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:

Hospira, Inc

INN (International Name):

AMPICILLIN SODIUM

Composition:

AMPICILLIN 1 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 and

Product summary:

Ampicillin and Sulbactam for Injection, USP (ampicillin sodium/sulbactam sodium) is supplied as a sterile white to yellowish dry powder in ADD-Vantage® Vials as follows: Each 1.5 grams ADD-Vantage® vial contains 1.5 g Ampicillin and Sulbactam for Injection, USP (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt). NDC 0409-2689-01-packed in trays of 10 vials. Each 3 grams ADD-Vantage® vial contains 3 g Ampicillin and Sulbactam for Injection, USP (equivalent to 2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt). NDC 0409-2987-03-packed in trays of 10 vials. The 1.5 g Ampicillin and Sulbactam for Injection, USP ADD-Vantage® vials are only to be used with an ADD-Vantage® Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 50 mL, 100 mL or 250 mL sizes. The 3 g Ampicillin and Sulbactam for Injection, USP ADD-Vantage® vials are only to be used with an ADD-Vantage® Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 100 mL or 250 mL sizes. 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. ADD-Vantage® is a registered trademark of Hospira, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMPICILLIN AND SULBACTAM- AMPICILLIN SODIUM AND SULBACTAM SODIUM
INJECTION, POWDER,
FOR SOLUTION
HOSPIRA, INC
----------
AMPICILLIN AND SULBACTAM FOR INJECTION, USP
ADD-VANTAGE VIALS
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:
Ampicillin and sulbactam for injection, USP parenteral combination, is
available as a white to yellowish
®
16
18
3
4
8
10
5
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 and 10.
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.
Each 1.5 grams ADD-Vantage® vial contains 1.5 g am