Drug Catalog - Product Detail
RASAGILINE 1MG TAB 30CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47781-0139-30 | ALVOGEN | 30 | 1MG | TABLET |
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Description
11. DESCRIPTION Rasagiline mesylate tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson’s disease. It is designated chemically as: 1H-Inden-1-amine, 2, 3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate. The molecular formula of rasagiline mesylate is (C 12 H 13 N)CH 4 SO 3 and its molecular weight is 267.34. Its structural formula is: Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each rasagiline mesylate tablets for oral administration contains rasagiline mesylate equivalent to 0.5 mg or 1 mg of rasagiline base. Each Rasagiline mesylate tablet also contains the following inactive ingredients: lactose monohydrate, pregelatinised starch, corn starch, talc, stearic acid, and citric acid monohydrate. structure
How Supplied
16. HOW SUPPLIED/STORAGE AND HANDLING Rasagiline Mesylate Tablets 0.5 mg: White to off-white, round, flat, beveled tablets, debossed with “R1” on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 47781-138-30) Rasagiline Mesylate Tablets 1 mg: White to off-white, round, flat, beveled tablets, debossed with “R2” on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 47781-139-30). Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Indications & Usage
1. INDICATIONS AND USAGE Rasagiline mesylate tablets are indicated for the treatment of Parkinson’s disease (PD). Rasagiline mesylate tablets, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson’s disease
Dosage and Administration
2. DOSAGE AND ADMINISTRATION Monotherapy: Rasagiline mesylate tablets 1 mg once daily (2.1) As adjunct without levodopa: Rasagiline mesylate tablets 1 mg once daily (2.1) As adjunct to levodopa: Rasagiline mesylate 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 mesylate tablets 0.5 mg once daily (2.2, 5.4) Patients with mild hepatic impairment: Rasagiline mesylate tablets 0.5 mg once daily. Rasagiline mesylate tablets should not be used in patients with moderate or severe hepatic impairment (2.3, 5.5) 2.1 General Dosing Recommendations When rasagiline mesylate tablets are prescribed as monotherapy or as adjunct therapy in patients not taking levodopa, patients may start rasagiline mesylate 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 mesylate 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 mesylate tablets are used in combination with levodopa, a reduction of the levodopa dose may be considered, based upon individual response. The recommended doses of rasagiline mesylate tablets 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 mesylate tablets 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 mesylate tablets 0.5 mg once daily. Rasagiline mesylate 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) ].