AMPICILLIN AND SULBACTAM- ampicillin sodium and sulbactam sodium injection, powder, for solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

AMPICILLIN SODIUM (UNII: JFN36L5S8K) (AMPICILLIN - UNII:7C782967RD), SULBACTAM SODIUM (UNII: DKQ4T82YE6) (SULBACTAM - UNII:S4TF6I2330)

Commercializzato da:

Fresenius Kabi USA, LLC

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

INDICATIONS AND USAGE: Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,* Klebsiella spp.* (including K. pneumoniae* ), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus .* NOTE: For information on use in pediatric patients see PRECAUTIONS, Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae* ), Bacteroides spp. (including B. fr

Dettagli prodotto:

HOW SUPPLIED: Ampicillin and Sulbactam for Injection, USP is supplied as a sterile off-white dry powder in glass vials. The following packages are available: NOTE: Ampicillin and Sulbactam for Injection, USP Sterile powder should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] prior to reconstitution. The vial stoppers do not contain natural rubber latex.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

AMPICILLIN AND SULBACTAM- AMPICILLIN SODIUM AND SULBACTAM SODIUM
INJECTION, POWDER,
FOR SOLUTION
FRESENIUS KABI USA, LLC
----------
AMPICILLIN AND SULBACTAM
_FOR INJECTION, USP_
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ampicillin and
Sulbactam for Injection, USP and other antibacterial drugs, Ampicillin
and Sulbactam for Injection, USP
should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by
bacteria.
DESCRIPTION:
Ampicillin and Sulbactam for Injection, USP, is a sterile, injectable
antibacterial combination, consisting
of the semisynthelic antibiotic ampicillin sodium and the
beta-lactamase inhibitor sulbactam sodium for
intravenous and intramuscular administration.
Ampicillin sodium is derived from the penicillin nucleus,
6-aminopenicillanic acid. Chemically, it is
monosodium (2S, 5R,
6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo
[3.2.0] heptane-2-carboxylate. The structural formula is:
C
H
N
NAO
S M.W. 371.39
Sulbactam sodium is a derivative of the basic penicillin nucleus.
Chemically, sulbactam sodium is
sodium penicillinate sulfone; sodium (2S,
5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-
2-carboxylate 4,4-dioxide. The structural formula is:
C
H
NNAO
S M.W. 255.22
Ampicillin and Sulbactam for Injection, USP parenteral combination, is
available as a white to off-white
dry powder for reconstitution. Ampicillin and Sulbactam for Injection,
USP dry powder is freely
16
18
3
4
8
10
5
soluble in aqueous diluents to yield pale yellow to yellow solutions
containing ampicillin sodium and
sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg
sulbactam per mL. The pH of the
solutions is between 8 and 10.
Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL)
are essentially colorless to pale
yellow. The pH of dilute solutions remains the same.
Each 1.5 g vial contains: 1.5 g Ampicillin and Sulbactam for Injection
(equivalent to 1 g ampicillin as th