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Clevidipine Butyrate

Pronunciation: klev-ID-i-peen BUE-ti-rate
Class: Calcium channel blocking agent

Trade Names

Cleviprex
- Injection, emulsion 0.5 mg/mL

Pharmacology

Mediates the influx of calcium during depolarization in arterial smooth muscle.

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Pharmacokinetics

Distribution

Plasma protein binding is greater than 99.5%. Steady-state Vd is 0.17 L/kg.

Metabolism

Rapidly metabolized by hydrolysis, primarily by esterases in the blood and extravascular tissues to inactive metabolites.

Elimination

Cl of the primary dihydropyridine metabolite is 0.03 L/h/kg and terminal half-life is 9 h. Major fraction excreted is 63% to 74% in the urine and 7% to 22% in the feces.

Onset

2 to 4 min.

Special Populations

Renal Function Impairment

No data available.

Hepatic Function Impairment

No data available.

Indications and Usage

Reduction of BP.

Contraindications

Allergies to soybeans, soy products, eggs, or egg products; patients with defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; patients with severe aortic stenosis.

Dosage and Administration

Adults

IV Titrate drug to achieve the desired BP reduction. Individualize the dose depending on the BP to be obtained and the response of the patient. Start with 1 to 2 mg/h. The dose may be doubled at 90-sec intervals, initially. As the BP approaches goal, the increase in dose should be less than doubling and the time between dose adjustments should be lengthened to every 5 to 10 min. Approximately a 1 to 2 mg/h increase will generally produce an additional 2 to 4 mm Hg decrease in systolic BP. The desired therapeutic response for most patients occurs at doses of 4 to 6 mg/h. No more than 1,000 mL or an average of 21 mg/h is recommended per 24-h period.

General Advice

  • Discontinue clevidipine or titrate downward while appropriate oral therapy is being established.
  • When an oral agent is being instituted, consider the lag time of onset of the oral agents effect. Monitor BP until desired effect is achieved.
  • Administer by a central or peripheral line. Administer using an infusion device allowing calibrated infusion rates.
  • Invert vial several times prior to administration.
  • Do not dilute clevidipine.
  • Clevidipine can be administered with water for injection, sodium chloride 0.9% injection, dextrose 5% injection, dextrose 5% in sodium chloride 0.9% injection, dextrose 5% in Ringer's lactate injection, Ringer's lactate injection, or amino acid 10%.

Storage/Stability

Store in refrigerator at 36° to 46°F. Do not freeze. Vials in cartons may be transferred to 77°F for a period not to exceed 2 months. Once the stopper is punctured, use within 4 h and discard unused portion, including product being infused.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Atrial fibrillation (21%).

CNS

Headache (6%).

GI

Nausea (21%); vomiting (3%).

Genitourinary

Acute renal failure (9%).

Precautions

Monitor

Monitor heart rate and BP continually during infusion, and then until vital signs are stable; monitor for possible rebound hypertension for at least 8 h after infusion is stopped in patients who receive clevidipine infusions and who are not transitioned to other antihypertensive therapies. Carefully monitor heart failure patients.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.

Beta-blocker withdrawal

Discontinue beta-blocker by gradually reducing the dose.

Heart failure

Can preclude negative inotropic effects and exacerbate heart failure.

Hypotension and reflex tachycardia

May occur, requiring dosage reduction.

Lipid intake

Clevidipine contains approximately 0.2 g of lipid per mL. In some patients with disorders in lipid metabolism, a reduction in the quantity of concomitantly consumed lipids may be necessary to compensate for the amount of lipid in clevidipine.

Overdosage

Symptoms

Expected effect is hypotension with reflex tachycardia.

Patient Information

  • Advise patients with underlying hypertension that they require continued follow-up for their medical condition.
  • Advise patients to contact their health care provider immediately if they experience a new hypertensive emergency: neurologic symptoms, visual changes, or evidence of CHF.

Copyright © 2009 Wolters Kluwer Health.

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