UNASYN- 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:

Roerig

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

UNASYN 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. pneumoniae 2), 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. pneumoniae 2), 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. fragilis 2). While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also ame

Product summary:

UNASYN® (ampicillin sodium/sulbactam sodium) is supplied as a sterile off-white dry powder in glass vials and piggyback bottles. The following packages are available: Vials containing 1.5 g (NDC 0049-0013-83) equivalent of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt). Vials containing 3 g (NDC 0049-0014-83) equivalent of UNASYN (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt). ADD-Vantage® package of 5 vials (NDC 0049-0031-02). Each vial containing 1.5 g (NDC 0049-0031-01) equivalent of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) are distributed by Pfizer Inc. ADD-Vantage® package of 5 vials (NDC 0049-0032-02). Each vial containing 3 g (NDC 0049-0032-01) equivalent of UNASYN (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) are distributed by Pfizer Inc. The 1.5 g UNASYN ADD-Vantage® vials are only to be used with the ADD-Vantage® Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 50 mL, 100 mL, or 250 mL sizes. The 3 g UNASYN ADD-Vantage® vials are only to be used with the ADD-Vantage® Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 100 mL or 250 mL sizes.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

UNASYN- AMPICILLIN SODIUM AND SULBACTAM SODIUM INJECTION, POWDER, FOR
SOLUTION
ROERIG
----------
UNASYN
(AMPICILLIN SODIUM/SULBACTAM SODIUM)
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF UNASYN AND OTHER ANTIBACTERIAL DRUGS, UNASYN SHOULD
BE
USED ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO
BE
CAUSED BY BACTERIA.
DESCRIPTION
UNASYN 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
UNASYN, ampicillin sodium/sulbactam sodium parenteral combination, is
available as a
white to off-white dry powder for reconstitution. UNASYN 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.
1.5 g of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g
sulbactam as the sodium
salt) parenteral contains approximately 115 mg (5 mEq) of sodium.
3 g of UNASYN (2 g ampicillin as the sodium salt plus 1 g