Fenoldopam warnings and precautions

Fenoldopam
CORLOPAM® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Fenoldopam
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Warnings and Precautions

WARNINGS

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

PRECAUTIONS

Intraocular Pressure: In a clinical study of 12 patients with open-angle glaucoma or ocular hypertension (mean baseline intraocular pressure was 29.2 mm Hg with a range of 22 to 33 mm Hg), infusion of fenoldopam at escalating doses ranging from 0.05 to 0.5 mcg/kg/min over a 3.5 hour period caused a dose-dependent increase in intraocular pressure (IOP). At the peak effect, the intraocular pressure was raised by a mean of 6.5 mm Hg (range -2 to +8.5 mm Hg, corrected for placebo effect). Upon discontinuation of the fenoldopam infusion, the IOP returned to baseline values within 2 hours. Fenoldopam administration to patients with glaucoma or intraocular hypertension should be undertaken with caution.

Tachycardia: Fenoldopam causes a dose-related tachycardia (Table 2 and Table 3), particularly with infusion rates above 0.1 mcg/kg/min. tachycardia in adults diminishes over time but remains substantial at higher doses. tachycardia in pediatric patients at doses > 0.8 mcg/kg/min persists at least for 4 hours.

Hypotension: Fenoldopam may occasionally produce symptomatic hypotension and close monitoring of blood pressure during administration is essential. (See Adverse Reactions.) It is particularly important to avoid systemic hypotension when administering the drug to patients who have sustained an acute cerebral infarction or hemorrhage. In pediatric patients, fenoldopam was only administered to patients with an indwelling intraarterial line.

Hypokalemia: Decreases in serum potassium occasionally to values below 3 mEq/L were observed after less than 6 hours of fenoldopam infusion. It is not clear if the Hypokalemia reflects a pressure natriuresis with enhanced potassium-sodium exchange or a direct drug effect. During clinical trials, electrolytes were monitored at intervals of 6 hours. Hypokalemia was treated with either oral or intravenous potassium supplementation. Patient management should include appropriate attention to serum electrolytes.

Intracranial Pressure: The effect of fenoldopam in the presence of increased intracranial pressure has not been studied.

Drug Interactions with Beta-Blockers: Concomitant use of fenoldopam with beta-blockers should be avoided. If the drugs are used together, caution should be exercised because unexpected hypotension could result from beta-blocker inhibition of the sympathetic reflex response to fenoldopam.