Levonorgestrel/Ethinylestradiol Tablets 28 (Triquilar® / トリキュラー錠28)

Description

Product Overview / 商品概要

Levonorgestrel/Ethinylestradiol Tablets 28 (トリキュラー錠28)
Generic: Levonorgestrel/Ethinylestradiol / レボノルゲストレル・エチニルエストラジオール
Therapeutic Category: Oral Contraceptive / 経口避妊剤
Manufactured by: Bayer Yakuhin, Ltd. / バイエル薬品株式会社

Composition & Specification / 組成・規格

Active Ingredient: 6 reddish-brown tablets: Levonorgestrel 0.050mg, Ethinylestradiol 0.030mg per tablet; 5 white tablets: Levonorgestrel 0.075mg, Ethinylestradiol 0.040mg per tablet; 10 light yellowish-brown tablets: Levonorgestrel 0.125mg, Ethinylestradiol 0.030mg per tablet; 7 white (large) tablets: contain no active ingredients / 赤褐色錠6錠：レボノルゲストレル0.050mg、エチニルエストラジオール0.030mg、白色錠5錠：レボノルゲストレル0.075mg、エチニルエストラジオール0.040mg、淡黄褐色錠10錠：レボノルゲストレル0.125mg、エチニルエストラジオール0.030mg、白色錠（大）7錠：有効成分を含有せず
Additives: Magnesium stearate, Povidone, Talc, Macrogol 6000, Montanate ester wax, Precipitated calcium carbonate, Purified sucrose, Lactose hydrate, Corn starch, Glycerin*1, Titanium oxide*1, Yellow ferric oxide*1, Ferric oxide*2 (*1: reddish-brown and light yellowish-brown tablets only; *2: reddish-brown tablets only) / ステアリン酸マグネシウム、ポビドン、タルク、マクロゴール6000、モンタン酸エステルワックス、沈降炭酸カルシウム、精製白糖、乳糖水和物、トウモロコシデンプン、グリセリン※1、酸化チタン※1、黄色三二酸化鉄※1、三二酸化鉄※2（※1：赤褐色錠及び淡黄褐色錠のみ、※2：赤褐色錠のみ）
Appearance: Reddish-brown tablets: Sugar-coated, diameter 5.7mm, thickness 3.6mm, weight 90mg. White tablets: Sugar-coated, diameter 5.7mm, thickness 3.6mm, weight 90mg. Light yellowish-brown tablets: Sugar-coated, diameter 5.7mm, thickness 3.6mm, weight 90mg. White (large) tablets: Sugar-coated, diameter 6.8mm, thickness 3.7mm, weight 140mg
外観: 赤褐色錠：糖衣錠、直径5.7mm、厚さ3.6mm、質量90mg。白色錠：糖衣錠、直径5.7mm、厚さ3.6mm、質量90mg。淡黄褐色錠：糖衣錠、直径5.7mm、厚さ3.6mm、質量90mg。白色錠（大）：糖衣錠、直径6.8mm、厚さ3.7mm、質量140mg

Indications / 効能効果

EN: Contraception
JA: 避妊

Dosage and Administration / 用法用量

EN: Take 1 tablet daily at a fixed time in the prescribed order (starting with the reddish-brown sugar-coated tablets) for 28 consecutive days. This 28-day period constitutes one cycle. Regardless of whether bleeding has stopped or continues, begin the next cycle on the 29th day and repeat in the same manner.
JA: 1日1錠を毎日一定の時刻に定められた順に従って（赤褐色糖衣錠から開始する）28日間連続投与する。以上28日間を投与1周期とし、出血が終わっているか続いているかにかかわらず29日目から次の周期の錠剤を投与し、以後同様に繰り返す。

Contraindications / 禁忌

EN: Women with hypersensitivity to any component of this product; patients with estrogen-dependent malignant tumors (e.g., breast cancer, endometrial cancer), cervical cancer, or suspected cases thereof; patients with undiagnosed abnormal genital bleeding; patients with thrombophlebitis, pulmonary embolism, cerebrovascular disorders, coronary artery disease, or a history thereof; smokers aged 35 years or older who smoke 15 or more cigarettes per day; patients with migraine with aura; patients with cardiac valvular disease complicated by pulmonary hypertension or atrial fibrillation, or with a history of subacute bacterial endocarditis; diabetic patients with vascular complications; women with thrombophilic predisposition; patients with antiphospholipid syndrome; patients within 4 weeks before surgery, within 2 weeks after surgery, within 4 weeks postpartum, or in prolonged immobilized state; patients with severe hepatic impairment; patients with hepatic tumors; patients with lipid metabolism disorders; patients with hypertension (except mild hypertension); patients with otosclerosis; patients with a history of jaundice, persistent pruritus, or herpes gestationis during pregnancy; pregnant women or women who may be pregnant; nursing mothers; women whose bone growth may not be complete
JA: 本剤の成分に対し過敏性素因のある女性、エストロゲン依存性悪性腫瘍（例えば、乳癌、子宮内膜癌）、子宮頸癌及びその疑いのある患者、診断の確定していない異常性器出血のある患者、血栓性静脈炎、肺塞栓症、脳血管障害、冠動脈疾患又はその既往歴のある患者、35歳以上で1日15本以上の喫煙者、前兆を伴う片頭痛の患者、肺高血圧症又は心房細動を合併する心臓弁膜症の患者、亜急性細菌性心内膜炎の既往歴のある心臓弁膜症の患者、血管病変を伴う糖尿病患者、血栓性素因のある女性、抗リン脂質抗体症候群の患者、手術前4週以内、術後2週以内、産後4週以内及び長期間安静状態の患者、重篤な肝障害のある患者、肝腫瘍のある患者、脂質代謝異常のある患者、高血圧のある患者（軽度の高血圧の患者を除く）、耳硬化症の患者、妊娠中に黄疸、持続性そう痒症又は妊娠ヘルペスの既往歴のある患者、妊婦又は妊娠している可能性のある女性、授乳婦、骨成長が終了していない可能性がある女性

Regulatory Information / 規制情報

Approval No.: 21800AMX10429000
Sales Started: October 2000 / 2000年10月
Classification Code: 872549
Storage: Store at room temperature / 室温保存
Shelf Life: 60 months / 60ヵ月

Packaging / 包装

Main Package (for sale): 28 tablets (PTP) x 10 / 28錠（PTP）×10
Other Available Packages (by special order): 280 tablets [28 tablets (PTP) x 10], 1400 tablets [28 tablets (PTP) x 50], 2520 tablets [28 tablets (PTP) x 90]

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.