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

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Eugia US LLC

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Ampicillin and sulbactam for injection 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

Povzetek izdelek:

Ampicillin and Sulbactam for Injection, USP is supplied as a sterile white to off-white, powder as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Sterile, Nonpyrogenic, Preservative-free. The vial stopper is not made with natural rubber latex. To report SUSPECTED ADVERSE EVENTS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions. All brands listed are the trademarks of their respective owners and are not trademarks of Eugia Pharma Specialities Limited. This product’s labeling may have been updated. For the most recent prescribing information, please visit eugiaus.com. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: March 2023 PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

AMPICILLIN AND SULBACTAM - AMPICILLIN SODIUM AND SULBACTAM
SODIUM INJECTION, POWDER, FOR SOLUTION
EUGIA US 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 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:
16
18
3
4
8
10
5
Ampicillin and sulbactam for injection, USP parenteral combination, is
available as a white
to off-white, crystalline powder for reconstitution. Ampicillin and
sulbactam for injection,
USP crystalline 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 to pale yellow. The pH of dilute solutions remains the same.
Each 1.5 g vial con