País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
DAPTOMYCIN (UNII: NWQ5N31VKK) (DAPTOMYCIN - UNII:NWQ5N31VKK)
Xellia Pharmaceuticals USA, LLC
INTRAVENOUS
PRESCRIPTION DRUG
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
Daptomycin for Injection is supplied as a sterile pale yellow to light brown lyophilized cake in a single-dose 15 mL vial containing 350 mg of daptomycin: Package of 1 (NDC 70594-053-01). Store original packages at refrigerated temperatures, 2 to 8°C (36 to 46°F); avoid excessive heat [see Dosage and Administration (2.5)] .
New Drug Application
DAPTOMYCIN- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION XELLIA PHARMACEUTICALS USA, LLC ---------- 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) ------------------9/2019 Dosage and Administration (2) ------------------9/2019 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) 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. (1.3) 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 (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, in Llegiu el document complet