Cleviprex (clevidipine butyrate)

Clevidipine dosage should be individualized to achieve the desired blood pressure reduction. The recommended initial adult IV dosage of clevidipine for the reduction of blood pressure when oral antihypertensive therapy is not feasible or desirable is 1-2 mg/hour. Initially, dosage may be doubled at short (90-second) intervals; as blood pressure approaches the desired value, dosage should be increased in smaller increments (less than doubling) at 5- to 10-minute intervals. An increase in dosage of approximately 1-2 mg/hour generally produces an additional 2- to 4-mm Hg decrease in systolic blood pressure. Blood pressure and heart rate should be monitored continuously during IV infusion and until vital signs are stable.

Desired therapeutic responses to clevidipine usually occur at IV dosages of 4-6 mg/hour. Patients with severe hypertension may require dosages up to 32 mg/hour. Most patients have received maximum dosages of 16 mg/hour or less; there is limited, short-term experience with dosages up to 32 mg/hour. Because each mL of emulsion contains 200 mg of lipids, the manufacturer recommends that no more than 1 L of clevidipine emulsion be administered in a 24-hour period (average clevidipine dosage of 21 mg/hour). In clinical studies, about 55 patients with hypertension received more than 500 mL of clevidipine emulsion in a 24-hour period. There is limited experience with infusion durations exceeding 72 hours at any dosage.

When IV clevidipine is used in adults who have a hypertensive emergency with a compelling indication (e.g., aortic dissection, severe preeclampsia or eclampsia+ , pheochromocytoma crisis+), systolic blood pressure should be reduced to less than 140 mm Hg during the first hour, and, in patients with acute aortic dissection, to less than 120 mm Hg within the first 20 minutes; beta-adrenergic blockade should precede clevidipine in such patients. In adults who have a hypertensive emergency without a compelling indication, systolic blood pressure should be reduced by no more than 25% within the first hour; then, if stable, to <160/100 mmHg within the next 2 to 6 hours, and then cautiously to 130 to 140 mmHg during the next 24 to 48 hours to limit target organ injury. If this blood pressure is well tolerated and the patient is clinically stable, further gradual reductions toward normal blood pressure can be implemented in the next 24-48 hours.

In patients being transferred to an oral antihypertensive agent, clevidipine should be discontinued or the dosage decreased while appropriate oral therapy is established; the lag time to onset of the oral antihypertensive agent's effects should be considered. Blood pressure monitoring should be continued until the desired effect is achieved. Patients who receive prolonged infusions of clevidipine and are not transferred to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours following discontinuance of the infusion.

Clevidipine injectable emulsion is administered by IV infusion into a central or peripheral vein using an infusion device allowing calibrated infusion rates. Commercially available standard plastic cannulae may be used to administer the infusion.

Vials of clevidipine injectable emulsion are intended for single use only. Aseptic technique should be maintained when handling clevidipine. Because the emulsion can support microbial growth, administration must be completed within 12 hours after initial puncture of the vial stopper; any unused portions remaining after the 12-hour time limit should be discarded.

Vials of clevidipine injectable emulsion should be inverted gently several times before use to ensure uniformity of the emulsion prior to administration.

Clevidipine should not be administered in the same IV line as other drugs. The commercially available emulsion should not be diluted; however, it may be administered with sterile water for injection, 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, lactated Ringer's and 5% dextrose injection, lactated Ringer's injection, or 10% amino acid injection. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Clevidipine injectable emulsion should be stored at 2-8degreesC; do not freeze. Store the single-use vials in the original cartons until use protected from light; protection from light during administration is not required. Vials may be removed from the refrigerator and stored at 25degreesC for <=2 months; however, the vials may not be returned to the refrigerator.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Defective lipid metabolism (e.g., pathologic hyperlipemia, lipoid nephrosis, acute pancreatitis associated with hyperlipemia).

*Severe aortic stenosis because afterload reduction may be expected to reduce myocardial oxygen delivery.

*Known hypersensitivity to soybeans, soy products, eggs, or egg products.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Most common adverse reactions (>2%) reported with clevidipine are headache, nausea, and vomiting.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy not established in children younger than 18 years of age.

There are insufficient available data derived from post-marketing reports with clevidipine use in pregnant women to inform a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Clevidipine has been shown to cross the placenta in rats. In animal studies, clevidipine was associated with increased incidences of intrauterine deaths, slightly reduced fetal weight, retarded skeletal development, abortion, and embryolethality at doses higher than the expected human dose. A dose-related increase in mortality, length of gestation, and prolonged parturition at dose levels of 13, 35, and 55 mg/kg per day was observed when clevidipine was administered to pregnant rats. There was no evidence that clevidipine was teratogenic at the highest dose levels studied in pregnant rats and rabbits.

There are risks to the mother (e.g., pre-eclampsia, gestational diabetes, premature delivery, delivery complications (e.g., need for cesarean section and postpartum hemorrhage)) and fetus (e.g., intrauterine growth restriction, intrauterine death) associated with poorly controlled hypertension in pregnancy; carefully monitor and manage pregnant women with hypertension accordingly.

There are no data on the presence of clevidipine in human milk; the effects of the drug on milk production or on the breastfed infant are also unknown.

The manufacturer makes no specific dosage recommendations for geriatric patients. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in geriatric patients should be considered.

No substantial differences in safety and efficacy relative to younger adults. While other reported clinical experience has not revealed age-related differences in response, dosage generally should be titrated carefully in geriatric patients, usually initiating therapy at the low end of the dosage range. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in geriatric patients also should be considered.