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Corlopam

Generic Name: Fenoldopam
Class: Direct Vasodilators
VA Class: AU100
Chemical Name: 6-Chloro-2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)-[1H]-3-benzazepine-7,8-diol methanesulfonate
Molecular Formula: C16H16ClNO3•CH3SO3H
CAS Number: 67227-57-0

Medically reviewed by Drugs.com. Last updated on Dec 16, 2019.

Introduction

Benzazepine-derivative vasodilating agent.1 10 11 12

Uses for Corlopam

Hypertension

Used for short-term (up to 48 hours), in-hospital management of severe hypertension in adults when rapid, but quickly reversible, emergency reduction of BP is clinically indicated (e.g., malignant hypertension with deteriorating end-organ function, hypertensive emergencies).1 10 1200 Transition to oral therapy with another antihypertensive agent may begin any time after BP is stable during fenoldopam infusion.1 10

Used for short-term (up to 4 hours), in-hospital management of hypertension in pediatric patients.1 Some experts state fenoldopam may be used for the management of acute severe hypertension in pediatric patients without life-threatening symptoms in whom oral therapy is not appropriate.1150

Hypotensive efficacy similar to that of sodium nitroprusside in adults with severe hypertension.1 10 11 12 13 14

Unlike sodium nitroprusside, fenoldopam is not associated with thiocyanate toxicity and is not degraded by light.10 11

May have beneficial effects on renal function;10 11 13 particularly useful in patients with severe hypertension associated with end-organ renal damage or volume overload (e.g., CHF, chronic renal insufficiency).11 14

Corlopam Dosage and Administration

General

  • Adjust dosage according to BP until target BP is reached.1

  • May abruptly discontinue fenoldopam infusion14 or gradually taper prior to discontinuance of therapy.10 14

  • May administer oral antihypertensive agents during fenoldopam infusion or following discontinuance of the infusion.1

Administration

For solution and drug compatibility information, see Compatibility under Stability.

IV Administration

Administer by continuous IV infusion.1

Dilution

Prior to administration, dilute fenoldopam injection concentrate in 0.9% sodium chloride injection or 5% dextrose injection.1

A final fenoldopam concentration of 60 mcg/mL generally recommended for pediatric use; final fenoldopam concentration of 40 mcg/mL recommended for adult use.1

Infusion solutions for pediatric patients: Add 3, 1.5, or 0.6 mL (30, 15, or 6 mg) of fenoldopam injection concentrate to 500, 250, or 100 mL, respectively, of diluent to achieve an infusion solution with a final fenoldopam concentration of 60 mcg/mL.1

Infusion solutions for adults: Add 4, 2, or 1 mL (40, 20, or 10 mg) of fenoldopam injection concentrate to 1000, 500, or 250 mL, respectively, of diluent to achieve an infusion solution with a final fenoldopam concentration of 40 mcg/mL.1

Rate of Administration

Pediatric patients: Individualize rate of administration according to body weight and desired rapidity and extent of pharmacodynamic effect.1 (See Dosage: Pediatric Patients under Dosage and Administration)

Adults: Individualize rate of administration according to body weight and desired rapidity and extent of pharmacodynamic effect.1 (See Dosage: Adults under Dosage and Administration.)

Dosage

Available as fenoldopam mesylate; dosage expressed in terms of fenoldopam.1

Pediatric Patients

Hypertension
IV

In-hospital, short-term (≤4 hours) BP reduction: Initially, 0.2 mcg/kg per minute by IV infusion recommended by manufacturer.1 May increase dosage every 20–30 minutes by up to 0.3–0.5 mcg/kg per minute to a maximum dosage of 0.8 mcg/kg per minute.1

Acute severe hypertension without life-threatening symptoms: Some experts suggest a dosage of 0.2–0.5 mcg/kg per minute by IV infusion, which may be titrated up to 0.8 mcg/kg per minute if necessary.1150 Reduce BP in such patients by ≤25% of the planned reduction over the first 8 hours, with remainder of reduction over next 12–24 hours.1150

