Medication Monitor

Generic Name (Trade Name—Company)
November 6, 2019

Omeprazole magnesium, amoxicillin, rifabutin

(Talicia—RedHill BioPharma)
FDA approves three-drug combination to treat H. pylori infection

RedHill BioPharma announced FDA approval of omeprazole magnesium, amoxicillin, and rifabutin delayed-release capsules for treatment of Helicobacter pylori infection in adults. The product is a combination of omeprazole, a proton pump inhibitor; amoxicillin, a penicillin-class antibacterial; and rifabutin, a rifamycin antibacterial­­.

The new agent is the only rifabutin-based therapy approved for the treatment of H. pylori infection. It is designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies.  

The recommended dosage is four capsules every 8 hours with food for 14 days. The capsules should be swallowed whole and not crushed or chewed. The drug should not be taken with alcohol.  

Common adverse reactions are diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.  

Warnings and precautions are hypersensitivity reactions, including serious and occasionally fatal reactions (e.g., anaphylaxis); Clostridioides difficilesssociated diarrhea; reduction in the efficacy of hormonal contraceptives; acute interstitial nephritis; and cutaneous and systemic lupus erythematosus.

RedHill expects to launch the drug in the first quarter of 2020.