AMPICILLIN AND SULBACTAM injection, powder, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

WG Critical Care, LLC

INN (International Name):

AMPICILLIN SODIUM

Sammensetning:

AMPICILLIN 1 g in 20 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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. fragilis ), and Enterobacter spp.* . Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli * , and Bacteroides spp.* (including B. fragilis * ). *Efficacy for this organism in this organ system was studied in fewer than 10 infections. Whi

Produkt oppsummering:

Ampicillin and Sulbactam for Injection, USP is supplied as a sterile off-white dry powder in glass vials. The following packages are available: Single-dose vials containing 1.5 g (NDC 44567-210-10) equivalent of Ampicillin and Sulbactam for Injection, USP (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) Single-dose vials containing 3 g (NDC 44567-211-10) equivalent of Ampicillin and Sulbactam for Injection, USP (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) Ampicillin and Sulbactam for Injection, USP sterile powder is to be stored at 20° to 25°C (68° to 77°F ) [See USP Controlled Room Temperature] prior to reconstitution. Manufactured for: WG Critical Care, LLC Paramus, NJ 07652 Revised: November 2020

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMPICILLIN AND SULBACTAM- AMPICILLIN AND SULBACTAM INJECTION, POWDER,
FOR
SOLUTION
AMPICILLIN AND SULBACTAM- AMPICILLIN AND SULBACTAM INJECTION, POWDER,
FOR
SOLUTION
WG CRITICAL CARE, LLC
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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 and other antibacterial drugs,
ampicillin and
sulbactam for injection should be used only to treat infections that
are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Ampicillin and Sulbactam for Injection, USP is an injectable
antibacterial combination
consisting of the semisynthetic antibacterial 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 and
has a molecular
weight of 371.39. Its chemical formula is C
H
N NaO S. The structural formula is:
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.
Its chemical formula is C H
NNaO S with a molecular weight of 255.22. The structural
formula is:
Ampicillin and Sulbactam for Injection, USP, ampicillin
sodium/sulbactam sodium
parenteral combination is available as a white to off-white dry powder
for reconstitution.
16
18
3
4
8
10
5
Ampicillin and Sulbactam for Injection, USP dry powder is freely
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