Amoxicillin, Omeprazole and Rifabutin

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. 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.

TALICIA is a combination of antibacterial drugs (rifabutin, amoxicillin) and a proton pump inhibitor (omeprazole as omeprazole magnesium), an antisecretory drug.

Administer four. TALICIA capsules three times daily (at least 4 hours apart, e.g., morning, mid-day, and evening) with food for 14 days. Swallow whole. Do not crush or chew. Do not take TALICIA with alcohol.

Known hypersensitivity to omeprazole, amoxicillin or any other beta-lactam antibacterial drugs, rifabutin or any other rifamycin, or any component of TALICIA. Rilpivirine-containing products. Delavirdine. Voriconazole.

Hypersensitivity Reactions: Serious and occasionally fatal reactions (e.g., anaphylaxis) have been reported with components of TALICIA. If hypersensitivity reactions occur, discontinue TALICIA and institute immediate therapy (e.g., anaphylaxis management). Severe Cutaneous Adverse Reactions (SCAR): There have been reports of SCAR with the components of TALICIA. Monitor closely and discontinue TALICIA at the first signs of SCAR. Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of TALICIA. If this occurs, discontinue TALICIA and institute appropriate therapy. Clostridioides difficile -Associated Diarrhea (CDAD): Evaluate if diarrhea occurs. Reduction in the Efficacy of Hormonal Contraceptives: Additional non-hormonal highly effective methods of contraception should be used while taking TALICIA.

The following serious adverse reactions are described below and elsewhere in labeling: Hypersensitivity Reactions Severe Cutaneous Adverse Reactions Drug-Induced Enterocolitis Syndrome (DIES) Clostridioides difficile -Associated Diarrhea Acute Tubulointerstitial Nephritis Cutaneous and Systemic Lupus Erythematosus Rash in Patients with Mononucleosis Uveitis Most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.

Components of TALICIA have the potential for clinically important drug interactions. See Full Prescribing Information for important drug interactions with TALICIA.

Store at 20°C to 25°C (68°F to 77°F). Store and Dispense in original container with a child-resistant closure.