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fenoldopam mesylate
(redirected from Corlopam)

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fenoldopam mesylate

Corlopam

Pharmacologic class: Dopamine receptor agonist (vasodilator)

Therapeutic class: Emergency antihypertensive

Pregnancy risk category B

Action

Stimulates dopamine1 postsynaptic receptors, causing vasodilation, decreasing blood pressure and total peripheral resistance, and increasing renal blood flow

Availability

Ampules: 10 mg/ml in single-dose, 5-ml ampules

Indications and dosages

Short-term (up to 48 hours) hospital management of severe hypertension when rapid blood pressure reduction is indicated

Hospitalized adults: Dosages highly individualized based on rate and magnitude of desired blood pressure decrease. Dosages of 0.01 to 1.6 mcg/kg/minute I.V. infusion have been studied in clinical trials. Titrate upward or downward no more often than q 15 minutes to achieve desired blood pressure, at recommended increments of 0.05 to 0.1 mcg/kg/minute.

Short-term (up to 4 hours) blood pressure reduction in hospitalized children

Hospitalized children: Dosages highly individualized based on rate and magnitude of desired blood pressure decrease. Dosages of 0.2 mcg/kg/minute I.V. were used initially in clinical trials; dosage increases up to 0.3 to 0.5 mcg/kg/minute q 20 to 30 minutes for up to 4 hours were well tolerated; dosages above 0.8 mcg/kg/minute have produced tachycardia with no additional benefit.

Contraindications

• Hypersensitivity to drug or sulfites

Precautions

Use cautiously in:
• glaucoma, increased intraocular pressure (IOP), tachycardia, hypotension, hypokalemia, hepatic disease
• patients receiving concurrent beta-adrenergic blockers.

Administration

Don't give as I.V. bolus. Give only by slow, continuous I.V. infusion using infusion pump, at a concentration of 40 mcg/ml or less (60 mcg/ml or less for children).
• Be aware that compatible solutions are 0.9% sodium chloride injection and 5% dextrose injection.

RouteOnsetPeakDuration
I.V.15 min20 minUnknown

Adverse reactions

CNS: anxiety, dizziness, headache, light-headedness, insomnia, nervousness

CV: angina pectoris, nonspecific chest pain, hypotension, palpitations, ST-segment and T-wave changes, tachycardia, bradycardia, heart failure, ischemic heart disease, myocardial infarction

EENT: increased IOP, nasal congestion

GI: nausea, vomiting, diarrhea, constipation, abdominal pain and fullness

GU: urinary tract infection, oliguria

Hematologic: leukocytosis, bleeding tendency

Metabolic: hypokalemia

Musculoskeletal: leg cramps, back pain

Respiratory: dyspnea, upper respiratory tract infection

Skin: diaphoresis, flushing

Other: injection site pain, fever, hypersensitivity reactions including anaphylaxis

Interactions

Drug-drug. Beta-adrenergic blockers: increased hypotension

Dopamine antagonists, metoclopramide: decreased fenoldopam effects

Drug-diagnostic tests. Aminotransferase, blood urea nitrogen, creatinine, glucose, lactate dehydrogenase, potassium: decreased levels

Patient monitoring

• Watch closely for signs and symptoms of anaphylaxis or severe asthma.
Check blood pressure carefully at least every 15 minutes to detect hypotension, especially in patient with acute cerebral infarction or hemorrhage.
• When desired blood pressure decrease occurs, discontinue therapy or taper dosage as ordered.
• Know that patients with asthma are at higher risk for sulfite sensitivity.
• Assess respiratory and cardiac status regularly.
• Monitor potassium level closely.
• Evaluate fluid intake and urinary output.

Patient teaching

Tell patient to immediately report signs or symptoms of anaphylaxis or breathing problems.
• Tell patient that drug may cause rapid heart rate and excessively lower blood pressure, possibly resulting in dizziness.



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The agency referred to correspondence between it and the firm regarding three homemade promotional pieces for Corlopam (fenoldopam mesylate) that FDA cited for promotion of unapproved uses including "cost-effective renal protection" and use in patients undergoing "cardia (sic) or peripheral vascular surgery, both as a potential renoprotective agent and antihyper-tensive.
Brexidol from the Chiesi Group, Corlopam from Elan PLC's Neurex organization and d-methylphenidate from Celgene Corporation will diversify and strengthen our revenue drivers for 1999 and beyond.
TORONTO--(BW HealthWire)--April 23, 1998--Biovail Corporation International (NYSE:BVF)(TSE:BVF) today announced that its wholly owned subsidiary, Crystaal Corporation ("Crystaal"), has entered into a licensing agreement with Neurex for the marketing of Corlopam (fenoldopan) in Canada.
 
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