AZILECT PACKAGE INSERT PDF

However, certain foods e. The selectivity for inhibiting MAO-B diminishes in a dose-related manner as the dose is progressively increased above the recommended daily dose [see Warnings and Precautions 5. If a sufficient clinical response is not achieved, the dose may be increased to 1 mg administered once daily. In clinical studies, dosage reduction of levodopa was allowed within the first 6 weeks if dopaminergic side effects, including dyskinesia and hallucinations, emerged.

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However, certain foods e. The selectivity for inhibiting MAO-B diminishes in a dose-related manner as the dose is progressively increased above the recommended daily dose [see Warnings and Precautions 5.

If a sufficient clinical response is not achieved, the dose may be increased to 1 mg administered once daily. In clinical studies, dosage reduction of levodopa was allowed within the first 6 weeks if dopaminergic side effects, including dyskinesia and hallucinations, emerged.

Patients with mild hepatic impairment should use 0. Rasagiline has not been studied in patients with severe renal impairment. Therefore, patients taking concomitant ciprofloxacin or other CYP1A2 inhibitors should use 0. 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 containing, as the active ingredient, rasagiline mesylate equivalent to 1 mg of rasagiline base.

Enter section text here 4. Serious adverse reactions have been precipitated with concomitant use of meperidine e. These adverse reactions are often described as "serotonin syndrome", a potentially serious condition, which can result in death. In the post-marketing period, serotonin syndrome has been reported in a patient erroneously treated with a higher than recommended dose of AZILECT 4 mg daily and tramadol. The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior.

Enter section text here 5. These adverse reactions are often described as "serotonin syndrome" which can result in death. In the post-marketing period, non-fatal cases of serotonin syndrome have been reported in patients treated with antidepressants concomitantly with AZILECT.

Furthermore, because the mechanisms of these reactions are not fully understood, it seems prudent, in general, to avoid the combination of AZILECT with any antidepressant. Because of the long half lives of certain antidepressants e. Patients with mild hepatic impairment should be given the dose of 0. Dietary tyramine restriction is not ordinarily required with ingestion of most foods and beverages that may contain tyramine, during treatment with recommended doses of AZILECT.

Patients should be advised to avoid foods e. Selectivity for inhibiting MAO-B diminishes in a dose-related manner as the dose is progressively increased above the recommended daily doses. There were no cases of hypertensive crisis in the clinical development program associated with 1 mg daily rasagiline treatment, in which most patients did not follow dietary tyramine restriction.

Rare cases of hypertensive crisis have been reported in the post-marketing period in patients after ingesting unknown amounts of tyramine-rich foods while taking recommended doses of AZILECT. For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis. Ideally, periodic skin examinations should be performed by appropriately qualified individuals e.

Decreasing the dose of levodopa may ameliorate this side effect. There was also an increased risk for some of these abnormalities at the lower 0. Clinical trial data further suggest that postural hypotension occurs most frequently in the first two months of AZILECT treatment and tends to decrease over time.

Some patients treated with AZILECT experienced a mildly increased risk for significant decreases in blood pressure unrelated to standing but while supine. The risk for post-treatment hypotension e. Postural hypotension led to drug discontinuation and premature withdrawal from clinical trials in one 0. The risk for developing post-treatment high blood pressure e. There was no increased frequency of the incidence of hypertension as an adverse reaction in the adjunctive treatment pivotal trials for AZILECT treatment vs placebo.

There was no observed increased risk for increasing blood pressure or high blood pressure based upon various measurements and analyses or for the development of hypertension as an adverse reaction in the monotherapy study for 1 mg daily AZILECT treatment vs placebo. In the monotherapy trial, hallucinations led to drug discontinuation and premature withdrawal from clinical trials in 1.

Patients should be informed of the possibility of developing hallucinations and instructed to report them to their health care provider promptly should they develop. Patients with a major psychotic disorder should ordinarily not be treated with AZILECT because of the risk of exacerbating the psychosis with an increase in central dopaminergic tone.

This adverse reaction has been reported with many anti-Parkinsonian drugs that increase central dopaminergic tone.

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There is the potential for inhibitors of this enzyme to alter rasagiline clearance when coadministered. The patients then lose their ability to control their movements reliably. It blocks the enzyme monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain. Advise azilfct that, if they have a major psychotic disorder, that rasagiline should not ordinarily be used. The mean volume of distribution at steady-state is 87 L, indicating that the tissue binding of rasagiline is in excess of plasma protein binding. Product details Name Azilect. The Committee recommended that Azilect be given marketing authorisation.

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