"The visible particulate matter is primarily made up of sub visible inert stainless steel particles of around 2.5 microns in diameter. Experimental animal and human data indicate that these particles are scavenged by macrophages and other cells of"...
- Patient Information:
Details with Side Effects
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
DOSAGE AND ADMINISTRATION
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.
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 theresponse of the patient.
Initiate the intravenous infusion of Cleviprex at 1-2 mg/hour.
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.
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.
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 > 500mL 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
Discontinue Cleviprex or titrate downward while appropriate oral therapy is established. When an oral antihypertensive agent is being instituted, consider the lag time of onset of the oral agent's effect. Continue blood pressure monitoring until desired effect is achieved.
Special populations were not specifically studied.In clinical trials, 78 patients with abnormal hepatic function(one or more of the following: elevatedserum bilirubin, AST/SGOT, ALT/SGPT) and 121patients with moderate to severe renalimpairment were treated with Cleviprex. An initial Cleviprex infusion rate of 1-2 mg/hour is appropriate in these patients.
Table 1 is a guideline for dosing conversion from mg/hour to mL/hour.
Table 1. Dose conversion
|Dose (mg/hour)||Dose (mL/hour)|
Instructions for Administration
Maintainaseptic technique while handling Cleviprex. Cleviprex is a single-use parenteral product. Do not use if contamination is suspected. Once the stopper is punctured, use within 12 hours and discard any unused portion.
Cleviprex is supplied in sterile, pre-mixed, ready-to-use 50 mL or 100 mL vials. Invert vial gently several times before use to ensure uniformity of the emulsion prior to administration. Inspect parenteral drug products for particulate matter and discoloration prior to administration whenever solution and container permit. Administer Cleviprex using aninfusion device allowing calibrated infusion rates. Commercially available standard plastic cannulae may be used to administer the infusion. Administer Cleviprex by a central line or a peripheral line.
Cleviprex should not be administered in the same line as other medications.
Cleviprex should not be diluted, but it can be administered with the following:
- Water for Injection, USP
- Sodium Chloride (0.9%) Injection, USP
- Dextrose (5%) Injection, USP
- Dextrose (5%) in Sodium Chloride (0.9%) Injection, USP
- Dextrose (5%) in Ringers Lactate Injection, USP
- Lactated Ringers Injection, USP
- 10% amino acid
Dosage Forms and Strengths
Cleviprex is a sterile, milky white injectable emulsion for intravenous use, available in the following two configurations:
- 50 mL single use vial with 0.5 mg/mL clevidipine
- 100 mL single use vial with 0.5 mg/mL clevidipine
Cleviprex (clevidipine)injectable emulsion is supplied as a sterile, milky white liquid emulsion product in single-use 50 mL or 100 mL glass vials at a concentration of 0.5 mg/mL of clevidipine.
NDC 65293-005-50: 50 mL vial
NDC 65293-005-00: 100 mL vial
Leave vials in cartons until use. Clevidipineis photosensitive and storage in cartons protects against photodegradation. Protection from light during administration is not required.
Store vials refrigerated at 2-8°C (36-46°F). Do notfreeze. Vials in cartons may be transferred to 25°C (77°F, USP controlled room temperature) for a period not to exceed 2 months.Upon transfer to room temperature, mark vials in cartons "This product was removed from the refrigerator on _/_/_ date.lt must be used or discarded 2 months after this date or the labeled expiration date (whichever date comes first)."Do not return to refrigerated storage after beginning room temperature storage.
Maintain aseptic technique while handling Cleviprex. Cleviprex is a single-use parenteral product that contains 0.005% disodium edetate to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental contamination. However, Cleviprex can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Do not use if contamination is suspected. Once the stopper is punctured, use within 12 hours and discard any unused portion.
Cleviprex inhibits microbial growth for up to 12 hours, as demonstrated by test data for representative USP microorganisms, staphylococcus epidermidis and serratiamarcescens.
Manufactured by: Fresenius KabiAustria GmbH, Graz, Austria. Marketed by: The Medicines Company, Parsippany, New Jersey07054. For information call: 888-977-MDCO (6326). Revised: 07/2011
Last reviewed on RxList: 1/4/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Cleviprex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get tips on handling your hypertension.