DAPTOMYCIN injection, powder, lyophilized, for solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Camber Pharmaceuticals Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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 31722-102-10). Store original packages at refrigerated temperatures, 2 to 8°C (36 to 46°F); avoid excessive heat [see Dosage and Administration (2.7)].

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

DAPTOMYCIN - DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CAMBER PHARMACEUTICALS INC.
----------
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, Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS) (5.4) 8/2020
Warnings and Precautions, Tubulointerstitial Nephritis (TIN) (5.5)
8/2020
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
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