- Approval Id
- e64ac686c0d88847
- Drug Name
- K-CAB FILM-COATED TABLETS 25MG
- Product Name
- K-CAB FILM-COATED TABLETS 25MG
- Approval Number
- SIN17411P
- Approval Date
- 2025-12-03
- Registrant
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Licence Holder
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE AND MODE OF ADMINISTRATION</strong><br>
For Adult Population:</p>
<ul>
<li>Treatment of Erosive Gastroesophageal Reflux Disease:<br>
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.</li>
<li>Treatment of Non-Erosive Gastroesophageal Reflux Disease:<br>
50 mg once daily for 4 weeks.</li>
<li>Treatment of Gastric Ulcer:<br>
50 mg once daily for 8 weeks.</li>
<li>Eradication of H. pylori concurrently given with appropriate antibiotic therapy treatment in patients with peptic ulcer and/or chronic atrophic gastritis:<br>
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.<br>
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.</li>
<li>Maintenance treatment to prevent the recurrence of Erosive Gastroesophageal Reflux Disease<br>
25 mg once daily</li>
</ul>
<p>K-CAB can be taken orally without regard to food.<br>
For Pediatric Population:<br>
Clinical safety and efficacy of K-CAB in Pediatric and adolescent patients have not been established.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong><br>
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.<br>
K-CAB is indicated for maintenance treatment to prevent the recurrence of Erosive Gastroesophageal Reflux Disease.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
Patients with hypersensitivity to the tegoprazan, any of the product components or substituted benzimidazoles. Patients who take atazanavir, nelfinavir or rilpivirine-containing products.<br>
Pregnant women or nursing mothers.</p>