Select initial dosage based on desired magnitude and rate of BP reduction for given clinical situation.1 Consult manufacturer’s labeling for detailed information on pharmacodynamic effects of fenoldopam dosages ranging from 0.05–3.2 mcg/kg per minute in pediatric patients.1

Adults

Severe Hypertension
IV

Usual initial dosage: 0.01–0.3 mcg/kg per minute.1 12 14 1200 To achieve desired therapeutic effect, may titrate dosage upward in increments of 0.05–0.1 mcg/kg per minute1 14 no more frequently than every 15 minutes until target BP is reached.1

Lower initial dosages (<0.1 mcg/kg per minute) titrated slowly have been associated with less reflex tachycardia.1

Select initial dosage based on desired magnitude and rate of BP reduction for given clinical situation.1 Consult manufacturer’s labeling for detailed information on pharmacodynamic effects of fenoldopam dosages ranging from 0.01–0.3 mcg/kg per minute in patients with severe hypertension.1

Hypertensive emergency in adults with a compelling indication (severe preeclampsia or eclampsia, pheochromocytoma crisis): Reduce SBP to <140 mm Hg during the first hour.1200

Hypertensive emergency in adults with a compelling indication (acute aortic dissection): Reduce SBP to <120 mm Hg within the first 20 minutes.1200

Hypertensive emergency in adults without a compelling indication: Reduce SBP by ≤25% within first hour, followed by further BP reduction if stable to 160/100 or 160/110 mm Hg within the next 2–6 hours; avoid excessive declines in BP that could precipitate renal, cerebral, or coronary ischemia.542 1200 If this BP is well tolerated and the patient is clinically stable, may implement further gradual reductions toward normal BP in the next 24–48 hours.1200

Prescribing Limits

Pediatric Patients

Hypertension
IV

Dosages >0.8 mcg/kg per minute result in increased tachycardia without further decrease in mean arterial pressure.1 Treatment duration should not exceed 4 hours.1

Adults

Severe Hypertension
IV

Dosages up to 1.6 mcg/kg per minute used in clinical trials.1 Maintenance infusions may be continued for up to 48 hours.1

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.1

Renal Impairment

No specific dosage recommendations at this time.1

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.1

Cautions for Corlopam

Contraindications

  • Manufacturer states that there are no known contraindications to use of fenoldopam.1

  • Some experts state the drug is contraindicated in patients at risk of increased IOP (i.e., glaucoma) or intracranial pressure and in those with a sulfite allergy.1200

Warnings/Precautions

Sensitivity Reactions

Sulfite Sensitivity

Commercially available formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.1 2 3 4 5 6 7 8 9

General Precautions

Cardiovascular Effects

Dose-related tachycardia reported, especially in adults receiving infusion rates >0.1 mcg/kg per minute and in pediatric patients receiving infusion rates >0.8 mcg/kg per minute.1 In adults, tachycardia may diminish over time with continued therapy at dosages of fenoldopam <0.1 mcg/kg per minute.1

ECG T wave inversion, extrasystoles, palpitations, cardiac failure, ischemic heart disease, and angina pectoris reported during clinical trials with fenoldopam.1

Hypokalemia

Decreases in serum potassium reported after <6 hours of fenoldopam infusion.1 Monitor serum potassium concentrations.1

Intraocular Pressure (IOP)

Dose-dependent, reversible increases in IOP reported in patients with glaucoma or ocular hypertension.1 10 14

Specific Populations

Pregnancy

Category B.1

Fetal harm not observed in animal reproductive studies with fenoldopam; however, reproductive studies in humans lacking.1 Use during pregnancy only if clearly needed.1

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 Discontinue nursing or the drug.1

