Regulatory Information
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**DOSAGE AND MODE OF ADMINISTRATION** _For Adult Population:_ - Treatment of Erosive Gastroesophageal Reflux Disease: 50 mg once daily for 4 weeks. For patients who do not heal or have persistent symptoms after 4 weeks, an additional 4-week treatment may be considered. - Treatment of Non-Erosive Gastroesophageal Reflux Disease: 50 mg once daily for 4 weeks. - Treatment of Gastric Ulcer: 50 mg once daily for 8 weeks. - Eradication of _H. pylori_ concurrently given with appropriate antibiotic therapy treatment in patients with peptic ulcer and/or chronic atrophic gastritis: Patients with _H. pylori_ infection should be treated with eradication therapy. Tegoprazan 50 mg, clarithromycin 500 mg, and amoxicillin 1 g are orally administered twice daily for 7 days. When selecting appropriate combination therapy, consideration should be given to official national, regional and local guidance regarding bacterial resistance, duration of treatment and appropriate use of antibacterial agents. K-CAB can be taken orally without regard to food. _For Pediatric Population:_ Clinical safety and efficacy of K-CAB in Pediatric and adolescent patients have not been established.
ORAL
Medical Information
**INDICATIONS** K-CAB is indicated for the treatment of Erosive Gastroesophageal Reflux Diseases, Non-Erosive Gastroesophageal Reflux Disease and Gastric Ulcer. K-CAB is also indicated for the eradication of _H. pylori_ when concurrently given with appropriate antibiotic therapy treatment in patients with peptic ulcer and/or chronic atrophic gastritis.
**CONTRAINDICATIONS** Patients with hypersensitivity to the tegoprazan, any of the product components or substituted benzimidazoles. Patients who take atazanavir, nelfinavir or rilpivirine-containing products. Pregnant women or nursing mothers.
A02BC09
tegoprazan
Manufacturer Information
UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
HK inno.N Corporation
Active Ingredients
Documents
Package Inserts
III. Package insert (new)(671693I00_14).pdf
Approved: January 11, 2023