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

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Armas Pharmaceuticals Inc.

Laluan pentadbiran:

INTRAMUSCULAR

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 or

Ringkasan produk:

Ampicillin and sulbactam for injection, USP is supplied as a sterile white to off-white dry powder in glass vials. The following packages are available: Vials containing 1.5 g equivalent of ampicillin and sulbactam for injection, USP (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt). Box of one vial NDC 72485-416-01 Box of 10 vials NDC 72485-416-10 Vials containing 3 g equivalent of ampicillin and sulbactam for injection, USP (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt). Box of one vial NDC 72485-417-01 Box of 10 vials NDC 72485-417-10 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.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

AMPICILLIN SODIUM AND SULBACTAM SODIUM- AMPICILLIN SODIUM, SULBACTAM
SODIUM INJECTION, POWDER, FOR SOLUTION
ARMAS PHARMACEUTICALS INC.
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
FOR INTRAMUSCULAR OR INTRAVENOUS USE
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:
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
16
18
3
4
8
10
5
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 r