Pronunciation:

klev-ID-i-peen

Brand Names:

• Cleviprex

Dosage Forms:

• Emulsion

Classifications:

Therapeutic—

Antihypertensive

Pharmacologic—

Calcium Channel Blocker

Chemical—

Dihydropyridine

Uses of This Medicine:

Clevidipine is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Clevidipine is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, clevidipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

This medicine is available only with your doctor's prescription.

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 have not been performed on the relationship of age to the effects of clevidipine in the pediatric population. Safety and efficacy have not been established.

Older adults—

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

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.

• Clopidogrel
• Dantrolene
• Darunavir
• Digoxin
• Epirubicin
• Itraconazole
• Lacosamide
• Melphalan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Indinavir
• Rifapentine

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 soybeans, soy products, eggs, or egg products or
• Aortic stenosis (narrowing of a valve in your heart), severe or
• Lipid metabolism problems (high blood fats) (e.g., hyperlipemia, lipoid nephrosis, pancreatitis with high blood lipids)—Should not be used in patients with these conditions.

• Heart failure or
• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

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

Precautions While Using This Medicine:

Your doctor will only give you a few doses of this medicine until your condition improves, and then you will be switched to another medicine that works the same way. If you have any concerns about this, talk to your doctor.

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:

More common

Agitation

confusion

decreased urine output

depression

dizziness

fainting

fast or irregular heartbeat

headache

hostility

irritability

lethargy

loss of consciousness

muscle twitching

nausea

rapid weight gain

seizures (convulsions)

stupor

swelling of the face, ankles, or hands

unusual tiredness or weakness

Rare

Chest pain or discomfort

difficult or labored breathing

pain or discomfort in the arms, jaw, back, or neck

shortness of breath

stopping of the heart

sweating

tightness in the chest

unconsciousness

very low blood pressure or pulse

vomiting

wheezing

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.