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Fenoldopam

Pronunciation

(fe NOL doe pam)

Index Terms

  • Fenoldopam Mesylate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Corlopam: 10 mg/mL (1 mL); 20 mg/2 mL (2 mL) [contains propylene glycol, sodium metabisulfite]

Generic: 10 mg/mL (1 mL [DSC]); 20 mg/2 mL (2 mL [DSC])

Brand Names: U.S.

  • Corlopam

Pharmacologic Category

  • Antihypertensive
  • Dopamine Agonist

Pharmacology

A selective postsynaptic dopamine agonist (D1-receptors) which exerts hypotensive effects by decreasing peripheral vasculature resistance with increased renal blood flow, diuresis, and natriuresis; 6 times as potent as dopamine in producing renal vasodilatation; has minimal adrenergic effects

Distribution

Vd: 0.6 L/kg

Metabolism

Hepatic via methylation, glucuronidation, and sulfation; the 8-sulfate metabolite may have some activity; extensive first-pass effect

Excretion

Urine (90%); feces (10%); Clearance: Children: 3 L/hour/kg

Onset of Action

IV: Children: 5 minutes; Adults: 10 minutes; Note: Majority of effect of a given infusion rate is attained within 15 minutes.

Duration of Action

IV: 1 hour

Half-Life Elimination

IV: Children: 3 to 5 minutes; Adults: ~5 minutes

Use: Labeled Indications

Severe hypertension: Short-term treatment of severe hypertension (up to 48 hours in adults while in hospital), including patients with malignant hypertension with deteriorating end-organ function; short-term (up to 4 hours while in hospital) blood pressure reduction in pediatric patients while in hospital

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Dosing: Adult

Severe hypertension: IV: Initial: 0.01 to 0.3 mcg/kg/minute; may increase in increments of 0.05 to 0.1 mcg/kg/minute every 15 minutes until target blood pressure is reached; the maximum infusion rate reported in clinical studies was 1.6 mcg/kg/minute; limit for short-term use (up to 48 hours)

Note: Oral antihypertensive agents may be added during fenoldopam infusion or after discontinuation.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Severe hypertension: IV: Initial: 0.2 mcg/kg/minute; may increase in increments of 0.3 to 0.5 mcg/kg/minute every 20 to 30 minutes (maximum dose: 0.8 mcg/kg/minute); limit for short-term (4 hours) use

Note: Oral antihypertensive agents may be added during fenoldopam infusion or after discontinuation.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; the effects of hemodialysis have not been evaluated.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Reconstitution

Dilute with NS or D5W to a final concentration of 40 mcg/mL (adults) or 60 mcg/mL (pediatric).

Administration

For continuous IV infusion only.

Compatibility

Stable with NS or D5W.

Y-site administration: Incompatible with aminophylline, amphotericin B, ampicillin, bumetanide, cefoxitin, dexamethasone sodium phosphate, diazepam, fosphenytoin, furosemide, ketorolac, methohexital, methylprednisolone sodium succinate, pentobarbital, phenytoin, prochlorperazine edisylate, sodium bicarbonate, thiopental.

Compatibility in syringe: Incompatible with ceftriaxone.

Storage

Store undiluted product at 2°C to 30°C (35°F to 86°F). Diluted solutions in NS or D5W that have been prepared but not administered should be discarded after 4 hours at room temperature or 24 hours refrigerated.

Drug Interactions

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Adverse Reactions

≥5%:

Cardiovascular: Cutaneous flushing, hypotension

Central nervous system: Headache

Gastrointestinal: Nausea

<5%:

Cardiovascular: Angina, bradycardia, chest pain, extrasystoles, heart failure, MI, orthostatic hypotension, palpitation, ST-T abnormalities, T-wave inversion, tachycardia

Central nervous system: Anxiety, dizziness, fever, insomnia

Endocrine & metabolic: Hyperglycemia, hypokalemia, LDH increased

Gastrointestinal: Abdominal pain/fullness, constipation, diarrhea, vomiting

Genitourinary: Urinary tract infection

Hematologic: Bleeding, leukocytosis

Hepatic: Transaminases increased

Local: Injection site reactions

Neuromuscular & skeletal: Back pain, limb cramps

Ocular: Intraocular pressure increased

Renal: BUN increased, creatinine increased, oliguria

Respiratory: Dyspnea, nasal congestion

Miscellaneous: Diaphoresis

Warnings/Precautions

Concerns related to adverse effects:

• Hypokalemia: Hypokalemia has been observed within 6 hours of fenoldopam infusion; monitor potassium concentrations appropriately.

• Tachycardia: Dose-related tachycardia can occur, especially at infusion rates >0.1 mcg/kg/minute (adults) and >0.8 mcg/kg/minute (pediatric). Doses lower than 0.1 mcg/kg/minute and slow up-titration is associated with less reflex tachycardia.

Disease-related concerns:

• Angina: Use with extreme caution in patients with obstructive coronary disease or ongoing angina pectoris; can increase myocardial oxygen demand due to tachycardia leading to angina pectoris.

• Glaucoma: Dose-dependent increase in intraocular pressure (IOP) has been reported in patients with glaucoma or intraocular hypertension; upon discontinuation, IOP returned to baseline within 2 hours.

Dosage form specific issues:

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

• Sulfites: Contains sulfites; may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, in susceptible individuals. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Monitoring Parameters

Blood pressure, heart rate, ECG; serum potassium concentrations

Pregnancy Risk Factor

B

Pregnancy Considerations

Fetal harm was not observed in animal studies; however, safety and efficacy have not been established for use during pregnancy. Use during pregnancy only if clearly needed.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, flushing, nausea, or injection site pain or irritation. Have patient report immediately to prescriber signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), tachycardia, severe dizziness, or passing out (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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