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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Claris Life Sciences Inc.

INN (International Name):

ampicillin sodium

Composition:

ampicillin 1 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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,2 Klebsiella spp.2 (including K. pneumoniae2 ), Proteus mirabilis,2 Bacteroides fragilis,2 Enterobacter spp.,2 and Acinetobacter calcoaceticus.2 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. pneumoniae2 ), Bacteroides spp. (including B. fragilis ), and Enterobacter spp.2 Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,2  and Bacteroides spp.2 (including B. fragilis2 ). __________ 2 Efficacy for this microorganism in this organ system was studied in fewer than 10 infec

Product summary:

Ampicillin and Sulbactam for Injection USP (ampicillin sodium/sulbactam sodium) is supplied as a sterile white to off-white dry powder in glass vials. The following packages are available: Vials containing 1.5 g (NDC 36000-094-10) equivalent of Ampicillin and Sulbactam for Injection, USP (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt). 10 vials in a unit carton. Vials containing 3 g (NDC 36000-095-10) equivalent of Ampicillin and Sulbactam for Injection, USP (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt). 10 vials in a unit carton.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN AND SULBACTAM- AMPICILLIN SODIUM AND SULBACTAM SODIUM
INJECTION, POWDER,
FOR SOLUTION
CLARIS LIFE SCIENCES INC.
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AMPICILLIN AND SULBACTAM FOR INJECTION, USP
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.
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 Swith 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 remains the same.
1