Pronunciation:

fen-OL-doe-pam

Brand Names:

• Corlopam

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antihypertensive

Pharmacologic—

Dopamine Agonist

Uses of This Medicine:

Fenoldopam injection is used for in-hospital, short-term (up to 48 hours) management of severe hypertension (high blood pressure) in adults. It is used when blood pressure is needed to be lowered quickly (including malignant hypertension with deteriorating end-organ function). This medicine is also used in children for in-hospital, short-term (up to 4 hours) reduction of blood pressure.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fenoldopam injection in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fenoldopam injection in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Alprenolol
• Atenolol
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Bucindolol
• Carteolol
• Carvedilol
• Celiprolol
• Dilevalol
• Esmolol
• Labetalol
• Landiolol
• Levobunolol
• Mepindolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nipradilol
• Olanzapine
• Oxprenolol
• Penbutolol
• Pindolol
• Propranolol
• Risperidone
• Sotalol
• Talinolol
• Tertatolol
• Timolol
• Xamoterol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to sulfites or
• Asthma—This medicine contains sodium metabisulfite, which can cause allergic reactions in patients with these conditions.

• Glaucoma, open-angle or
• Hypokalemia (low potassium in the blood) or
• Ocular hypertension (increased pressure in the eye) or
• Tachycardia (fast or uneven heartbeat)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

Your doctor will check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to check if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

Hypokalemia may occur after less than 6 hours of receiving this medicine. Tell your doctor right away if you or your child has dry mouth, increased thirst, muscle cramps, nausea or vomiting, or uneven heartbeat.

Call your doctor right away if you or your child has blurred vision, changes in vision, chest pain, decreased urine output, rapid weight gain, or swelling of your hands, ankles, or feet. These may be symptoms of a new hypertensive emergency.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

Less common or rare

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

Incidence not known

Blurred vision

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

sweating

Some side effects 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:

More common

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

Less common or rare

Abdominal or stomach pain

anxiety

dizziness

increased sweating

muscle spasms

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.