Pronunciation: feh-NAHL-doe-pam MEH-sih-LATE
- Injection, concentrate 10 mg/mL
D 1 -like dopamine receptor agonist and binds with moderate affinity to α 2 -adrenoceptors.
Steady-state levels are attained in approximately 20 min (4 t ½ s) and are proportional to the infusion rate.
Conjugated by methylation, glucuronidation, and sulfation.
Elimination t ½ is about 5 min in mild to moderate hypertension. Approximately 90% of infused dose is eliminated in urine and 10% in feces. About 4% is excreted unchanged. In pediatric patients, 1 mo to 12 yr of age, the elimination t ½ and Cl were 3 to 5 min and 3 L/h/kg, respectively.
Rapid onset and quickly reversible. Most of the effect of a given infusion rate is attained in 15 min.
Special PopulationsRenal Function Impairment
Cl not altered in adult patients with end-stage renal disease.Hepatic Function Impairment
Cl not altered in adult patients with severe hepatic failure.Elderly
Pharmacokinetics not altered by age.Gender
Pharmacokinetics not altered by gender.Race
Pharmacokinetics not altered by race.
Indications and UsageAdults
Short-term (up to 48 h), in-hospital management of severe hypertension when rapid, but quickly reversible, emergency reduction of BP is indicated, including malignant hypertension with deteriorating end-organ function.Children
Short-term (up to 4 h), in-hospital reduction in BP.
Dosage and AdministrationAdults
IV In general, doses below 0.1 mcg/kg/min have modest effects and appear marginally useful in acutely hypertensive patients. As the initial dose increases, there is a greater and more rapid BP reduction. Lower initial doses (0.03 to 0.1 mcg/kg/min) slowly titrated have been associated with less reflex tachycardia than higher initial doses (0.3 mcg/kg/min or more). Most of the effect of a given infusion rate is attained in 15 min.Children
IV In clinical trials, the usual starting dose was 0.2 mcg/kg/min with an effect on mean arterial pressure (MAP) evident within 5 min. At a constant infusion rate, the effect was maximal after 20 to 25 min. Increased dosages up to 0.3 to 0.5 mcg/kg/min q 20 to 30 min were generally well tolerated. Tachycardia without further decrease in MAP occurred at dosages greater than 0.8 mcg/kg/min. Upon discontinuation, and after an average of 4 h of therapy, BP and heart rate returned to near baseline within 30 min.
- Contents of ampule must be diluted before infusion; each ampule is for single use only.
- Only dilute in sodium chloride 0.9% injection or dextrose 5% injection.
- Dose must be individualized based on body weight and desired rapidity and extent of pharmacologic effect.
- Do not administer if particulate matter or cloudiness noted.
- Administer by continuous IV infusion, not by bolus.
- Avoid hypotension and rapid decreases of BP.
- Infusion can be abruptly discontinued or gradually tapered prior to discontinuation.
- Use of a calibrated, mechanical continuous infusion pump is recommended for proper control of infusion rate.
- Administer IV by continuous infusion pump appropriate for the delivery of low infusion rates.
Store ampules at 35.6° to 86°F. Diluted solution is stable under normal temperature and ambient light for at least 24 h. Discard unused, diluted solution within 24 h.
Drug InteractionsBeta-blockers (eg, propranolol)
If possible, avoid coadministration with fenoldopam because of possible hypotension caused by beta-blocker inhibition of the sympathetic reflex response to fenoldopam.Concomitant antihypertensive agents (eg, alpha-blockers, ACE inhibitors, calcium channel-blockers, diuretics)
Limited experience available.
Laboratory Test Interactions
None well documented.
Hypotension (at least 5%); angina pectoris, bradycardia, extrasystole, heart failure, ischemic heart disease, MI, palpitations (0.5% to 5%).
Headache (at least 5%); pyrexia (0.5% to 5%).
Flushing (at least 5%).
Nausea (at least 5%).
Oliguria (0.5% to 5%).
Bleeding, leukocytosis (0.5% to 5%).
Elevated BUN, LDH, serum glucose, and transaminase (0.5% to 5%).
Limb cramp (0.5% to 5%).
Dyspnea, upper respiratory disorder (0.5% to 5%).
Nonspecific chest pain (0.5% to 5%).
Monitor heart rate and BP of children continuously, usually by way of an intra-arterial line.
Category B .
Antihypertensive effects have not been studied in children 12 to 16 yr of age. Consider the patient's clinical condition and concomitant drug therapy during dose selection.
Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.
Product contains metabisulfite and can cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, in susceptible people.
Dose-related tachycardia may occur, particularly with infusion rates greater than 0.l mcg/kg/min. Symptomatic hypotension may occur. Hypotension and tachycardia are the most common adverse reactions in children during short-term administration (30 min).
Decreases in serum potassium below 3 mEq/L may occur.
Because dose-dependent increases in IOP may occur with fenoldopam infusion (peak effect mean increase of 6.5 mm Hg), use with caution in patients with glaucoma or intraocular hypertension.
- Caution patient that this item contains sulfite that can cause allergic reactions in certain individuals (eg, asthma patients).
- Instruct patient to inform health care provider of glaucoma, increased IOP, or beta-blocker use before administration of this medicine.
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