Pediatric Use

Antihypertensive effects of fenoldopam evaluated in pediatric patients (age <1 month [≥2 kg or full term] to 12 years) requiring BP reduction.1

Long-term effects of fenoldopam on growth and development in pediatric patients have not been studied.1

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.1 (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Headache,1 10 11 12 14 cutaneous dilation (flushing),1 10 11 12 14 nausea,1 12 14 hypotension.1 12

Interactions for Corlopam

Not metabolized by CYP isoenzymes.1

Specific Drugs

Drug

Interaction

Comments

ACE inhibitors

Pharmacokinetic interaction unlikely1 14

β-Adrenergic blocking agents

May cause hypotension secondary to β-blocker inhibition of sympathetic reflex response to fenoldopam1

Avoid concomitant use; if used concomitantly, monitor BP frequently1

Cardiac glycosides

Pharmacokinetic interaction unlikely1 11 15

Nitroglycerin (sublingual)

Pharmacokinetic interaction unlikely15

Corlopam Pharmacokinetics

Absorption

Onset

Adults: Rapid onset of response.1 11 12 Most of the antihypertensive effect attained in 15 minutes.1 11 15

Pediatric patients: Effect on BP and heart rate evident within 5 minutes after starting infusion.1 Effects increased with time for 15–25 minutes; an effect was still observed at an average of 4 hours after initiation of the infusion.1

Duration

Adults: Substantial effect persisted through 48 hours of continuous infusion.1 Following discontinuance of fenoldopam infusion, BP gradually returned to pretreatment values with no evidence of rebound hypertension.1 12 14

Pediatric patients: BP and heart rate approached baseline values during the 30 minutes following discontinuance of fenoldopam infusion.1

Distribution

Extent

Distributed into milk in rats; not known whether distributed into human milk.1

Only minimal amounts (≤0.005%) cross the blood-brain barrier in rats.1 10

Plasma Protein Binding

Approximately 85–90%.10 14

Elimination

Metabolism

Metabolized principally by conjugation (methylation, glucuronidation, sulfation)1 11 14 to inactive metabolites.1 Not metabolized by cytochrome P-450 enzymes.1

Elimination Route

Excreted in urine (90%) mainly as inactive metabolites and in feces (10%).1 About 4% of the dose is excreted unchanged.1

Half-life

Adults: About 5–10 minutes.1 10 11 14

Pediatric patients (1 month to 12 years of age): About 3–5 minutes.1

Special Populations

Clearance of fenoldopam is not altered in patients with end-stage renal disease undergoing continuous ambulatory peritoneal dialysis (CAPD) or in patients with severe hepatic failure.1 Data lacking on effects of hemodialysis on pharmacokinetics of fenoldopam.1

Stability

Storage

Parenteral

Injection

2–30°C.1

Ampuls and vials of fenoldopam injection concentrate are for single use only.1

Diluted solutions are stable under normal ambient light and temperature conditions for at least 24 hours.1 Use diluted solutions within 24 hours; discard thereafter.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 5% in water

Sodium chloride 0.9%

Drug CompatibilityHID
Y-Site Injection Compatibility

Compatible

Alfentanil HCl

Amikacin sulfate

Aminocaproic acid

Amiodarone HCl

Ampicillin sodium-sulbactam sodium

Argatroban

Atracurium besylate

Atropine sulfate

Aztreonam

Butorphanol tartrate

Calcium gluconate

Cefazolin sodium

Cefepime HCl

Cefotaxime sodium

Cefotetan disodium

Ceftazidime

Ceftriaxone sodium

Cefuroxime sodium

Chlorpromazine HCl

Ciprofloxacin

Cisatracurium besylate

Clindamycin phosphate

Co-trimoxazole

Dexmedetomidine HCl

Digoxin

Diltiazem HCl

Diphenhydramine HCl

Dobutamine HCl

Dolasetron mesylate

Dopamine HCl

Doxycycline hyclate

Droperidol

Enalaprilat

Ephedrine sulfate

Epinephrine HCl

Erythromycin lactobionate

Esmolol HCl

Famotidine

Fentanyl citrate

Fluconazole

Gentamicin sulfate

Granisetron HCl

Haloperidol lactate

Heparin sodium

Hetastarch in lactated electrolyte injection (Hextend)

