Description
Product Overview / 商品概要
Sonias Combination Tablets HD (Pioglitazone Hydrochloride / Glimepiride 30mg/3mg) (ソニアス配合錠HD)
Generic: Pioglitazone Hydrochloride / Glimepiride / ピオグリタゾン塩酸塩・グリメピリド
Therapeutic Category: Thiazolidinedione / Sulfonylurea Combination – Type 2 Diabetes Treatment / チアゾリジン系薬／スルホニルウレア系薬配合剤 -2型糖尿病治療剤-
Manufactured by: T’s Pharmaceutical Co., Ltd. / T’s製薬株式会社
Composition & Specification / 組成・規格
Active Ingredient: Pioglitazone Hydrochloride 33.06mg (as Pioglitazone 30mg) and Glimepiride 3mg per tablet / 1錠中：ピオグリタゾン塩酸塩 33.06mg（ピオグリタゾンとして30mg）、グリメピリド 3mg
Additives: Lactose hydrate, Hydroxypropylcellulose, Croscarmellose sodium, Magnesium stearate, Microcrystalline cellulose, Polysorbate 80, Yellow ferric oxide / 乳糖水和物、ヒドロキシプロピルセルロース、クロスカルメロースナトリウム、ステアリン酸マグネシウム、結晶セルロース、ポリソルベート80、黄色三二酸化鉄
Appearance: Uncoated tablet consisting of a white to yellowish-white layer and a yellowish-white layer. Diameter: 8.1mm, Thickness: approx. 3.3mm, Weight: 200mg. Identification code: 324
外観: 白色～帯黄白色の層と帯黄白色の層からなる素錠。直径8.1mm、厚さ約3.3mm、重量200mg。識別コード：324
Indications / 効能効果
EN: Type 2 diabetes mellitus, only when combination therapy with pioglitazone hydrochloride and glimepiride is considered appropriate.
JA: 2型糖尿病 ただし、ピオグリタゾン塩酸塩及びグリメピリドの併用による治療が適切と判断される場合に限る。
Dosage and Administration / 用法用量
EN: Orally administer 1 tablet (pioglitazone/glimepiride 15mg/1mg or 30mg/3mg) once daily before or after breakfast in adults.
JA: 通常、成人には1日1回1錠（ピオグリタゾン/グリメピリドとして15mg/1mg又は30mg/3mg）を朝食前又は朝食後に経口投与する。
Contraindications / 禁忌
EN: Patients with heart failure or history of heart failure; patients with severe hepatic or renal impairment; patients with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes; patients with severe infections, perioperative status, or serious trauma; patients with gastrointestinal disorders such as diarrhea or vomiting; pregnant women or women of childbearing potential; patients with history of hypersensitivity to any component of this product or sulfonamide drugs.
JA: 心不全の患者及び心不全の既往歴のある患者、重篤な肝又は腎機能障害のある患者、重症ケトーシス・糖尿病性昏睡又は前昏睡・1型糖尿病の患者、重症感染症・手術前後・重篤な外傷のある患者、下痢・嘔吐等の胃腸障害のある患者、妊婦又は妊娠している可能性のある女性、本剤の成分又はスルホンアミド系薬剤に対し過敏症の既往歴のある患者
Regulatory Information / 規制情報
Approval No.: 22300AMX00441
Sales Started: June 2011 / 2011年6月
Classification Code: 873969
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, with desiccant] / 100錠［10錠（PTP）×10、乾燥剤入り］
Other Available Packages (by special order): 100 tablets [10 tablets (PTP) x 10, with desiccant]
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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