AMPICILLIN AND SULBACTAM injection, powder, for solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ampicillin sodium (UNII: JFN36L5S8K) (ampicillin - UNII:7C782967RD), sulbactam sodium (UNII: DKQ4T82YE6) (sulbactam - UNII:S4TF6I2330)

Disponível em:

Sagent Pharmaceuticals

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. Wh

Resumo do produto:

Ampicillin and Sulbactam for Injection, USP is supplied as follows: Ampicillin and Sulbactam for Injection, USP is a sterile off-white dry powder. Prior to reconstitution, store dry powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AMPICILLIN AND SULBACTAM- AMPICILLIN AND SULBACTAM INJECTION, POWDER,
FOR
SOLUTION
SAGENT PHARMACEUTICALS
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
(FOR INTRAVENOUS OR INTRAMUSCULAR USE)
SAGENT
Rx only
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF AMPICILLIN AND SULBACTAM FOR INJECTION 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.
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 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 s