Corlopam Side Effects

Generic Name: fenoldopam

Note: This page contains information about the side effects of fenoldopam. Some of the dosage forms included on this document may not apply to the brand name Corlopam.

Not all side effects for Corlopam may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to fenoldopam: parenteral injection

Side effects include:

Adults: Headache, flushing, nausea, hypotension, hypokalemia.

Pediatric patients: Hypotension, tachycardia.

For Healthcare Professionals

Applies to fenoldopam: intravenous solution

Cardiovascular

Fenoldopam can cause dose-related increases in heart rate and tachycardia and symptomatic decreases in blood pressure. Caution is recommended when administering this drug to patients with acute cerebral infarction or hemorrhage. In addition, because some elderly people may not tolerate sudden or significant decreases in systemic blood pressure due to decreased intracerebral vascular autoregulation, cautious reduction of blood pressure with fenoldopam (the active ingredient contained in Corlopam) is recommended when treating the elderly with emergent hypertension.

Animal data have revealed evidence of arterial lesions that have not been documented in humans. These lesions have been characterized by dose-related medial necrosis and hemorrhage in the renal and splanchnic arteries of rats given fenoldopam intravenously in dosages ranging from 1 to 100 mcg/kg/min for 24 hours (the latter dosage is over 300 times the maximum recommended human infusion rate (on a per kg basis). (Similar lesions have been associated with the use of dopamine.) Animal data are conflictual as dog data have not revealed these lesions. The suspected mechanism involves activation of the D1-like dopaminergic receptors.

Oral administration of fenoldopam to rats was associated with a higher incidence of polyarteritis nodosa compared with controls.[Ref]

Cardiovascular side effects are the most common and potentially serious side effects. In controlled trials of patients with severe hypertension and end-organ damage, 3% (4/137) patients withdrew from therapy due to excessive hypotension. Reflex tachycardia has rarely been associated with the use of this drug. Tachycardia can be associated with increased cardiac work, oxygen demand, and can increase the risk of myocardial ischemia. This may be especially important in some patients with underlying coronary artery disease. Other cardiovascular events associated with the use of fenoldopam include ST-T wave ECG changes in 6% to 33% (suggestive of ischemia) and flushing in 7% to 11% of patients (probably due to peripheral vasodilation). Less common cardiovascular side effects include extrasystoles, palpitations, bradycardia, heart failure, myocardial infarction, and angina pectoris (less than 1% of patients). Many of these events may reflect underlying disease in the populations studied.[Ref]

Nervous system

Nervous system side effects have included dose-related headaches in 11% to 36% and dizziness in 10% of patients. Less commonly, anxiety and insomnia have been associated with the use of fenoldopam (the active ingredient contained in Corlopam) [Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea in 20% of patients and rare complaints of vomiting, abdominal pain/fullness, constipation, or diarrhea.[Ref]

Metabolic

Rarely, the use of fenoldopam (the active ingredient contained in Corlopam) has been associated with metabolic side effects, including decreased serum potassium concentrations to values below 3.0 mEq/L. It is unknown whether this hypokalemia resulted from a pressure natriuresis (with enhanced sodium-potassium exchange) or a direct drug effect. Appropriate monitoring of serum potassium and electrolytes is recommended during fenoldopam infusions.[Ref]

Other metabolic side effects have included elevated BUN, serum glucose, LDH, and serum transaminase values.[Ref]

Hematologic

Hematologic side effects have only rarely been associated with the use of fenoldopam (the active ingredient contained in Corlopam) They have included leukocytosis and bleeding.[Ref]

Respiratory

Reported respiratory problems may have been related to underlying disease, and have included dyspnea, wheezing, and nasal congestion.[Ref]

