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:

AGILA SPECIALTIES PRIVATE LIMITED

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Composition:

VANCOMYCIN 10 g in 100 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
AGILA SPECIALTIES PRIVATE LIMITED
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VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
(FORMERLY: STERILE VANCOMYCIN HYDROCHLORIDE)
PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION
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 an off white to light
tan colored lyophilized plug or
powder, for preparing intravenous (IV) infusions. Each Vancomycin
Hydrochloride for Injection, USP
10 g Pharmacy Bulk Package bottle contains vancomycin hydrochloride
equivalent to 10 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 100 mg/mL for the 10 g Pharmacy Bulk
Package bottle, the pH of the
solution is between 2.5 to 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_a)-(3_S_, 6_R_, 7_R_, 22_R_, 23_S_, 26_S_, 36_R_,
38a_R_)-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- [(2_R_)-4-
methyl-2-(methylamino)valeramido]- 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-carboxyli