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Azilect

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Azilect

Azilect

INDICATIONS

AZILECT (rasagiline tablets) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease as initial monotherapy and as adjunct therapy to levodopa.

The effectiveness of AZILECT (rasagiline) was demonstrated in patients with early Parkinson's disease who were receiving AZILECT (rasagiline) as monotherapy and who were not receiving any concomitant dopaminergic therapy. The effectiveness of AZILECT (rasagiline) as adjunct therapy was demonstrated in patients with Parkinson's disease who were treated with levodopa.

DOSAGE AND ADMINISTRATION

AZILECT (rasagiline) is a selective inhibitor of monoamine oxidase (MAO)-B at recommended doses of 0.5 or 1 mg daily. Dietary tyramine restriction is not ordinarily required with recommended doses of AZILECT (rasagiline) . However, certain foods (e.g., aged cheeses, such as Stilton cheese) may contain very high amounts (i.e., > 150 mg) of tyramine and could potentially cause a hypertensive “cheese” reaction in patients taking AZILECT (rasagiline) even at the recommended dose due to mild increased sensitivity to tyramine. The selectivity for inhibiting MAO-B diminishes in a dose-related manner as the dose is progressively increased above the recommended daily do se [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY and PATIENT INFORMATION].

Monotherapy

The recommended AZILECT (rasagiline) dose for the treatment of Parkinson's disease patients is 1 mg administered orally once daily.

Adjunctive Therapy

The recommended initial dose is 0.5 mg administered orally 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 (rasagiline) 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 (rasagiline) 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 (rasagiline) plasma concentrations will increase in patients with hepatic impairment. Patients with mild hepatic impairment should use 0.5 mg daily of AZILECT (rasagiline) . AZILECT (rasagiline) should not be used in patients with moderate or severe hepatic impairment [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, and CLINICAL PHARMACOLOGY].

Patients with Renal Impairment

Dose adjustment of AZILECT (rasagiline) is not required for patients with mild or moderate renal impairment because AZILECT (rasagiline) plasma concentrations are not increased in patients with moderate renal impairment. Rasagiline has not been studied in patients with severe renal impairment.

Patients Taking Ciprofloxacin or 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 WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

AZILECT (rasagiline) 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 containing, as the active ingredient, rasagiline mesylate equivalent to 0.5 mg of rasagiline base.

AZILECT (rasagiline) 1 mg Tablets: White to off-white, round, flat, beveled tablets, debossed with “GIL 1” on one side and plain on the other side containing, as the active ingredient, rasagiline mesylate equivalent to 1 mg of rasagiline base.

AZILECT (rasagiline) 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 (rasagiline) 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).

Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131. Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454. Product of Israel

Last reviewed on RxList: 12/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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