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Basic Drug Info
Drug Name:Cleviprex
Manufacturer:The Medicines Company
Other Info:

Cleviprex was evaluated in a randomized, placebo-controlled, single-blind, parallel 72 hour continuous infusion study in 61 mild to moderate essential hypertensives.

The mean baseline blood pressure was 151/86 mmHg.Subjects were randomized to placebo or to 2, 4, 8, or 16 mg/hour.

Doses above 2 mg/hour were started at 2 mg/hour and force-titrated in 2-fold increments at 3-minute intervals.

Blood pressure, heart rate, and blood levels of clevidipine butyrate were measured during the infusion period.

Blood levels were monitored 1 hour after the infusion was discontinued.

Blood pressure and heart rate were monitored for 8 hours and also at 96 hours after the termination of infusion.

Systolic blood pressure effect was related to the concentration of clevidipine butyrate and plateaued at higher measured concentrations, with the maximal effect estimated at 25% of baseline systolic blood pressure.

The estimated infusion rate necessary to achieve half of this maximal effect was approximately 10 mg/hour.



Clinical Trials:


Indications and Usage
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
Contraindications
Cleviprex is contraindicated in patients with:Allergy to soy or eggs (4.1)Defective lipid metabolism (4.2)Severe aortic stenosis (4.3)
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Immediate hypersensitivity -- Hypersensitivity reactions which occur within minutes of exposure to challenging antigen due to the release of histamine which follows the antigen-antibody reaction and causes smooth muscle contraction and increased vascular permeability.

Aortic Valve Stenosis -- A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.


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