clevidipine (Rx)

>10%

AFib (21%)

Nausea (21%)

1-10%

Acute renal failure (9%)

Headache (6%)

Vomiting (3%)

<1%

Cardiac arrest

Myocardial infarction

Postmarketing Reports

Increased blood triglycerides

Ileus

Nausea

Hypersensitivity

Hypotension

Reflex tachycardia

Decreased oxygen saturation (possible pulmonary shunting)

Contraindications

Hypersensitivity to drug, soy or egg products

Defective lipid metabolism

Acute pancreatitis if accompanied by hyperlipidemia

Severe aortic stenosis

Cautions

Use aseptic technique and discard unused product within 12hr of stopper puncture

May produce systemic hypotension and reflex tachycardia; if either occurs, decrease dose of drug; there is limited experience with short-duration therapy with beta-blockers as a treatment for drug-induced tachycardia; beta-blocker use for this purpose not recommended

Drug contains approximately 0.2 g of lipid per mL (2.0 kcal); lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism; for these patients, a reduction in quantity of concurrently administered lipids may be necessary to compensate for amount of lipid infused as part of drug formulation

Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure; monitor heart failure patients carefully

Drug is not a beta-blocker, does not reduce heart rate, and gives no protection against effects of abrupt beta-blocker withdrawal; beta-blockers should be withdrawn only after gradual reduction in dose

Patients who receive prolonged infusions and are not transitioned to other antihypertensive therapies should be monitored for possibility of rebound hypertension for at least 8 hr after infusion is stopped

There is no information to guide use of drug in treating hypertension associated with pheochromocytoma

Pregnancy

Available data based on post-marketing reports with use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to mother and fetus associated with poorly controlled hypertension in pregnancy

Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section and postpartum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly

Animal data

• In animal studies, drug was associated with increased incidences of intrauterine deaths, slightly reduced fetal weight, retarded skeletal development, abortion, and embryo lethality at doses higher than the expected human dose
• No evidence of embryo-fetal malformation was found with continuous IV infusion of clevidipine administered to pregnant rats and rabbits during the period of organogenesis at multiples of 2.8 and 7.6 times the expected human dose of 16 mg/hr respectively

Lactation

There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production

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.

Mechanism of Action

Calcium channel blocker (dihydropyridine): inhibits transmembrane influx of extracellular Ca ions across membranes of myocardial cells and vascular smooth muscle cells, without changing serum calcium concentrations, resulting in inhibition of cardiac and vascular smooth muscle contraction, thereby dilating main coronary and systemic arteries

Pharmacokinetics

Onset: 2-4 minutes

Protein Bound: 99.5%

Metabolized in blood and extravascular tissues

Half-Life: Initial 1 minute; terminal 15 minutes

Excretion: Urine (63-74%); feces (7-22%)

IV Compatibilities

Not diluted but compatible w/ following solvents: SWI; NS; D5W; D5/NS; D5/LR; LR; 10% aminoacid

IV Administration

Milky white emulsion

No preservatives-use within 4 hr of puncturing stopper

Doesn't need dilution