VANCOMYCIN HYDROCHLORIDE injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VANCOMYCIN HYDROCHLORIDE (UNII: 71WO621TJD) (VANCOMYCIN - UNII:6Q205EH1VU)

Available from:

Zhejiang Novus Pharma Co., Ltd.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

How supplied Vancomycin Hydrochloride for Injection is a white, almost white to tan to brown, sterile spray-dried powder in Pharmacy Bulk Package 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. Strength  Unit of Sale 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)] .

Authorization status:

New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER,
FOR SOLUTION
ZHEJIANG NOVUS PHARMA CO., LTD.
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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
PHARMACY BULK PACKAGE. N