or PATIENT COUNSELING INFORMATION.
Revised: 08/2008
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Monitoring
2.2 Recommended Dosing
2.3 Instructions for Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Known Allergy
4.2 Defective Lipid Metabolism
4.3 Severe Aortic Stenosis
5 WARNINGS AND PRECAUTIONS
5.1 Need for Aseptic Technique
5.2 Hypotension and Reflex Tachycardia
5.3 Lipid Intake
5.4 Negative Inotropy
5.5 Beta-Blocker Withdrawal
5.6 Rebound Hypertension
5.7 Pheochromocytoma
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.3 Developmental Toxicology
14 CLINICAL STUDIES
14.1 Perioperative Hypertension
14.2 Severe Hypertension
14.3 Essential Hypertension
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
2 DOSAGE AND ADMINISTRATION
2.1 Monitoring
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 infusion is recommended per 24-hour period. In clinical trials, 55 hypertensive patients were treated with > 500 mL of Cleviprex infusion per 24-hour period. There is little experience with infusion durations beyond 72 hours at any dose.
Transition to an oral antihypertensive agent
