DOSAGE AND ADMINISTRATION
Tyramine-rich foods, beverages, or dietary supplements and amines (from over-the-counter cough/cold medications) should be avoided to prevent a possible hypertensive crisis/"cheese reaction" during rasagiline treatment. (See WARNINGS, Need for Restriction of Dietary Tyramine and Amines Contained in Medications).
Monotherapy
The recommended AZILECT dose for the treatment of Parkinson's disease patients is 1 mg administered once daily.
Adjunctive Therapy
The recommended initial dose is 0.5 mg administered once daily. If a sufficient clinical response is not achieved, the dose may be increased to 1 mg administered once daily.
Change of Levodopa Dose in Adjunct Therapy
When AZILECT is used in combination with levodopa, a reduction of the levodopa dosage may be considered based upon individual response. During the controlled trials of AZILECT as adjunct therapy to levodopa, levodopa dosage was reduced in some patients. In clinical studies, dosage reduction of levodopa was allowed within the first 6 weeks if dopaminergic side effects, including dyskinesia and hallucinations, emerged. In Study 1, levodopa dosage reduction occurred in 8% of patients in the placebo group and in 16% and 17% of patients in the 0.5 mg/day and 1 mg/day rasagiline groups, respectively. In those patients who had levodopa dosage reduced, the dose was reduced on average by about 7%, 9%, and 13% in the placebo, 0.5 mg/day, and 1 mg/day groups, respectively. In Study 2, levodopa dosage reduction occurred in 6% of patients in the placebo group and in 9% in the rasagiline 1 mg/day group. In patients who had their levodopa dosage reduced, the dose was reduced on average by about 13% and 11% in the placebo and the rasagiline groups, respectively.
Patients with Hepatic Impairment
AZILECT plasma concentrations will increase in patients with hepatic impairment. Patients with mild hepatic impairment should use 0.5 mg daily of AZILECT. AZILECT should not be used in patients with moderate or severe hepatic impairment (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency and WARNINGS, Hepatic Insufficiency).
Patients Taking Ciprofloxacin and Other CYP1A2 Inhibitors
Rasagiline plasma concentrations are expected to double in patients taking concomitant ciprofloxacin and other CYP1A2 inhibitors. Therefore, patients taking concomitant ciprofloxacin or other CYP1A2 inhibitors should use 0.5 mg daily of AZILECT. (See CLINICAL PHARMACOLOGY, Drug-Drug Interactions , Ciprofloxacin and Effect of other drugs on the metabolism of AZILECT ; and WARNINGS, Ciprofloxacin and Other CYP1A2 Inhibitors).
|
HOW SUPPLIED
AZILECT 0.5 mg Tablets:
White to off-white, round, flat, beveled tablets, debossed with "GIL 0.5" on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 68546-142-56).
AZILECT 1 mg Tablets:
White to off-white, round, flat, beveled tablets, debossed with "GIL 1" on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 68546-229-56).
Storage
Store at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F).
Rx only
Manufactured by:
Teva Pharmaceutical Industries Ltd.
Kfar Saba 44102, Israel
Marketed by:
Teva Neuroscience, Inc.
Kansas City, MO 64131
Revision 03/2009
|
