VANCOMYCIN- vancomycin hydrochloride injection, powder, lyophilized, for solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

vancomycin hydrochloride (UNII: 71WO621TJD) (vancomycin - UNII:6Q205EH1VU)

Fáanlegur frá:

Sagent Pharmaceuticals

INN (Alþjóðlegt nafn):

vancomycin hydrochloride

Samsetning:

vancomycin 5 g in 100 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin Hydrochloride for Injection, USP 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, skin and skin structure infections. When staphylococcal infecti

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

VANCOMYCIN- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED,
FOR
SOLUTION
SAGENT PHARMACEUTICALS
----------
VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
(FORMERLY: STERILE VANCOMYCIN HYDROCHLORIDE)
(FOR INTRAVENOUS USE AFTER DILUTION)
SAGENT
Rx only
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
vancomycin hydrochloride and other antibacterial drugs, vancomycin
hydrochloride
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 an off white to
buff-colored lyophilized
powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk
Package bottles
containing the equivalent of 5 grams or 10 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 50 mg per mL for the 5 gram Pharmacy Bulk Package
bottle and 100
mg per mL for the 10 gram Pharmacy Bulk Package bottle, 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).
Vancomycin Hydrochloride for Injection, USP is a tricyclic
glycopeptide antibiotic derived
from _Amycolatopasis orientalis_ (formerly _Nocardia orientalis_).
The chemical name for vancomycin hydrochloride is (_S_ )-
(_3S_,_6R,7R,22R,23S_,_26S_,_36R,38aR_)-44-[[2-_O_-(3-Amino-
2,3,6-trideoxy-3-_C_-methyl-α-
L-_lyxo_-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-
2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-
7,22,28,30,32-pentahydroxy-6-
[(_2R_)-4-methyl-2-(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-_22H_-8,11:18,21-
dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-_1H_,_16H_-
[1,6,9]oxadiazacyclohexadecino[4,5-_m_][10,2,16]benzoxadiazacyclotetracosine-26-
carboxylic acid, monohydrochloride. The molecular formula is C
H
Cl
N O
•HCl and