Fenoldopam Mesylate
Loading...Fenoldopam Mesylate Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Fenoldopam Mesylate Injection, USP is indicated for the in-hospital, short-term (up to 48 hours) management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is clinically indicated, including malignant hypertension with deteriorating end-organ function. Transition to oral therapy with another agent can begin at any time after blood pressure is stable during fenoldopam infusion.
Fenoldopam is indicated for the in-hospital, short-term (up to 4 hours) reduction in blood pressure (See CLINICAL PHARMACOLOGY: Pediatric Patients).
History
There is currently no drug history available for this drug.
Other Information
Fenoldopam Mesylate Injection, USP is a dopamine D1-like receptor agonist. The product is formulated as a solution to be diluted for intravenous infusion. Chemically it is 6-chloro-2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)-[1H]-3-benzazepine-7,8-diol methanesulfonate with the following structure:
FenoldopamMesylate
Fenoldopam mesylate is a white to off-white powder with a molecular weight of 401.87 and a molecular formula of C17H20ClNO6S. It is sparingly soluble in water, ethanol and methanol, and is soluble in propylene glycol.
Ampules: Each 1 mL contains, in sterile aqueous solution, citric acid 3.44 mg, fenoldopam mesylate equivalent to fenoldopam 10 mg, propylene glycol 518 mg, sodium citrate dihydrate 0.61 mg, sodium metabisulfite 1 mg, and water for injection.
Sources
Fenoldopam Mesylate Manufacturers
-
Sandoz Inc
![Fenoldopam Mesylate Injection, Solution [Sandoz Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fenoldopam Mesylate | Sandoz Inc
Adult PatientsThe optimal magnitude and rate of blood pressure reduction in acutely hypertensive patients have not been rigorously determined, but, in general, both delay and too rapid decreases appear undesirable in sick adult patients. An initial Fenoldopam Mesylate Injection, USP dose may be chosen from Table 2 and 3 in the Clinical Pharmacology Section that produces the desired magnitude and rate of blood pressure reduction in a given clinical situation. Doses below 0.1 mcg/kg/min have very modest effects and appear only marginally useful in this population. In general, as the initial dose increases, there is a greater and more rapid blood pressure reduction. However, lower initial doses (0.03 to 0.1 mcg/kg/min) titrated slowly have been associated with less reflex tachycardia than have higher initial doses (≥0.3 mcg/kg/min). In clinical trials, doses from 0.01 to 1.6 mcg/kg/min have been studied. Most of the effect of a given infusion rate is attained in 15 minutes.
Fenoldopam Mesylate Injection, USP 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, USP infusion. In clinical trials, fenoldopam 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.
The Fenoldopam Mesylate Injection, USP infusion can be abruptly discontinued or gradually tapered prior to discontinuation. Oral antihypertensive agents can be added during Fenoldopam Mesylate Injection, USP infusion or following its discontinuation. Patients in controlled clinical trials have received intravenous fenoldopam for as long as 48 hours.
Login To Your Free Account