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Informed Consent Risk of Cheese Reaction PowerPoint PPT Presentation


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Informed Consent Risk of Cheese Reaction

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Informed consent risk of cheese reaction l.jpg

Informed ConsentRisk of Cheese Reaction

  • A possible risk of using selegiline is uncontrolled hypertension (high blood pressure), the so-called “cheese reaction”, which can occur if you eat foods containing tyramine, e.g., aged cheese, liquor, dry sausage, yogurt, raisins, liver, pickled herring, Fava beans, sauerkraut, and over-the-counter cough/cold medications. Therefore, it is important that you tellyour doctor immediately if you have any of the following symptoms: headache, heart palpitations, a sense of constriction in the throat or chest, sweating, dizziness, neck stiffness, nausea, or vomiting.

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Proposed Label for 30-40 mg Diet (excerpt)

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Patient Information on Dietary Modifications

  • A modified diet is not necessary when taking EMSAM 6mg/24 hours (20mg)

  • The consumption of certain foods and beverages during treatment with EMSAM 9mg/24 hours (30mg) or 12mg/24 hours (40mg) dose may lead to a sudden, large increase in blood pressure, called a ‘‘hypertensive crisis’’ (a potentially life-threatening situation). (See What are the possible side effects of EMSAM?)

  • Dietary Modifications:

    • To prevent a hypertensive crisis, the following foods and beverages should be avoided beginning on the first day of EMSAM 9mg/24 hours (30mg) or 12mg/24 hours (40mg) treatment and continue until 2 weeks after a dose reduction to EMSAM 6mg/24 hours (20mg) or stopping EMSAM 9mg/24 hours (30mg) or 12mg/24 hours (40mg):

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    Patient Information on Dietary Modifications (Continued)

    • Dietary Modifications:

      • 12mg/24 hours (40mg):

        • Air dried, aged and fermented meats, sausages and salamis (including cacciatore, hard salami and mortadella); pickled herring; and any spoiled or improperly stored meat, poultry and fish (e.g., foods that have undergone changes in coloration, odor, or become moldy)

        • Broad bean pods (fava bean pods)

        • Aged cheeses

        • All varieties of tap beer, and beers that have not been pasteurized so as to allow for ongoing fermentation should be avoided during EMSAM treatment

        • Concentrated yeast extract (e.g., Marmite), sauerkraut, all soybean products (including soy sauce and tofu)

      • All foods must be fresh or properly frozen

      • Avoid foods when you are unaware of storage conditions

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    Informed ConsentDescription of Symptoms of Hypertensive Crisis

    • Severe headache, flushing, sudden elevation of blood pressure, awareness of rapid or pounding heart, nausea, vomitting, sweating, fever, and chest pain. Although rare, hypertensive crisis may be a life-threatening reaction that requires immediate medical attention.

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    Transdermal SelegilinePivotal Trial II: P0052 Acute MDD

    HAMD-28:

    p < 0.03 p <0.04

    Dosage

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    Transdermal SelegilinePivotal Trial II: P0052 Acute MDD

    p < 0.03 p <0.04

    HAMD-28

    Dosage

    2 - 18


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    Responder Rates* for MDD Patients inPlacebo-Controlled Studies

    % Improved

    * Defined as CGI-I score of 1 or 2

    2 - 11


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    Tyramine Pressor Dose and TSF Values for Individual Subjects Challenged in the Fasted and Fed States

    *Fasted - lowest value obtained during 30-90 days of EMSAM 40 mg treatment

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