Clevidipine

Clevidipine is a calcium channel blocker that treats high blood pressure (hypertension) in people who cannot take medicine by mouth.

Clevidipine may also be used for reasons not mentioned in this medication guide.

Clevidipine 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 monitored closely. Your dose will be adjusted as your blood pressure gets back to normal.

You may be prescribed another blood pressure medication to take after your treatment with clevidipine.

If your doctor does not prescribe blood pressure medication for you to continue taking, you will need to be monitored for at least 8 hours after your last clevidipine injection to ensure your blood pressure does not increase again.

Continue taking your blood pressure medicine as directed, even if you feel fine. High blood pressure often has no symptoms. You may need to take blood pressure medicine for the rest of your life.

You may need to follow a special diet to lower your fat intake. Follow all instructions from your doctor or dietitian. Learn about the foods to eat or avoid to help manage your condition.

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

In an emergency, you might not be able to inform caregivers about your health conditions. Ensure that any doctor treating you later is aware that you received clevidipine.

You should not be treated with clevidipine if you are allergic to it, 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 clevidipine, 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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 side effects of clevidipine 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.

Usual Adult Dose for Hypertension:

Initial dose: 1 to 2 mg/hour IV infusionDose 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.

Because you will receive clevidipine in a clinical setting, you are not likely to skip a dose.

Since clevidipine is given by a healthcare professional in a medical setting, an overdose is unlikely to happen.

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

If you have been taking a beta-blocker medication (such as atenolol, carvedilol, metoprolol, nebivolol, propranolol, sotalol, and others), you should not stop taking it suddenly. Follow your doctor's instructions on how to reduce your dose gradually. Stopping a beta-blocker too quickly can lead to serious heart problems that clevidipine will not prevent.

Other medications may affect clevidipine, including both prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any medicine you start or stop using.