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

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Eugia US LLC

SNN (starptautisko nepatentēto nosaukumu):

AMPICILLIN SODIUM

Kompozīcija:

AMPICILLIN 100 mg in 1 mL

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Ampicillin and Sulbactam for Injection, USP (Pharmacy Bulk Package) is supplied as follows:     Ampicillin and Sulbactam for Injection, USP is a white to off-white powder. Store dry powder at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Sterile, Nonpyrogenic, Preservative-free. The vial stopper is not made with natural rubber latex. To report SUSPECTED ADVERSE EVENTS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions. All brands listed are the trademarks of their respective owners and are not trademarks of Eugia Pharma Specialities Limited. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: December 2022

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

AMPICILLIN AND SULBACTAM - AMPICILLIN SODIUM AND SULBACTAM
SODIUM INJECTION, POWDER, FOR SOLUTION
EUGIA US LLC
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
RX ONLY
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, USP
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.
HOWEVER, THE INTENT OF THE 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
16
18
3
4
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 parenteral combination, is
available as a white to
off-white, crystalline powder for reconstitution. Ampicillin and
sulbactam for injection
crystalline 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