omeprazole magnesium, amoxicillin and rifabutin
Drug Details
- Generic Name
- omeprazole magnesium, amoxicillin and rifabutin
- Brand Names
- Talicia
- Application Number
- NDA213004
- Sponsor
- RedHill Biopharma Ltd
- NDC Codes
- 1
- Dosage Forms
- CAPSULE, DELAYED RELEASE
- Routes
- ORAL
- Active Ingredients
- AMOXICILLIN, OMEPRAZOLE MAGNESIUM, RIFABUTIN
Indications and Usage
1 INDICATIONS AND USAGE TALICIA is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults. ( 1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of TALICIA and other antibacterial drugs, TALICIA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2) 1.1 Helicobacter pylori Infection TALICIA is indicated for the treatment of Helicobacter pylori infection in adults [see Clinical Studies (14 ) ] . 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of TALICIA and other antibacterial drugs, TALICIA 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.