AMPICILLIN AND SULBACTAM 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:

Civica, Inc.

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 studied in fewer than 10 infections

Product summary:

Ampicillin and Sulbactam for Injection is supplied as follows: Ampicillin and Sulbactam for Injection is a sterile white to off-white dry powder supplied in glass vials. Storage Conditions Prior to reconstitution store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Brands listed are the trademarks of their respective owners. Manufactured for: Civica, Inc. Lehi, Utah 84043 Manufactured by: Astral SteriTech Pvt. Ltd. 911, G.I.D.C., Makarpura, Vadodara – 390010 Gujarat, India. Code No.: GUJ/DRUGS/G/28/674 Date: November 2022 Commodity Number: 3BAJ03-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN AND SULBACTAM- AMPICILLIN AND SULBACTAM INJECTION, POWDER,
FOR
SOLUTION
CIVICA, INC.
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
(FOR INTRAMUSCULAR OR INTRAVENOUS USE)
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 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, ampicillin sodium/sulbactam
sodium parenteral
combination, is available as a white to off-white dry powder for
reconstitution. Ampicillin
and Sulbactam for Injection 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 8.0 and 10.0.
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 gra