demser
Demser (Metyrosine) is a catecholamine synthesis inhibitor used to treat Pheochromocytoma.
Metyrosine · by Bausch
Key facts
- Active ingredient
- Metyrosine
- Drug class
- Catecholamine Synthesis Inhibitor
- Form
- Capsule
- Strength
- Metyrosine 250MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- pheochromocytoma
- Manufacturer
- Bausch
- FDA application
- NDA017871
What is Demser?
From the FDA label:DEMSER (metyrosine) is (–)-α-methyl- L -tyrosine or (α-MPT). It has the following structural formula: Metyrosine is a white to off-white, crystalline compound of molecular weight 195.22. It is very slightly soluble in water, acetone, and methanol, and insoluble in chloroform and benzene. It is soluble in acidic aqueous solutions. It is also soluble in alkaline aqueous solutions, but is subject to oxidative degradation under these conditions. DEMSER is supplied as capsules for oral administration. Each capsule contains 250 mg metyrosine. Inactive ingredients are colloidal silicon dioxide, gelatin, hydroxypropyl cellulose, magnesium stearate, titanium dioxide, FD&C Blue 2 and edible black ink. image
How to use
The recommended initial dosage of DEMSER for adults and children 12 years of age and older is 250 mg orally four times daily. This may be increased by 250 mg to 500 mg every day to a maximum of 4 g/day in divided doses. When used for preoperative preparation, the optimally effective dosage of DEMSER should be given for at least five to seven days. Optimally effective dosages of DEMSER usually are between 2 and 3 g/day, and the dose should be titrated by monitoring clinical symptoms and catecholamine excretion. In patients who are hypertensive, dosage should be titrated to achieve normalization of blood pressure and control of clinical symptoms. In patients who are usually normotensive, dosage should be titrated to the amount that will reduce urinary metanephrines and/or vanillylmandelic acid by 50% or more. If patients are not adequately controlled by the use of DEMSER, an alpha-adrenergic blocking agent (phenoxybenzamine) should be added. Use of DEMSER in children under 12 years of age has been limited and a dosage schedule for this age group cannot be given.
Side effects
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. In most patients who experience sedation, temporary changes in sleep pattern occur following withdrawal of the drug. Changes consist of insomnia that may last for two or three days and feelings of increased alertness and ambition. Even patients who do not experience sedation while on DEMSER may report symptoms of psychic stimulation when the drug is discontinued. Extrapyramidal Signs: Extrapyramidal signs such as drooling, speech difficulty, and tremor have been reported in approximately 10% of patients. These occasionally have been accompanied by trismus and frank parkinsonism. Anxiety and Psychic Disturbances: Anxiety and psychic disturbances such as depression, hallucinations, disorientation, and confusion may occur. These effects seem to be dose-dependent and may disappear with reduction of dosage. Diarrhea Diarrhea occurs in about 10% of patients and may be severe.…
Warnings
Important safety information
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 . )
Who should not take Demser
DEMSER is contraindicated in persons known to be hypersensitive to this compound.
Overdose — what happens if you take too much
Signs of metyrosine overdosage include those central nervous system effects observed in some patients even at low dosages. At doses exceeding 2000 mg/day, some degree of sedation or feeling of fatigue may persist. Doses of 2000-4000 mg/day can result in anxiety or agitated depression, neuromuscular effects (including fine tremor of the hands, gross tremor of the trunk, tightening of the jaw with trismus), diarrhea, and decreased salivation with dry mouth. Reduction of drug dose or cessation of treatment results in the disappearance of these symptoms. The acute toxicity of metyrosine was 442 mg/kg and 752 mg/kg in the female mouse and rat, respectively.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Demser treat?
- Demser (Metyrosine) may be used to treat pheochromocytoma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Demser?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Demser. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Demser?
- Demser is marketed by Bausch. You can see Bausch's full profile, rating, and other products on pharmaranks.
- Is Demser a brand-name or generic drug?
- Demser is a brand-name product with the active ingredient Metyrosine.
- Is Demser available over the counter?
- No. Demser is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Demser come in?
- Demser is currently marketed as capsule, per the FDA's National Drug Code Directory.
- What class of drug is Demser?
- Demser is classified as catecholamine synthesis inhibitor, per the FDA's Established Pharmacologic Class.
- Is Demser FDA-registered?
- Demser is on record with the U.S. FDA under application number NDA017871. You can verify this on its official FDA label.
- Is Demser safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Demser. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Demser?
- Demser's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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