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CUBICIN
Bacterial infections
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Drug Name:

CUBICIN Rx

Generic Name and Formulations:
Daptomycin 500mg/vial; lyophilized pwd for IV inj after reconstitution (with 0.9% sodium chloride) or IV infusion after reconstitution and dilution; preservative-free; requires refrigeration.

Company:
Merck & Co., Inc.

Therapeutic Use:

Indications for CUBICIN:

Susceptible complicated skin and skin structure infections (cSSSI) in adults and pediatrics (1–17yrs). S. aureus bacteremia in adults (including MRSA and MSSA right-sided endocarditis) and in pediatrics (1–17yrs).

Limitations Of use:

Not for treatment of pneumonia or left-sided endocarditis due to S. aureus. Not studied in prosthetic valve endocarditis. Not recommended in pediatrics (<1yr) due to risk of potential effects on muscular, neuromuscular, and/or nervous systems (peripheral and/or central).

Adult:

Give by IV inj over 2mins or IV infusion over 30mins. cSSSI: 4mg/kg once every 24hrs for 7–14 days. S. aureus bacteremia or endocarditis: 6mg/kg once every 24hrs for 2–6 weeks. Renal impairment (CrCl <30mL/min): decrease dosing interval to once every 48hrs; coincide dose for after dialysis.

Children:

<1yr: not recommended. Give by IV infusion over 60mins (1–6yrs) or 30mins (7–17yrs). cSSSI (1–<2yrs): 10mg/kg once every 24hrs; (2–6yrs): 9mg/kg once every 24hrs; (7–11yrs): 7mg/kg once every 24hrs; (12–17yrs): 5mg/kg once every 24hrs. Treat up to 14 days. S. aureus bacteremia (1–6yrs): 12mg/kg once every 24hrs; (7–11yrs): 9mg/kg once every 24hrs; (12–17yrs): 7mg/kg once every 24hrs. Treat up to 42 days. Renal impairment (CrCl <30mL/min): not established.

Warnings/Precautions:

Monitor for development of muscle pain or weakness (esp. distal extremities). Monitor CPK weekly (more frequently in those with concomitant statin therapy or elevated CPK); discontinue if CPK (≥5xULN) and myopathy occur, or if CPK (≥10xULN) without myopathy occurs. Renal impairment: monitor renal function and CPK more frequently than once weekly. Discontinue immediately if eosinophilic pneumonia develops; treat with systemic steroids. Monitor for neuropathy; consider discontinuation if occurs. Persisting or relapsing S. aureus bacteremia/endocarditis: repeat blood cultures and evaluate. Decreased efficacy observed in adults with moderate baseline renal impairment. Severe hepatic impairment. Pregnancy. Nursing mothers.

Interactions:

Consider suspending agents associated with rhabdomyolysis (eg, statins). May cause false prolongation of PT or elevation of INR when certain recombinant thromboplastin reagents are utilized for the assay.

See Also:

CUBICIN RF

Pharmacological Class:

Cyclic lipopeptide.

Adverse Reactions:

Diarrhea, headache, dizziness, rash, abnormal LFTs, elevated CPK, UTIs, hypotension, dyspnea, vomiting, abdominal pain, pruritus, pyrexia, sepsis, bacteremia, chest pain, edema, pharyngolarygeal pain, increased sweating, insomnia, hypertension; hypersensitivity reactions, myopathy, rhabdomyolysis, C. difficile-associated diarrhea.

Generic Availability:

NO

How Supplied:

Single-dose vial (10mL)—1

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