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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Fenoldopam causes a dose-related tachycardia, particularly with infusion rates above 0.1 mcg/kg/min ( 5.1 ). • Hypokalemia: Monitor potassium levels ( 5.2 ). • Increased intraocular pressure in patients with glaucoma or intraocular hypertension ( 5.3 ). • Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms in susceptible patients ( 5.4 ). 5.1 Tachycardia Fenoldopam causes a dose-related tachycardia, particularly with infusion rates above 0.1 mcg/kg/min in adults and >0.8 mcg/kg/min in pediatric patients. Tachycardia in adults may diminish with continued therapy at doses of fenoldopam of <0.1 mcg/kg/min. 5.2 Hypokalemia Hypokalemia has been observed after less than 6 hours of fenoldopam infusion. Hypokalemia reflects a pressure natriuresis with enhanced potassium-sodium exchange or a direct drug effect. Monitor serum potassium levels. 5.3 Increased 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. 5.4 Allergic Reactions Associated with Sulfite 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 non-asthmatic people.
6 ADVERSE REACTIONS The most common events (occurring in more than 5% of patients) reported associated with use are headache, cutaneous dilation (flushing), nausea, and hypotension ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common reactions associated with fenoldopam use are headache, cutaneous dilation (flushing), nausea, and hypotension, each reported in more than 5% of patients. Adverse reactions 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 Table 3 . There was no clear dose relationship, except possibly for headache, nausea, flushing. Table 3. Adverse reactions in fixed-dose studies occurring in > 5% of subjects on fenoldopam Event Placebo (n = 7) Fenoldopam (n = 125) n (%) n (%) Headache 1 (14%) 30 (24%) Nausea 0 15 (12%) Vomiting 0 7 (6%) Injection site reaction 0 9 (7%) Electrocardiogram T wave inversion 0 7 (6%) The following additional adverse reactions were observed more frequently in patients treated with fenoldopam Incidence 0.5% to 5% Metabolism and Nutrition Disorders — Hypokalemia Psychiatric Disorders — Nervousness/Anxiety, insomnia Nervous System Disorders — Dizziness Cardiac Disorders — Extrasystoles, palpitations, cardiac failure, ischemic heart disease, myocardial infarction, angina pectoris, tachycardia Gastrointestinal Disorders — Abdominal pain Skin and Subcutaneous Tissue Disorders — Hyperhidrosis Musculoskeletal and Connective Tissue Disorders —Muscle spasms Renal and Urinary Disorders — Oliguria General Disorders and Administration Site Conditions —Chest pain, pyrexia Investigations — Blood urea increased, blood creatinine increased, blood glucose increased, transaminases increased, blood lactate dehydrogenase increased 6.2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of CORLOPAM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Voluntary reports of adverse reactions temporally associated with CORLOPAM that have been received since market introduction include the following: Cardiac Disorders — Cardiogenic shock Vascular Disorders — Hypotension Gastrointestinal Disorders — Abdominal distension Investigations — Electrocardiogram ST segment depression, oxygen saturation decreased