Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycins.
Talicia is contraindicated in patients receiving delavirdine, voriconazole or rilpivirine-containing products.
Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.
Clostridioides difficile-associated diarrhea has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
Talicia may cause fetal harm and is not recommended for use in pregnancy. It may also reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment or severe renal impairment.
Cutaneous lupus erythematosus and systemic lupus erythematosus have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.
The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
Use of clarithromycin-containing regimens is not recommended in many cases
Due to long-term health risks of H. pylori and decreasing efficacy of current therapies, the ACG 2017 guideline for H. pylori recommends against using clarithromycin-containing regimens in: patients with any previous macrolide exposure OR in areas where clarithromycin resistance exceeds 15% OR in areas where clarithromycin resistance is unknown.15
In fact, in a 2018 U.S. multicenter study conducted at 55 sites across 20 states, in vitro testing found that of 345 H. pylori isolates taken from patients, 17.4% were resistant to clarithromycin – a resistance rate which already exceeds the 15% threshold in ACG guideline recommendations for clarithromycin use in H. pylori.15,16
Because symptom relief does not correlate with eradication, the ACG 2017 guideline for H. pylori also recommends a “test-treat-confirm” approach.14
Whenever H. pylori infection is identified and treated, testing by urea breath test, fecal antigen test, or biopsy-based testing to prove eradication of H. pylori should be performed. This testing should be performed 4 weeks after the completion of antibiotic therapy and after PPI therapy has been withheld for 2 weeks.
It is important to note that the ACG guidelines generally recommend against using serology for H. pylori testing as it can remain positive even after successful eradication and thus is an inadequate test for active infection.15