clevidipine (Cleviprex)

Dosing and uses of Cleviprex (clevidipine)

• Adult
• Pediatric
• Geriatric

 

Adult dosage forms and 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

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Geriatric dosage forms and strengths

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)

 

Cleviprex (clevidipine) adverse (side) effects

>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)

 

Warnings

Contraindications

Hypersensitivity to drug, soy or egg products

Defective lipid metabolism

Acte pancreatitis if accompanied by hyperlipidemia

Severe aortic stenosis

 

Cautions

CHF

Risk of hypotension & reflex tachycardia

Contains no preservatives

Potential for rebound HTN after stoppage of prolonged infusion

 

Pregnancy and lactation

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.

 

Pharmacology of Cleviprex (clevidipine)

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%)

 

Administration

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