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HSA Approval

K-CAB FILM-COATED TABLETS 50MG

SIN16672P

K-CAB FILM-COATED TABLETS 50MG

K-CAB FILM-COATED TABLETS 50MG

January 11, 2023

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

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

Tegoprazan

50.0mg

Tegoprazan

Documents

Package Inserts

III. Package insert (new)(671693I00_14).pdf

Approved: January 11, 2023

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