DAPTOMYCIN injection, powder, lyophilized, for solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Mylan Institutional LLC

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Daptomycin for injection 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). 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. Daptomycin for injection is indicated for the treatment of pediatric patients (1 to 17 years of age) with Staphylococcus aureus bloodstream infections (bacteremia). Daptomycin for injection is not indicated for the treatment of pneumonia. Daptomycin for injection is not i

ملخص المنتج:

Daptomycin for injection is supplied as a sterile pale yellow to light brown lyophilized cake or powder in a single-dose vial containing 500 mg of daptomycin: Package of 1 (NDC 67457-813-50). Store original packages at refrigerated temperatures, 2ºC to 8ºC (36ºF to 46ºF); avoid excessive heat. Storage conditions for the reconstituted and diluted solutions are described in another section of the prescribing information [see Dosage and Administration (2.7)].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DAPTOMYCIN- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
MYLAN INSTITUTIONAL LLC
----------
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
RECENT MAJOR CHANGES
Dosage and Administration (2) 2/2022
Warnings and Precautions, Development of Drug-Resistant Bacteria
(5.12) 10/2021
INDICATIONS AND USAGE
Daptomycin for injection is a lipopeptide antibacterial indicated for
the treatment of:
•
•
•
Limitations of Use:
•
•
•
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 or prevent
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*
Pediatric Patients
•
•
•
12 to 17 years
Up to 14 days
7 to 11 years
2 to 6 years
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)
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