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Ordering Information for CLEVIPREX® (clevidipine)

CLEVIPREX vial
CLEVIPREX® (clevidipine)
injectable emulsion
50 mL and 100 mL

CLEVIPREX® (1 box of 10, 50 mL vials)

NDC No.
NDC 65293-005-55
Carton weight
50 mL carton weight, 3.5 lbs/1.6 kg
Carton dimensions
50 mL carton size: 260x104x84 mm/10.23x4.09x3.31 in (LxWxH)

CLEVIPREX® (1 box of 10, 100 mL vials)

NDC No.
NDC 65293-005-11
Carton weight
100 mL carton weight, 5.5 lbs/2.5 kg
Carton dimensions
100 mL carton size: 285x111x117 mm/11.22x4.37x4.61 in (LxWxH)

Ordering information

CLEVIPREX® is a wholesaler-stocked product. Please use standard ordering procedure through your wholesaler. If product is not available at your wholesaler, your wholesaler can easily coordinate a drop shipment via Next-Day Saver from a Chiesi USA distribution provider.

Wholesaler item numbers for liquid vials

Wholesaler 25 mg/50 mL 50 mg/100 mL
ABC 10113363 10113364
Cardinal 4522801 4522785
HD Smith 2528396 2528388
McKesson 3433570 3433604
Morris & Dickson 239160 239210

For questions not answered on this website, contact Chiesi USA, Inc. Medical Information at 1-888-661-9260.

Product overview

How supplied

CLEVIPREX® is supplied as a sterile, milky-white lipid emulsion in single-use 50 mL and 100 mL glass vials at a concentration of 0.5 mg/mL of clevidipine for intravenous administration.1

Metabolism

CLEVIPREX® is rapidly metabolized by blood and tissue esterases; initial phase half life of approximately 1 minute.1

Mechanism of action

CLEVIPREX® blocks the entry of calcium through L-type calcium channels which mediate the influx of calcium during depolarization in arterial smooth muscle, decreasing systemic vascular resistance and resulting in a reduction of mean arterial pressure.1

Storage

Leave vials in cartons until use. Clevidipine is photosensitive and storage in cartons protects against photodegradation. Protection from light during administration is not required.1

Store vials refrigerated at 2°C–8°C (36°F–46°F). Do not freeze. 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. It 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.1

Reference: 1. CLEVIPREX® (clevidipine) Prescribing Information. 2013.

Important Safety Information

CLEVIPREX® (clevidipine) Injectable Emulsion is contraindicated in patients with:

  • Allergies to soybeans, soy products, eggs, or egg products;
  • Defective lipid metabolism seen in conditions such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and
  • Severe aortic stenosis.

CLEVIPREX® is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture.

Hypotension and reflex tachycardia are potential consequences of rapid upward titration of CLEVIPREX®. 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.

CLEVIPREX® contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism.

Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.

CLEVIPREX® 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.

There is no information to guide use of CLEVIPREX® in treating hypertension associated with pheochromocytoma.

Most common adverse reactions for CLEVIPREX® (>2%) are headache, nausea, and vomiting.

See Full Prescribing Information

www.cleviprex.com

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