1. Clinical & Scientific Overview
Norethisterone, Medroxyprogesterone Acetate & Dydrogesterone (TIP-MED-000099, Reference Code [6.9]) is classified under
Thyroid, Pituitary, Adrenal & Hormonal Medicines (Ch 06) as a Oral Synthetic Progestogens & Retroprogesterone (Schedule H | NLEM 2022).
Within the Indian regulatory and compendial framework, it is governed under Schedule H & Schedule G Prescription Drug ('Caution: It is dangerous to take this preparation except under medical supervision' — Drugs Rules 1945).
Representative Indian Market Examples (Edition 2.7 Ch 06 [6.9], p. 76): Norethisterone: Primolut-N (Zydus/Bayer), Regestrone (Torrent), Sysron-N. Medroxyprogesterone (MPA): Meprate (Serum), Deviry (Torrent). Dydrogesterone: Duphaston (Abbott), Dydroboon (Mankind) — Strengths & Dosage Forms: Norethisterone Tablets: 5 mg, 10 mg CR. Medroxyprogesterone Tablets: 2.5 mg, 5 mg, 10 mg (Depot Injection: 150 mg/mL DMPA [Antara]). Dydrogesterone Tablets: 10 mg, 20 mg SR
Norethisterone Tablets: 5 mg, 10 mg CR. Medroxyprogesterone Tablets: 2.5 mg, 5 mg, 10 mg (Depot Injection: 150 mg/mL DMPA [Antara]). Dydrogesterone Tablets: 10 mg, 20 mg SR
3. Mechanism of Action & Pharmacodynamics
Oral Synthetic Progestogens & Retroprogesterone (Schedule H | NLEM 2022) acting on target receptor/enzyme pathways in Thyroid, Pituitary, Adrenal & Hormonal Medicines (Ch 06): clinical efficacy is mediated via Oral Synthetic Progestogens & Retroprogesterone (Schedule H | NLEM 2022) for Abnormal uterine bleeding (AUB), secondary amenorrhoea (progesterone withdrawal test), endometriosis, menstrual postponement (Norethisterone), luteal phase support, threatened/recurrent miscarriage & infertility (Dydrogesterone).
4. Therapeutic Indications & Evidence-Supported Uses
- Abnormal uterine bleeding (AUB), secondary amenorrhoea (progesterone withdrawal test), endometriosis, menstrual postponement (Norethisterone), luteal phase support, threatened/recurrent miscarriage & infertility (Dydrogesterone)
🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Menstrual Delay: Norethisterone 5 mg PO TDS starting 3–4 days before expected period. Withdrawal Bleed / AUB: MPA 10 mg OD–BD or Norethisterone 5 mg BD–TDS for 5–10 days. Threatened Miscarriage: Dydrogesterone 40 mg stat, then 10 mg BD/TDS (or 20 mg SR OD)
Administration & Meal Timing: May be taken with or without food with water | Morning & Evening (BD) or TDS at regular 8- or 12-hourly intervals
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: Caution in fluid-retaining states. Hepatic: Contraindicated in severe hepatic impairment or active liver disease
Renal: Caution in fluid-retaining states. Hepatic: Contraindicated in severe hepatic impairment or active liver disease
Renal: Caution in fluid-retaining states. Hepatic: Contraindicated in severe hepatic impairment or active liver disease
7. Contraindications, Precautions & High-Risk Warnings
- CONTRAINDICATIONS: Active venous thromboembolism (DVT/PE), arterial thromboembolic disease (stroke/MI), breast or genital malignancy, severe hepatic dysfunction, and undiagnosed vaginal bleeding. Norethisterone and MPA are CONTRAINDICATED during pregnancy (virilisation of female foetus!), whereas Dydrogesterone is non-androgenic and approved for threatened miscarriage!
Key Clinical Precautions: Renal: Caution in fluid-retaining states. Hepatic: Contraindicated in severe hepatic impairment or active liver disease
8. Adverse Effects Profile
- Breakthrough spotting, breast tenderness, bloating, mild headache, nausea, mood changes, weight fluctuation
- Venous thromboembolism (DVT, pulmonary embolism — especially with high-dose Norethisterone 15 mg/d, obesity, or smoking!), cholestatic jaundice, retinal thrombosis
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- CYP3A4 inducers (Rifampicin, Carbamazepine, Phenytoin, Phenobarbital) accelerate progestogen metabolism and cause breakthrough bleeding / treatment failure
- Norethisterone is partially metabolised (~0
- 4–1%) to Ethinylestradiol in vivo, increasing VTE risk at 15 mg/day!
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.
Pharmacist Patient Counselling Points:
- Patient Counselling Checklist: Always perform a urine pregnancy test before taking Meprate or Primolut-N to bring on a delayed period (only Duphaston/Progesterone is safe in early pregnancy); stop immediately if unilateral calf pain/swelling, chest pain, or sudden headache/vision loss occurs
- Meal & Clock Timing Instruction: May be taken with or without food with water (Morning & Evening (BD) or TDS at regular 8- or 12-hourly intervals)
- Missed Dose Protocol: Take as soon as remembered (irregular timing causes breakthrough spotting!)
- Geriatric Dispensing Pearl: Avoid high-dose progestogens in older women with VTE or cardiovascular risk factors
Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Norethisterone Tablets: 5 mg, 10 mg CR. Medroxyprogesterone Tablets: 2.5 mg, 5 mg, 10 mg (Depot Injection: 150 mg/mL DMPA [Antara]). Dydrogesterone Tablets: 10 mg, 20 mg SR
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 06 [6.9] (p. 76)
Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: HANDBOOK_SOURCE_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.
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