Corlopam

Corlopam is a prescription medication used for short-term treatment of severe high blood pressure in hospitalized patients.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Corlopam is part of the drug class:

• Adrenergic and dopaminergic agents

Severe Hypertension

Used for short-term (up to 48 hours) 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) in an inpatient setting.1 10 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) management of hypertension in pediatric patients in an inpatient setting.1

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

General

• Pediatric patients: Continuously monitor heart rate and BP, usually via an intra-arterial line.1

• Adults: Monitor BP and heart rate at frequent intervals, usually every 10–15 minutes; intra-arterial BP monitoring not required in adults.1 10

• Avoid hypotension and rapid decreases in BP.1

• May abruptly discontinue fenoldopam infusion1 14 or gradually taper prior to discontinuance of therapy.1 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.

Administer by IV infusion only.1 Do not administer by rapid IV (bolus) injection.1

IV Administration

Administer by IV infusion using a calibrated, mechanical infusion pump to allow precise measurement of flow rate.1 In pediatric patients, use a calibrated, mechanical infusion pump appropriate for the delivery of low infusion rates.1

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

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

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 concentration of 60 mcg/mL.1 It may be necessary to increase concentration of fenoldopam in the infusion solutions because of volume overload.1 Low flow rates (e.g., <0.5 mL/hour) may be impractical.1

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 concentration of 40 mcg/mL.1

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

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

Dosage

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

Pediatric Patients

Usual initial dosage: 0.2 mcg/kg per minute.1 May increase dosage every 20–30 minutes by up to 0.3–0.5 mcg/kg per minute.1 Maximum effect observed at 0.8 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 0.05–3.2 mcg/kg per minute in pediatric patients.1

Adults

Usual initial dosage: 0.1–0.3 mcg/kg per minute.1 12 14 To achieve desired therapeutic effect, may titrate dosage upward or downward in increments of 0.05–0.1 mcg/kg per minute,1 14 no more frequently than every 15 minutes (and less frequently as goal BP is approached).1

Dosages <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

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

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

Not metabolized by CYP isoenzymes.1

Specific Drugs

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

You or your child may receive other medicines taken by mouth during treatment or after receiving this medicine.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Corlopam while you are pregnant.

10 mg/mL solution in single-dose vial

10 mg/mL solution in single-dose ampule

Beta-Blockers

Avoid concomitant use of fenoldopam with beta-blockers. If the drugs are used together, blood pressure should be monitored frequently because hypotension could result from beta-blocker inhibition of the sympathetic reflex response to fenoldopam.

                                                                               EN-4150
Hospira, Inc., Lake Forest, IL 60045 USA                                                                                

Applies to fenoldopam: intravenous solution

Along with its needed effects, fenoldopam (the active ingredient contained in Corlopam) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking fenoldopam:

• Chest pain or discomfort
• convulsions
• decrease in the amount of urine
• dilated neck veins
• dry mouth
• extreme fatigue
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• increased thirst
• irregular breathing
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• shortness of breath
• swelling of the face, fingers, feet, or lower legs
• unusual tiredness or weakness
• weight gain

• Blurred vision
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating

Some side effects of fenoldopam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• headache

• Abdominal or stomach pain
• anxiety
• dizziness
• increased sweating
• muscle spasms
• trouble sleeping