Renal

In general, the use of fenoldopam (the active ingredient contained in Corlopam) has been shown to preserve or improve renal function in patients with severe hypertension. The only adverse effects have been rare cases of elevated BUN and oliguria. The vasodilating effects of this drug have been observed in renal afferent and efferent arterioles. In humans, limited data have shown increases in renal blood flow in hypertensive and normal subjects treated with intravenous fenoldopam. However, no beneficial clinical effect on renal function has been shown in patients with heart failure or hepatic or severe renal disease. The manufacturer promotes this drug's positive effect on the kidney. In clinical trials, use of fenoldopam has been shown to maintain renal perfusion and increase both enuresis and diuresis in patients with normal kidneys and in those with impaired renal function.[Ref]

Musculoskeletal

Rare complaints of musculoskeletal cramping and back pain have been associated with the use of fenoldopam (the active ingredient contained in Corlopam) [Ref]

Ocular

The use of fenoldopam (the active ingredient contained in Corlopam) has been associated with increased intraocular pressure (IOP) in healthy volunteers and in patients with hypertension. Dose-related increases of 6.5 mm Hg have been associated with fenoldopam infusions of 0.5 mcg/kg/min in patients with open-angle glaucoma after 3.5 hours. The mechanism is unknown. Caution is recommended when administering this drug to patients with glaucoma or other causes of increased IOP.[Ref]

Data have shown that the infusions of fenoldopam up to 0.5 mcg/kg/min have been associated with significant increases in IOP without significant changes in macular blood flow, visual field, aqueous outflow facility, and aqueous humor production. The increase in IOP among the patients studied (patients with elevated IOP or primary open-angle glaucoma) during infusions of fenoldopam suggests that dopamine-1 (D1) receptors play a role in the regulation of IOP.[Ref]

Endocrine

Fenoldopam (the active ingredient contained in Corlopam) indirectly produces some endocrinologic changes. It induces systemic and renal vasodilation and natriuresis by direct stimulation of D1-like receptors in the proximal renal tubule, which is (partially) counteracted by a rise of plasma renin activity and subsequently of aldosterone. Increased plasma aldosterone can result in a mild kaliuresis and hypokalemia.[Ref]

Hepatic

Use of fenoldopam (the active ingredient contained in Corlopam) in patients with hepatic failure has been approved by the FDA. However, although this drug has been shown to safely decrease systemic blood pressure in this population, increased portal pressures have been documented in patients with liver cirrhosis and ascites (in some cases without significant desired increases in renal blood flow). Because of the increased portal pressure (theoretically due to increased mesenteric blood flow), some experts have expressed concern that this drug could increase the risk of hemorrhage from esophageal varices.[Ref]

References

1. "Product Information. Corlopam (fenoldopam)." Neurex, Menlo Park, CA.

2. Gluck Z, Jossen L, Weidmann P, Gnadinger MP, Peheim E "Cardiovascular and renal profile of acute peripheral dopamine1- receptor agonism with fenoldopam." Hypertension 10 (1987): 43-54

3. Panacek EA, Bednarczyk EM, Dunbar LM, Foulke GE, Holcslaw TL "Randomized, prospective trial of fenoldopam vs sodium nitroprusside in the treatment of acute severe hypertension. Fenoldopam Study Group." Acad Emerg Med 2 (1995): 959-65

4. Holcslaw TL, Beck TR "Clinical experience with intravenous fenoldopam." Am J Hypertens 3 (1990): s120-5

5. White WB, Radford MJ, Gonzalez FM, Weed SG, McCabe EJ, Katz AM "Selective dopamine-1 agonist therapy in severe hypertension: effects of intravenous fenoldopam." J Am Coll Cardiol 11 (1988): 1118-23

6. Ventura HO, Messerli FH, Frohlich ED, Kobrin I, Oigman W, Dunn FG, Carey RM "Immediate hemodynamic effects of a dopamine-receptor agonist (fenoldopam) in patients with essential hypertension." Circulation 69 (1984): 1142-5

7. Brogden RN, Markham A "Fenoldopam: a review of its pharmacodynamic and pharmacokinetic properties and intravenous clinical potential in the management of hypertensive urgencies and emergencies." Drugs 54 (1997): 634-50

