DAPTOMYCIN injection, powder, lyophilized, for solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

BE Pharmaceuticals Inc.

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

How Supplied Daptomycin for Injection is supplied as a sterile, nonpyrogenic, preservative-free, pale yellow to light brown lyophilized cake or powder in single-dose vials as follows: NDC                             Daptomycin for Injection                    Package Factor 71839-108-01               350 mg Single-Dose Vial                   1 vial per carton 71839-108-10               350 mg Single-Dose Vial                   10 vials per carton 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)].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DAPTOMYCIN - DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
BE PHARMACEUTICALS 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
RECENT MAJOR CHANGES
Indications and Usage (1) 2/2022
Dosage and Administration (2) 2/2022
Warnings and Precautions (5) 2/2022
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