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:

Eugia US LLC

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Composition:

VANCOMYCIN 500 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vancomycin Hydrochloride for Injection 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 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 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 infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis ), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin Hydrochloride for Injection has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection and other antibacterial drugs, Vancomycin Hydrochloride for Injection 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. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections. Vancomycin hydrochloride for injection is contraindicated in patients with known hypersensitivity to this antibiotic.

Product summary:

Vancomycin Hydrochloride for Injection, USP is a white or off-white to light tan lyophilized powder or cake and is supplied as follows: Store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sterile, Lyophilized, Preservative free The vial stoppers 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
EUGIA US LLC
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VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
FOR INTRAVENOUS USE
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 white or off-white to
light tan sterile,
lyophilized and preservative free powder or cake, for preparing
intravenous (IV)
infusions, in vials each containing the equivalent of 500 mg or 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.
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.
Vancomycin is a tricyclic glycopeptide antibiotic derived from
_Amycolatopsis orientalis_
(formerly _Nocardia orientalis_). Vancomycin hydrochloride USP is a
white or almost white,
hygroscopic powder. The chemical name for vancomycin hydrochloride is
3S-
[3_R_*,6_S_*(_S_*),7_S_*,22_S_*,23_R_*,26_R_*,36_S_*,38a_S_*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-
amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-
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-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-
pentaoxo-22_H_-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-
1_H_,16_H_-[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 the mol