CUBICIN RF- daptomycin injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Daptomycin (UNII: NWQ5N31VKK) (Daptomycin - UNII:NWQ5N31VKK)

Available from:

Merck Sharp & Dohme LLC

INN (International Name):

Daptomycin

Composition:

Daptomycin 500 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CUBICIN® RF is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only). CUBICIN RF is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. CUBICIN RF is indicated for the treatment of pediatric patients (1 to 17 years of age) with Staphylococcus aureus bloodstream infections (bacteremia). CUBICIN RF is not indicated for the treatment of pneumonia. CUBICIN RF is not indicated for the treatment of left-sided infective endocarditis due

Product summary:

CUBICIN RF (daptomycin for injection) is supplied as a sterile pale yellow to light brown lyophilized powder in a single-dose vial containing 500 mg of daptomycin: Package of 1 (NDC 67919-012-01). Store original packages at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Storage conditions for the reconstituted and diluted solutions are described in another section of the prescribing information [see Dosage and Administration (2.7)] .

Authorization status:

New Drug Application

Summary of Product characteristics

CUBICIN RF- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
MERCK SHARP & DOHME LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CUBICIN RF SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CUBICIN RF.
CUBICIN RF (DAPTOMYCIN FOR INJECTION), FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
CUBICIN RF is a lipopeptide antibacterial indicated for the treatment
of:
Complicated skin and skin structure infections (cSSSI) in adult and
pediatric patients (1 to 17 years of
age) (1.1) and,
_Staphylococcus aureus_ bloodstream infections (bacteremia), in adult
patients including those with
right-sided infective endocarditis, (1.2)
_Staphylococcus aureus_ bloodstream infections (bacteremia) in
pediatric patients (1 to 17 years of age).
(1.3)
Limitations of Use:
CUBICIN RF is not indicated for the treatment of pneumonia. (1.4)
CUBICIN RF is not indicated for the treatment of left-sided infective
endocarditis due to _S. aureus_. (1.4)
CUBICIN RF is not recommended in pediatric patients younger than one
year of age due to the risk of
potential effects on muscular, neuromuscular, and/or nervous systems
(either peripheral and/or
central) observed in neonatal dogs. (1.4)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of CUBICIN RF and
other antibacterial drugs, CUBICIN RF should be used to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria. (1.5)
DOSAGE AND ADMINISTRATION
Adult Patients
Administer to ADULT PATIENTS intravenously in 0.9% sodium chloride,
either by injection over a 2-
minute period or by infusion over a 30-minute period. (2.1, 2.7)
Recommended dosage regimen for adult patients (2.2, 2.4, 2.6):
CREATININE CLEARANCE
(CL
)
DOSAGE REGIMEN
CSSSI
FOR 7 TO 14 DAYS
_S. AUREUS_ BACTEREMIA
FOR 2 TO 6 WEEKS
*
≥30 mL/min
4 mg/kg once every 24 hours
6 mg/kg once every 24 hours
<30 mL/min, including
hemodialysis and CAPD
4 mg/kg once every 48 ho