Cleviprex .5 mg/mL
clevipidine · EMULSION · Chiesi USA, Inc.
Cleviprex is a calcium channel blocker medication given by intravenous infusion that is used to lower blood pressure in patients who cannot take blood pressure medicine by mouth. It works quickly to help manage high blood pressure in hospital settings.
Key Facts
- Brand Name
- Cleviprex
- Generic Name
- clevipidine
- NDC Code (Product)
10122-610- Manufacturer
- Chiesi USA, Inc.
- Strength
- .5 mg/mL
- Dosage Form
- EMULSION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA022156
- Drug Class
- Dihydropyridine Calcium Channel Blocker [EPC]
- Marketing Start
- 09/15/2008
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous use : Cleviprex is intended for intravenous use. Titrate Cleviprex to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure response of the patient and the goal blood pressure. (2.2) Monitoring : Monitor blood pressure and heart rate during infusion, and until vital signs stabilize. (2.1) Initial dose : Initiate intravenous infusion of Cleviprex at 1- 2 mg/hour. (2.2) Dose titration : Double the dose at short (90 second) intervals initially. As the blood pressure approaches goal, increase the dose by less than doubling and lengthen the time between dose adjustments to every 5-10 minutes. An approximately 1-2 mg/hour increase will generally produce an additional 2-4 mmHg decrease in systolic pressure. (2.2) Maintenance dose : Most patients will achieve the desired therapeutic response at approximately 4-6 mg/hour. Severe hypertension is likely to require higher doses. (2.2) Maximum dose : Most patients have received maximum doses of 16 mg/hour or less. There is limited experience with short-term dosing as high as 32 mg/hour. Because of lipid load restrictions, no more than 1000 mL or an average …
Contraindications
4 CONTRAINDICATIONS Cleviprex is contraindicated in patients with: Allergy to soy or eggs (4.1) Defective lipid metabolism (4.2) Severe aortic stenosis (4.3) 4.1 Known Allergy Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products. 4.2 Defective Lipid Metabolism Cleviprex is contraindicated in patients with defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia. 4.3 Severe Aortic Stenosis Cleviprex is contraindicated in patients with severe aortic stenosis because afterload reduction can be expected to reduce myocardial oxygen delivery.
Drug Interactions
7 DRUG INTERACTIONS No clinical drug interaction studies were conducted. Clevidipine and its major dihydropyridine metabolite do not have the potential for blocking or inducing any CYP enzyme. At clinically relevant concentrations, clevidipine and its metabolites do not inhibit or induce any CYP450 enzymes. The potential of clevidipine to interact with other drugs is low. (7)
Adverse Reactions
6 ADVERSE REACTIONS The following risk is discussed elsewhere in the labeling: Hypotension and Reflex Tachycardia [see Warnings and Precautions (5.2)] Most common adverse reactions (>2%) are headache, nausea, and vomiting. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact The Medicines Company at 1-888-977-MDCO (6326) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Cleviprex clinical development included 19 studies, with 99 healthy subjects and 1307 hypertensive patients who received at least one dose of clevidipine (1406 total exposures). Clevidipine was evaluated in 15 studies in hypertensive patients: 1099 patients with perioperative hypertension, 126 with severe hypertension and 82 patients with essential hypertension. The desired therapeutic response was achieved at doses of 4-6 mg/hour. Cleviprex was infused for <24 hours in the majority of patients (n=1199); it was infused as a continuous infusion in an additional 93 patients for durations between 24 and 72 hours. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in th…
Frequently Asked Questions
What is Cleviprex used for?
Cleviprex is a calcium channel blocker medication given by intravenous infusion that is used to lower blood pressure in patients who cannot take blood pressure medicine by mouth. It works quickly to help manage high blood pressure in hospital settings.
Is Cleviprex a controlled substance?
Cleviprex is not classified as a controlled substance by the DEA.
What is the generic name for Cleviprex?
The generic name for Cleviprex is clevipidine. There are no other listed brand versions of clevipidine.
What is the NDC code for Cleviprex .5 mg/mL?
The NDC (National Drug Code) for Cleviprex .5 mg/mL is 10122-610, listed by Chiesi USA, Inc..
Other Cleviprex Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)