Cubicin
Cubicin Information
Cubicin (daptomycin for injection) is indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative or anaerobic organisms.
Cubicin (daptomycin) is not indicated for the treatment of pneumonia.
How Does Cubicin Work?
Cubicin (daptomycin) is an antibacterial agent of a new class of antibiotics, the cyclic lipopeptides. Cubicin (daptomycin) is a natural product which has clinical utility in the treatment of infections caused by aerobic Gram-positive bacteria. The in vitro spectrum of activity of Cubicin (daptomycin) encompasses most clinically relevant Gram-positive pathogenic bacteria. Cubicin (daptomycin) retains potency against antibiotic-resistant Gram-positive bacteria, including isolates resistant to methicillin, vancomycin, and linezolid. Cubicin (daptomycin) exhibits rapid, concentration-dependent bactericidal activity against Gram-positive organisms in vitro. This has been demonstrated both by time-kill curves and by MBC/MIC ratios using broth dilution methodology.
In vitro studies have demonstrated additive or indifferent interactions of Cubicin (daptomycin) with other antibiotics. Antagonism, as determined by kill curve studies, has not been observed. In vitro synergistic interactions occurred with aminoglyco-sides and ß-lactam antibiotics against some isolates of staphylococci and enterococci, including some MRSA isolates.
The mechanism of action of Cubicin (daptomycin) is distinct from any other antibiotic. Daptomycin binds to bacterial membranes and causes a rapid depolarization of membrane potential. The loss of membrane potential leads to inhibition of protein, DNA, and RNA synthesis, which results in bacterial cell death.
Cubicin Ingredients and Composition
How To Take Cubicin and Cubicin Dosage and Administration
Complicated Skin and Skin Structure Infections:
Cubicin (daptomycin) 4 mg/kg should be administered over a 30-minute period by intravenous infusion in 0.9% sodium chloride injection once every 24 hours for 7-14 days. Doses of Cubicin (daptomycin) higher than 4 mg/kg/day have not been studied in Phase 3 controlled clinical trials.In Phase 1 and 2 clinical studies,CPK elevations appeared to be more frequent when daptomycin was dosed more frequently than once daily. Therefore, Cubicin (daptomycin) should not be dosed more frequently than once a day.
Because Cubicin (daptomycin) is eliminated primarily by the kidney, a dosage modification is recommended for patients with creatinine clearance <30 mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). The recommended dosing regimen is 4 mg/kg once every 24 hours for patients with CLCR ≤ 30 mL/min and 4 mg/kg once every 48 hours for CLCR <30 mL/min, including those on hemodialysis or CAPD. When possible, Cubicin (daptomycin) should be administered following hemodialysis on hemodialysis days.
Preparation of Cubicin (daptomycin) for Administration:
Cubicin (daptomycin) is supplied in single-use vials containing either 250 or 500 mg daptomycin as a sterile, lyophilized powder. The contents of a Cubicin (daptomycin) 250 mg vial should be reconstituted with 5 mL of 0.9% sodium chloride injection. The contents of a Cubicin (daptomycin) 500 mg vial should be reconstituted with 10 mL of 0.9% sodium chloride injection. Reconstituted Cubicin (daptomycin) should be further diluted with 0.9% sodium chloride injection to be administered by intravenous infusion over a period of 30 minutes.
Since no preservative or bacteriostatic agent is present in Cubicin (daptomycin), aseptic technique must be used in preparation of final intravenous 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.
Cubicin (daptomycin) vials are for single-use only.
Parenteral drug products should be inspected visually for particulate matter prior to administration.
Because only limited data are available on the compatibility of Cubicin (daptomycin) with other intravenous substances, additives or other medications should not be added to daptomycin single-use vials or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed with a compatible infusion solution before and after infusion with daptomycin.
Compatible Intravenous Solutions:
Cubicin (daptomycin) is compatible with 0.9% sodium chloride injection and lactated Ringer's injection. Cubicin (daptomycin) is not compatible with dextrose-containing diluents.
If you suspect a Cubicin Overdose
In the event of Cubicin overdose, supportive care is advised with maintenance of glomerular filtration. Daptomycin is slowly cleared from the body by hemodialysis (approximately 15% recovered over 4 hours) or by peritoneal dialysis (approximately 11% recovered over 48 hours).
Cubicin Side Effects
Cubicin Precautions and Contraindications
Cubicin (daptomycin) is contraindicated in patients with known hypersensitivity to daptomycin.
Cubicin Clinical Trials and Studies
Storing Cubicin
Store original Cubicin (daptomycin) packages at refrigerated temperatures 2 to 8°C (36 to 46°F); avoid excessive heat.
