G03AC03 levonorgestrel

GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens

健保收載品項 FDA 已核准 TFDA 在效許可證 25 健保給付條款 1

健保收載品名:蜜蕊娜子宮內投藥系統

FDA 適應症

美國 FDA 核准成分 levonorgestrel and ethinyl estradiol (商品名 AMAZON BASIC CARE LEVONORGESTREL / Climara Pro / Dolishale / Econ Morning After / Fem Choice morning after / Levonorgestrel) · 仿單更新 2026-03-26

INDICATIONS AND USAGE DOLISHALE is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During The First Year of Typical Use and The First Year of Perfect Use of Contraception and The Percentage Continuing Use at The End of the First Year. United States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3 Method (1) Typical Use 1 (2) Perfect Use 2 (3) (4) Chance 4 85 85 Spermicides 5 26 6 40 Periodic abstinence 25 63 Calendar 9 Ovulation Method 3 Sympto-Thermal 6 2 Post-Ovulation 1 Cap 7 Parous Women 40 26 42 Nulliparous Women 20 9 56 Sponge Parous Women 40 20 42 Nulliparous Women 20 9 56 Diaphragm 7 20 6 56 Withdrawal 19 4 Condom 8 Female (Reality™) 21 5 56 Male 14 3 61 Pill 5 71 Progestin only 0.5 Combined 0.1 IUD Progesterone T 2.0 1.5 81 Copper T380A 0.8 0.6 78 LNg 20 0.1 0.1 81 Depo-Provera ® 0.3 0.3 70 Levonorgestrel Implants (Norplant ® ) 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100 Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9 Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10 Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998. 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 7. With spermicidal cream or jelly. 8. Without spermicides. 9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets. 10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

資料來源:openFDA(美國 FDA Structured Product Labeling)。為英文原文,僅供對照。

TFDA 適應症

台灣食藥署在效西藥許可證 25 張。

適應症(去重後 4 項):

  1. 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。
  2. 事前無避孕措施之緊急避孕措施。
  3. 無事前避孕措施之緊急避孕措施。
  4. 無事前避孕之緊急避孕措施。
許可證品項:藥品外觀與仿單(23 項)
品名外觀仿單/外盒
蜜蕊娜子宮內投藥系統 仿單 · 外盒
后定諾錠0.75公絲 圓形 · 白 · 刻痕:無 · 標記:INOR · 6 外觀圖 仿單 · 外盒
后安錠1.5毫克 仿單 · 外盒
愛后定 錠 1.5毫克 圓形 · 白 · 刻痕:無 · 標記:G00 · 8.5 外觀圖 仿單 · 外盒
韻急停錠0.75毫克 仿單 · 外盒
韻急停錠1.5毫克 仿單 · 外盒
適安樂錠1.5毫克 圓形 · 白 · 刻痕:無 · 標記:J06 · 8 外觀圖 仿單 · 外盒
"培力" 愉婷錠 圓形 · 白 · 刻痕:無 · 標記:PL / T05 · 7 外觀圖 仿單 · 外盒
安立婷 錠 1.5 毫克 圓形 · 白 · 刻痕:無 · 標記:SYN / ALT · 7 外觀圖 仿單 · 外盒
后保寧 錠 750 微公克 仿單 · 外盒
“信東”蕾后定錠 1.5 毫克 仿單 · 外盒
后寧錠 750 微公克 仿單 · 外盒
“一成”諾無錠 0.75 毫克 仿單
“培力”愉婷錠1.5毫克 圓形 · 白 · 刻痕:無 · 標記:PL / T47 · 7 外觀圖 仿單 · 外盒
可後安錠1.5毫克 圓形 · 粉 · 刻痕:無 · 7 外觀圖 仿單 · 外盒
妊止膜衣錠1.5毫克 圓形 · 粉 · 刻痕:無 · 7 外觀圖 仿單 · 外盒
后保寧錠1.5毫克 圓形 · 白;;;綠 · 刻痕:無 · 標記:YSP 209 · 9 外觀圖 仿單 · 外盒
"杏輝"韻婷錠1.5毫克 圓形 · 白 · 刻痕:無 · 標記:SP2 · 7 外觀圖 仿單 · 外盒
莉潔婷錠1.5毫克 圓形 · 白 · 刻痕:無 · 標記:LIG / 1 5 · 7 外觀圖 仿單 · 外盒
后服寧錠1.5毫克 圓形 · 白 · 刻痕:無 · 標記:PL / T47 · 7 外觀圖 仿單 · 外盒
后韻錠1.5毫克 仿單 · 外盒
"黃氏"息孕錠 圓形 · 白 · 刻痕:直線 · 標記:H · 7 外觀圖 仿單 · 外盒
美諾錠1.5毫克 仿單 · 外盒

資料來源:食藥署「西藥許可證」+「藥品 ATC 碼」+「藥品仿單或外盒」+「藥品外觀」開放資料。

NHI 給付規定

直接適用條款

§ 5.3.5 Levonorgestrel intrauterine system (如Mirena):(104/2/1、107/4/1)
激素及影響內分泌機轉藥物 › 動情激素、黃體激素及治療不孕症藥物
Levonorgestrel intrauterine system (如Mirena):(104/2/1、107/4/1)

限使用於連續3個月(含)以上月經經血過多導致嚴重貧血(Hemoglobin≦10g/dL)之婦女,且每次使用後之五年內,不得再次使用。
歷史演變(2 次異動)
生效日異動說明
104/2/1legacy_boan_parsed:ch05.txt
107/4/1legacy_boan_parsed:ch05.txt

實證補充

本藥品尚無實證補充整理(未來新增 Review/指引知識時補列)。


FDA 段:openFDA US SPL · TFDA 段:食藥署西藥許可證+ATC 分類開放資料 · NHI 段:健保署「全民健康保險藥品給付規定」(更新日 2026-05-31)· 實證補充段:人工彙整。 本頁為資訊整理,實際給付與適應症以主管機關公告為準。