VANCOMYCIN HYDROCHLORIDE injection powder lyophilized for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Composition:

VANCOMYCIN 500 mg in 100 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
CARDINAL HEALTH
----------
VANCOMYCIN
HYDROCHLORIDE for Injection, USP
ADD-VANTAGE
VIALS
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of vancomycin and
other antibacterial drugs, vancomycin should be used only to treat or
prevent infections that are proven
or strongly suspected to be caused by bacteria.
DESCRIPTION
Vancomycin Hydrochloride for Injection, USP, intravenous, is a
chromatographically purified tricyclic
glycopeptide antibiotic derived from _Amycolatopsis orientalis_
(formerly _Nocardia orientalis_) and has the
molecular formula C
H Cl
N O • HCl. The molecular weight is 1485.74; 500 mg of the base is
equivalent to 0.34 mmol, 750 mg of the base is equivalent to 0.51
mmol, and 1 g of the base is equivalent
to 0.67 mmol.
Vancomycin Hydrochloride has the following structural formula:
The ADD-Vantage™ vials contain sterile vancomycin hydrochloride
equivalent to either 500 mg,
750 mg, or 1 g vancomycin activity for reconstitution in the
ADD-Vantage flexible diluent container
containing 5% dextrose injection or 0.9% sodium chloride injection.
Vancomycin Hydrochloride is a
white to tan lyophilized powder. May contain hydrochloric acid and/or
sodium hydroxide for pH
adjustment. When reconstituted in water, it forms a clear, light to
dark tan solution with a pH of
4.0 (2.5 to 4.5). This product is oxygen sensitive.
™
66
75
2
9
24
The solutions contain no bacteriostat, antimicrobial agent (except
vancomycin) or buffer and are
intended for use only as a single-dose injection only with the
ADD-Vantage Flexible Diluent Container.
FURTHER DILUTION IS REQUIRED BEFORE USE (see DOSAGE AND
ADMINISTRATION).
CLINICAL PHARMACOLOGY
Vancomycin is poorly absorbed after oral administration; it is given
intravenously for therapy of
systemic infections. Intramuscular injection is painful.
Vancomycin Hydrochloride for Injection, USP is administered
intravenously for therapy of systemi