Clevidipine

Generic name: clevidipine
Brand name: Cleviprex
Dosage form: intravenous emulsion (0.5 mg/mL)
Drug class: Calcium channel blocking agents

Medically reviewed by  A Ras MD.

What is clevidipine?

Clevidipine is a prescription medicine that is used to lower blood pressure.

Description

Cleviprex is a sterile, milky-white emulsion containing 0.5 mg/mL of clevidipine suitable for intravenous administration. Clevidipine is a dihydropyridine calcium channel blocker. Chemically, the active substance, clevidipine, is butyroxymethyl methyl 4-(2´,3´-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. It is a racemic mixture with a molecular weight of 456.3 g/mol. Each enantiomer has equipotent antihypertensive activity. The structure and formula are:

Clevidipine Structure and Formula

Clevidipine is practically insoluble in water and is formulated in an oil-in-water emulsion. In addition to the active ingredient, clevidipine, Cleviprex contains soybean oil (200 mg/mL), glycerin (22.5 mg/mL), purified egg yolk phospholipids (12 mg/mL),oleic acid (0.3 mg/mL), disodium edetate (0.05 mg/mL), and sodium hydroxide to adjust pH. Cleviprex has a pH of 6.0 – 8.0 and is a ready-to-use emulsion.

 Mechanism of Action

Clevidipine is a dihydropyridine L-type calcium channel blocker. L-type calcium channels mediate the influx of calcium during depolarization in arterial smooth muscle. Experiments in anesthetized rats and dogs show that clevidipine reduces mean arterial blood pressure by decreasing systemic vascular resistance. Clevidipine does not reduce cardiac filling pressure (pre-load), confirming lack of effects on the venous capacitance vessels.

Before taking clevidipine, tell your doctor:

  • If you are allergic to clevidipine; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have problems with fat metabolism like high triglycerides, pancreatitis caused by high triglycerides, or a certain kidney problem (lipoid nephrosis or minimal change disease).
  • If you have narrowing of the main artery from the heart (aorta) or very narrow heart valve (aortic stenosis).

This is not a list of all drugs or health problems that interact with clevidipine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take clevidipine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take clevidipine?

  • Tell all of your health care providers that you take clevidipine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Check blood pressure and heart rate as the doctor has told you.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is clevidipine best taken?

Use clevidipine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are the side effects of clevidipine that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Very bad dizziness or passing out.
  • Change in eyesight.
  • Heart failure has gotten worse in some people taking clevidipine. If you have heart failure, talk with your doctor. Call your doctor right away if you have shortness of breath, a big weight gain, or swelling in the arms or legs.

What are some other side effects of clevidipine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out clevidipine?

  • If you need to store clevidipine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

  • PRINCIPAL DISPLAY PANEL

     

    Package Label – Principal Display Panel – 25mg/50mL Outer Carton

    Package Label - Principal Display Panel - 25mg/50mL Outer Carton

     

    Package Label – Principal Display Panel – 50mg/100mL Vial Label

    Package Label - Principal Display Panel - 50mg/100mL Vial Label

    SRC: NLM .