Corlopam (Intravenous)

Fenoldopam injection is used for short-term management of severe hypertension (high blood pressure) in adults while they are in the hospital, for up to 48 hours. It is used when there is a need to quickly lower blood pressure, including in cases of malignant hypertension with worsening organ function. This medicine is also used in children for short-term reduction of blood pressure in the hospital, for up to 4 hours.

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

Your doctor will closely monitor you or your child while receiving this medicine. This helps the doctor see if the medicine is working properly. Blood tests may be needed to check for side effects.

Hypokalemia may happen in less than 6 hours after receiving this medicine. Tell your doctor immediately if you or your child experiences dry mouth, increased thirst, muscle cramps, nausea or vomiting, or an 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 signs of a new hypertensive emergency.

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

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. Here are important points to think about for this medicine:

Allergies

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

Pediatric

Studies so far have not shown any specific problems in children that would limit the use of fenoldopam injection.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the use of fenoldopam injection. However, older patients are more likely to have kidney, liver, or heart issues, which may need careful monitoring and dose adjustments when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there might be an interaction. In these cases, your doctor may adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are highlighted for their significance but are not a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around meal times or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to 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 these patients.

• 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 worsen these conditions.

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.

In the U.S.

• Corlopam

Available Dosage Forms:

• Solution

Therapeutic Class: Antihypertensive

Pharmacologic Class: Dopamine Agonist

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.