Mucosta

Mucosta

rebamipide

Manufacturer:

Otsuka

Distributor:

DKSH
Full Prescribing Info
Contents
Rebamipide.
Description
Each tablet contains 100 mg of rebamipide.
Indications/Uses
Gastric ulcers.
Treatment of gastric mucosal lesions (erosion, bleeding, redness and edema) in the following disease: acute gastritis and acute exacerbation of chronic gastritis.
Dosage/Direction for Use
Adults: administer orally 100 mg as rebamipide three times daily. But in case of gastric ulcers, in the morning, evening, and before bedtime.
Contraindications
MUCOSTA Tablets are contraindicated in the following patients: Patients with a history of hypersensitivity to any ingredient of this drug.
Special Precautions
Use in Pregnancy & Lactation: 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.)
Nursing should be interrupted when this drug is administered to. (Rat studies have shown that rebamipide is excreted in the breast milk.)
Use in Children: The safety of this drug in low-birth-weight infants, newborns, suckling infants, infants and children has not been established. (Clinical experience is insufficient.)
Use in the Elderly: 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.
Use In Pregnancy & Lactation
Use during Pregnancy, Delivery, or Lactation: 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.)
Nursing should be interrupted when this drug is administered to. (Rat studies have shown that rebamipide is excreted in the breast milk.)
Adverse Reactions
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) in Japan.
Clinically significant adverse reactions: 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.
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.
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.
Other adverse reactions: (See table.)

Click on icon to see table/diagram/image
Storage
Keep in room temperature (1-30°C) in well-closed light-resistant container.
Shelf Life: 36 months after the date of manufacture.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BX14 - rebamipide ; Belongs to the class of other drugs used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Tab 100 mg x 10 x 10's.
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