metyrosine

FDA Drug Profile — Demser, metyrosine

Drug Details

Generic Name
metyrosine
Brand Names
Demser, metyrosine
Application Number
NDA017871
Sponsor
Bausch Health US, LLC
NDC Codes
2
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
METYROSINE

Indications and Usage

INDICATIONS AND USAGE Metyrosine capsules are indicated in the treatment of patients with pheochromocytoma for: Preoperative preparation of patients for surgery Management of patients when surgery is contraindicated Chronic treatment of patients with malignant pheochromocytoma Metyrosine capsules are not recommended for the control of essential hypertension.

Warnings

WARNINGS Maintain Fluid Volume During and After Surgery When metyrosine is used preoperatively, alone or especially in combination with alphaadrenergic blocking drugs, adequate intravascular volume must be maintained intraoperatively (especially after tumor removal) and postoperatively to avoid hypotension and decreased perfusion of vital organs resulting from vasodilatation and expanded volume capacity. Following tumor removal, large volumes of plasma may be needed to maintain blood pressure and central venous pressure within the normal range. In addition, life-threatening arrhythmias may occur during anesthesia and surgery, and may require treatment with a beta-blocker or lidocaine. During surgery, patients should have continuous monitoring of blood pressure and electrocardiogram. Intraoperative Effects While the preoperative use of metyrosine capsules in patients with pheochromocytoma is thought to decrease intraoperative problems with blood pressure control, metyrosine does not eliminate the danger of hypertensive crises or arrhythmias during manipulation of the tumor, and the alpha-adrenergic blocking drug, phentolamine, may be needed. Interaction with Alcohol Metyrosine may add to the sedative effects of alcohol and other CNS depressants, e.g., hypnotics, sedatives, and tranquilizers. (See PRECAUTIONS, Information for Patients and Drug Interactions .)