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http://tinyurl.com/azilectFDAlabel


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>Information for Patients
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>Patients and caregivers should be informed about which foods and 
>beverages to avoid because of high tyramine content.They should be 
>informed that a hypertensive crisis could occur after ingestion of 
>certain foods (e.g., aged cheeses, pickled herring, yeast extract) 
>or beverages (e.g., some red wines and certain beers) containing 
>significant amounts of tyramine, or amines contained in some 
>medications including some over-the-counter cough/cold medications. 
>Foods high in tyramine content include those that have undergone 
>protein change by aging, fermentation, pickling, or smoking to 
>improve flavor such as aged cheeses, air-dried meats, sauerkraut, 
>soy sauce, tap/draft beers and red wines. The tyramine content of 
>any protein-rich food may be increased if stored for long periods or 
>improperly refrigerated.
>
>Patients and caregivers should be informed of the signs and symptoms 
>associated with hypertensive crisis, including severe headache, 
>blurred vision, difficulty thinking, seizures, chest pain, 
>unexplained nausea or vomiting, or signs or symptoms of a 
>stroke.  Patients and caregivers should seek immediate medical 
>attention for patients who develop any severe headache or other 
>atypical or unusual symptoms not previously experienced.  (See 
><http://dailymed.nlm.nih.gov/dailymed/archives/http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=11322#A54FBD8C-670C-4E03-BAC2-71BF546F37AF>WARNINGS).
>
>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.  Patients 
>should not use meperidine with AZILECT.
>
>Patients taking AZILECT as adjunct to levodopa should be advised 
>there is the possibility of increased dyskinesia and postural hypotension.
>
>Patients are advised to monitor for melanomas frequently and on a 
>regular basis.  Ideally, periodic skin examinations should be 
>performed by appropriately qualified individuals (e.g., dermatologists).
>
>Patients should be instructed to take AZILECT as prescribed.  If a 
>dose is missed, the patient should not double-up the dose of 
>AZILECT.  The next dose should be taken at the usual time on the following day.
>
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>Drug Interactions
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>Meperidine
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>Serious, sometimes fatal reactions have been precipitated with 
>concomitant use of meperidine (e.g., Demerol and other tradenames) 
>and MAO inhibitors including selective MAO-B inhibitors. (See 
><http://dailymed.nlm.nih.gov/dailymed/archives/http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=11322#A330CD11-BFD0-4079-A8F7-DF8EABB477B4>CONTRAINDICATIONS).
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>Dextromethorphan
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>The concomitant use of AZILECT and dextromethorphan was not allowed 
>in clinical studies.  The combination of MAO inhibitors and 
>dextromethorphan has been reported to cause brief episodes of 
>psychosis or bizarre behavior. Therefore, in view of AZILECT's MAO 
>inhibitory activity, dextromethorphan should not be used 
>concomitantly with AZILECT. (See 
><http://dailymed.nlm.nih.gov/dailymed/archives/http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=11322#A330CD11-BFD0-4079-A8F7-DF8EABB477B4>CONTRAINDICATIONS).
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>Sympathomimetic Medications
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>The concomitant use of AZILECT and sympathomimetic medications was 
>not allowed in clinical studies.   Severe hypertensive reactions 
>have followed the administration of sympathomimetics and 
>non-selective MAO inhibitors. One case of hypertensive crisis has 
>been reported in a patient taking the recommended doses of a 
>selective MAO-B inhibitor and a sympathomimetic medication 
>(ephedrine).  Therefore, in view of AZILECT's MAO inhibitory 
>activity, AZILECT should not be used concomitantly with 
>sympathomimetics including nasal and oral decongestants and cold 
>remedies.  (See 
><http://dailymed.nlm.nih.gov/dailymed/archives/http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=11322#A330CD11-BFD0-4079-A8F7-DF8EABB477B4>CONTRAINDICATIONS 
>and 
><http://dailymed.nlm.nih.gov/dailymed/archives/http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=11322#A4D59127-FA1F-4D69-8CC5-5CCFC5FDC42D>WARNINGS, 
>Need for Restriction of Dietary Tyramine and Amines Contained in Medications).
>
>
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>MAO Inhibitors
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>AZILECT should not be administered along with other MAO inhibitors 
>because of the increased risk of non-selective MAO inhibition that 
>may lead to a hypertensive crisis. (See 
><http://dailymed.nlm.nih.gov/dailymed/archives/http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=11322#A330CD11-BFD0-4079-A8F7-DF8EABB477B4>CONTRAINDICATIONS).
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>Selective Serotonin Reuptake Inhibitors (SSRIs), Tricyclic and 
>Tetracyclic Antidepressants
>
>
>
>Concomitant use of SSRI, tricyclic, and tetracyclic antidepressants 
>with AZILECT is not recommended. (See 
><http://dailymed.nlm.nih.gov/dailymed/archives/http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=11322#A54FBD8C-670C-4E03-BAC2-71BF546F37AF>WARNINGS).
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>Levodopa/carbidopa
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>(See 
><http://dailymed.nlm.nih.gov/dailymed/archives/http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=11322#A65301C1-C288-4F47-9D4D-C004DA17BB2E>CLINICAL 
>PHARMACOLOGY, Drug-Drug Interactions; 
><http://dailymed.nlm.nih.gov/dailymed/archives/http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=11322#A5A90675-7928-4A07-A595-FB6FF5842DCD>PRECAUTIONS, 
>General, Dyskinesias Due to Levodopa Treatment

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