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Azilect

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Azilect

Azilect

PATIENT INFORMATION

Coadministration of Antidepressants and Other Drugs

Patients should inform their physician if they are taking, or planning to take, any prescription or over-the counter drugs, especially antidepressants and over-the-counter cold medications, since there is a potential for interaction with AZILECT (rasagiline) . Because patients should not use meperidine or certain other analgesics with AZILECT (rasagiline) , they should contact their healthcare provider before taking analgesics [see WARNINGS AND PRECAUTIONS].

Ciprofloxacin or Other CYP1A2 Inhibitors

Patients should be informed that they should contact their healthcare provider of AZ ILECT if they take ciprofloxacin or a similar d rug that could increase blood levels of rasagiline because of the need to adjust the dose of AZILECT [see WARNINGS AND PRECAUTIONS].

Risk of Hypertensive Crisis and Nonselective Monoamine Oxidase Inhibition Above the Recommended Doses

Patients should be advised not to exceed the maximum recommended daily dose of 1 mg/day (0.5 m g/day for subjects with mild hepatic impairment and subjects using concomitant ciprofloxacin and other CYP1A2inhibitors).

The risk of using higher than recommended daily doses of AZILECT (rasagiline) should be explained, and a brief description of the hypertensive/cheese reaction provided.

The possibility exists that very tyramine-rich foods (e.g., aged cheese such as Stilton) could possibly cause an increase in blood pressure. Patients should be advised to avoid certain foods (e.g. ., aged cheese) containing a very large amount of tyramine while taking recommended doses of AZILECT (rasagiline) because of the potential for large increases in blood pressure. If patients eat foods very rich in tyramine and do not feel well soon after eating, they should contact their healthcare provider [see WARNINGS AND PRCAUTIONS].

Melanoma

It is not known if melanoma is associated with Parkinson's disease or the medicines used to treat Parkinson's disease. Patients being treated with AZILECT (rasagiline) should be advised to have periodic skin examinations. [see WARNINGS AND PRECAUTIONS ].

Dyskinesia

Patients taking AZILECT (rasagiline) as adjunct to levodopa should be advised that there is a possibility of dyskinesia or increased dyskinesia [see WARNINGS AND PRECAUTIONS].

Lowering of Blood Pressure and Postural/Orthostatic Hypotension

Patients should be advised that they may develop postural (orthostatic) hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating. Hypotension and /or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). Accordingly, patients should be cautioned against standing up rapidly after sitting or lying down, especially if they have been doing so for prolonged periods, and especially, at the initiation o f treatment with AZILECT [see WARNINGS AND PRECAUTIONS].

Elevation of Blood Pressure

Patients should be alerted to the possibility of increases in blood pressure during treatment with AZILECT (rasagiline) . Exacerbation of hypertension may occur. Medication dose adjustment may be necessary if elevation of blood pressure is sustained over multiple e valuations [see WARNINGS AND PRECAUTIONS].

Hallucinations / Psychotic-Like Behavior

Patients should be informed that hallucinations or other manifestations of psychotic -like behavior can occur when taking AZILECT (rasagiline) . Patients should also be advised that, if they have a major psychotic disorder, that AZILECT (rasagiline) should not ordinarily be used because of the risk of exacerbating the psychosis. Patients with a major psychotic disorder should also be aware that m any treatments for psychosis may decrease the effectiveness of AZILECT [see WARNINGS AND PRECAUTIONS].

Withdrawal-Emergent Hyperpyrexia and Confusion

Patients should be told to contact their healthcare provider if they wish to discontinue Azilect (rasagiline) .

Missing Dose

Patients should be instructed to take AZILECT (rasagiline) as prescribed. If a dose is missed, the patient should not double-up the dose of AZILECT (rasagiline) . The next dose should be taken at the usual time on t he following day.

Impulse Control/Compulsive Behaviors

There have been reports of patients experiencing intense urges to gamble, increased sexual urges, other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone and that are generally used for the treatment of Parkinson's disease (including AZILECT (rasagiline) ). Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduce d or the medication was stopped. Prescribers should ask patient s about the development of new or increased gambling urges, sexual urges, or other urges while being treated with rasagiline. Patient s should inform their physician if they experience new or increased gambling urges, increased sexual urges, or other intense urges while taking rasagiline. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking rasagiline.

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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