clevidipine (Cleviprex)
Classes: Calcium Channel Blockers; Calcium Channel Blockers, Dihydropyridine
Dosing and uses of Cleviprex (clevidipine)
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