Hydrocortisone sodium succinate

Hydromorphone HCl

Hydroxyzine HCl

Iodixanol

Iohexol

Iopamidol

Ioxaglate meglumine-ioxaglate sodium

Isoproterenol HCl

Labetalol HCl

Levofloxacin

Lidocaine HCl

Linezolid

Lorazepam

Magnesium sulfate

Mannitol

Meperidine HCl

Metoclopramide HCl

Metronidazole

Micafungin sodium

Midazolam HCl

Milrinone lactate

Morphine sulfate

Nalbuphine HCl

Naloxone HCl

Nicardipine HCl

Nitroglycerin

Norepinephrine bitartrate

Ondansetron HCl

Pancuronium bromide

Phenylephrine HCl

Piperacillin sodium-tazobactam sodium

Potassium chloride

Procainamide HCl

Promethazine HCl

Propofol

Propranolol HCl

Quinupristin-dalfopristin

Ranitidine HCl

Remifentanil HCl

Rocuronium bromide

Sufentanil citrate

Theophylline

Tobramycin sulfate

Vancomycin HCl

Vecuronium bromide

Verapamil HCl

Incompatible

Aminophylline

Amphotericin B

Ampicillin sodium

Bumetanide

Cefoxitin sodium

Dexamethasone sodium phosphate

Diazepam

Fosphenytoin sodium

Furosemide

Ketorolac tromethamine

Methohexital sodium

Methylprednisolone sodium succinate

Pentobarbital sodium

Phenytoin sodium

Prochlorperazine edisylate

Sodium bicarbonate

Actions

  • Rapid-acting vasodilator.1 10 12 14

  • Agonist for D1-like dopamine receptors; binds with moderate affinity to α2-adrenoreceptors.1 10 11 12 13 14 Not a selective α-adrenoreceptor antagonist at therapeutic concentrations.11

  • In animals, has vasodilating effects in coronary, renal, mesenteric, and peripheral arteries; however, all vascular beds do not respond uniformly to the drug.1

  • Vasodilating effects have been demonstrated in renal efferent and afferent arterioles.1

  • In patients with severe hypertension, produces dose-related, rapid-onset decreases in SBP and DBP and dose-related increases in heart rate.1 11

  • May increase plasma norepinephrine concentration.1

    May have beneficial effects on renal function; increases in urinary output, sodium excretion, and Clcr observed in patients with severe hypertension, including those with renal impairment.10 11 13 14

Advice to Patients

  • Importance of advising patients with underlying hypertension that they require continued follow-up for their medical condition and that they should continue taking their oral antihypertensive drug(s) as directed.1

  • Importance of advising patients to contact a healthcare professional immediately if they develop signs and symptoms of a new hypertensive emergency (e.g., neurologic symptoms, visual changes, evidence of CHF).1

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Fenoldopam Mesylate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection concentrate, for IV infusion only

10 mg (of fenoldopam)/mL*

Corlopam

Hospira

Fenoldopam Mesylate Injection

AHFS DI Essentials™. © Copyright 2020, Selected Revisions December 16, 2019. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Hospira. Corlopam (fenoldopam mesylate injection) prescribing information. Lake Forest, IL; 2015 Dec.

