Fexuclue Special Precautions

The following patients should be administered with care: Patients with hepatic impairment (no experience of use); Patients with renal impairment (no experience of use); Elderly (refer to Use in the Elderly as follows); Patients who have a history of hypersensitivity or allergy to Yellow 4 Tartrazine.
General Cautions: Since the Product may relieve symptoms of malignant tumors or delay the diagnosis, if a malignant tumor is suspected by warning symptoms (unintended significant weight loss, recurrent vomiting, dysphagia, hemoptysis, melena, etc.) and a gastric ulcer is present or suspected, it should be administered after confirming that it is not malignant.
The number of bacteria usually present in the gastrointestinal tract increases when acidity in the stomach decreases due to proton pump inhibitors (PPls). The risk of infection of the gastrointestinal tract by bacteria such as Salmonella, Campylobacter and Clostridium difficile may slightly increase when treated with gastric acid inhibitors. This is associated with an increased risk of Clostridium difficile diarrhea and several observational studies have reported that this risk is increased, especially in hospitalized patients. This diagnosis should be considered when diarrhea does not improve. Clostridium difficile diarrhea has been reported with the used of almost all antimicrobial agents.
Proton Pump Inhibitor (PPI) treatment has been reported to have the potential of being associated with an increased risk of osteoporosis-related fractures of the hip, wrist and spine. The risk of fracture was increased in patients receiving high doses of PPls (defined as repeated daily administration) and in patients with long-term use longer than a year.
In the case of patients at risk of developing osteoporosis and osteoporotic fractures, appropriate clinical monitoring is recommended according to the latest clinical guidelines.
Hypomagnesemia was rarely reported in patients who had been under treatment with a proton pump inhibitor (PPI) for more than 3 months and the most frequent cases were treated for more than a year. In most patients, treatment of hypomagnesemia requires magnesium supplementation and discontinuation of PPL Patents requiring long-term treatment or co-administering digox11 or drugs that cause hypomagnesemia (e.g., diuretics) require periodic monitoring of magnesium levels, including at the initiation of treatment. Serious adverse events include stiffness, arrhythmia and seizures.
Increase of serum gastrin was reported 11 patients who had been under treatment with a proton pump inhibitor (PPI). Increased gastrin can cause enterochromaffin-like cell hyperplasia and increased serum Chromogranin A (CgA) levels. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors.
Use in Patients with Renal Impairment: The safety and efficacy of the Product in patients with renal impairment have not been established.
Use in Patients with Hepatic Impairment: The safety and efficacy of the Product in patients with hepatic impairment have not been established.
Use in Children: The clinical safety and efficacy of the Product in children and adolescents have not been established.
Use in the Elderly: In general, physiological functions such as hepatic functions or renal functions are deteriorated in the elderly, so it should be administered carefully.