DAPTOMYCIN injection, powder, lyophilized, for solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

DAPTOMYCIN (UNII: NWQ5N31VKK) (DAPTOMYCIN - UNII:NWQ5N31VKK)

Διαθέσιμο από:

Hospira, Inc.

INN (Διεθνής Όνομα):

DAPTOMYCIN

Σύνθεση:

DAPTOMYCIN 500 mg in 10 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Daptomycin for Injection is indicated for the treatment of adult patients 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). Pediatric use information is approved for Merck & Co., Inc.'s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Daptomycin for Injection 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. Pediatric use information is approved for Merck & Co., Inc.'s Cubicin (daptomyc

Περίληψη προϊόντος:

Daptomycin for Injection is supplied as a sterile pale yellow to light brown lyophilized cake or powder in a single-dose 10 mL vial containing 500 mg of daptomycin: Package of 1 (NDC 0409-0106-01) Store original packages at refrigerated temperatures, 2 to 8°C (36 to 46°F); avoid excessive heat [see Dosage and Administration (2.7) ].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

DAPTOMYCIN- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DAPTOMYCIN FOR INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DAPTOMYCIN FOR
INJECTION.
DAPTOMYCIN FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Daptomycin for Injection is a lipopeptide antibacterial indicated for
the treatment of:
•
•
Limitations of Use
Daptomycin for Injection is not indicated for the treatment of
pneumonia. (1.4)
Daptomycin for Injection is not indicated for the treatment of
left-sided infective endocarditis due to _S. aureus_. (1.4)
Daptomycin for Injection 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 Daptomycin for Injection and other
antibacterial drugs, Daptomycin for Injection should be used to treat
infections that are proven or strongly suspected to be
caused by bacteria. (1.5)
DOSAGE AND ADMINISTRATION
Adult Patients
•
•
*
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 hours
6 mg/kg
once every 48 hours
There are two formulations of daptomycin that have differences
concerning storage and reconstitution. Carefully follow
the reconstitution and storage procedures in labeling. (2.7)
•
DOSAGE FORMS AND STRENGTHS
For Injection: 500 mg lyophilized cake or powder for reconstitution in
a single-dose vial (3)
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
Complicated skin and skin structure infections (cSSSI) in adult
patients (1.1) and,
_Staphylococcus aureus_ bloodstr