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MEDICINE MONOGRAPH CODE: [6.6]-C34 ID: TIP-MED-000304

Danazol

Active Ingredient / Scientific Identity: Danazol • Class: Systemic Glucocorticoids (Deflazacort, Dexamethasone), Mineralocorticoid (Fludrocortisone), and Oral Progestogens (Norethisterone, Medroxyprogesterone)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Danazol ([6.6]-C34 | ID: TIP-MED-000304) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/6-6-c34-danazol/
Generic / Entity NameDanazol ([6.6]-C34)
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassSystemic Glucocorticoids (Deflazacort, Dexamethasone), Mineralocorticoid (Fludrocortisone)
Available Dosage FormsDeflazacort Tablets: 6 mg, 12 mg, 24 mg, 30 mg; Dexamethasone Tablets: 0.5 mg, 4 mg, 8 mg & Injection 4 mg/mL;
Regulatory ClassificationSchedule H & Schedule G Prescription Drug ('Caution: It is dangerous to take this pre
Key Warning & Review DateRenal: Monitor fluid retention and BP with Fludrocortisone and steroids in CKD. Hepatic: Oral progestogens (Norethisterone/Me
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H & Schedule G Prescription Drug ('Caution:✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Danazol (TIP-MED-000304, Reference Code [6.6]-C34) is classified under Thyroid, Pituitary, Adrenal & Hormonal Medicines (Ch 06) as a Systemic Glucocorticoids (Deflazacort, Dexamethasone), Mineralocorticoid (Fludrocortisone), and Oral Progestogens (Norethisterone, Medroxyprogesterone). 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 constituent under primary monograph [6.6] (Cortisone Acetate, Betamethasone & Danazol (Specialised Adrenal & Endocrine Steroids)). Representative Indian Market Examples (Edition 2.7 Ch 06 [6.6], p. 74): Deflazacort: Defcort (Macleods), Dezacor, Orthocort (1 mg, 6 mg, 12 mg, 24 mg, 30 mg). Dexamethasone: Dexona (Zydus—0.5 mg, 4 mg), Decdan. Fludrocortisone: Floricot (Samarth—100 mcg [0.1 mg]). Progestogens: Primolut-N (Norethisterone 5 mg - Bayer/Zydus), Regestrone, Meprate (Medroxyprogesterone 10 mg - Serum) — Strengths & Dosage Forms: Deflazacort Tablets: 6 mg, 12 mg, 24 mg, 30 mg; Dexamethasone Tablets: 0.5 mg, 4 mg, 8 mg & Injection 4 mg/mL; Fludrocortisone Tablets: 0.1 mg (100 mcg); Norethisterone Tablets: 5 mg, 10 mg CR; Medroxyprogesterone Acetate Tablets: 2.5 mg, 5 mg, 10 mg
Co-indexed constituent under primary monograph [6.6] (Cortisone Acetate, Betamethasone & Danazol (Specialised Adrenal & Endocrine Steroids)). Representative Indian Market Examples (Edition 2.7 Ch 06 [6.6], p. 74): Deflazacort: Defcort (Macleods), Dezacor, Orthocort (1 mg, 6 mg, 12 mg, 24 mg, 30 mg). Dexamethasone: Dexona (Zydus—0.5 mg, 4 mg), Decdan. Fludrocortisone: Floricot (Samarth—100 mcg [0.1 mg]). Progestogens: Primolut-N (Norethisterone 5 mg - Bayer/Zydus), Regestrone, Meprate (Medroxyprogesterone 10 mg - Serum) — Strengths & Dosage Forms: Deflazacort Tablets: 6 mg, 12 mg, 24 mg, 30 mg; Dexamethasone Tablets: 0.5 mg, 4 mg, 8 mg & Injection 4 mg/mL; Fludrocortisone Tablets: 0.1 mg (100 mcg); Norethisterone Tablets: 5 mg, 10 mg CR; Medroxyprogesterone Acetate Tablets: 2.5 mg, 5 mg, 10 mg
Dosage Forms & Available Strengths:
Deflazacort Tablets: 6 mg, 12 mg, 24 mg, 30 mg; Dexamethasone Tablets: 0.5 mg, 4 mg, 8 mg & Injection 4 mg/mL; Fludrocortisone Tablets: 0.1 mg (100 mcg); Norethisterone Tablets: 5 mg, 10 mg CR; Medroxyprogesterone Acetate Tablets: 2.5 mg, 5 mg, 10 mg
Routes: Oral / Parenteral / Topical per formulation

