Ampicillin sulbactam indications and usage

Ampicillin/Sulbactam
UNASYN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
Compatibility, Reconstitution, and Stability
Directions For Use
How Supplied
Other Size Packages Available
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Indications and Usage

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

• Acinetobacter calcoaceticus*
• Bacteroides fragilis*
• Enterobacter spp.*
• Escherichia coli*
• Klebsiella spp.* (including K. pneumoniae*)
• Proteus mirabilis*
• Staphylococcus aureus

Intra-Abdominal Infections

• Bacteroides species, including B. fragilis
• Enterobacter spp.*
• Escherichia coli*
• Klebsiella spp.* (including K. pneumoniae*)

Gynecological Infections

• Bacteroides species, including B. fragilis
• Escherichia coli*

^* Efficacy for this organism in this organ system was studied in fewer than 10 infections.

While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with UNASYN due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to UNASYN should not require the addition of another antibiotic. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to UNASYN. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of UNASYN and other antibacterial drugs, UNASYN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

References

Adapted from the FDA Package Insert.