Clevidipine

Dosage Forms & Strengths

infusion solution

• 0.5mg/mL

Hypertension

1-2 mg/hr (2-4 mL/hr), double dose q90sec initially; as blood pressure approaches goal, increase dose by less than doubling, and increase time between adjustments to q5-10min 

Maintenance: 4-6 mg/hr; not to exceed 21 mg/hr (1000 mL within 24 hour period)

Renal Impairment

Dose adjustment not necessary

Hepatic Impairment

Dose adjustment not necessary

Safety and efficacy not established

Initiate dosing at the low end of the dosage range

Hypertension

1-2 mg/hr (2-4 mL/hr), double dose q90sec initially; as blood pressure approaches goal, increase dose by less than doubling, and increase time between adjustments to q5-10min 

Maintenance: 4-6 mg/hr; not to exceed 21 mg/hr (1000 mL within 24 hour period)

Pregnancy Category: C

Lactation: Not known if excreted into breast milk, do not nurse

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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

Tell your caregiver at once if you have a serious side effect such as:

• feeling like you might pass out;
• rapid heart rate;
• urinating less than usual or not at all;
• weakness, confusion, increased thirst, loss of appetite, vomiting, pounding heartbeats or fluttering in your chest;
• swelling, weight gain, feeling short of breath;
• vomiting, diarrhea, stomach cramps, bloating, severe constipation;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;
• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop); or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, uneven heartbeats, seizure).

Less serious side effects may include:

• mild headache;
• mild nausea; or
• mild constipation.

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.

Clevidipine is a prescription medication used to lower blood pressure when an oral (by mouth) medication is not an option.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Clevidipine may be found in some form under the following brand names:

• Cleviprex

Clevidipine is part of the drug class:

• Dihydropyridine derivatives

Take clevidipine exactly as prescribed.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of clevidipine at the same time.

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).

If possible 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.

FDA pregnancy category C. It is not known whether clevidipine is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant.

It is not known whether clevidipine passes into breast milk or if it could harm a nursing baby. Before you receive this medication, tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible before you are treated with clevidipine to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

There may be other drugs that can interact with clevidipine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Use this medicine 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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take clevidipine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to clevidipine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

• Cleviprex

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Alpha1-Blockers: May enhance the hypotensive effect of Calcium Channel Blockers. Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Atosiban: Calcium Channel Blockers may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): Calcium Channel Blockers (Dihydropyridine) may enhance the hypotensive effect of Calcium Channel Blockers (Nondihydropyridine). Calcium Channel Blockers (Nondihydropyridine) may increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Monitor therapy

Calcium Salts: May diminish the therapeutic effect of Calcium Channel Blockers. Monitor therapy

Dapoxetine: May enhance the orthostatic hypotensive effect of Calcium Channel Blockers. Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Efavirenz: May decrease the serum concentration of Calcium Channel Blockers. Monitor therapy

Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Magnesium Salts: Calcium Channel Blockers may enhance the adverse/toxic effect of Magnesium Salts. Magnesium Salts may enhance the hypotensive effect of Calcium Channel Blockers. Monitor therapy

Melatonin: May diminish the antihypertensive effect of Calcium Channel Blockers (Dihydropyridine). Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Neuromuscular-Blocking Agents (Nondepolarizing): Calcium Channel Blockers may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

QuiNIDine: Calcium Channel Blockers (Dihydropyridine) may decrease the serum concentration of QuiNIDine. Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of QuiNIDine. QuiNIDine may increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Monitor therapy

Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Clevidipine is contraindicated in patients with soybean, soy product, egg, or egg product allergies; in patients with defective lipid metabolism, including pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis (if accompanied by hyperlipidemia); and in patients with severe aortic stenosis (afterload reduction can be expected to decrease myocardial oxygen delivery).

Blood pressure and heart rate should be monitored constantly during infusion, and then until vital signs are stable. Patients not transitioned to another antihypertensive treatment following prolonged clevidipine infusions should be monitored for at least 8 hours after the infusion is stopped in case of rebound hypertension.

Continued blood pressure monitoring is recommended for patients transitioned to an oral antihypertensive agent until the desired effect is reached.

Dihydropyridine calcium channel blockers may produce negative inotropic effects and worsen heart failure. Heart failure patients should be carefully monitored.

Clevidipine contains about 0.2 g of lipid per mL (2.0 kcal). Patients with significant lipid metabolism disorders may require lipid intake restrictions and a decrease in concurrently administered lipids may be necessary to compensate for the amount infused as part of the clevidipine formulation.

Safety and efficacy have not been established in pediatric patients (less than 18 years of age).

Clevidipine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of increased maternal and fetal mortality and length of gestation. There are no controlled data in human pregnancy. Clevidipine is only recommended for use during pregnancy when benefit outweighs risk.