藥品異動通知2024.02.02

藥理作用/作用機轉

Combination hormonal contraceptives prevent pregnancy by suppressing ovulation. Drospirenone is a spironolactone analogue with antimineralocorticoid and antiandrogenic activity. Estetrol is a synthetic analogue of a natural estrogen synthesized by the fetal liver and present only during pregnancy. It is not metabolized to estradiol or estriol.

適應症/

劑量

PO

【Adult】

　●Contraception: 1 tablet QD in the order presented on the blister pack. For patients not currently using a hormonal contraceptive, the first active tablet should be taken on the first day of the menstrual cycle (day 1 start).

【Pediatric】Postmenarche patients

　●Contraception: One tablet QD in the order presented on the blister pack. For patients not currently using a hormonal contraceptive, the first active tablet should be taken on the first day of the menstrual cycle (day 1 start).

【Geriatric】Refer to adult dosing.

『Renal Impairment: Adult』

Use is contraindicated

『Hepatic Impairment: Adult』

Use is contraindicated

使用禁忌

Hormonally sensitive malignancy, undiagnosed abnormal uterine bleeding, hepatic adenoma, hepatocellular carcinoma, acute hepatitis, severe (decompensated) cirrhosis, use of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, adrenal insufficiency, kidney impairment.

警告/預防

Bleeding irregularities, cervical cancer, chloasma, cholestasis, hepatic adenomas or carcinomas, hyperkalemia, lipid effects, retinal thrombosis, thromboembolic disorders.

不良反應

【>10%】Gynecological bleeding, mood disorder

【1% to 10%】Acne vulgaris, breast changes, decreased libido, loss of libido, weight gain, dysmenorrhea , depression, headache

【<1%】Thromboembolic complications, hyperkalemia

懷孕用藥分級(FDA)

D /避免使用

健保規範

• 藥品說明：

• 藥品理由：

其他

粉紅色有效藥錠：15 mg Estetrol Monohydrate (E4) (等同14.2 mg的Estetrol) and 3 mg Drospirenone (DRSP)。

白色無作用藥錠：該藥錠不含有效成分。

應依照鋁箔標示順序使用。

漏服補服方法請見仿單

避免用於抽菸且35歲以上之女性。

偏頭痛狀況若加劇請回診告知醫師。

執行大型手術請提前告知醫師用藥史。