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Acute Care Hospital Products
NASDAQ: MDCO
Acute Care Hospital Products
NASDAQ: MDCO
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Dosing and Administration
Dosing and Administration
Predictable BP Control With Convenient Dosing
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 an infusion 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
- 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
Non–Weight-Based Dosing Regimen
Cleviprex is intended for intravenous (IV) use and should be titrated to achieve the desired blood pressure (BP) reduction. Dosage must be individualized, depending on the BP to be obtained, and the response of the patient. No dosage adjustment is required for patients with underlying hepatic or renal impairment.
Maintenance Dose
- Most patients will achieve desired therapeutic response at 4-6 mg/h
Maximum Dose
- Most patients have received maximum doses of 16 mg/h or less
- Because of lipid load restrictions, no more than 1000 mL, or an average of 21 mg/h, is recommended per 24-hour period
- There is little experience with infusions beyond 72 hours at any dose
Transitioning From Cleviprex to Oral Antihypertensive Therapy
- 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 monitoring BP until desired effect is achieved
Storing Cleviprex
- Leave Cleviprex vials in cartons until administration to protect from light
- Protection from light during administration is not required
- Vials should be stored refrigerated at 2-8°C (36-46°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, indicated by the "Discard By" Date marked by the dispensing pharmacist, and should not be returned to refrigerated storage after beginning room temperature storage
IMPORTANT SAFETY INFORMATION
Cleviprex is intended for intravenous use. Titrate drug depending on the response of the individual patient to achieve the desired blood pressure reduction. 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.
Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis.
Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. Dihydropyridine 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.
Most common adverse reactions (> 2%) are headache, nausea, and vomiting.
Cleviprex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Maintain aseptic technique while handling Cleviprex. Cleviprex contains phospholipids and can support microbial growth. Do not use if contamination is suspected. Once the stopper is punctured, use and discard within 4 hours.
Please see full Prescribing Information.