3. Mechanism of Action & Pharmacodynamics

Systemic Glucocorticoids (Deflazacort, Dexamethasone), Mineralocorticoid (Fludrocortisone), and Oral Progestogens (Norethisterone, Medroxyprogesterone) acting on target receptor/enzyme pathways in Thyroid, Pituitary, Adrenal & Hormonal Medicines (Ch 06): clinical efficacy is mediated via Systemic Glucocorticoids (Deflazacort, Dexamethasone), Mineralocorticoid (Fludrocortisone), and Oral Progestogens (Norethisterone, Medroxyprogesterone) for • Deflazacort: Oxazoline derivative of prednisolone (6 mg Deflazacort = 5 mg Prednisolone) used in rheumatoid arthritis, asthma, nephrotic syndrome, and Duchenne muscular dystrophy (slightly lower diabetogenic and bone loss profile at equipotent doses, though all steroid precautions still apply). • Dexamethasone: Long-acting potent glucocorticoid (0.75 mg = 5 mg Prednisolone; zero mineralocorticoid activity) used in cerebral oedema, chemotherapy antiemesis, severe COVID/pulmonary inflammation, and multiple myeloma. • Fludrocortisone (Floricot 0.1 mg): Potent mineralocorticoid for aldosterone replacement in primary Addison's disease and severe neurogenic orthostatic hypotension. • Norethisterone / Medroxyprogesterone: Abnormal uterine bleeding (AUB), endometrial hyperplasia, secondary amenorrhoea, endometriosis, and menstrual postponement..

4. Therapeutic Indications & Evidence-Supported Uses

  • • Deflazacort: Oxazoline derivative of prednisolone (6 mg Deflazacort = 5 mg Prednisolone) used in rheumatoid arthritis, asthma, nephrotic syndrome, and Duchenne muscular dystrophy (slightly lower diabetogenic and bone loss profile at equipotent doses, though all steroid precautions still apply)
  • • Dexamethasone: Long-acting potent glucocorticoid (0
  • 75 mg = 5 mg Prednisolone
  • zero mineralocorticoid activity) used in cerebral oedema, chemotherapy antiemesis, severe COVID/pulmonary inflammation, and multiple myeloma
  • • Fludrocortisone (Floricot 0
  • 1 mg): Potent mineralocorticoid for aldosterone replacement in primary Addison's disease and severe neurogenic orthostatic hypotension
  • • Norethisterone / Medroxyprogesterone: Abnormal uterine bleeding (AUB), endometrial hyperplasia, secondary amenorrhoea, endometriosis, and menstrual postponement

🇮🇳 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: General Adult Reference: Deflazacort: 6 mg–30 mg OD after breakfast. Dexamethasone: 0.5 mg–8 mg/day after breakfast. Fludrocortisone: 50 mcg–200 mcg (0.5 to 2 tablets of 0.1 mg) once daily in the morning. Norethisterone: 5 mg twice or three times daily for 5–21 days per gynaecologist schedule. Follow physician prescription.

Administration & Meal Timing: Take with or after meals (especially breakfast for corticosteroids) to prevent gastric irritation. | Corticosteroids & Fludrocortisone: Once daily in the morning after breakfast. Progestogens (Norethisterone/Medroxyprogesterone): Divided 2–3 times daily or once daily at the same clock hour.

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Follows class pharmacokinetic profile detailed in parent monograph [6.6].
Metabolism & Biotransformation:
Renal: Monitor fluid retention and BP with Fludrocortisone and steroids in CKD. Hepatic: Oral progestogens (Norethisterone/Meprate) are contraindicated in severe hepatic dysfunction or active jaundice.
Elimination & Renal Adjustment:
Renal: Monitor fluid retention and BP with Fludrocortisone and steroids in CKD. Hepatic: Oral progestogens (Norethisterone/Meprate) are contraindicated in severe hepatic dysfunction or active jaundice.
Hepatic Impairment Considerations:
Renal: Monitor fluid retention and BP with Fludrocortisone and steroids in CKD. Hepatic: Oral progestogens (Norethisterone/Meprate) are contraindicated in severe hepatic dysfunction or active jaundice.

