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Corlopam

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Corlopam

Corlopam

Corlopam Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Corlopam (fenoldopam mesylate) Injection is a dopamine receptor agonist (vasodilator) used for in-hospital, short-term (up to 48 hours) management of severe high blood pressure (hypertension) when rapid, but quickly reversible, emergency reduction of blood pressure is indicated. This medication is available in generic form. Common side effects include headache, flushing, nausea and low blood pressure (hypotension).

The drug dose rate of Corlopam is individualized for each patient according to body weight and according to the desired rapidity and extent of pharmacodynamic effect. Corlopam may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Corlopam should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Corlopam (fenoldopam mesylate) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Corlopam FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adult Patients: Fenoldopam causes a dose-related fall in blood pressure and increase in heart rate (see PRECAUTIONS, Tachycardia, and Hypotension). In controlled clinical studies of severe hypertension in patients with end-organ damage, 3% (4/137) of patients withdrew because of excessive falls in blood pressure. Increased heart rate could, in theory, lead to ischemic cardiac events or worsened heart failure, although these events have not been observed. The most common events reported as associated with fenoldopam use are headache, cutaneous dilation (flushing), nausea, and hypotension, each reported in more than 5% of patients.

Adverse reactions in controlled trials in hypertensive adult patients

Adverse events occurring more than once in any dosing group (once if potentially important or plausibly drug-related) in the fixed-dose constant-infusion studies are presented in the following Table by infusion-rate group. There was no clear dose relationship, except possibly for headache, nausea, flushing.

Table 4: ADVERSE EVENTS* FROM FIXED-DOSE INFUSION STUDIES BY DOSAGE GROUP

Body System Fenoldopam Dosage (mcg/kg/min) (Adults)
Event Placebo
(n=7)
0.01
(n=26)
0.03-0.04
(n=31)
0.1
(n=28)
0.3-0.4
(n= 29)
0.6-0.8
(n=11)
Body, General Headache 1 5 4 7 8 6
Injection site reaction 0 1 3 0 3 2
Cardiovascular ST-T abnormalities (primarily T-wave inversion) 0 2 4 0 1 0
Flushing 0 0 0 0 1 3
Hypotension** 0 0 0 2 0 2
Postural hypotension 0 2 0 0 0 0
Tachycardia** 0 0 0 0 0 2
Digestive Nausea 0 3 0 3 5 4
Vomiting 0 2 0 2 1 2
Abdominal pain/fullness 0 2 0 0 2 1
Constipation 0 0 0 0 0 2
Diarrhea 0 0 0 0 2 0
Metabolic and Nutritional Increased creatinine** 0 0 2 0 0 0
Hypokalemia** 0 2 2 0 1 0
Nervous Nervousness/anxiety 0 0 1 0 0 2
Insomnia 0 2 0 0 0 0
Dizziness 0 1 1 2 2 0
Respiratory Nasal congestion 0 0 0 0 0 2
Skin and Appendages Sweating 0 0 0 1 1 2
Urogenital Urinary tract infection 0 2 0 1 0 0
Musculoskeletal Back pain 0 1 0 1 2 2
*Includes events reported by 2 or more patients receiving fenoldopam treatment across all dose groups.
**Investigator defined; no protocol definition.

Adverse effects in overall database

The adverse event incidences listed below are based on observations of over 1,000 fenoldopam treated adult patients and not listed in Table 4 above.

Events reported with a frequency between 0.5-5% in patients treated with IV fenoldopam

Cardiovascular: extrasystoles, palpitations, bradycardia, heart failure, ischemic heart disease, myocardial infarction, angina pectoris

Metabolic: elevated BUN, elevated serum glucose, elevated transaminase, elevated LDH

General Body: non-specific chest pain, pyrexia

Hematologic/Lymphatic: leukocytosis, bleeding

Respiratory: Dyspnea, upper respiratory disorder

Genitourinary: Oliguria

Musculoskeletal: limb cramp

Pediatric Patients: In pediatric patients, the most common adverse events reported during short term administration in controlled trials (30 minutes) were hypotension and tachycardia. However, because of the short exposure, there is limited experience with defining adverse events in children. The long-term effects of fenoldopam on growth and development have not been studied.

Read the entire FDA prescribing information for Corlopam (Fenoldopam Mesylate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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