Description
Ampicillin and Sulbactam for injection is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. It is a white to off-white crystalline powder for reconstitution.
Formulation:
Each vial contains:
Ampicillin (as Sodium), USP ……….. 1g
Sulbactam (as Sodium), USP ……… 500 mg
Packaging/Availability:
Molded glass vial with butyl rubber stopper and aluminum-plastic cap (Box of 1’s)
Indications & Dosage
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.*
– 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.
Dosage and Administration
The recommended adult dosage of this product is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.
Distribution
Distributed by:
ASIANMEDS, INC.
8F RBMT Bldg., corner C3 & 5th avenue,
Grace Park, Caloocan City
Imported by:
EURO-CARE PRODUCTS, PHILS.
Tinio St., San Nicolas,
Gapan City 3105 Nueva Ecija
Manufactured by:
NORTH CHINA PHARMACEUTICAL CO., LTD.
Shijiazhuang, China
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