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:

SAMSON MEDICAL TECHNOLOGIES LLC

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Composition:

VANCOMYCIN 100 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-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 other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adj

Product summary:

Vancomycin Hydrochloride for Injection, USP is a sterile, lyophilized powder available in the following SmartPak®  Pharmacy Bulk Package:          100 grams* (1 Pharmacy Bulk Package) Product No. 7100  NDC 66288-7100-1 sold in individual bags.          *Each 100 gram pharmacy bulk package contains sterile vancomycin hydrochloride equivalent to 100 grams of vancomycin Prior to reconstitution, Vancomycin Hydrochloride for Injection, USP should be stored at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. SmartPak® system components are 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
SAMSON MEDICAL TECHNOLOGIES LLC
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VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
RX ONLY
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION
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, PHARMACY BULK PACKAGE BAG
SMARTPAK SHOULD
NOT BE USED IN PATIENTS WHO REQUIRE LESS THAN A 500 MG DOSE OF
VANCOMYCIN.
Vancomycin Hydrochloride for Injection, USP is a white to almost white
to brownish lyophilized
powder for preparing intravenous (I.V.) infusions, in bags containing
the equivalent of 100 grams
vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When
reconstituted with Sterile
Water for Injection to a concentration of 100 mg/mL, a clear,
brownish-yellow solution is formed with
the pH of the solution between 2.5 and 4.5. This product is oxygen
sensitive. Vancomycin
Hydrochloride for Injection, USP should be administered intravenously
in diluted solution (see
DOSAGE AND ADMINISTRATION). AFTER RECONSTITUTION FURTHER DILUTION IS
REQUIRED BEFORE USE.
Each SmartPak Pharmacy Bulk Package contains Vancomycin Hydrochloride
for Injection, USP
equivalent to 100 grams of vancomycin activity and is intended for
intravenous infusion only following
further dilution. A Pharmacy Bulk Package is a sterile dosage form
containing many single doses. The
contents are intended for use in a pharmacy admixture program and are
restricted to the preparation of
admixtures for intravenous infusion.
VANCOMYCIN HYDROCHLORIDE FOR INJECTION PHARMACY BULK PACKAGE BAG
SMARTPAK SHOULD NOT BE USED IN PATIENTS WHO REQUIRE LESS THAN A 500
MG DOSE OF VANCOMYCIN.
BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES