TALICIA

The pharmacokinetic parameters of the components of TALICIA are summarized in Table 3 .

Table 3Mean (Standard Deviation) Pharmacokinetic Parameters of the Components of TALICIA C max =Maximum plasma concentration, AUC 24 =Area under the concentration vs. 24-hour time curve a C max and AUC 24 , estimates derived from 15 healthy subjects following administration of four TALICIA capsules three times in a day (8 hours apart) resulting in the total daily oral doses of 150 mg rifabutin, 3000 mg amox...

The effectiveness and safety of TALICIA were evaluated in a randomized, double-blind, controlled study of TALICIA in treatment-naïve H. pylori -positive adult patients complaining of epigastric pain/discomfort (

Study 1NCT03198507). H. pylori infection at baseline was defined as positive by 13 C urea breath test (UBT) and follow-up upper endoscopy (culture, histology, or Campylobacter -like organism test). Patients were randomized 1:1 to TALICIA or control (total daily dose of amoxicillin 3000 mg and omeprazole 120 mg) administered for 14 consecutive days. The trial was performed in the U.S a...

The following serious adverse reactions are described below and elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.4) ] Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.6) ] Cutaneous and Systemic Lupus Erythema...

Known hypersensitivity to omeprazole, amoxicillin or any other beta-lactam antibacterial drugs, rifabutin or any other rifamycin, or any component of TALICIA. ( 4.1 ) Rilpivirine-containing products. ( 4.2 ) Delavirdine. ( 4.3 ) Voriconazole. ( 4.4 ) 4.1 Hypersensitivity Reactions TALICIA is contraindicated in patients with known hypersensitivity to the components of TALICIA: amoxicillin [or other...

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). ( 5.1 ) 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. ( 5.2 ) Drug-induced enterocolitis syndrome (DIES) has been ...

7 DRUG INTERACTIONS Components of TALICIA have the potential for clinically important drug interactions. See Full Prescribing Information for important drug interactions with TALICIA. ( 4 , 5.7 ) 7.1 Interactions with Other Drugs and Diagnostics Drug interaction studies with TALICIA have not been conducted. The drug interaction information described here is based on the prescribing information of ...