CLEVIPREX
Clinical safety rating
cautionComprehensive clinical and safety monograph for CLEVIPREX (CLEVIPREX).
Cleviprex (clevidipine) is a dihydropyridine L-type calcium channel blocker with high vascular selectivity. It inhibits calcium influx into vascular smooth muscle cells, causing arterial vasodilation and reduced peripheral vascular resistance.
| Metabolism | Rapidly metabolized by esterases in the blood and extravascular tissues to an inactive carboxylic acid metabolite (H152/81). Not primarily dependent on hepatic CYP450 enzymes. |
| Excretion | Renal: 63–73% as metabolites, fecal: 7–10%, unchanged drug in urine: <1% |
| Half-life | Terminal elimination half-life: 2.7 minutes (dihydropyridine ring reduction) and 15 minutes (ester hydrolysis); clinical context: rapid offset allows precise titration |
| Protein binding | 87–97% bound to plasma proteins (primarily albumin) |
| Volume of Distribution | 0.32 L/kg (approx. 22 L for 70 kg); indicates limited extravascular distribution |
| Bioavailability | Intravenous: 100% (only route administered) |
| Onset of Action | Intravenous: 2–4 minutes |
| Duration of Action | Infusion rate-dependent; steady-state achieved within 5–10 min; effects dissipate within 5–15 min after infusion stop due to rapid metabolism |
| Molecular Weight | 456.82 Da |
Initiate intravenous infusion at 1-2 mg/kg/hr, titrate by 0.5-1 mg/kg/hr every 90 minutes up to maximum 32 mg/kg/hr. Maintenance dose: 4-6 mg/kg/hr. Route: IV. Frequency: continuous infusion.
| Dosage form | EMULSION |
| Renal impairment | No dose adjustment required for renal impairment. Clevidipine is not removed by dialysis. |
| Liver impairment | Contraindicated in patients with severe hepatic impairment (Child-Pugh Class C). Use with caution in moderate impairment (Child-Pugh B); consider lower initial doses and titrate slowly. |
| Pediatric use | Safety and efficacy not established in pediatric patients. No FDA-approved dosing recommendations. |
| Geriatric use | No specific dose adjustment required. Elderly patients may be more sensitive to hypotensive effects; use lower initial doses and titrate cautiously. |
| 1st trimester | Clevidipine is contraindicated in the first trimester due to risk of fetal harm; animal studies show embryotoxicity. |
| 2nd trimester | Use only if potential benefit justifies risk; limited human data, but fetal hypotension and acidosis possible. |
| 3rd trimester | May cause maternal hypotension and reduced uteroplacental blood flow; avoid during labor and delivery. |
Clinical note
Comprehensive clinical and safety monograph for CLEVIPREX (CLEVIPREX).
| Placental transfer | Clevidipine is highly protein bound and likely crosses placenta; animal studies demonstrate transfer. |
| Breastfeeding | No human data on presence in breast milk; due to high protein binding and short half-life, excretion is likely minimal. Use with caution. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | Cleviprex (clevidipine) is a calcium channel blocker. No adequate and well-controlled studies in pregnant women. In animal studies, no teratogenic effects were observed at clinically relevant doses. However, maternal toxicity at high doses led to fetal effects (reduced fetal weight, delayed ossification). First trimester: limited data; risk cannot be excluded. Second and third trimesters: may cause fetal acidosis, hypotension, and bradycardia due to maternal hypotension. Use only if potential benefit justifies potential risk. |
| Fetal Monitoring | Continuous monitoring of maternal blood pressure and heart rate during infusion. Fetal heart rate monitoring recommended due to risk of fetal bradycardia. Maternal acid-base status and venous pH monitoring in prolonged use or high doses. |
| Fertility Effects | No human data on fertility. Animal studies (rats) showed no impairment of fertility at doses up to 10 times the maximum recommended human dose based on body surface area. |
■ FDA Black Box Warning
None.
| Serious Effects |
Allergy to clevidipine or soybeans/soy productsAllergy to eggs or egg productsDefective lipid metabolism (e.g., lipoid nephrosis, acute pancreatitis with hyperlipidemia)Severe aortic stenosis
| Precautions | Use caution in patients with heart failure, as beta-blocker withdrawal may exacerbate angina; continue beta-blocker therapy., Hypotension and reflex tachycardia may occur; monitor blood pressure and heart rate closely., Can cause acute kidney injury or worsening of renal function in at-risk patients., Lipid emulsion formulation; use caution in patients with severe hypertriglyceridemia or lipid metabolism disorders., Contains soybean oil and egg lecithin; contraindicated in patients with allergies to soybeans or eggs., Not recommended for use in pediatric patients due to lack of safety and efficacy data. |
| Food/Dietary | No specific food interactions; administer IV only. The lipid emulsion contains soybean oil and egg lecithin; contraindicated in patients with allergies to soy or eggs. No oral intake required. |
| Clinical Pearls | CLEVIPREX (clevidipine) is an ultrashort-acting dihydropyridine calcium channel blocker for IV use in perioperative hypertension. Onset within 2-4 minutes, half-life ~1 minute. Titrate every 5-10 minutes; avoid in severe aortic stenosis, heart failure with reduced ejection fraction, and lipid disorders (formulated in lipid emulsion). Monitor for reflex tachycardia. Use aseptic technique; discard unused portion after 12 hours. |
| Patient Advice | This medication is given intravenously to rapidly lower blood pressure during surgery or in hospital settings. · You will be closely monitored for heart rate and blood pressure changes during infusion. · Report any symptoms like chest pain, shortness of breath, or irregular heartbeat immediately. · Do not stop or adjust the infusion on your own; it is controlled by healthcare staff. · Inform your doctor if you have any allergies to eggs, soybeans, or lipids. |
Loading safety data…