DAPTOMYCIN injection, powder, lyophilized, for solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Sagent Pharmaceuticals

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

How Supplied Daptomycin for Injection is supplied as a sterile, nonpyrogenic, preservative-free, pale yellow to light brown lyophilized cake in single-dose vials as follows: The container closure is not made with natural rubber latex. Storage Conditions Store refrigerated between 2°C and 8°C (36°F and 46° F); 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)] .

Autorisation status:

New Drug Application

Produktets egenskaber

DAPTOMYCIN- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
SAGENT PHARMACEUTICALS
----------
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
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:
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:
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 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
C