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:

Meitheal Pharmaceuticals Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 fewer than 10 infections. While ampicil

Product summary:

Ampicillin and Sulbactam for Injection, USP (ampicillin sodium/sulbactam sodium) Pharmacy Bulk Package is supplied as follows: Ampicillin and Sulbactam for Injection, USP powder should be stored at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature], prior to reconstitution. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . This product’s label may have been updated. For current full prescribing information, please visit www.meithealpharma.com. Brands listed are the trademarks of their respective owners. Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2023 Meitheal Pharmaceuticals Inc. Mfd. by Istituto Biochimico Italiano Aprilia, Italy 04011 March 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN AND SULBACTAM- AMPICILLIN SODIUM AND SULBACTAM
SODIUM INJECTION, POWDER, FOR SOLUTION
MEITHEAL PHARMACEUTICALS INC.
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
(FOR INTRAVENOUS USE)
PHARMACY BULK PACKAGE -
Rx only
NOT FOR DIRECT INFUSION
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 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. THE
INTENT OF THIS PHARMACY BULK PACKAGE IS FOR PREPARATION OF
SOLUTIONS FOR IV INFUSION ONLY.
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
16
18
3
4
8
10
5
parenteral combination, is available as a white to off-white dry
powder for reconstitution.
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 betwe