See 17 for PATIENT COUNSELING INFORMATION 

Revised: 07/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 
1INDICATIONS AND USAGE
2DOSAGE AND ADMINISTRATION
2.1Monitoring
2.2 Recommended Dosing
2.3Instructions for Administration
3DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Known Allergy
4.2Defective Lipid Metabolism
4.3Severe Aortic Stenosis
5WARNINGS AND PRECAUTIONS
5.1 Need for Aseptic Technique
5.2Hypotension and Reflex Tachycardia
5.3Lipid Intake
5.4 Negative Inotropy
5.5 Beta-Blocker Withdrawal
5.6Rebound Hypertension
5.7Pheochromocytoma
6ADVERSE REACTIONS
6.1Clinical Trials Experience
7DRUG INTERACTIONS
8USE IN SPECIFIC POPULATIONS
8.1Pregnancy
8.2Labor and Delivery
8.3 Nursing Mothers
8.4Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility
13.3Developmental Toxicology
14CLINICAL STUDIES
14.1 Perioperative Hypertension
14.2Severe Hypertension
14.3Essential Hypertension
16HOW SUPPLIED/STORAGE AND HANDLING
17PATIENT COUNSELING INFORMATION
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FULL PRESCRIBING INFORMATION
1INDICATIONS AND USAGE
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
2DOSAGE AND ADMINISTRATION
2.1Monitoring
Monitor blood pressure and heart rate continually during infusion, and then until vital signs are stable. Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped. These patients may need follow-up adjustments in blood pressure control.
2.2 Recommended Dosing
Cleviprex is intended for intravenous use. Titrate drug to achieve the desired blood pressure reduction. Individualize dosage depending on the blood pressure to be obtained and the response of the patient.
Initial dose: Initiate the intravenous infusion of Cleviprex at 1-2 mg/hour.
Dose titration: The dose may be doubled at short (90 second) intervals initially. As the blood pressure approaches goal, the increase in doses should be less than doubling and the time between dose adjustments should be lengthened to every 5-10 minutes. An approximately 1-2 mg/hour increase will generally produce an additional 2-4 mmHg decrease in systolic pressure.
Maintenance dose: The desired therapeutic response for most patients occurs at doses of 4-6 mg/hour. Patients with severe hypertension may require doses up to 32 mg/hour, but there is limited experience at this dose rate.
Maximum dose: Most patients were treated with maximum doses of 16 mg/hour or less. There is limited short-term experience with doses up to 32 mg/hour. Because of lipid load restrictions, no more than 1000 mL or an average of 21 mg/hour of Cleviprex infus