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Safety & Side Effects
Contraindications
1.
Patients who have a history of hypersensitivity to the Product or its components
2.
Patients taking a drug containing atazanavir, nelfinavir, or rilpivirine (refer to ‘5. Interactions’)
3.
Pregnant and lactating women (refer to ‘6. Administration to Pregnant and Lactating Women’)
4.
Patients who have congenital conditions for lactose such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, as this medicine contains lactose
The following patients should be administered with care
1.
Patients with hepatic impairment (no experience of use)
2.
Patients with renal impairment (no experience of use)
3.
Elderly (refer to ‘8. Geriatric Use’)
4.
Patients who have a history of hypersensitivity or allergy to Yellow 4 Tartrazine
Adverse Event
A total of two clinical trials were conducted in patients with erosive esophagitis (EE). Of the subjects who participated in the clinical trials, 183 received 40 mg of the Product. Adverse events reported in clinical trials are as follow. Adverse events (1% or more) and adverse drug reactions (*) commonly reported in the Product administration group are shown in the following Table 1.
Table 1. Adverse events reported by 1% or more in clinical trials
System Organ Class (SOC) | Adverse Event |
Gastrointestinal disorders | Dyspepsia , diarrhea, nausea*, abdominal discomfort*, chronic gastritis, gastritis, erosive gastritis |
Skin and subcutaneous tissue disorders | Erythema*, pruritus* |
Nervous system disorders | Headache* |
Musculoskeletal and connective tissue disorders | Back pain |
Other adverse events reported in clinical trials with an incidence of less than 1% after administration of the Product are listed according to the major system organ class as follows.
Gastrointestinal disorders: Hiatal hernia, Brunner’s gland hyperplasia
Infections and infestations: Bronchitis, herpes simplex, influenza, periodontitis, pharyngitis, vaginal infection
Skin and subcutaneous tissue disorders: Dermatitis contact, swelling face*
General disorders and administration site conditions: Chest discomfort, feeling abnormal*, edema, pain, pyrexia
Nervous system disorders: Dizziness, dysgeusia*
Musculoskeletal and connective tissue disorders: Myalgia*, musculoskeletal pain, neck pain
Eye disorders: Cataract, conjunctival haemorrhage*, retinal tear
Ear and labyrinth disorders: Ear discomfort*
Respiratory, thoracic and mediastinal disorders: Rhinorrhoea
Metabolic and nutritional disorders: Hypertriglyceridemia
General Cautions
1.
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.
2.
The number of bacteria usually present in the gastrointestinal tract increases when acidity in the stomach decreases due to proton pump inhibitors (PPIs). 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.
3.
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 PPIs (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.
In the case of patients at risk of developing osteoporosis and osteoporotic fractures, appropriate clinical monitoring is recommended according to the latest clinical guidelines.
4.
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 PPI. Patents requiring long-term treatment or co-administering digoxin 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.
Interactions
1.
Since the administration of the Product raises the pH in the stomach, it can interact with drug absorption in the case of oral drugs, where the pH of the stomach is an important determinant of bioavailability. Therefore, the use of the Product may reduce the bioavailability of drugs that depends on the gastric pH, such as atazanavir and nelfinavir.
2.
The Product is mainly metabolized by CYP3A4 and partially by CYP2B6, CYP2C19 and CYP2D6.
3.
When 80 mg of the Product and clarithromycin were co-administered, the AUCτ of the Product and clarithromycin were shown to be 1.1 times and 0.77 times, respectively, which were not clinically significant.
4.
When the Product, clarithromycin and amoxicillin were co-administered, the AUCτ of amoxicillin was shown to be 0.86 times, but it was not clinically significant.
Use in Pregnant & Lactating Women, Pediatric, Geriatric, Patients with Renal & Hepatic Impairment
Pregnant Women
Lactating Women
Pediatric
Geriatric
Renal Impairment
Hepatic Impairment
The safety and efficacy of the Product in patients with hepatic impairment have not been established.
Treatment in Case of Overdose
No cases of severe overdose of the Product have been reported. In clinical trials, there has been experience of single dose of the Product up to 320 mg. In the event of overdose, the patient should be monitored for symptoms of toxicity and if necessary, general adjuvant treatment should be provided.