Cleviprex

DRUG 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)-l,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:

Cleviprex
  (clevidipine)Structural Formula Illustration

Clevidipineis 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.

What are the possible side effects of clevidipine (Cleviprex)?

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

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • slow heart rate;
  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, vomiting;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid...

Read All Potential Side Effects and See Pictures of Cleviprex


Cleviprex Patient Information Including Side Effects

Brand Names: Cleviprex

Generic Name: clevidipine (Pronunciation: kle VID a peen)

  • What is clevidipine (Cleviprex)?
  • What are the possible side effects of clevidipine (Cleviprex)?
  • What is the most important information I should know about clevidipine (Cleviprex)?
  • What should I discuss with my healthcare provider before I receive clevidipine (Cleviprex)?
  • How is clevidipine given (Cleviprex)?
  • What happens if I miss a dose (Cleviprex)?
  • What happens if I overdose (Cleviprex)?
  • What should I avoid while receiving clevidipine (Cleviprex)?
  • What other drugs will affect clevidipine (Cleviprex)?
  • Where can I get more information?

What is clevidipine (Cleviprex)?

Clevidipine is in a group of drugs called calcium channel blockers. Clevidipine relaxes (widens) blood vessels and improves blood flow.

Clevidipine is an injectable medication that is used to treat high blood pressure (hypertension) in people who cannot take medicine by mouth.

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

What are the possible side effects of clevidipine (Cleviprex)?

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

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • slow heart rate;
  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, vomiting;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

  • headache; or
  • mild nausea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about clevidipine (Cleviprex)?

You should not receive this medication if you are allergic to clevidipine, eggs, or soy products. You also should not receive clevidipine if you have high cholesterol or triglyceride levels in your blood, pancreatitis with high cholesterol or triglycerides, a kidney disorder called lipoid nephrosis, or severe narrowing of the aortic valve in your heart (aortic stenosis).

Before you receive clevidipine, tell your doctor if you have food allergies, pancreatitis, pheochromocytoma (an adrenal gland tumor), heart disease, or a history of high cholesterol.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

Tell your doctor about all other heart or blood pressure medications you are using.

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