Data from FDA - Curated by EPG Health - Last updated 31 December 2017

Indication(s)

1 INDICATIONS AND USAGE Fenoldopam injection is a dopaminergic agonist indicated: •In adult patients for short term management of severe hypertension when rapid and reversible reduction of blood pressure is clinically indicated, including for malignant hypertension with deteriorating end-organ function (1.1). •In pediatric patients for short-term reduction in blood pressure (1.2). 1.1 Adult Patients Fenoldopam is indicated for in-hospital, short-term (up to 48 hours) management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is clinically indicated, including malignant hypertension with deteriorating end-organ function. Transition to oral therapy with another agent can begin at any time after blood pressure is stable during fenoldopam infusion. 1.2 Pediatric Patients Fenoldopam is indicated for in-hospital, short-term (up to 4 hours) reduction in blood pressure [see Clinical Pharmacology (12.2)].

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Advisory information

contraindications
4 CONTRAINDICATIONS None. •None (4).
Adverse reactions
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 Hospira, Inc. at 1-800-441-4100, 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 clinical 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 difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure. Voluntary reports of adverse reactions temporally associated with Corlopam that have been received since market introduction and that may have no causal relationship with the drug include the following: Cardiac Disorders — Cardiogenic shock Vascular Disorders — Hypotension Gastrointestinal Disorders — Abdominal distension Investigations — Electrocardiogram ST segment depression, oxygen saturation decreased

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION •Adults: Initiate dosing at 0.01 to 0.3 mcg/kg/min by continuous infusion. Dosing can be increased in increments of 0.05 to 0.1 mcg/kg/minute every 15 minutes or longer until target blood pressure is reached (2.1). •Dilute prior to administration (2.1, 2.2). •Pediatrics: Initiate dosing at 0.2 mcg/kg/minute by continuous infusion and titrate dose by 0.3 to 0.5 mcg/kg/min every 20-30 minutes to a maximum dose of 0.8 mcg/kg/minute (2.1, 2.2). 2.1 Recommended Dosage Adult Patients Initiate dosing at 0.01 to 0.3 mcg/kg/min as a continuous intravenous infusion. Dosing may be increased in increments of 0.05 to 0.1 mcg/kg/minute every 15 minutes or longer, until target blood pressure is reached [see Clinical Pharmacology (12.2)]; the maximal infusion rate reported in clinical studies was 1.6 mcg/kg/minute. Doses lower than 0.1 mcg/kg/min and slow up-titration have been associated with less reflex tachycardia. Maintenance infusions may be continued for up to 48 hours. Oral antihypertensive agents can be added during fenoldopam infusion or after discontinuation. Pediatric Patients Initiate dosing at 0.2 mcg/kg/minute and titrate dose by 0.3 to 0.5 mcg/kg/min every 20-30 minutes to a maximum dose of 0.8 mcg/kg/minute. Higher doses generally produced no further decreases in MAP but did worsen tachycardia. 2.2 Preparation and Administration Dilute contents of ampules or vials with 0.9% Sodium Chloride Injection or 5% Dextrose in Water before infusion. Each ampule or vial is for single use only. Discard diluted solution if not being administered to a patient after 4 hours at room temperature or 24 hours at refrigerated temperature. Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or cloudiness is observed, discard the drug. Table 1. Dilution Instructions for Adults mL of Concentrate (mg of drug) Added to Final Concentration 4 mL (40 mg) 1000 mL 40 mcg/mL 2 mL (20 mg) 500 mL 40 mcg/mL 1 mL (10 mg) 250 mL 40 mcg/mL Table 2. Dilution Instructions for Pediatric Patients mL of Concentrate (mg of drug) Added to Final Concentration 3 mL (30 mg) 500 mL 60 mcg/mL 1.5 mL (15 mg) 250 mL 60 mcg/mL 0.6 mL (6 mg) 100 mL 60 mcg/mL Rates of infusion in mL/hour for fenoldopam may be calculated using the following formula: Infusion Rate (mL/h) = [Dose (mcg/kg/min) x Weight (kg) x 60 min/h] Concentration (mcg/mL) Example calculations for infusion rates are as follows: Example 1: for a 60 kg patient at an initial dose of 0.01 mcg/kg/min using a 40 mcg/mL concentration, the infusion rate would be as follows: Infusion Rate (mL/h) = [0.01 (mcg/kg/min) x 60 (kg) x 60 (min/h)] = 0.9 (mL/h) 40 (mcg/mL) Example 2: for a 10 kg patient at a dose of 0.2 mcg/kg/min using a 60 mcg/mL concentration, the infusion rate would be as follows: Infusion Rate (mL/h) = [0.2 (mcg/kg/min) x 10 (kg) x 60 (min/h)] = 2.0 (mL/h) 60 (mcg/mL)
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B. Oral reproduction studies have been performed in rats and rabbits at doses of 12.5 to 200 mg/kg/day and 6.25 to 25 mg/kg/day, respectively. Studies have revealed maternal toxicity at the highest doses tested but no evidence of impaired fertility or harm to the fetus due to fenoldopam. There are, however, no adequate and well-controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, fenoldopam should be used in pregnancy only if clearly needed. 8.3 Nursing Mothers Fenoldopam is excreted in milk in rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, discontinue nursing or fenoldopam. 8.4 Pediatric Use Safety and effectiveness of fenoldopam have been established in the age groups age < 1 month (at least 2 kg or full term) to 12 years old requiring blood pressure reduction [see Clinical Pharmacology (12.2)]. The adverse event profile in pediatric patients is similar to that seen in adults. The pharmacokinetics of fenoldopam are independent of age when corrected for body weight. The long-term effects of fenoldopam on growth and development have not been studied. 8.5 Geriatric Use Clinical studies of fenoldopam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Interactions

7 DRUG INTERACTIONS •Beta-blockers: Avoid concomitant use (7.1). 7.1 Beta-Blockers Avoid concomitant use of fenoldopam with beta-blockers. If the drugs are used together, blood pressure should be monitored frequently because hypotension could result from beta-blocker inhibition of the sympathetic reflex response to fenoldopam.

More information

Category Value
Authorisation number NDA019922
Agency product number HA3R0MY016
Orphan designation No
Product NDC 0409-2304,0409-3373
Date Last Revised 30-11-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 1730929
Marketing authorisation holder Hospira, Inc.