Each MUCOSTA Tablet contains 100 mg of rebamipide.
INDICATIONS :
Gastric ulcer in combination with offensive factor inhibitors (Proton Pump Inhibitors, Anticholinergic,
H2-antagonist).
Gastritis
CONTRA INDICATIONS :
Patients with a history of hypersensitivity to any ingredient of this drug.
DOSAGE AND ADMINISTRATION :
Gastric ulcers : In combination with offensive factor inhibitors the usual adult dosage of MUCOSTA Tablets is one tablet (100 mg of rebamipide) orally three times daily, in the morning, in the evening, and before bedtime.
Gastritis : The usual adult dosage of MUCOSTA Tablets is one tablet (100 mg of rebamipide) orally three times daily.
PRECAUTIONS : 1.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.
2.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. (Rat studies have shown that rebamipide is excreted in the breast milk)
3.Pediatric Use
The safety of this drug in low birth weight infants, newborns, suckling infants, and children has not been established. (Clinical experience is insufficient)
4.Precautions for Use Patient's Instructions for Use
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).
ADVERSE REACTIONS
Of 10,047 petients 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 incidence of adverse reactions is < 0.1% as following : hypersensitivity (rash, pruritus), gastrointestinal (constipation, feeling of abdomen enlarged).