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:

Mylan Institutional LLC

INN (International Name):

AMPICILLIN SODIUM

Composition:

AMPICILLIN 100 mg in 1 mL

Administration route:

INTRAMUSCULAR

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 ampicillin an

Product summary:

Ampicillin and sulbactam for injection, USP, a sterile white to off-white dry powder, is available in Pharmacy Bulk Package bottle containing ampicillin sodium and sulbactam sodium equivalent to 10 g ampicillin and 5 g sulbactam × 1 (NDC 67457-649-10). 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN SODIUM AND SULBACTAM SODIUM- AMPICILLIN SODIUM AND
SULBACTAM
SODIUM INJECTION, POWDER, FOR SOLUTION
MYLAN INSTITUTIONAL LLC
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF AMPICILLIN
AND SULBACTAM AND OTHER ANTIBACTERIAL DRUGS, AMPICILLIN AND SULBACTAM
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, ampicillin
sodium/sulbactam sodium 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 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 solu