Description
Product Overview / 商品概要
Rebamipide Tablets 100mg (ムコスタ錠100mg)
Generic: Rebamipide / レバミピド
Therapeutic Category: Gastritis and Gastric Ulcer Treatment Agent / 胃炎・胃潰瘍治療剤
Manufactured by: Otsuka Pharmaceutical Co., Ltd. / 大塚製薬株式会社
Composition & Specification / 組成・規格
Active Ingredient: Rebamipide 100mg per tablet / 1錠中レバミピド100mg
Additives: Crystalline cellulose, Hydroxypropyl cellulose, Magnesium stearate, Hypromellose, Macrogol 6000, Titanium oxide / 結晶セルロース、ヒドロキシプロピルセルロース、ステアリン酸マグネシウム、ヒプロメロース、マクロゴール6000、酸化チタン
Appearance: White film-coated tablets, diameter 8.1mm, thickness 3.4mm, weight approximately 175mg
外観: 白色のフィルムコート錠、直径8.1mm、厚さ3.4mm、重さ約175mg
Indications / 効能効果
EN: Gastric ulcer; Improvement of gastric mucosal lesions (erosion, hemorrhage, redness, edema) in acute gastritis and acute exacerbation of chronic gastritis
JA: 胃潰瘍、下記疾患の胃粘膜病変（びらん、出血、発赤、浮腫）の改善：急性胃炎、慢性胃炎の急性増悪期
Dosage and Administration / 用法用量
EN: For gastric ulcer: Usually, administer 1 tablet (100mg as rebamipide) orally three times daily in the morning, evening, and at bedtime in adults. For improvement of gastric mucosal lesions in acute gastritis and acute exacerbation of chronic gastritis: Usually, administer 1 tablet (100mg as rebamipide) orally three times daily in adults.
JA: 〈胃潰瘍〉通常、成人には1回1錠（レバミピドとして100mg）を1日3回、朝、夕及び就寝前に経口投与する。〈下記疾患の胃粘膜病変（びらん、出血、発赤、浮腫）の改善：急性胃炎、慢性胃炎の急性増悪期〉通常、成人には1回1錠（レバミピドとして100mg）を1日3回経口投与する。
Contraindications / 禁忌
EN: Patients with a history of hypersensitivity to any component of this product
JA: 本剤の成分に対し過敏症の既往歴のある患者
Regulatory Information / 規制情報
Approval No.: 22100AMX01561
Sales Started: December 1990 / 1990年12月
Classification Code: 872329
Storage: Store at room temperature / 室温保存
Shelf Life: 36 months / 36箇月
Packaging / 包装
Main Package (for sale): 100 tablets (10 tablets x 10) / 100錠（10錠×10）
Other Available Packages (by special order): PTP: 100 tablets (10 tablets x 10), 500 tablets (10 tablets x 50), 1,050 tablets (21 tablets x 50); Plastic bottle: 500 tablets (bulk)
Full product insert (添付文書) is attached as a downloadable PDF. For detailed precautions, drug interactions, and safety information, please refer to the official package insert.
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