TabletsClinical Overview
Norethisterone (Acetate Controlled Release Tablets 10mg) is a potent first-generation synthetic 19-nortestosterone-derived progestogen on the WHO Model List of Essential Medicines. It induces profound secretory transformation of the endometrium and inhibits pituitary gonadotropin release, preventing ovulation and stabilizing the uterine vascular bed. Indicated for the treatment of dysfunctional uterine bleeding (DUB / menorrhagia), endometriosis, postponement of menstruation, secondary amenorrhea, and severe premenstrual syndrome (PMS).
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
Take orally with water, with or without meals: For menorrhagia / DUB arrest: 5 mg three times daily for 10 days (bleeding typically arrests within 24-48 hours; withdrawal bleed occurs 2-4 days post-completion). For postponement of menses: 5 mg three times daily starting 3 to 5 days before expected menstruation and continued for up to 14 days; menses resumes 2-3 days after stopping. For Controlled Release (CR 10mg): Take 10 to 15 mg once daily as prescribed; swallow whole without chewing.
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: Breakthrough bleeding, spotting, amenorrhea, breast discomfort, nausea, headache, fluid retention, weight gain, and mild acne. Rare/Severe: Venous thromboembolism (DVT, PE), retinal vein thrombosis, jaundice, and depression.
*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: Contraindicated in active or past thromboembolic disorders, severe arterial disease, undiagnosed abnormal vaginal bleeding, history of liver tumors or severe liver disease, and known hormone-sensitive malignancies. NOT safe in pregnancy (potential risk of fetal virilization with prolonged high doses).
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.