MUCOSTA® Tablets 100
Each MUCOSTA Tablet contains 100 mg of rebamipide.
- Gastric ulcer in combination with offensive factor inhibitors (Proton Pump Inhibitors, Anticholinergic,
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.
1.Use in the Elderly
- Gastritis : The usual adult dosage of MUCOSTA Tablets is one tablet (100 mg of rebamipide) orally three times daily.
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)
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).
Of 10,047 petients treated, adverse reactions, including abnormal laboratory findings, were reported in 54 patients (0.54%). The incidence of adverse reactions is < 0.1% as following : hypersensitivity (rash, pruritus), gastrointestinal (constipation, feeling of abdomen enlarged).
Presentation & Packaging :
Mucosta Tablets 100
- Boxes of 10 blister of 10 tablets
- Reg. No. DKL 0518707017A1
DRUG PRESCRIPTION ONLY
For full prescribing information is available on request :
PT Otsuka Indonesia
Perkantoran Hijau Arkadia, Tower A, Lt.3
Jl. Letjen TB Simatupang Kav. 88, Jakarta 12520
Telp.: (021) 782 7660 (Hunting)
Fax. : (021) 782 7663 - 64