TabletsClinical Overview
Ulipristal Acetate Tablets 5 mg is an orally active, synthetic Selective Progesterone Receptor Modulator (SPRM). It exerts tissue-specific partial agonistic and antagonistic effects on human progesterone receptors, directly suppressing endometrial proliferation, inducing amenorrhea, inhibiting ovulation, and promoting apoptosis in uterine leiomyoma cells, resulting in rapid reduction of uterine fibroid size and heavy menstrual bleeding. Indicated for pre-operative and intermittent medical management of moderate to severe symptoms of uterine fibroids (leiomyomas) in adult women of reproductive age.
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
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.
General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.
Possible 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.
*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.
Precautions & 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.
Schedule H (Prescription Required)
This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.
Medical Disclaimer: Statutory Gynecological, Obstetric & Endocrinological Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice or reproductive healthcare guidance. Hormonal medications, uterotonics, corticosteroids, fertility therapies, and emergency contraceptives have profound systemic actions and must be administered strictly under the supervision of a registered gynecologist, obstetrician, or endocrinologist.