STERILE VANCOMYCIN HYDROCHLORIDE- 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:

Rebel Distributors Corp

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Composition:

VANCOMYCIN 500 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vancomycin 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 hydrochloride 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 adjuncts to appropriat

Product summary:

21695-424-01 – Sterile Vancomycin Hydrochloride, USP equivalent to 500 mg vancomycin in a 10 mL flip top vial in packages of 10 vials. Storage: Prior to reconstitution, store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. In animal studies, hypotension and bradycardia occurred in dogs receiving an intravenous infusion of vancomycin 25 mg/kg, at a concentration of 25 mg/mL and an infusion rate of 13.3 mL/min.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

STERILE VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
REBEL DISTRIBUTORS CORP
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STERILE VANCOMYCIN HYDROCHLORIDE USP 500 MG & 1 G
STERILE VANCOMYCIN HYDROCHLORIDE, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of vancomycin and
other antibacterial drugs, vancomycin should be used to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Sterile Vancomycin Hydrochloride, USP is a lyophilized powder, for
preparing intravenous (IV)
infusions. Each vial contains the equivalent of 500 mg or 1 gram
vancomycin base; 500 mg of base is
equivalent to 0.34 mmol. Vancomycin hydrochloride is an off-white to
tan colored lyophilized powder.
It may contain hydrochloric acid and/or sodium hydroxide for pH
adjustment. When reconstituted with
Sterile Water for Injection, USP it forms a clear solution with the pH
of the solution between 2.5 and
4.5. This product is oxygen sensitive.
Vancomycin hydrochloride is prepared as a solution and lyophilized in
its final container.
Vancomycin is a tricyclic glycopeptide antibiotic derived from
_Amycolatopasis orientalis _(formerly
_Nocardia orientalis_). The molecular formula is C
H Cl
N O • HCl and the molecular weight is
1,485.71.
Vancomycin Hydrochloride has the following chemical designation:
(_S_ )-(_3S_,_6R,7R,22R,23S_,_26S_,_36R,38aR_)-44-[[2-_O_-(3-Amino-
2,3,6-trideoxy-3-_C_-methyl-(-L-_lyxo_-
hexopyranosyl)-
(-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. Its structural formula is:
CLINICAL PHARMACOLOGY
Vancomycin is poorly absorbed after oral administration; it is given
i