DOSAGE AND ADMINISTRATION:
| Phase 1 and 2 clinical studies, CPK elevations appeared to be more frequent when CUBICIN was dosed more frequently than once daily. Therefore, CUBICIN should not be dosed more frequently than once a day. |
Complicated Skin and Skin Structure Infections:
CUBICIN 4 mg/kg should be administered over a 30-minute period by IV infusion in 0.9% sodium chloride injection once every 24 hours for 7 to 14 days. In
Staphylococcus aureus Bloodstream Infections (Bacteremia), Including Those with Right-Sided Endocarditis, Caused by Methicillin-Susceptible and Methicillin-Resistant Strains:
CUBICIN 6 mg/kg should be administered over a 30-minute period by IV infusion in 0.9% sodium chloride injection once every 24 hours for a minimum of 2 to 6 weeks. Duration of treatment should be based on the treating physician’s working diagnosis. There are limited safety data for the use of CUBICIN for more than 28 days of therapy.
Renal
Impairment: Recommended
Dosage in Adult Patients
Creatinine Clearance
(CL CR ) |
Dosage
Regimen
(cSSSI) |
Dosage Regimen
( S. aureus
Bloodstream
Infections) |
| >/=30
mL/min |
4 mg/kg
once
every 24 hours |
6 mg/kg
once
every 24 hours |
| <30
mL/min, including hemodialysis or CAPD |
4 mg/kg
once
every 48 hours |
6 mg/kg
once
every 48 hours |
PREPARATION: CUBICIN is supplied in single-use vials containing 500 mg daptomycin as a sterile, lyophilized
powder. The contents of a CUBICIN 500 mg vial should be reconstituted using aseptic
technique as follows:
Note: To minimize foaming, AVOID vigorous agitation or shaking of the vial during or after
reconstitution.
1. Remove the polypropylene flip-off cap from the CUBICIN vial to expose the central
portion of the rubber stopper.
2. Slowly transfer 10 mL of 0.9% sodium chloride injection through the center of the rubber
stopper into the CUBICIN vial, pointing the transfer needle toward the wall of the vial.
3. Ensure that the entire CUBICIN product is wetted by gently rotating the vial.
4. Allow the product to stand undisturbed for 10 minutes.
5. Gently rotate or swirl the vial contents for a few minutes, as needed, to obtain a
completely reconstituted solution.
Reconstituted CUBICIN should be further diluted with 0.9% sodium chloride injection to be
administered by IV infusion over a period of 30 minutes.
Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be
used in preparation of final IV solution. Stability studies have shown that the reconstituted
solution is stable in the vial for 12 hours at room temperature or up to 48 hours if stored under
refrigeration at 2 to 8°C (36 to 46°F). The diluted solution is stable in the infusion bag for 12
hours at room temperature or 48 hours if stored under refrigeration. The combined time (vial
and infusion bag) at room temperature should not exceed 12 hours; the combined time (vial and
infusion bag) under refrigeration should not exceed 48 hours.
SUPPLIED: CUBICIN is supplied in single-use vial containing 500 mg daptomycin as a sterile, lyophilized powder.
Compatible Intravenous Solutions: CUBICIN is compatible with 0.9% sodium chloride injection and lactated
Ringer’s injection. CUBICIN is not compatible with dextrose-containing diluents.
STORAGE: Store original packages at refrigerated temperatures 2 to 8°C (36 to 46°F); avoid excessive heat.
| Source:
CUBICIN [package insert]. Lexington, MA 02421 USA: Cubist Pharmaceuticals, Inc., October 2007. |
|
