藥碼
MIR03
藥名
Levonorgestrel 52 mg/Set
英文商品名
Mirena (20 mcg/24 H) IU System
中文商品名
蜜蕊娜子宮內投藥系統
螢幕名
Mirena (20 mcg/24 H) IU System
劑型
IUS
規格
Levonorgestrel 52mg/Set
成分
藥理分類
Progestins
健保碼
BC225015FR
ATC碼
藥品圖片
外觀圖片
適應症
Contraception, Female.
Emergency contraception - Postcoital contraception.
Menorrhagia.
藥理
Levonorgestrel is a synthetic and biologically active progestogen that inhibits ovulation or fertilization via alteration of tubal transport of sperm and/or ova and thickening the cervical mucus. It also inhibits implantation via alteration of the endometrium .
藥動學
Distribution:
Vd: 1.8 L/kg
Metabolism:
Serum/Plasma: Extent unknown, via conjugation
Liver: Extent unknown, primarily via CYP3A4
Substrate of CYP450 enzymes, especially CYP3A4
Excretion:
Renal: 45% changed and unchanged
禁忌症
Acute liver disease or liver tumor (benign or malignant)
Acute or history of pelvic inflammatory disease or active endometritis, unless there has been a subsequent intrauterine pregnancy
Breast carcinoma , known or suspected, current or history of
Conditions associated with increased susceptibility to infections (eg, leukemia, AIDS, IV drug abuse) , including pelvic infection
Congenital or acquired uterine anomaly, including fibroids, that distorts the uterine cavity and would be incompatible with correct intrauterine contraceptive system (IUS) placement
Genital bleeding of unknown etiology
Hypersensitivity to any component of the product
Intrauterine device that has not been removed
Known or suspected hormone-sensitive cancer, current or history of
Known or suspected uterine or cervical neoplasia , or unresolved, abnormal Pap smear
Infected abortion in the past 3 months
Pregnancy, known or suspected
Thrombophlebitis or thromboembolic disorders (current)
Untreated cervicitis or vaginitis, including bacterial vaginosis or other lower genital-tract infections, until infection is controlled
Use of intrauterine system as post-coital (emergency) contraception
Uterine bleeding of unknown etiology
懷孕分類
Fetal risk has been demonstrated. (TH)
哺乳分類
Infant risk cannot be ruled out.(MDX)
副作用
Common:
Dermatologic: Acne (6.8% to 14.5% )
Gastrointestinal: Abdominal pain (12.7% to 13.3% ), Nausea (Intrauterine route, up to 9.4% ; oral route, 13.7% ; subdermal route, 11.6% )
Neurologic: Dizziness (9.6% to 14.5% ), Headache (Intrauterine route, 8.7% to 12.9% ; oral route, 10.3% ; subdermal route, 30.5% ), Migraine (Intrauterine route, 2.3% to 3.3% )
Reproductive: Abnormal vaginal bleeding (1% to 57% ), Amenorrhea (Mirena(R), 18.4% ; Skyla(TM), up to 12% ; Kyleena(TM), up to 23% ; Liletta(TM), up to 38% ; Jadelle(R), 7.9% to 12.3% ), Bleeding between periods (Mirena(R), 31.9% ), Breast tenderness (Intrauterine route, 3.3% to 3.5% ; oral route, 8.2% ), Discharge from female genitalia (Mirena(R), 14.9% ; Kyleena(TM), 4.5% Skyla(TM), 4.2% ; Liletta(R), 5.3% ; Jadelle(R) subdermal, 30.3% ), Dysmenorrhea (5.6% to 8.6% ), Hypomenorrhea (Mirena(R), 23.4% ; subdermal, 1.7% to 2.6% ), Menorrhagia (Oral route, 30.9% ; subdermal route, 1.4% to 27% ; intrauterine route, 7.9% to 11.9% ), Pain in female pelvis (Intrauterine route, 6.2% to 8.2% ; subdermal route, 24.4% ), Pain of breast (Intrauterine route, 7.1% to 8.5% ), Vaginitis (16.3% ), Vulvovaginitis (Intrauterine route, 10.5% to 24.3% )
Other: Fatigue (13.3% )
Serious:
Cardiovascular: Myocardial infarction
Dermatologic: Implant site reaction
Endocrine metabolic: Breast cancer
Gastrointestinal: Cholecystitis
Hematologic: Deep venous thrombosis, Venous thrombosis
Hepatic: Cholelithiasis, Cholestatic jaundice syndrome
Neurologic: Idiopathic intracranial hypotension (Rare ), Thrombotic stroke
Ophthalmic: Thrombosis of retinal vein
Psychiatric: Depressed mood (Intrauterine route, 0.2% to 0.5% ), Suicidal
Reproductive: Actinomycotic infection, Cyst of ovary (Liletta(TM), 4.3% ; Skyla(TM), 13.2% ; Kyleena(TM), 22.2% ),
Ectopic pregnancy (Intrauterine route, 0.1 to 0.6% per year ), Expulsion intrauterine contraceptive device (Intrauterine route, 3.2% to less than 5% ), Miscarriage (Kyleena(TM), 0.2% ), Pelvic inflammatory disease (Intrauterine route, 0.4% to 0.5% ), Uterine perforation by intrauterine contraceptive device (Intrauterine route, less than 0.1% )
Respiratory: Pulmonary embolism
Other: Sepsis
劑量和給藥方法

在月經開始的7天內,或在第一孕期流產或小產後立即,或在第二孕期流產或小產或分娩後至少6週且子宮完全恢復正常後,將一個52毫克系統置入子宮內,無需使用備用避孕措施。

Insert a 52 mg system intrauterinely within 7 days of the onset of menstruation, immediately after first-trimester abortion or miscarriage, or after a minimum of 6 weeks following second-trimester abortion, miscarriage, or childbirth, once the uterus has fully involuted, without the need for backup contraception.

避孕之療效可長達8年;治療月經過多和預防雌激素補充治療引起的子宮內膜增生兩者療效則最長5年。

The contraceptive efficacy can last up to 8 years; the efficacy for both treating heavy menstrual bleeding and preventing endometrial hyperplasia caused by estrogen replacement therapy lasts up to 5 years. <2024/9/13>

小兒調整劑量
腎功能調整劑量
肝功能調整劑量
安定性
藥袋資訊
臨床用途
避孕、月經經血過多、預防雌激素補充治療引起的子宮內膜增生
主要副作用
多種月經出血模式改變、良性的卵巢囊腫
泡製方法
儲存方式
請置於 15-30℃ 乾燥處儲存
注意事項
其他說明
水台N1 | 藥庫 外用/水D21
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
3958
自費價
4749.6
仿單
資料庫
健保給付規定