8. Abdelwahab W, Frishman W, Landau A "Management of hypertensive urgencies and emergencies." J Clin Pharmacol 35 (1995): 747-62

9. White WB, Halley SE "Comparative renal effects of intravenous administration of fenoldopam mesylate and sodium nitroprusside in patients with severe hypertension." Arch Intern Med 149 (1989): 870-4

10. Hadengue A, Moreau R, Bacq Y, Gaudin C, Braillon A, Lebrec D "Selective dopamine DA1 stimulation with fenoldopam in cirrhotic patients with ascites: a systemic, splanchnic and renal hemodynamic study." Hepatology 13 (1991): 111-6

11. Bughi S, Horton R, Antonipillai I, Manoogian C, Ehrlich L, Nadler J "Comparison of dopamine and fenoldopam effects on renal blood flow and prostacyclin excretion in normal and essential hypertensive subjects." J Clin Endocrinol Metab 69 (1989): 1116-21

12. Hill AJ, Feneck RO, Walesby RK "A comparison of fenoldopam and nitroprusside in the control of hypertension following coronary artery surgery." J Cardiothorac Vasc Anesth 7 (1993): 279-84

13. Harvey JN, Worth DP, Brown J, Lee MR "The effect of oral fenoldopam (SKF 82526-J), a peripheral dopamine receptor agonist, on blood pressure and renal function in normal man." Br J Clin Pharmacol 19 (1985): 21-7

14. Carey RM, Stote RM, Dubb JW, Townsend LH, Rose CE Jr, Kaiser DL "Selective peripheral dopamine-1 receptor stimulation with fenoldopam in human essential hypertension." J Clin Invest 74 (1984): 2198-207

15. Shusterman NH, Elliott WJ, White WB "Fenoldopam, but not nitroprusside, improves renal function in severely hypertensive patients with impaired renal function." Am J Med 95 (1993): 161-8

16. Ruilope LM, Robles RG, Miranda B, Tovar J, Alcazar JM, Sancho J, Rodicio JL, Martinez A, Astorga A, Beck T "Renal effects of fenoldopam in refractory hypertension." J Hypertens 6 (1988): 665-9

17. Girbes AR, Smit AJ, Meijer S, Reitsma WD "Renal and endocrine effects of fenoldopam and metoclopramide in normal man." Nephron 56 (1990): 179-85

18. Lass NA, Glock D, Goldberg LI "Cardiovascular and renal hemodynamic effects of intravenous infusions of the selective DA1 agonist, fenoldopam, used alone or in combination with dopamine and dobutamine." Circulation 78 (1988): 1310-5

19. Martin SW, Broadley KJ "Renal vasodilatation by dopexamine and fenoldopam due to alpha 1- adrenoceptor blockade." Br J Pharmacol 115 (1995): 349-55

20. O'Connell DP, Ragsdale NV, Boyd DG, Felder RA, Carey RM "Differential human renal tubular responses to dopamine type 1 receptor stimulation are determined by blood pressure status." Hypertension 29 (1997): 115-22

21. Murphy MB, McCoy CE, Weber RR, Frederickson ED, Douglas FL, Goldberg LI "Augmentation of renal blood flow and sodium excretion in hypertensive patients during blood pressure reduction by intravenou administration of the dopamine1 agonist fenoldopam." Circulation 76 (1987): 1312-8

22. Elliott WJ, Weber RR, Nelson KS, et al "Renal and hemodynamic effects of intravenous fenoldopam versus nitroprusside in severe hypertension." Circulation 81 (1990): 970-7

23. Nichols AJ, Ruffolo RR Jr, Brooks DP "The pharmacology of fenoldopam." Am J Hypertens 3 (1990): s116-9

24. Everitt DE, Boike SC, Piltz-Seymour JR, VanCoevorden R, Audet P, Zariffa N, Jorkasky D "Effect of intravenous fenoldopam on intraocular pressure in ocular hypertension." J Clin Pharmacol 37 (1997): 312-20

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