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Fenoldopam Mesylate

Pronouncation: (feh-NAHL-doe-pam MEH-sih-LATE)
Class: Antihypertensive

Trade Names:
Corlopam
- Injection, concentrate 10 mg/mL

Pharmacology

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Compare with other drugs.

D ₁ -like dopamine receptor agonist and binds with moderate affinity to α ₂ -adrenoceptors.

Pharmacokinetics

Absorption

Steady-state levels are attained in approximately 20 min (4 t _½ s) and are proportional to the infusion rate.

Metabolism

Conjugated by methylation, glucuronidation, and sulfation.

Elimination

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.

Onset

Rapid onset and quickly reversible. Most of the effect of a given infusion rate is attained in 15 min.

Special Populations

Renal 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 Usage

Adults

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.

Contraindications

Standard considerations.

Dosage and Administration

Adults

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.

General Advice

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.

Adults
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.

Children
Administer IV by continuous infusion pump appropriate for the delivery of low infusion rates.

Storage/Stability

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 Interactions

Beta-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.

Adverse Reactions

Cardiovascular

Hypotension (at least 5%); angina pectoris, bradycardia, extrasystole, heart failure, ischemic heart disease, MI, palpitations (0.5% to 5%).

CNS

Headache (at least 5%); pyrexia (0.5% to 5%).

Dermatologic

Flushing (at least 5%).

GI

Nausea (at least 5%).

Genitourinary

Oliguria (0.5% to 5%).

Hematologic-Lymphatic

Bleeding, leukocytosis (0.5% to 5%).

Metabolic-Nutritional

Elevated BUN, LDH, serum glucose, and transaminase (0.5% to 5%).

Musculoskeletal

Limb cramp (0.5% to 5%).

Respiratory

Dyspnea, upper respiratory disorder (0.5% to 5%).

Miscellaneous

Nonspecific chest pain (0.5% to 5%).

Precautions

Monitor

Monitor heart rate and BP of children continuously, usually by way of an intra-arterial line.

Pregnancy

Category B .

Lactation

Undetermined.

Children

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.

Elderly

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.

Sulfite Sensitivity

Product contains metabisulfite and can cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, in susceptible people.

CV

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).

Hypokalemia

Decreases in serum potassium below 3 mEq/L may occur.

IOP

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.

Overdosage

Symptoms

Excessive hypotension.

Patient Information

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.