years yet to come [0.5:<0.1 mcg/kg per minute have very modest effects and appear only marginally useful. 1 Lower initial dosages (0.03 0.1 mcg/kg per minute) titrated slowly are associated with less reflex tachycardia than higher initial dosages ( 0.3 mcg/kg per minute). 1 It appears that higher dosages (0.8 mcg/kg per minute) were not associated with greater response than 0.4 mcg/kg per minute. 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 Prescribing Limits Pediatric Patients Severe 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 studied. 1 Treatment duration should not exceed 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 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 patients receiving infusion rates >0.1 mcg/kg per minute. 1 In adults, tachycardia diminishes over time but remains substantial at higher dosages. 1 In pediatric patients receiving dosages >0.8 mcg/kg per minute, tachycardia persists for at least 4 hours. 1 Theoretical risk of ischemic cardiac events or worsened heart failure secondary to tachycardia associated with fenoldopam. 1 Symptomatic hypotension reported. 1 Avoid systemic hypotension, particularly in patients with acute cerebral infarction or hemorrhage. 1 Hypokalemia Decreases in serum potassium (occasionally to concentration <3 mEq/L) reported after> <6 hours of fenoldopam infusion. 1 Monitor serum electrolytes frequently (e.g., every 6 hours). 1 In case of hypokalemia, treat with oral or IV potassium supplementation as needed. 1 Intraocular Pressure (IOP) Dose-dependent, reversible increases in IOP reported. 1 10 14 Use with caution in patients with glaucoma or intraocular hypertension. 1 14 Intracranial Pressure Effect of fenoldopam in patients with increased intracranial pressure not studied to date. 1 Adequate Patient Monitoring Adults: Monitor BP and serum electrolytes frequently. 1 Also monitor heart rate. 1 Pediatric patients: Continuously monitor heart rate and BP. 1 15 Specific Populations Pregnancy Category B. 1 Lactation Distributed into milk in rats; not known whether distributed into human milk. 1 Use caution. 1 Pediatric Use In pediatric patients, administer fenoldopam only in those with an indwelling intra-arterial line. 1 Antihypertensive effects of fenoldopam evaluated in pediatric patients (age> <1 month [ 2 kg or full term] to 12 years) requiring BP reduction. 1 Continuously monitor heart rate and BP in pediatric patients, via an indwelling intra-arterial line. 1 Long-term effects of fenoldopam on growth and development in pediatric patients have not been studied. 1 Insufficient experience in patients 12 16 years of age to determine whether children in this age group respond differently than younger patients or adults. 1 Consider patient s clinical condition and concomitant drug therapy when selecting dosage in pediatric patients 12 16 years of age. 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 Adults: Headache, 1 10 11 12 14 flushing, 1 10 11 12 14 nausea, 1 12 14 hypotension, 1 12 hypokalemia. 12 Pediatric patients: Hypotension, 1 tachycardia. 1 Interactions for Corlopam Not metabolized by CYP isoenzymes. 1 Specific Drugs Drug Interaction Comments ACE inhibitors Pharmacokinetic interaction unlikely 1 14 α-Adrenergic blocking agents Pharmacokinetic interaction unlikely 1 β-Adrenergic blocking agents May cause unexpected hypotension secondary to β-blocker inhibition of sympathetic reflex response to fenoldopam 1 Avoid concomitant use; if used concomitantly, exercise caution 1 Calcium-channel blocking agents Pharmacokinetic interaction unlikely 1 Cardiac glycosides Pharmacokinetic interaction unlikely 1 11 15 Diuretics (thiazide-like, loop) Pharmacokinetic interaction unlikely 1 Nitroglycerin (sublingual) Pharmacokinetic interaction unlikely 1 15 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. 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 Effects of hemodialysis on pharmacokinetics of fenoldopam not evaluated. 