DAPTOMYCIN injection, powder, lyophilized, for solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Dr. Reddy's Laboratories Inc.,

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 (daptom

Rezumat produs:

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:   350 mg Single-Dose Vial 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. Discard unused portion.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

DAPTOMYCIN- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
DR. REDDY'S LABORATORIES 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
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) and,
_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. (1.3)
Daptomycin for Injection is not indicated for the treatment of
left-sided infective endocarditis due to _S._
_aureus_. (1.3)
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. (1.4)
DOSAGE AND ADMINISTRATION
Administer to adult patientsintravenously in 0.9% sodium chloride,
either by injection over a 2-minute
period or by infusion over a 30-minute period. (2.1, 2.5)
Recommended dosage regimen for adult patients (2.2, 2.3, 2.4):
CREATININE CLEARANCE
(CLCR)
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*
*Administered following hemodialysis on hemodialysis days.
There are other formulations of daptomycin that have differences
concerning storage and
reconstitution. Carefully follow the reconstitution and storage
procedures in labeling. (2.5)
Do not use in conjunction with ReadyMED elastome