DAPTOMYCIN injection, powder, lyophilized, for solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Cipla USA Inc.

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 (daptomy

उत्पाद समीक्षा:

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 69097-850-67                         350 mg Single-Dose Vial                                  1 vial 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. Discard unused portion.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

DAPTOMYCIN - DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CIPLA USA 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 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, 2.5)
• 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 wi