Teva Pharmaceuticals announced that the FDA has approved revised Prescribing Information for Azilect (rasagiline tablets) reducing medication and food restrictions. The new labeling reflects reduced concerns regarding the concomitant use of Azilect with other medications, including many over-the-counter cough/cold medications. Additionally, patients taking Azilect no longer need to follow a general dietary restriction of ordinary levels of tyramine. However, due to potential mild increased sensitivity in some patients, very high levels of tyramine (eg, >150mg) should be avoided.

The update to the prescribing information was based on clinical data from a double-blind, placebo-controlled, randomized, dose-ranging study that confirmed the mechanism of action of Azilect as a selective monoamine-oxidase-B (MAO-B) inhibitor at the recommended doses of 0.5mg and 1mg. Non-selective MAO inhibitors may interfere with the breakdown and elimination of tyramine in the body, which can induce hypertensive reactions.

Azilect is indicated for the treatment of the signs and symptoms of Parkinson’s Disease as initial monotherapy and as an adjunct to levodopa.

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