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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AuroMedics Pharma LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 studie

Product summary:

Ampicillin and Sulbactam for Injection, USP is supplied as follows: Ampicillin and Sulbactam for Injection, USP is a white to off-white powder. 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 AuroMedics Pharma 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 Aurobindo Pharma Limited. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad - 500038 India Revised: 10/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN AND SULBACTAM - AMPICILLIN SODIUM AND SULBACTAM SODIUM
INJECTION, POWDER,
FOR SOLUTION
AUROMEDICS PHARMA LLC
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
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 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 parenteral combination, is
available as a white to off-white,
crystalline powder for reconstitution. Ampicillin and sulbactam for
injection crystalline powder is
16
18
3
4
8
10
5
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 infusion bottle contains: 1.5 g of ampic