2. Food and Drug Administration. Sulfites in foods and drugs. FDA Drug Bull. 1983; 13:12. http://www.ncbi.nlm.nih.gov/pubmed/6604672?dopt=AbstractPlus

3. Sogn D. The ubiquitous sulfites. JAMA. 1984; 251:2986 7. Editorial. http://www.ncbi.nlm.nih.gov/pubmed/6716628?dopt=AbstractPlus

4. Koepke JW, Christopher KL, Chai H et al. Dose dependent bronchospasm from sulfites in isoetharine. JAMA. 1984; 251:2982 3. http://www.ncbi.nlm.nih.gov/pubmed/6716626?dopt=AbstractPlus

5. Twarog FJ, Leung DYM. Anaphylaxis to a component of isoetharine (sodium bisulfite). JAMA. 1982; 248:2030 1. http://www.ncbi.nlm.nih.gov/pubmed/7120631?dopt=AbstractPlus

6. Baker GJ, Collett P, Allen DH. Bronchospasm induced by metabisulphite containing foods and drugs. Med J Aust. 1981; 2:614 7. http://www.ncbi.nlm.nih.gov/pubmed/7334982?dopt=AbstractPlus

7. Koepke JW, Selner JC, Dunhill AL. Presence of sulfur dioxide in commonly used bronchodilator solutions. J Allergy Clin Immunol. 1983; 72:504 8. http://www.ncbi.nlm.nih.gov/pubmed/6630799?dopt=AbstractPlus

8. Food and Drug Administration. Sulfiting agents; labeling in drugs for human use: warning statement. [Docket No. 84N 0113] Fed Regist. 1985; 50:47558 63.

9. Food and Drug Administration Center for Food Safety and Applied Nutrition. The reexamination of the GRAS status of sulfiting agents, January 1985. (Doc. No. 223-83-2020.) Bethesda, MD: FASEB Life Sciences Research Office.

10. Murphy MB, Murray C, Shorten GD. Fenoldopam—a selective peripheral dopamine-receptor agonist for the treatment of severe hypertension. N Engl J Med. 2001; 345:1548-57. http://www.ncbi.nlm.nih.gov/pubmed/11794223?dopt=AbstractPlus

11. Post JB IV, Frishman WH. Fenoldopam: a new dopamine agonist for the treatment of hypertensive urgencies and emergencies. J Clin Pharmacol. 1998; 38:2-13. http://www.ncbi.nlm.nih.gov/pubmed/9597553?dopt=AbstractPlus

12. Panacek EA, Bednarczyk EM, Dunbar LM et al. Randomized, prospective trial of fenoldopam vs sodium nitroprusside in the treatment of acute severe hypertension. Acad Emerg Med. 1995; 2:959-65. http://www.ncbi.nlm.nih.gov/pubmed/8536121?dopt=AbstractPlus

13. Shusterman NH, Elliott WJ. Fenoldopam, but not nitroprusside, improves renal function in severely hypertensive patients with impaired renal function. Am J Med. 1993; 95:161-8. http://www.ncbi.nlm.nih.gov/pubmed/8102835?dopt=AbstractPlus

14. Brogden RN, Markham A. Fenoldopam: a review of its pharmacodynamic and pharmacokinetic properties and intravenous clinical potential in the management of hypertensive urgencies and emergencies. Drugs. 1997; 54:634-50. http://www.ncbi.nlm.nih.gov/pubmed/9339965?dopt=AbstractPlus

15. Hospira, Lake Forest, IL: Personal communication.

542. Marik PE, Varon J. Hypertensive crises: challenges and management. Chest. 2007; 131:1949-62. http://www.ncbi.nlm.nih.gov/pubmed/17565029?dopt=AbstractPlus

1150. Flynn JT, Kaelber DC, Baker-Smith CM et al. Clinical practice guideline for screening and management of high blood pressure in children and adolescents. Pediatrics. 2017; 140 http://www.ncbi.nlm.nih.gov/pubmed/28827377?dopt=AbstractPlus

1200. Whelton PK, Carey RM, Aronow WS et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018; 71:el13-e115. http://www.ncbi.nlm.nih.gov/pubmed/29133356?dopt=AbstractPlus

HID. Trissel LA. Handbook on injectable drugs. 20th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2019.