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General Precaution: In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with tegoprazan may alleviate symptoms and delay diagnosis.
Cyanocobalamin (Vitamin B12) Deficiency: Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
Bone Fracture: Several published observational studies suggest that Proton Pump Inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose (defined as multiple daily doses) and long-term PPI therapy (a year or longer). Patients should use the appropriate dose and shortest duration of tegoprazan therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
Hypomagnesemia has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPIs. For patients expected to be on prolonged treatment or who take tegoprazan with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of treatment and periodically. Serious adverse reactions include tetany, arrhythmias, and seizures.
Decreased gastric acidity due to PPIs increases counts of bacteria normally present in the gastrointestinal tract. Treatment with gastric acid suppressants may possibly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile. Published observational studies suggest that PPI therapy may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD), especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve. CDAD has been reported with use of nearly all antibacterial agents. Patients should use the lowest dose and shortest duration of tegoprazan therapy appropriate to the condition being treated.
Use in Specific Populations: Renal Impairment: Safety and efficacy of K-CAB have not been established in patients with renal impairment.
Hepatic Impairment: Safety and efficacy of K-CAB have not been established in patients with hepatic impairment.
Effect on Ability to Drive and Use Machine: No studies on the effects on the ability to drive and use machines have been performed for tegoprazan, and the loss of this ability cannot be predicted from its pharmacological action. Nevertheless, when considering the patient's ability to drive and use machines, the clinical condition of the patient and the adverse reactions of the drug should be considered.
Use in Children: Clinical safety and efficacy of K-CAB in paediatric and adolescent patients have not been established.
Use in the Elderly: In general, K-CAB should be administered to elderly patients with caution, keeping in mind the greater frequency of decreased physiological functions, such as liver or kidney.
