Hormones and Agents Affecting Hormonal Mechanism: Estrogens, Progestins, Contraceptives and Related Agents
OESMY1 “Esmya tablet” 5 mg/tab
適應症：使用於患有中等至嚴重程度子宮纖維瘤症狀的生育年齡成年女性，作為手術前治療之用。
Usual dose:
1 Tab PO QD for up to 3 months with or without food
Treatments should only be initiated when menstruation has occurred:
The first treatment course should start during the first week of menstruation.
Re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion.
If a patient misses a dose, the patient should take ulipristal acetate as soon as possible. If the dose was missed by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
No dose adjustment is recommended for patients with mild hepatic impairment. In the absence of specific studies, ulipristal acetate is not recommended in patients with moderate or severe hepatic impairment unless the patient is closely monitored.
The safety and efficacy of ulipristal acetate was only established in women of 18 years and older.
Emergency contraception – Postcoital contraception
30 mg ORALLY as soon as possible within 120 hours (5 days) of unprotected intercourse or a known or suspected contraceptive failure; if vomiting occurs within 3 hours, consider repeating dose; repeated use within the same menstrual cycle is not recommended.
Precautions:
Ectopic pregnancy may occur; monitoring recommended.
Not recommended for repeated use during same menstrual cycle.
Return to fertility is rapid following use; initiate or continue barrier-method contraception for the remaining menstrual cycle.
Exclude pregnancy if menses are delayed beyond 1 week; use may cause menses to occur earlier or later than expected
Intermenstrual bleeding has been reported.
Use does not prevent HIV infection, AIDS, or other sexually transmitted diseases.
Not for use in pediatric patients prior to menarche.
Use in breastfeeding women not recommended.
Use in postmenopausal women not recommended.
Contraindications: Pregnancy, known or suspected.
Adverse effects: abdominal pain, nausea, dizziness, headache, fatigue, intermenstrual bleeding, dysmenorrhea.