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • Glucocorticoids: Same precautions as Prednisolone (hyperglycaemia, GI ulceration with NSAIDs, osteoporosis, infection, HPA suppression—note that Dexamethasone has a 36–54 hour biological half-life and strongly suppresses the HPA axis!). Fludrocortisone: Contraindicated in congestive heart failure and uncontrolled severe hypertension. Progestogens: Contraindicated in active venous thromboembolism (DVT/PE), arterial thromboembolic disease (stroke/MI), undiagnosed vaginal bleeding, breast cancer, severe liver disease, and pregnancy.

Key Clinical Precautions: Renal: Monitor fluid retention and BP with Fludrocortisone and steroids in CKD. Hepatic: Oral progestogens (Norethisterone/Meprate) are contraindicated in severe hepatic dysfunction or active jaundice.

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Deflazacort/Dexamethasone: Hyperglycaemia, insomnia, dyspepsia, Cushingoid changes. Fludrocortisone: Sodium/water retention, ankle oedema, supine hypertension, hypokalaemia. Norethisterone/Medroxyprogesterone: Breakthrough spotting, breast tenderness, bloating, fluid retention, headache, mood swings.
  • Dexamethasone/Deflazacort: Adrenal crisis on abrupt withdrawal, GI bleed, avascular necrosis. Fludrocortisone: Severe hypokalaemia, congestive heart failure, severe supine hypertension. Norethisterone: Venous thromboembolism (DVT/PE), cerebral thrombosis, cholestatic jaundice.
Serious / Dose-Limiting Adverse Effects:

    9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions

    • CYP3A4 inducers (rifampicin, phenytoin, carbamazepine) accelerate clearance of dexamethasone, deflazacort, and progestogens
    • NSAIDs + glucocorticoids cause peptic ulceration
    • Fludrocortisone + loop/thiazide diuretics cause profound hypokalaemia

    10. Clinical Monitoring, Patient Counselling & Storage

    Clinical & Laboratory Monitoring: Monitor clinical parameters per parent monograph [6.6].

    Pharmacist Patient Counselling Points:

    • Patient Counselling Checklist: • Steroid Potency Equivalence Check: Ensure patients and staff know that 6 mg Deflazacort = 5 mg Prednisolone = 4 mg Methylprednisolone = 0.75 mg Dexamethasone—never confuse mg strengths across steroids! • Floricot Storage Alert: Some Fludrocortisone brands require refrigerator storage (2°C–8°C) or cool storage (<25°C)—check the strip/bottle label carefully in Indian summers. • Primolut-N / Meprate Counselling: Explain that missing a tablet triggers spotting, and that a normal period-like withdrawal bleed is expected 3 to 7 days after finishing the prescribed course.
    • Meal & Clock Timing Instruction: Take with or after meals (especially breakfast for corticosteroids) to prevent gastric irritation. (Corticosteroids & Fludrocortisone: Once daily in the morning after breakfast. Progestogens (Norethisterone/Medroxyprogesterone): Divided 2–3 times daily or once daily at the same clock hour.)
    • Missed Dose Protocol: Take as soon as remembered on the same day. For Norethisterone in Abnormal Uterine Bleeding, missing even 1–2 doses causes immediate breakthrough vaginal bleeding—maintain strict 8- or 12-hourly clock adherence!
    • Geriatric Dispensing Pearl: Dexamethasone has a very high rate of steroid-induced delirium, insomnia, and severe hyperglycaemia in the elderly. When Fludrocortisone is prescribed for geriatric neurogenic orthostatic hypotension (e.g., in Parkinson's or diabetic autonomic neuropathy), check both standing BP and lying-down (supine) BP, and monitor serum potassium closely.

    Storage, Stability & Dispensing Safeguards: COLD CHAIN MANDATORY (2°C–8°C): Store in a pharmaceutical refrigerator between 2°C and 8°C; DO NOT FREEZE. Protect from light and heat during dispensing.

    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.

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    Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/6-6-c34-danazol/, 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.