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

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.

• Administer four (4) TALICIA capsules every 8 hours with food for 14 days. • Swallow whole. Do not crush or chew. • Do not take TALICIA with alcohol.

Most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.

• Known hypersensitivity to omeprazole, amoxicillin or any other betalactam 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). • Clostridioides difficile-Associated Diarrhea (CDAD): Evaluate if diarrhea occurs. • Reduction in the Efficacy of Hormonal Contraceptives: Additional nonhormonal highly effective methods of contraception should be used while taking TALICIA. • Acute Interstitial Nephritis (AIN): Observed in patients taking (Proton Pump Inhibitors (PPIs) and penicillins. Discontinue TALICIA if AIN develops. • Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue TALICIA and evaluate.