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Otsuka [ East Malaysia: Zuellig Pharma West Malaysia: Zuellig Pharma ]
MIMS Class : Antacids, Antireflux Agents & Antiulcerants
Contents Rebamipide
Indications Gastric ulcers. Treatment of gastric mucosal lesions (erosion, bleeding,
redness and edema) in the following conditions: Acute gastritis and acute
exacerbation of chronic gastritis.
Dosage Adults: ð
Usual Dose: 1 tab orally 3 times daily (in the
morning, in the evening and before bedtime).
"
The safety of Mucosta in low birth weight infants,
newborns, suckling infants and children has not been established.
(Clinical experience is insufficient.)
"$ Special care is required in elderly patients to
minimize the risk of gastrointestinal disorders because these patients may
be physiologically more sensitive to Mucosta than younger patients.
Adverse Drug Of 10,047 patients treated, adverse reactions including abnormal
Reactions laboratory findings were reported in 54 patients (0.54%). Of 3035
patients >65 years, adverse reactions were noted in 18 patients (0.59%).
The nature and incidence of adverse reactions were not different between
the elderly and younger patients. The summary of data as follows
includes adverse reactions voluntarily reported after marketing (figures
are total cases reported at the time of approval and at the completion of
re-examination of Mucosta).
Shelf-Life: 3 years.
Description Each tablet also contains the following inactive ingredients:
Microcrystalline cellulose, low-substituted hydroxypropyl cellulose,
hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methyl
cellulose 2910, polyethylene glycol 6000 and titanium oxide.
Rebamipide is (±)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl]
propionic acid. Its molecular formula is C19H15ClN2O4 and has a
molecular weight of 370.79. Melting Point: 292.5°C (decomposition).
"&
Plasma Concentrations: Following single oral
administration of Mucosta 100 mg to 27 healthy male subjects in a fasted
state, tmax is 2.4±1.2 hrs, Cmax is 216±79 ng/mL with t½ of 1.9±0.7 hrs
(calculated from values up to 12 hrs) and AUC24 hrs of 874±209
ng·hr/mL.