DAPTOMYCIN- daptomycin injection, powder, lyophilized, for solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Jiangsu Hengrui Medicine Co., Ltd.

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 (daptomyci

Sommarju tal-prodott:

Daptomycin for Injection is supplied as a sterile, nonpyrogenic, preservative-free pale yellow to light brown lyophilized cake/powder in a single-dose 20 mL vial containing 500 mg of daptomycin: Package of 1 (NDC 57884-3151-1). The container closure is not made with natural rubber latex. Store original packages at refrigerated temperatures, 2° to 8°C (36° to 46°F); avoid excessive heat [see Dosage and Administration (2.7)]. Discard unused portion.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

DAPTOMYCIN- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
JIANGSU HENGRUI MEDICINE CO., LTD.
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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)
9/2017
Dosage and Administration ( 2)
9/2017
INDICATIONS AND USAGE
Daptomycin for Injection is a lipopeptide antibacterial indicated for
the treatment of:
Complicated skin and skin structure infections (cSSSI) in adult
patients ( 1.1)
_Staphylococcus aureus_ bloodstream infections (bacteremia), in adult
patients including those with right-sided infective
endocarditis ( 1.2)
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. ( 2.1, 2.7)
Recommended dosage regimen for adult patients ( 2.2, 2.4, 2.6):
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 he