Source: Web Search Publisher: Manufactured By: Korea Otsuka Pharmaceutical Co., Ltd., Gyeonggi-do, Korea Under Authority of: Otsuka Pharmaceutical Co., Ltd., Japan Marketed By: Otsuka Pakistan Limited (A company of Otsuka Group Japan) ...
Patients with a history of hypersensitivity to any ingredient of this drug.
Special care is required in elderly patients to minimize the risk of gastrointestinal disorders, because these patients may be physiologically more sensitive to this drug than younger patients.
The safety of this drug in low birth weight infants, newborns, suckling infants, infants and children has not been established (Clinical experience is insufficient).
Patients should be instructed not to ingest any portion of the press-through package (PTP). (There have been reports that the sharp edges of the sheet can cut or penetrate the esophageal mucosa if accidentally ingested, resulting in mediastinitis or other serious complications.)
(1) This drug should be administered to pregnant or possibly pregnant women only if the anticipated therapeutic benefit is thought to outweigh any potential risk. (The safety of this drug in pregnant women has not been established.)
(2) Nursing should be interrupted when this drug is administered to. (Rat studies have shown that rebamipide is excreted in the breast milk.)
Of 10,047 patients treated, adverse reactions, including abnormal laboratory findings, were reported in 54 patients (0.54%). Of 3,035 patients aged over 65 years, adverse reactions were noted in 18 patients (0.59%). The nature and incidence of adverse reactions showed no differences between elderly and younger patients. The following summary of data includes adverse reactions voluntarily reported after marketing (Figures are total cases reported at the time of approval and at the completion of reexamination of MUCOSTA Tablets 100).
1) Shock, anaphylactoid reactions (incidence unknown*): Shock or anaphylactoid reactions may occur. Patients should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.
2) Leukopenia (incidence <0.1%) and thrombocytopenia (incidence unknown*): Leukopenia and thrombocytopenia may occur. Patient should therefore be closely monitored. If abnormal findings are observed, the drug should be discontinued and appropriate measures taken.
3) Hepatic dysfunction (incidence <0.1%) and jaundice (incidence unknown*): Hepatic dysfunction and jaundice, as indicated by increases in AST (GOT), ALT (GPT), y-GTP, and alkaline phosphatase levels, have been reported in patients receiving MUCOSTA Tablets. Patient should therefore be closely monitored. If abnormal laboratory findings are observed, the drug should be discontinued and appropriate measures taken.
| <0.1% | *Incidence Unknown | |
|---|---|---|
| Hyper-sensitivitynote1 | Rash, pruritus, drug- eruption-like eczema, other symptoms of hypersensitivity | Urticaria |
| Neuro-psychiatric | Numbness, dizziness, sleepiness | |
| Gastro-intestinal | Constipation, feeling of abdomen enlarged, diarrhea, nausea, vomiting, heartburn, abdominal pain, belching, taste abnormality, etc. | Thirst |
| Hepaticnote2 | Increased AST (GOT), ALT (GPT), y-GTP, alkaline phosphatase levels | |
| Hematologic | Leukopenia, granulocytopenia, etc. | Thrombocytopenia |
| Other | Menstrual disorders, increased BUN levels, edema, feeling of a foreign body in the pharynx | Breast swelling and pain, gynecomastia induction of lactation, palpitations, fever, facial flushing, numbness of tongue, cough, respiratory distress, alopecia |
Note 1: If such symptoms of hypersensitivity occur, the drug should be discontinued frequency
Note 2: If transaminase levels are markedly increased or fever and rash develop, the drug should be discontinued and appropriate measures should be taken.
* The incidence rates of voluntarily reported adverse reactions are not known.
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