AMPICILLIN AND SULBACTAM injection, powder, for solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Sagent Pharmaceuticals

INN (Alþjóðlegt nafn):

ampicillin sodium

Samsetning:

ampicillin 10 g in 100 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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. While ampicilli

Vörulýsing:

Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is supplied as follows: Ampicillin and Sulbactam for Injection, USP is a sterile white to off-white dry powder supplied in glass bottles. Ampicillin and Sulbactam for Injection, USP is also available as follows: Prior to reconstitution store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Brands listed are the trademarks of their respective owners. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2018 Sagent Pharmaceuticals, Inc. Revised: May 2018 SAGENT Pharmaceuticals®

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

AMPICILLIN AND SULBACTAM- AMPICILLIN AND SULBACTAM INJECTION, POWDER,
FOR
SOLUTION
SAGENT PHARMACEUTICALS
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
(FOR INTRAVENOUS USE)
SAGENT
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 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 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