Indications
DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended for the control of essential hypertension.
Contraindications
DEMSER is contraindicated in persons known to be hypersensitive to this compound.
Warnings and precautions
Maintain Fluid Volume During and After Surgery When DEMSER is used preoperatively, alone or especially in combination with alpha-adrenergic 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 DEMSER in patients with pheochromocytoma is thought to decrease intraoperative problems with blood pressure control, DEMSER 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 DEMSER 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 . )
Adverse reactions
Central Nervous System Sedation: The most common adverse reaction to DEMSER is moderate to severe sedation, which has been observed in almost all patients. It occurs at both low and high dosages. Sedative effects begin within the first 24 hours of therapy, are maximal after two to three days, and tend to wane during the next few days. Sedation usually is not obvious after one week unless the dosage is increased, but at dosages greater than 2000 mg/day some degree of sedation or fatigue may persist.
At a glance
- Brand name
- Demser
- Active substance
- metyrosine
- Pharmacologic class
- Catecholamine Synthesis Inhibitor
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Bausch
- Status
- Prescription
- FDA approval
- 3 Oct 1979
- Application
- NDA017871-001



