Cleviprex
(Clevidipine)Cleviprex Prescribing Information
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
2.2 Recommended DosingCleviprex 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.
Table 1 is a guideline for dosing conversion from mg/hour to mL/hour.
Dose (mg/hour) | Dose (mL/hour) |
| 1 | 2 |
| 2 | 4 |
| 4 | 8 |
| 6 | 12 |
| 8 | 16 |
| 10 | 20 |
| 12 | 24 |
| 14 | 28 |
| 16 | 32 |
| 18 | 36 |
| 20 | 40 |
| 22 | 44 |
| 24 | 48 |
| 26 | 52 |
| 28 | 56 |
| 30 | 60 |
| 32 | 64 |
2.1 MonitoringMonitor 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 DosingCleviprex 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.
Table 1 is a guideline for dosing conversion from mg/hour to mL/hour.
Dose (mg/hour) | Dose (mL/hour) |
| 1 | 2 |
| 2 | 4 |
| 4 | 8 |
| 6 | 12 |
| 8 | 16 |
| 10 | 20 |
| 12 | 24 |
| 14 | 28 |
| 16 | 32 |
| 18 | 36 |
| 20 | 40 |
| 22 | 44 |
| 24 | 48 |
| 26 | 52 |
| 28 | 56 |
| 30 | 60 |
| 32 | 64 |
2.2 Recommended DosingCleviprex 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.
Table 1 is a guideline for dosing conversion from mg/hour to mL/hour.
Dose (mg/hour) | Dose (mL/hour) |
| 1 | 2 |
| 2 | 4 |
| 4 | 8 |
| 6 | 12 |
| 8 | 16 |
| 10 | 20 |
| 12 | 24 |
| 14 | 28 |
| 16 | 32 |
| 18 | 36 |
| 20 | 40 |
| 22 | 44 |
| 24 | 48 |
| 26 | 52 |
| 28 | 56 |
| 30 | 60 |
| 32 | 64 |
2.2 Recommended DosingCleviprex 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.
Table 1 is a guideline for dosing conversion from mg/hour to mL/hour.
Dose (mg/hour) | Dose (mL/hour) |
| 1 | 2 |
| 2 | 4 |
| 4 | 8 |
| 6 | 12 |
| 8 | 16 |
| 10 | 20 |
| 12 | 24 |
| 14 | 28 |
| 16 | 32 |
| 18 | 36 |
| 20 | 40 |
| 22 | 44 |
| 24 | 48 |
| 26 | 52 |
| 28 | 56 |
| 30 | 60 |
| 32 | 64 |
2.2 Recommended DosingCleviprex 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.
Table 1 is a guideline for dosing conversion from mg/hour to mL/hour.
Dose (mg/hour) | Dose (mL/hour) |
| 1 | 2 |
| 2 | 4 |
| 4 | 8 |
| 6 | 12 |
| 8 | 16 |
| 10 | 20 |
| 12 | 24 |
| 14 | 28 |
| 16 | 32 |
| 18 | 36 |
| 20 | 40 |
| 22 | 44 |
| 24 | 48 |
| 26 | 52 |
| 28 | 56 |
| 30 | 60 |
| 32 | 64 |
Cleviprex is a sterile, milky white injectable emulsion for intravenous use, available in the following configurations:
- 50 mL single use vial with 0.5 mg/mL clevidipine
- 100 mL single use vial with 0.5 mg/mL clevidipine
- 250 mL single use vial with 0.5 mg/mL clevidipine
8.4 Pediatric UseThe safety and effectiveness of Cleviprex in children under 18 years of age have not been established.
Cleviprex is contraindicated in patients with:
- Allergy to soy or eggs
4.1 Known AllergyCleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products.
- Defective lipid metabolism
4.2 Defective Lipid MetabolismCleviprex is contraindicated in patients with defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia.
- Severe aortic stenosis
4.3 Severe Aortic StenosisCleviprex is contraindicated in patients with severe aortic stenosis because afterload reduction can be expected to reduce myocardial oxygen delivery.
- Maintain aseptic technique. Discard unused portion 12 hours after stopper puncture.
5.1 Need for Aseptic TechniqueUse aseptic technique and discard any unused product within 12 hours of stopper puncture
[see Dosage and Administration (2.3)]. - Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex.
5.2 Hypotension and Reflex TachycardiaCleviprex may produce systemic hypotension and reflex tachycardia. If either occurs, decrease the dose of Cleviprex. There is limited experience with short-duration therapy with beta-blockers as a treatment for Cleviprex-induced tachycardia. Beta-blocker use for this purpose is not recommended.
- Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
5.4 Negative InotropyDihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
- Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal.
5.5 Beta-Blocker WithdrawalCleviprex is not a beta-blocker, does not reduce heart rate, and gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose.
- 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.
5.6 Rebound HypertensionPatients 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.