1 Stability Storage Parenteral Injection 2 30 C. 1 Ampuls 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 Compatibility HID Compatible Dextrose 5% in water Sodium chloride 0.9% Drug Compatibility HID Y-Site Injection Compatibility Compatible Alfentanil HCl Amikacin sulfate Aminocaproic acid Amiodarone HCl Ampicillin sodium-sulbactam sodium Argatroban Atracurium besylate Atropine sulfate Aztreonam Bretylium tosylate Butorphanol tartrate Calcium gluconate Cefazolin sodium Cefepime HCl Cefotaxime sodium Cefotetan disodium Ceftazidime Ceftizoxime sodium Ceftriaxone sodium Cefuroxime sodium Chlorpromazine HCl Cimetidine 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 Gatifloxacin Gentamicin sulfate Granisetron HCl Haloperidol lactate Heparin sodium Hetastarch in lactated electrolyte injection (Hextend) Hydrocortisone sodium succinate Hydromorphone HCl Hydroxyzine HCl Inamrinone lactate Isoproterenol HCl Labetalol HCl Levofloxacin Lidocaine HCl Linezolid Lorazepam Magnesium sulfate Mannitol Meperidine HCl Metoclopramide HCl Metronidazole Midazolam HCl Milrinone lactate Mivacurium chloride 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 Ticarcillin disodium-clavulanate potassium Tobramycin sulfate Vancomycin Vecuronium bromide Verapamil HCl Incompatible Aminophylline Amphotericin B Ampicillin sodium Bumetanide Cefoxitin sodium Dexamethasone sodium phosphate Diazepam Fosphenytoin sodium Furosemide Ketorolac tromethamine Methylprednisolone sodium succinate Pentobarbital sodium Phenytoin sodium Prochlorperazine edisylate Sodium bicarbonate Thiopental sodium Actions Agonist for D 1 -like dopamine receptors; binds with moderate affinity to α 2 -adrenoreceptors. 1 10 11 12 13 14 Not a selective α-adrenoreceptor antagonist at therapeutic concentrations. 11 Rapid-acting vasodilator. 1 10 12 14 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 Cl cr observed in patients with severe hypertension, including those with renal impairment. 10 11 13 14 Advice to Patients 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. Fenoldopam Mesylate Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection concentrate, for IV infusion only 10 mg (of fenoldopam)/mL Corlopam (with propylene glycol and sodium metabisulfite) Hospira Fenoldopam Mesylate Injection (with propylene glycol and sodium metabisulfite) Ben Venue Laboratories AHFS DI Essentials. Copyright 2017, Selected Revisions July 1, 2008. 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; 2005 Mar. 2. Food and Drug Administration. Sulfites in foods and drugs. FDA Drug Bull . 1983; 13:12. [PubMed 6604672] 3. Sogn D. The ubiquitous sulfites. JAMA . 1984; 251:2986 7. Editorial. [PubMed 6716628] 4. Koepke JW, Christopher KL, Chai H et al. Dose dependent bronchospasm from sulfites in isoetharine. JAMA . 1984; 251:2982 3. [PubMed 6716626] 5. Twarog FJ, Leung DYM. Anaphylaxis to a component of isoetharine (sodium bisulfite). JAMA . 1982; 248:2030 1. [PubMed 7120631] 6. Baker GJ, Collett P, Allen DH. Bronchospasm induced by metabisulphite containing foods and drugs. Med J Aust . 1981; 2:614 7. [PubMed 7334982] 7. Koepke JW, Selner JC, Dunhill AL. Presence of sulfur dioxide in commonly used bronchodilator solutions. J Allergy Clin Immunol . 1983; 72:504 8. [PubMed 6630799] 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. [PubMed 11794223] 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. [PubMed 9597553] 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. [PubMed 8536121] 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. [PubMed 8102835] 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. [PubMed 9339965] 15. Hospira, Lake Forest, IL: Personal communication. 16. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 691-8. HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 691-8. Next Interactions Print this page Add to My Med List More about Corlopam (fenoldopam) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons 0 Reviews Add your own review/rating Generic Availability Drug class: agents for hypertensive emergencies Consumer resources Corlopam Corlopam (Advanced Reading) Professional resources Corlopam (FDA) Fenoldopam (AHFS Monograph) Related treatment guides Hypertensive Emergency Prevention of Radiographic Contrast Nephropathy> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Pfizer Inc. Drug Class Agents for hypertensive emergencies Related Drugs Hypertensive Emergency hydralazine , enalapril , nifedipine , labetalol , captopril , Vasotec , Apresoline , methyldopa , Capoten , Normodyne , Trandate , nitroprusside , More... Prevention of Radiographic Contrast Nephropathy fenoldopam , More... Corlopam Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } organization
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