Ulipristal

Active pharmaceutical substance formulated in Jan Aushadhi generic products for Women's Health & Hormones treatment.

🧴 Clinical Application

Take orally 5 mg once daily with water, with or without food. Treatment course consists of up to 3 months continuously, starting during the first week of a menstrual bleeding cycle. If repeat courses are prescribed, each course must start during the first week of the second menstrual cycle following completion of the previous cycle. Liver function tests (LFTs) must be performed prior to starting, monthly during the first 2 courses, and 2-4 weeks after stopping.

⚠️ Side Effects

Common: Amenorrhea (cessation of menses - therapeutic effect), endometrial thickening (PRM-associated endometrial changes - PAEC), hot flashes, headache, breast tenderness, abdominal pain, and fatigue. Rare/Severe: Drug-induced liver injury (DILI - acute liver failure requiring transplantation in rare post-marketing cases), severe allergic reactions.

🛡️ Safety Warnings

Black Box Warning / Regulatory Alert: Risk of rare but severe drug-induced liver injury; strict hepatic monitoring mandatory (ALT/AST >2x ULN contraindicates therapy). Contraindicated in pregnancy, lactation, abnormal genital bleeding of unknown etiology, uterine/cervical/ovarian/breast malignancy, and severe hepatic impairment. Non-hormonal contraception must be used during treatment.