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:

Slate Run Pharmaceuticals, LLC

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

Product summary:

Vancomycin Hydrochloride for Injection USP is supplied as follows:  NDC  Vancomycin Hydrochloride for Injection USP  Package Size  70436-020-82 500 mg Vial (equivalent to 500 mg vancomycin)   10 vials per carton  70436-021-82  1 g Vial (equivalent to 1 gram vancomycin)  10 vials per carton Prior to reconstitution, store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
SLATE RUN PHARMACEUTICALS, LLC
----------
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 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 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
_Amycolatopasis orientalis_
(formerly _Nocardia orientals_). 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 molecular weight is 1,485.74. Vancomycin
hydrochloride has the following structural formula:
66
75
2
9
24
CLINICAL PHARMACOLO