Country: United States
Language: English
Source: NLM (National Library of Medicine)
VANCOMYCIN HYDROCHLORIDE (UNII: 71WO621TJD) (VANCOMYCIN - UNII:6Q205EH1VU)
Zhejiang Novus Pharma Co., Ltd.
INTRAVENOUS
PRESCRIPTION DRUG
Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of septicemia due to: - Susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci. - Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. Vancomycin Hydrochloride for Injection administered intravenously is indicated in adults and pediatric patients less than 18 years of age for the treatment of infective endocarditis due to: - Susceptible isolates of MRSA. - Viridans group streptococci Streptococcus gallolyticus (previously known as Streptococcus bovis ), Enterococcus species and Corynebacterium species. For enterococcal endocarditis, use Vancomycin Hydrochloride for Injection in combination with an aminoglycoside. - Methicillin-susceptible staphylococci in
How supplied Vancomycin Hydrochloride for Injection is a white, almost white to tan to brown, sterile spray-dried powder in single-dose vials each containing vancomycin hydrochloride equivalent to 500 mg or 1 g of vancomycin base. The vial stopper is not made with natural rubber latex. NDC No. Unit of sale Strength Unit of Sale NDC for Each Vial Storage Store at 20°C to 25°C (68°F to 77°F). Brief exposure to 15°C to 30°C (59°F to 86°F) is permitted [See USP Controlled Room Temperature]. Storage after reconstitution and dilution is described elsewhere in the labeling [see Dosage and Administration (2.5, 2.8)] .
New Drug Application
VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION ZHEJIANG NOVUS PHARMA CO., LTD. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VANCOMYCIN HYDROCHLORIDE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VANCOMYCIN HYDROCHLORIDE FOR INJECTION. VANCOMYCIN HYDROCHLORIDE FOR INJECTION, FOR INTRAVENOUS USE OR ORAL USE INITIAL U.S. APPROVAL: 1958 INDICATIONS AND USAGE Vancomycin Hydrochloride for Injection is a glycopeptide antibacterial indicated in adult and pediatric patients less than 18 years of age as follows: Vancomycin Hydrochloride for Injection ADMINISTERED INTRAVENOUSLY is indicated for the treatment of: o Septicemia (1.1) o Infective Endocarditis (1.2) o Skin and Skin Structure Infections (1.3) o Bone Infections (1.4) o Lower Respiratory Tract Infections (1.5) Vancomycin Hydrochloride for Injection ADMINISTERED ORALLY is indicated for the treatment of: o _Clostridioides difficile_-associated diarrhea (1.6) o Enterocolitis caused by _Staphylococcus aureus_ (including methicillin-resistant strains) (1.7) Limitations of Use (1.8) Vancomycin Hydrochloride for Injection ADMINISTERED INTRAVENOUSLY is not approved for the treatment of _C. difficile_-associated diarrhea and enterocolitis caused by susceptible isolates of _Staphylococcus aureus_ because it is not effective. Vancomycin _Hydrochloride_ for Injection ADMINISTERED ORALLY is not approved for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections because it is not effective. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.9) DOSAGE AND ADMINISTRATION See full prescribing Read the complete document