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:

Fresenius Kabi USA, 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, 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 infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin Hydrochloride for Injection, USP 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, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP 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, 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 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, supplied as follows: 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
For intravenous use.
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 an off-white to
buff-colored lyophilized
powder, for preparing intravenous (IV) infusions, in vials each
containing the equivalent
of 500 mg or 1 g vancomycin base. 500 mg of the base is 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
_Amycolatopasis orientalis_
(formerly _Nocardia orientalis_). The chemical name for vancomycin
hydrochloride is [3_S_-
[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)-β-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.
Vancomycin
hydrochloride has the following structural formula:
C
H CL
N O
•HCL M.W. 1485.71
CLINICAL PHARMACOLOGY
Vancomycin is poorly absorbed after