THE INDIAN PHARMACIST Official Circular Pharmacy Logo THE INDIAN PHARMACISTLearn. Explore. Practise. Excel.
MEDICINE MONOGRAPH CODE: [6.9]-CMP39 ID: TIP-MED-000309

Natural Micronized Progesterone IP

Active Ingredient / Scientific Identity: Natural Micronized Progesterone IP • Class: Oral Synthetic Progestogens & Retroprogesterone (Schedule H | NLEM 2022)

⚖️ Compare Profile
THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Natural Micronized Progesterone IP ([6.9]-CMP39 | ID: TIP-MED-000309) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/6-9-cmp39-natural-micronized-progesterone-ip/
Generic / Entity NameNatural Micronized Progesterone IP ([6.9]-CMP39)
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassOral Synthetic Progestogens & Retroprogesterone (Schedule H | NLEM 2022)
Available Dosage FormsStandard approved strengths (refer to comparative context)
Regulatory ClassificationSchedule H & Schedule G Prescription Drug ('Caution: It is dangerous to take this pre
Key Warning & Review DateRenal: Caution in fluid-retaining states. Hepatic: Contraindicated in severe hepatic impairment or active liver disease
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H & Schedule G Prescription Drug ('Caution:✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Natural Micronized Progesterone IP (TIP-MED-000309, Reference Code [6.9]-CMP39) 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).

Verified Indian Market Examples / Compendial Status:
Co-indexed per approved Author Decision DEC-04 (Option 4A; displaced HTML [12.18] & Inventory CSV mono-13-7). Bio-identical corpus luteum progesterone (Susten, Naturogest 100–400 mg oral/vaginal softgel) for luteal support and preterm birth prevention.
Co-indexed per approved Author Decision DEC-04 (Option 4A; displaced HTML [12.18] & Inventory CSV mono-13-7). Bio-identical corpus luteum progesterone (Susten, Naturogest 100–400 mg oral/vaginal softgel) for luteal support and preterm birth prevention.
Dosage Forms & Available Strengths:
Standard approved strengths (refer to comparative context)
Routes: Oral / Parenteral

3. Mechanism of Action & Pharmacodynamics

Co-indexed per approved Author Decision DEC-04 (Option 4A; displaced HTML [12.18] & Inventory CSV mono-13-7). Bio-identical corpus luteum progesterone (Susten, Naturogest 100–400 mg oral/vaginal softgel) for luteal support and preterm birth prevention.

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: Co-indexed per approved Author Decision DEC-04 (Option 4A; displaced HTML [12.18] & Inventory CSV mono-13-7). Bio-identical corpus luteum progesterone (Susten, Naturogest 100–400 mg oral/vaginal softgel) for luteal support and preterm birth prevention.

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 & Disposition:
Comparative pharmacokinetic profile co-indexed under [6.9].
Metabolism & Biotransformation:
Renal: Caution in fluid-retaining states. Hepatic: Contraindicated in severe hepatic impairment or active liver disease
Elimination & Renal Adjustment:
Renal: Caution in fluid-retaining states. Hepatic: Contraindicated in severe hepatic impairment or active liver disease
Hepatic Impairment Considerations:
Renal: Caution in fluid-retaining states. Hepatic: Contraindicated in severe hepatic impairment or active liver disease

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • 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

Common & Mechanism-Related Adverse Effects:
  • 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
Serious / Dose-Limiting Adverse Effects:

    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 parameters per parent class monograph [6.9].

    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)

    THE 12-STEP ORAL DRUG JOURNEY THROUGH THE HUMAN BODY (LADME) Note: IV bolus enters Step 6 directly (F = 100%); Sublingual & Transdermal routes bypass Step 4–5 Portal First-Pass Metabolism 1. Oral Administration • Tablet / Capsule swallowed • Gastric emptying to duodenum pH 1.5–3.5 (Stomach) 2. Disintegration & Dissolution • Tablet breaks into granules • API dissolves in GI fluid Noyes-Whitney Dissolution Rate 3. GI Epithelial Absorption • Crosses intestinal villi • Passive / Active / P-gp efflux Small Intestine (Large Surface Area) 4. Portal Circulation • Mesenteric veins → Portal vein • Delivers blood to liver sinusoids Pre-systemic Venous Conduit 5. First-Pass Metabolism • Gut & hepatic CYP450 extraction • High: GTN, Propranolol, Morphine Determines Bioavailability (F = f_a × (1-E_H)) 6. Systemic Circulation • Hepatic vein → IVC → Heart • Unbound vs Albumin-bound drug Only FREE drug is active 7–8. Tissue Distribution (Vd) • Capillary permeation to organs • Blood-Brain & Placental barriers Vd = Dose / C_0 (L or L/kg) 9. Target Site of Action • Receptors (GPCR, Ion channel) • Enzymes & Carrier Transporters Pharmacodynamic Effect (E_max, EC50) 10. Hepatic Biotransformation • Phase I (CYP450 Oxidation/Hydrolysis) • Phase II (Glucuronidation/Sulfation) Converts lipophilic drug → hydrophilic metabolite 11. Renal & Biliary Elimination • Nephron: Filtration + Secretion − Reabsorption • Biliary excretion & Enterohepatic recycling Total Clearance CL_tot = CL_renal + CL_hepatic 12. Excretion from the Body • Urine (Primary polar metabolite route) • Bile/Faeces, Expired Air, Sweat, Milk Elimination Half-Life t1/2 = (0.693 × Vd) / CL
    svg-v339-01-adme-12-step-journey — 8.1 Complete 12-Step Journey of an Orally Administered Drug (ADME): Figure 8.1: The 12-step physiological journey of a typical orally administered solid dosage form through Liberation, Absorption, Distribution, Metabolism, and Excretion (LADME). Note: Parenteral (IV), sublingual, and inhalational routes bypass gastrointestinal absorption and/or hepatic first-pass metabolism.

    12. Authoritative References, Regulatory Sources & Editorial Disclaimer

    Primary Compendial & Guideline Reference: Indian Pharmacopoeia (IP 2022) • NFI • CDSCO

    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: VERIFIED_EDUCATIONAL_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.

    ← Back to All 644 Reference Profiles 📖 Explore 40 Knowledge Hub Articles → ✉️ Report Errata / Feedback
    Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/6-9-cmp39-natural-micronized-progesterone-ip/, Last Reviewed: 2026-11-10) is an educational reference sheet for students and healthcare learners. It is NOT an official prescribing guideline or patient-specific treatment order.