fosfomycin disodium
Drug Details
- Generic Name
- fosfomycin disodium
- Brand Names
- Contepo
- Application Number
- NDA212271
- Sponsor
- Meitheal Pharmaceuticals Inc.
- NDC Codes
- 1
- Dosage Forms
- INJECTION, POWDER, FOR SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- FOSFOMYCIN SODIUM
Indications and Usage
1 INDICATIONS AND USAGE CONTEPO is an epoxide antibacterial indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including acute pyelonephritis caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae . ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of CONTEPO and other antibacterial drugs, CONTEPO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis CONTEPO is indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae . 1.2 Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of CONTEPO and other antibacterial drugs, CONTEPO should be used only to treat 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.