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When AZILECT is used in combination with levodopa, a reduction of the levodopa dose may be considered, based upon individual response.The recommended doses of AZILECT should not be exceeded because of risk of hypertension 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 containing, as the active ingredient, rasagiline mesylate equivalent to 0.5 mg of rasagiline base. AZILECT is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior.Dietary tyramine restriction is not required during treatment with recommended doses of AZILECT.
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If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., driving a motor vehicle, conversations, eating), AZILECT should ordinarily be discontinued.
If a decision is made to continue these patients on AZILECT, advise them to avoid driving and other potentially dangerous activities.
For this reason, prescribers should monitor patients for drowsiness or sleepiness, because some of the events occur well after initiation of treatment with dopaminergic medication.
Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.
AZILECT should not be used in patients with moderate or severe hepatic impairment In Study 3, the incidence of orthostatic hypotension consisting of a systolic blood pressure decrease (≥ 30 mm Hg) or a diastolic blood pressure decrease (≥ 20 mm Hg) after standing was 13% with AZILECT (1 mg/day) compared to 9% with placebo At the 1 mg dose, the frequency of orthostatic hypotension (at any time during the study) was approximately 44% for AZILECT vs 33% for placebo for mild to moderate systolic blood pressure decrements (≥ 20 mm Hg), 40% for AZILECT vs 33% for placebo for mild to moderate diastolic blood pressure decrements (≥ 10 mm Hg), 7% for AZILECT vs 3% for placebo for severe systolic blood pressure decrements (≥ 40 mm Hg), and 9% for AZILECT vs 6% for placebo for severe diastolic blood pressure decrements (≥ 20 mm Hg).