: 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抯 effect. Continue blood pressure monitoring until desired effect is achieved.
Special populations: Special populations were not specifically studied. In clinical trials, 78 patients with abnormal hepatic function (one or more of the following: elevated serum bilirubin, AST/SGOT, ALT/SGPT) and 121 patients with moderate to severe renal impairment 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 Dose
(mg/hour) (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
2.3 Instructions for Administration
Maintain aseptic technique while handling Cleviprex. Cleviprex is a single-use parenteral product that contains phospholipids and can support microbial growth. Do not use if contamination is suspected. Once the stopper is punctured, use within 4 hours and discard any unused portion including that which is currently being infused.
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 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
3 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 butyrate
-
100 mL single-use vial with 0.5 mg/mL clevidipine butyrate
4 CONTRAINDICATIONS
Cleviprex is a sterile, milky white injectable emulsion for intravenous use,
4.1 Known Allergy
Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products.
4.2 Defective Lipid Metabolism
Cleviprex is contraindicated in patients with defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia.
4.3 Severe Aortic Stenosis
Cleviprex is contraindicated in patients with severe aortic stenosis because afterload reduction can be expected to reduce myocardial oxygen delivery.
5 WARNINGS AND PRECAUTIONS
5.1 Need for Aseptic Technique Use aseptic technique and discard any unused product梚ncluding product being infused梬ithin 4
