Description
Product Overview / 商品概要
Dotinurad Tablets 0.5mg (ユリス錠0.5mg)
Generic: Dotinurad / ドチヌラド
Therapeutic Category: Selective Uric Acid Reabsorption Inhibitor – Hyperuricemia Treatment Agent / 選択的尿酸再吸収阻害薬－高尿酸血症治療剤－
Manufactured by: Mochida Pharmaceutical Co., Ltd. / 持田製薬株式会社
Composition & Specification / 組成・規格
Active Ingredient: Dotinurad 0.5mg per tablet / 1錠中 ドチヌラド 0.5mg
Additives: Lactose hydrate, D-mannitol, Microcrystalline cellulose, Hypromellose, Carmellose, Magnesium stearate / 乳糖水和物、D-マンニトール、結晶セルロース、ヒプロメロース、カルメロース、ステアリン酸マグネシウム
Appearance: White to pale yellowish-white, uncoated tablet. Diameter: approx. 6.5mm, Thickness: approx. 2.8mm, Weight: approx. 100mg. Identification code: FY321
外観: 白色～淡黄白色、素錠。直径 約6.5mm、厚さ 約2.8mm、質量 約100mg。識別コード FY321
Indications / 効能効果
EN: Gout, Hyperuricemia
JA: 痛風、高尿酸血症
Dosage and Administration / 用法用量
EN: In adults, initiate treatment at 0.5mg of dotinurad once daily orally. Subsequently, increase the dose gradually as needed while monitoring serum uric acid levels. The usual maintenance dose is 2mg once daily, which may be adjusted according to the patient’s condition, with a maximum dose of 4mg once daily.
JA: 通常、成人にはドチヌラドとして1日0.5mgより開始し、1日1回経口投与する。その後は血中尿酸値を確認しながら必要に応じて徐々に増量する。維持量は通常1日1回2mgで、患者の状態に応じて適宜増減するが、最大投与量は1日1回4mgとする。
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.: 30200AMX00020000
Sales Started: May 2020 / 2020年5月
Classification Code: 873949
Storage: Store at room temperature / 室温保存
Shelf Life: 3 years / 3年
Packaging / 包装
Main Package (for sale): 100 tablets [10 tablets (PTP) x 10] / 100錠［10錠（PTP）×10］
Other Available Packages (by special order): 100 tablets [10 tablets (PTP) x 10], 500 tablets [10 tablets (PTP) x 50]
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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