AMPICILLIN SODIUM AND SULBACTAM SODIUM injection, powder, for solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Mylan Institutional LLC

Az alkalmazás módja:

INTRAMUSCULAR

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

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 67457-348-15 Box of 10 vials NDC 67457-348-10 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 67457-349-03 Box of 10 vials NDC 67457-349-10 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

AMPICILLIN SODIUM AND SULBACTAM SODIUM- AMPICILLIN SODIUM AND
SULBACTAM
SODIUM INJECTION, POWDER, FOR SOLUTION
MYLAN INSTITUTIONAL LLC
----------
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:
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 solutions rem