Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
RASAGILINE MESYLATE (UNII: LH8C2JI290) (RASAGILINE - UNII:003N66TS6T)
Micro Labs Limited
ORAL
PRESCRIPTION DRUG
Rasagiline tablets are indicated for the treatment of Parkinson's disease (PD). Rasagiline tablet 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 tablet and initiation of treatment with these medications. Rasagiline tablet is contraindicated for use with St. John’s wort and with cyclobenzaprine. Rasagiline tablet is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. 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 to rats during gestation and lactation resulted in decreased survival and reduced body weight in the offspring at doses si
Rasagiline 0.5 mg Tablets: White to off-white, circular, flat faced beveled edge, uncoated tablets, debossed with “0.5” on one face and plain on the other side containing, as the active ingredient, rasagiline mesylate equivalent to 0.5 mg of rasagiline base. Bottles of 30 NDC 42571-220-30 Bottles of 500 NDC 42571-220-05 Bottles of 1000 NDC 42571-220-10 Rasagiline 1 mg Tablets: White to off-white, circular, flat faced beveled edge, uncoated tablets, debossed with “1” on one face and plain on the other side containing, as the active ingredient, rasagiline mesylate equivalent to 1 mg of rasagiline base. Bottles of 30 NDC 42571-221-30 Bottles of 500 NDC 42571-221-05 Bottles of 1000 NDC 42571-221-10 Storage: Store at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F).[see USP Controlled Room Temperature].
Abbreviated New Drug Application
RASAGILINE - RASAGILINE TABLET MICRO LABS LIMITED ---------- 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 USE INITIAL U.S. APPROVAL: 2006 INDICATIONS AND USAGE Rasagiline tablets are monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson's disease ( 1) 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) DOSAGE FORMS AND STRENGTHS Rasagiline 0.5 mg tablets ( 3) Rasagiline 1 mg tablets ( 3) CONTRAINDICATIONS Concomitant use of meperidine, tramadol, methadone, propoxyphene dextromethorphan, St. John’s wort, cyclobenzaprine, or another (selective or non-selective) MAO inhibitor ( 4) 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) ADVERSE REACTIONS Most common adverse reactions (incidence 3% or greater than placeb Citiți documentul complet