Cleviprex belongs to a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

Cleviprex is used to treat high blood pressure (hypertension) in people who cannot take medicine by mouth.

Cleviprex may also be used for purposes not listed in this medication guide.

If possible before you receive Cleviprex, tell your doctor if you have high cholesterol or triglycerides (especially if you also have pancreatitis), aortic stenosis (narrowing of aortic valves in the heart), lipoid nephrosis (a kidney disorder), or if you are allergic to eggs or soy products.

In an emergency, you may not be able to tell caregivers about your health conditions. Make sure any doctor caring for you afterward knows you received this medicine.

Cleviprex is given as an infusion into a vein. A healthcare provider will give you this injection.

Your blood pressure and other vital signs will be watched closely. Your dose will be adjusted as your blood pressure normalizes.

You may be given another blood pressure medication to take after treatment with Cleviprex.

If your doctor does not prescribe blood pressure medication for you to keep taking, you will need to be watched for at least 8 hours after your last Cleviprex injection to make sure your blood pressure does not go back up again.

Keep using your blood pressure medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

You may need to follow a special diet to reduce your intake of fats. Follow all instructions of your doctor or dietitian. Learn about the foods to eat or avoid to help control your condition.

Usual Adult Dose for Hypertension:

Initial dose: 1 to 2 mg/hour IV infusion

Dose titration: Dose may be doubled at short (90 second) intervals initially. As blood pressure approaches goal, dose increases should be less than doubling and intervals between dose adjustments should increase to every 5 to 10 minutes. An increase of approximately 1 to 2 mg/hour generally produces an additional 2 to 4 mmHg decrease in systolic pressure.

Maintenance dose: The desired therapeutic response for most patients occurs at doses of 4 to 6 mg/hour. Patients with severe hypertension may require doses up to 32 mg/hour.

Maximum dose: Most patients were treated with maximum doses of 16 mg/hour or less; however, there is limited short-term experience with doses up to 32 mg/hour. Due to lipid load restrictions, no more than 1000 mL (or an average of 21 mg/hour) is recommended per 24-hour period.

Duration of therapy: There is little experience with infusion durations beyond 72 hours at any dose.

Transition to an oral antihypertensive agent: Discontinue this drug or titrate downward while appropriate oral treatment is established.

Use: Reduction of blood pressure when oral treatment is not feasible or not desirable.

You should not be treated with Cleviprex if you are allergic to clevidipine, or if you have:

• high cholesterol or triglycerides (especially if you also have pancreatitis);

• problems with metabolizing fats;

• severe narrowing of the aortic valve in your heart (aortic stenosis);

• a kidney disorder called lipoid nephrosis; or

• an allergy to eggs, soybeans, or soy products.

If possible before you receive Cleviprex, tell your caregivers if you have ever had:

• high cholesterol;

• pancreatitis;

• congestive heart failure;

• food allergies;

• pheochromocytoma (an adrenal gland tumor); or

• liver or kidney disease.

In an emergency, you may not be able to tell caregivers if you are pregnant or breastfeeding. Make sure any doctor caring for your pregnancy or your baby knows you received this medicine.

Because you will receive Cleviprex in a clinical setting, you are not likely to miss a dose.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Cleviprex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

• chest pain;

• pounding heartbeats or fluttering in your chest;

• a light-headed feeling, like you might pass out;

• severe dizziness or confusion;

• vision problems;

• shortness of breath; or

• swelling in your hands or feet.

Common Cleviprex side effects may include:

• headache; or

• nausea and vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you have been using a beta-blocker medication (such as atenolol, carvedilol, metoprolol, nebivolol, propranolol, sotalol, and others), you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose. Stopping a beta-blocker too quickly can cause serious heart problems that will not be prevented by Cleviprex.

Other drugs may interact with clevidipine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.