Products - Mucosta

Under the corporate philosophy of 'Otsuka - people creating new products for better health worldwide,' Otsuka Pharmaceutical Co., Ltd. is engaged in the production and sale of innovative, creative pharmaceuticals, nutritional products, and cosmetics, aiming to be a global value-creating company that contributes to the health and wellness of people worldwide.

• Pletaal

• Aminoleban

• Meptin

• Firebird

• Abilify

• Mucosta

• Mikelan

Go beyond healing

Mucosta ® Tablet contains 100mg of rebamipide.

Indications:
Indicated for the treatment of gastric mucosal lesions (erosions, bleeding, redness, and edema) in the following conditions: acute gastritis and acute exacerbation of chronic gastritis: The usual adult dosage of Mucosta ® Tablet is one tablet (100 mg) orally three times daily. Gastric ulcers: The usual adult dosage of Mucosta ® Tablet is one table (100 mg) orally three times daily, in the morning, in the evening and before bed.

Precautions:
Adverse Reactions 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 were not different between the elderly and younger patients. The following summary of data includes adverse reactions voluntarily reported after marketing (Figures are total cases reported from the time of approval up to June 2001) (Figures are total cases reported at the time of approval and at the time of completion of re-examination of Mucosta ® Tablets.)

Use during pregnancy, delivery or lactation

1. This drug should be used by pregnant or possibly pregnant women only if the anticipated therapeutic benefit is thought to outweigh any potential risk. (The safety of Rebamipide in pregnant women has not been established
2. Nursing should be interrupted when this drug is administered to a nursing woman. (Rat studies showed that Rebamipide is distributed in breast milk in nursing rats).

Use in the Elderly:
Special care should be given to elderly patients to minimize the risk of gastrointestinal disorder because these patients may be physiologically more sensitive to this drug than younger patients.

Pediatric Use:
The safety of this drug in children has not been established (clinical experience in children is insufficient)

Toxicity:
Reproductive and developmental toxicity studies of rebamipide were conducted using SD rats treated prior to and in the early gestational period at 30 - 1,000 mg/kg/day. SD rats and NZW rabbits treated during the organogenic period at 30 - 1,000 mg/kg/day, respectively, and SD rats treated during the perinatal and lactational periods at 10-1,000 mg/Kg/day. The drug exhibited no toxic effects in either parents or F1 offspring in these species.

Plasma Concentration:
The table below shows the pharmacokinetic parameters of rebamipide following single oral administration of MUCOSTA® Tablets 100 at a dose of 100 mg to 27 healthy male subjects in a fasted state.

Pharmacokinetic Parameters of Rebamipide

	tmax (hr)	Cmax (ng/mL)	t1/2 (hr)	AUC24h (ng/hr/mL
MUCOSTA®	2.4+-1.2	216+-79	1.9+-0.7	874+-209

The absorption rate of rebamipide following single oral administration at a dose of 150 mg to 6 healthy subjects in a fed state tended to be slower than that in a fasted state. However, food did not affect bioavailability of the drug in humans. Pharmacokinetic parameters obtained from patients with renal impairment after single oral administration of rebamipide at 100 mg revealed higher plasma concentrations and a longer elimination half-life compared with those in healthy subjects. At steady-state, rebamipide plasma concentrations observed in dialyzed renal patients following repeated administration were very close to the values simulated from single administration. Therefore, the drug as not considered to accumulate.