FENOLDOPAM (CORLOPAM ®)
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Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
| ----Final conc: 40 mcg/ml -----
[10 mg] [250 ml] [Titrate]
[20 mg] [500 ml] [Titrate]
Stability / Miscellaneous
Stability / Miscellaneous
Indications: Short term treatment (up to 48hrs) of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is indicated. May be discontinued abruptly or tapered gradually.
Dosing: Usual initial rate: 0.1 mcg/kg/min, increased by increments of 0.05 to 0.1 mcg/kg/min at 15-20min intervals until target blood pressure reached. Usual effective doses: 0.1 to 1.6 mcg/kg/min. Generally, lower initial doses (0.03 to 0.1 mcg/kg/min) titrated slowly, have been associated with less reflex tachycardia.
MOA: Selective dopamine (D1) agonist which decreases peripheral vascular resistance; increases renal blood flow; increased diuresis and natriuresis. 6 times as potent as dopamine in producing renal vasodilation.
Mechanism of Action
In animals, fenoldopam has vasodilating effects in coronary, renal, mesenteric and peripheral arteries. All vascular beds, however, do not respond uniformly to fenoldopam. Vasodilating effects have been demonstrated in renal efferent and afferent arterioles.
The pharmacokinetics of fenoldopam were not influenced by age, gender, or race in adult patients with a hypertensive emergency. There have been no formal drug-drug interaction studies using intravenous fenoldopam. Clearance of parent (active) fenoldopam is not altered in adult patients with end-stage renal disease on continuous ambulatory peritoneal dialysis (CAPD) and is not altered in adult patients with severe hepatic failure. The effects of hemodialysis on the pharmacokinetics of fenoldopam have not been evaluated.
INDICATIONS AND USAGE
Pediatric Patients: Information related to the indicated use of fenoldopam injection in pediatric patients is approved for Abbott Laboratories’ fenoldopam drug products. However, due to Abbott’s marketing exclusivity rights, this drug product is not labeled for pediatric use.
Pharmacodynamics and Clinical Studies
Table 1 PHARMACODYNAMIC EFFECTS OF FENOLDOPAM IN MILD TO MODERATE ADULT HYPERTENSIVE PATIENTS
In a multicenter, randomized, double-blind comparison of four infusion rates, fenoldopam mesylate was administered as constant rate infusions of 0.01, 0.03, 0.1 and 0.3 mcg/kg/min for up to 24 hours to 94 adult patients experiencing hypertensive emergencies (defined as diastolic blood pressure ≥120 mm Hg with evidence of compromise of end-organ function involving the cardiovascular, renal, cerebral or retinal systems). Infusion rates could be doubled after one hour if clinically indicated. There were dose-related, rapid-onset, decreases in systolic and diastolic blood pressures and increases in heart rate (Table 2).
Table 2 PHARMACODYNAMIC EFFECTS OF FENOLDOPAM IN ADULT HYPERTENSIVE EMERGENCY PATIENTS
Two hundred and thirty six severely hypertensive adult patients (DBP ≥120 mm Hg), with or without end-organ compromise, were randomized to receive in two open-label studies either fenoldopam or nitroprusside. The response rate was 79% (92/117) in the fenoldopam group and 77% (90/119) in the nitroprusside group. Response required a decline in supine diastolic blood pressure to less than 110 mm Hg if the baseline were between 120 and 150 mm Hg, inclusive, or by ≥40 mm Hg if the baseline were ≥150 mm Hg. Patients were titrated to the desired effect. For fenoldopam, the dose ranged from 0.1 to 1.5 mcg/kg/min; for nitroprusside, the dose ranged from 1.0 to 8.0 mcg/kg/min. As in the study in mild to moderate hypertensives, most of the effect seen at one hour is present at 15 minutes. The additional effect seen after 1 hour occurs in all groups and may not be drug-related (there was no placebo group for evaluation).
Pediatric Patients: Information related to the pharmacodynamics of fenoldopam injection in pediatric patients is approved for Abbott Laboratories’ fenoldopam drug products. However, due to Abbott’s marketing exclusivity rights, this drug product is not labeled for pediatric use.
DOSAGE AND ADMINISTRATION
Fenoldopam mesylate injection should be administered by continuous intravenous infusion. A bolus dose should not be used. Hypotension and rapid decreases of blood pressure should be avoided. The initial dose should be titrated upward or downward, no more frequently than every 15 minutes (and less frequently as goal pressure is approached) to achieve the desired therapeutic effect. The recommended increments for titration are 0.05 to 0.1 mcg/kg/min.
Use of a calibrated, mechanical infusion pump is recommended for proper control of infusion rate during fenoldopam mesylate injection infusion. In clinical trials, fenoldopam mesylate injection treatment was safely performed without the need for intra-arterial blood pressure monitoring; blood pressure and heart rate were monitored at frequent intervals, typically every 15 minutes. Frequent blood pressure monitoring is recommended.
Fenoldopam mesylate injection infusion can be abruptly discontinued or gradually tapered prior to discontinuation. Oral antihypertensive agents can be added during fenoldopam mesylate injection infusion or following its discontinuation. Patients in controlled clinical trials have received intravenous fenoldopam mesylate injection for as long as 48 hours.
PREPARATION OF INFUSION SOLUTION
The drug dose rate must be individualized according to body weight and according to the desired rapidity and extent of pharmacodynamic effect. Table 4 provides the calculated infusion volume in mL/hour for a range of drug doses and body weights. The infusion should be administered using a calibrated mechanical infusion pump that can accurately and reliably deliver the desired infusion rate.
Table 4 (continued) FENOLDOPAM ADULT INFUSION RATES (mL/hour) DRUG DOSAGE FOR ADULTS > 40 KG, USING 40 MCG/ML CONCENTRATION NOTE: CONCENTRATION IS DIFFERENT FROM PEDIATRIC PATIENTS, SEE BELOW: PEDIATRIC PATIENTS
Pediatric Patients: Information related to the dosing and administration of fenoldopam injection in pediatric patients is approved for Abbott Laboratories’ fenoldopam drug products. However, due to Abbott’s marketing exclusivity rights, this drug product is not labeled for pediatric use.
Store at 2° to 30°C (35.6° to 86°F). Discard unused portion.
Source: [package insert]
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user’s use of or reliance upon this material.PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. Read the disclaimer