, arthralgia, cough, and insomnia. Table 2 lists adverse reactions that occurred in 2% or greater in patients receiving rasagiline as adjunct therapy without levodopa and numerically more frequent than in the placebo group in Study 2. Table 2: Adverse Reactions* in Study 2 Rasagiline Tablet 1 mg (N=162) Placebo (N=164) % of Patients % of Patients Dizziness 7 6 Peripheral edema 7 4 Headache 6 4 Nausea 6 4 Fall 6 1 Arthralgia 5 2 Back pain 4 3 Cough 4 1 Insomnia 4 1 Upper respiratory tract infection 4 2 Orthostatic hypotension 3 1 *Incidence 2% or greater in rasagiline tablet 1 mg group and numerically more frequent than in placebo group There were no significant differences in the safety profile based on age or gender. In Study 3, adverse event reporting was considered more reliable than Study 4; therefore, only the adverse event data from Study 3 are presented below. In Study 3, approximately 9% of the 164 patients treated with rasagiline tablet 0.5 mg/day and 7% of the 149 patients treated with rasagiline tablet 1 mg/day discontinued treatment due to adverse reactions, compared to 6% of the 159 patients who received placebo. The adverse reactions that led to discontinuation of more than one rasagiline-treated patient were diarrhea, weight loss, hallucination, and rash. The most commonly observed adverse reactions in Study 3 (incidence in rasagiline-treated patients 3% or greater than the incidence in placebo-treated patients) included dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, fall, and tenosynovitis. Table 3 lists adverse reactions that occurred in 2% or greater of patients treated with rasagiline tablet 1 mg/day and that were numerically more frequent than the placebo group in Study 3. Table 3: Adverse Reactions* in Study 3 Rasagiline tablet 1 mg (N=149) Rasagiline tablet 0.5 mg (N=164) Placebo (N=159) % of patients % of patients % of patients Dyskinesia 18 18 10 Accidental injury 12 8 5 Nausea 12 10 8 Headache 11 8 10 Fall 11 12 8 Weight loss 9 2 3 Constipation 9 4 5 Postural hypotension 9 6 3 Arthralgia 8 6 4 Vomiting 7 4 1 Dry mouth 6 2 3 Rash 6 3 3 Somnolence 6 4 4 Abdominal pain 5 2 1 Anorexia 5 2 1 Diarrhea 5 7 4 Ecchymosis 5 2 3 Dyspepsia 5 4 4 Paresthesia 5 2 3 Abnormal dreams 4 1 1 Hallucinations 4 5 3 Ataxia 3 6 1 Dyspnea 3 5 2 Infection 3 2 2 Neck pain 3 1 1 Sweating 3 2 1 Tenosynovitis 3 1 0 Dystonia 3 2 1 Gingivitis 2 1 1 Hemorrhage 2 1 1 Hernia 2 1 1 Myasthenia 2 2 1 *Incidence 2% or greater in rasagiline tablet 1 mg group and numerically more frequent than in placebo group Several of the more common adverse reactions seemed dose-related, including weight loss, postural hypotension, and dry mouth. There were no significant differences in the safety profile based on age or gender. During all Parkinson’s disease phase 2/3 clinical trials, the long-term safety profile was similar to that observed with shorter duration exposure. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of rasagiline. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and Subcutaneous Tissue Disorders: Melanoma
Information for Patients
17. PATIENT COUNSELING INFORMATION Hypertension Advise patients that treatment with recommended doses of rasagiline may be associated with elevations of blood pressure. Tell patients who experience elevation of blood pressure while taking rasagiline to contact their healthcare provider. The risk of using higher than recommended daily doses of rasagiline should be explained, and a brief description of the tyramine associated hypertensive reaction provided. Advise patients to avoid certain foods (e.g., aged cheese) containing a very large amount of tyramine while taking recommended doses of rasagiline because of the potential for large increases in blood pressure. If patients eat foods very rich in tyramine and do not feel well soon after eating, they should contact their healthcare provider [see Warnings and Precautions (5.1) ] . Serotonin Syndrome Tell patients to inform their physician if they are taking, or planning to take, any prescription or over-the-counter drugs, especially antidepressants and over-the-counter cold medications, since there is a potential for interaction with rasagiline. Because patients should not use meperidine or certain other analgesics with rasagiline, they should contact their healthcare provider before taking analgesics [see Contraindications (4) and Warnings and Precautions (5.2) ]. Falling Asleep During Activities of Daily Living and Somnolence Advise and alert patients about the potential for sedating effects associated with rasagiline and other dopaminergic medications, including somnolence and particularly to the possibility of falling asleep while engaged in activities of daily living. Because somnolence can be a frequent adverse reaction with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with rasagiline and other dopaminergic medications to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Patients should not drive, operate machinery, or work at heights during treatment if they have previously experienced somnolence and/or have fallen asleep without warning prior to use of rasagiline. Because of possible additive effects, advise patients to exercise caution when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants) in combination with rasagiline or when taking concomitant medications that increase plasma levels of rasagiline (e.g., ciprofloxacin) [see Warnings and Precautions (5.3) ]. Ciprofloxacin or Other CYP1A2 Inhibitors Inform patients that they should contact their healthcare provider of rasagiline if they take ciprofloxacin or a similar drug that could increase blood levels of rasagiline because of the need to adjust the dose of rasagiline [see Dosage and Administration (2.2) and Warnings and Precautions (5.4) ]. Hepatic Impairment Tell patients who have hepatic problems to contact their healthcare provider regarding possible changes in rasagiline dosing [see Warnings and Precautions (5.5) ] . Hypotension / Orthostatic Hypotension Patients should be advised that they may develop orthostatic hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). Accordingly, patients should be cautioned against standing up rapidly after sitting or lying down, especially if they have been doing so for prolonged periods, and especially, at the initiation of treatment with rasagiline [see Warnings and Precautions (5.6) ] . Dyskinesia Advise patients taking rasagiline as adjunct to levodopa that there is a possibility of dyskinesia or increased dyskinesia [see Warnings and Precautions (5.7) ] . Hallucinations / Psychotic-Like Behavior Inform patients that hallucinations or other manifestations of psychotic-like behavior can occur when taking rasagiline. Advise patients that, if they have a major psychotic disorder, that rasagiline should not ordinarily be used because of the risk of exacerbating the psychosis. Patients with a major psychotic disorder should also be aware that many treatments for psychosis may decrease the effectiveness of rasagiline [see Warnings and Precautions (5.8) ] . Impulse Control/Compulsive Behaviors Advise patients that they may experience intense urges to gamble, increased sexual urges, other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone and that are generally used for the treatment of Parkinson’s disease (including rasagiline). Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges, or other urges while being treated with rasagiline. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges, or other intense urges while taking rasagiline. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking rasagiline [see Warnings and Precautions (5.9) ] . Withdrawal-Emergent Hyperpyrexia and Confusion Tell patients to contact their healthcare provider if they wish to discontinue rasagiline [see Warnings and Precautions (5.10) ] . Missing Dose Instruct patients to take rasagiline as prescribed. If a dose is missed, the patient should not double-up the dose of rasagiline. The next dose should be taken at the usual time on the following day. Pregnancy Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant [see Use in Specific Populations (8.1) ]. Manufactured by: Micro Labs Limited Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev.10/2021
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.