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:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.  When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.  In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci.  It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to othe

Product summary:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
FRESENIUS KABI USA, LLC
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VANCOMYCIN HYDROCHLORIDE FOR INJECTION USP
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Vancomycin
Hydrochloride for Injection, USP and other antibacterial drugs,
Vancomycin Hydrochloride for
Injection, USP 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 is a lyophilized powder,
for preparing intravenous (IV)
infusions, in vials each containing the equivalent of 1 g vancomycin
base. 500 mg of the base are
equivalent to 0.34 mmol. When reconstituted with Sterile Water for
Injection to a concentration of 50
mg/mL, the pH of the solution is between 2.5 and 4.5. Vancomycin
Hydrochloride for Injection, USP
should be administered intravenously in diluted solution (see DOSAGE
AND ADMINISTRATION).
FURTHER DILUTION IS REQUIRED BEFORE USE.
Vancomycin is a tricyclic glycopeptide antibiotic derived from
_Amycolatopasis orientalis_ (formerly
_Nocardia orientalis_). Vancomycin hydrochloride has the following
structural formula:
C
H
CL
N
O
• HCL M.W. 1485.73
CLINICAL PHARMACOLOGY:
Vancomycin is poorly absorbed after oral administration.
In subjects with normal kidney function, multiple IV dosing of 1 g of
vancomycin (15 mg/kg) infused
over 60 minutes produces mean plasma concentrations of approximately
63 mcg/mL immediately at the
completion of infusion, mean plasma concentrations of approximately 23
mcg/mL two hours after
infusion, and mean plasma concentrations of approximately 8 mcg/mL 11
hours after the end of the
infusion. Multiple dosing of 500 mg infused over 30 minutes produces
mean plasma concentrations of
about 49 mcg/mL at the completion of infusion, mean plasma
concentrations of about 19 mcg/mL two
hours after infusion, and mean plasma concentrations of about 10
mcg/mL six hours after infusion. The
6 6
75
2
9
24
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