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MEDICINE MONOGRAPH CODE: [6.8]-C36 ID: TIP-MED-000306

Fludrocortisone Acetate

Active Ingredient / Scientific Identity: Fludrocortisone Acetate • Class: Oxazoline Glucocorticoid & Potent Synthetic Mineralocorticoid (Schedule H)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Fludrocortisone Acetate ([6.8]-C36 | ID: TIP-MED-000306) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/6-8-c36-fludrocortisone-acetate/
Generic / Entity NameFludrocortisone Acetate ([6.8]-C36)
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassOxazoline Glucocorticoid & Potent Synthetic Mineralocorticoid (Schedule H)
Available Dosage FormsDeflazacort Tablets: 6 mg, 12 mg, 24 mg, 30 mg; Suspension: 6 mg/5 mL (Deflazacort 6 mg = Prednisolone 5 mg).
Regulatory ClassificationSchedule H & Schedule G Prescription Drug ('Caution: It is dangerous to take this pre
Key Warning & Review DateRenal & Hepatic: In moderate-to-severe hepatic impairment or CKD, monitor BP and Serum K+/Na+ closely on Fludrocortisone
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H & Schedule G Prescription Drug ('Caution:✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Fludrocortisone Acetate (TIP-MED-000306, Reference Code [6.8]-C36) is classified under Thyroid, Pituitary, Adrenal & Hormonal Medicines (Ch 06) as a Oxazoline Glucocorticoid & Potent Synthetic Mineralocorticoid (Schedule H). 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 [6.8] (Deflazacort & Fludrocortisone Acetate). Representative Indian Market Examples (Edition 2.7 Ch 06 [6.8], p. 75): Deflazacort: Defcort (Macleods), Dezacor, Orthocort, Mahacort-DZ. Fludrocortisone: Florinef, Fludrocort (Samrath) — Strengths & Dosage Forms: Deflazacort Tablets: 6 mg, 12 mg, 24 mg, 30 mg; Suspension: 6 mg/5 mL (Deflazacort 6 mg = Prednisolone 5 mg). Fludrocortisone Tablets: 100 mcg (0.1 mg)
Co-indexed constituent under primary monograph [6.8] (Deflazacort & Fludrocortisone Acetate). Representative Indian Market Examples (Edition 2.7 Ch 06 [6.8], p. 75): Deflazacort: Defcort (Macleods), Dezacor, Orthocort, Mahacort-DZ. Fludrocortisone: Florinef, Fludrocort (Samrath) — Strengths & Dosage Forms: Deflazacort Tablets: 6 mg, 12 mg, 24 mg, 30 mg; Suspension: 6 mg/5 mL (Deflazacort 6 mg = Prednisolone 5 mg). Fludrocortisone Tablets: 100 mcg (0.1 mg)
Dosage Forms & Available Strengths:
Deflazacort Tablets: 6 mg, 12 mg, 24 mg, 30 mg; Suspension: 6 mg/5 mL (Deflazacort 6 mg = Prednisolone 5 mg). Fludrocortisone Tablets: 100 mcg (0.1 mg)
Routes: Oral / Parenteral / Topical per formulation

3. Mechanism of Action & Pharmacodynamics

Oxazoline Glucocorticoid & Potent Synthetic Mineralocorticoid (Schedule H) acting on target receptor/enzyme pathways in Thyroid, Pituitary, Adrenal & Hormonal Medicines (Ch 06): clinical efficacy is mediated via Oxazoline Glucocorticoid & Potent Synthetic Mineralocorticoid (Schedule H) for Deflazacort: Duchenne muscular dystrophy (DMD), rheumatoid arthritis, asthma/allergic disorders, nephrotic syndrome. Fludrocortisone: Primary adrenal insufficiency (Addison's disease) and salt-wasting congenital adrenal hyperplasia (alongside Hydrocortisone), severe neurogenic orthostatic hypotension.

4. Therapeutic Indications & Evidence-Supported Uses

  • Deflazacort: Duchenne muscular dystrophy (DMD), rheumatoid arthritis, asthma/allergic disorders, nephrotic syndrome
  • Fludrocortisone: Primary adrenal insufficiency (Addison's disease) and salt-wasting congenital adrenal hyperplasia (alongside Hydrocortisone), severe neurogenic orthostatic hypotension

🇮🇳 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: Deflazacort: 6–36 mg PO OD in the morning (DMD: 0.9 mg/kg/day OD). Fludrocortisone: 50–200 mcg (0.5–2 tablets) PO OD in the morning

Administration & Meal Timing: Take in the morning with breakfast | Morning (8:00 AM)

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Follows class pharmacokinetic profile detailed in parent monograph [6.8].
Metabolism & Biotransformation:
Renal & Hepatic: In moderate-to-severe hepatic impairment or CKD, monitor BP and Serum K+/Na+ closely on Fludrocortisone
Elimination & Renal Adjustment:
Renal & Hepatic: In moderate-to-severe hepatic impairment or CKD, monitor BP and Serum K+/Na+ closely on Fludrocortisone
Hepatic Impairment Considerations:
Renal & Hepatic: In moderate-to-severe hepatic impairment or CKD, monitor BP and Serum K+/Na+ closely on Fludrocortisone

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • Deflazacort is a glucocorticoid prodrug (6 mg = 5 mg Prednisolone) — shares ALL corticosteroid risks (HPA suppression, infection, hyperglycaemia, cataracts)! Fludrocortisone is contraindicated in uncontrolled hypertension, congestive heart failure, and systemic fungal infections

Key Clinical Precautions: Renal & Hepatic: In moderate-to-severe hepatic impairment or CKD, monitor BP and Serum K+/Na+ closely on Fludrocortisone

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Deflazacort: Weight gain, Cushingoid facies, hyperglycaemia, dyspepsia. Fludrocortisone: Sodium/water retention, ankle oedema, hypertension, hypokalaemia
  • Adrenal crisis if stopped abruptly; Fludrocortisone overdose causes severe hypertension, cardiomegaly, congestive heart failure, and profound hypokalaemia
Serious / Dose-Limiting Adverse Effects:

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

    • CYP3A4 inhibitors (Clarithromycin, Itraconazole, Fluconazole) increase active 21-desacetyldeflazacort 3-fold (reduce Deflazacort to 1/3 of dose!); Rifampicin/Carbamazepine reduce efficacy; Amphotericin B and Loop/Thiazide diuretics worsen hypokalaemia

    10. Clinical Monitoring, Patient Counselling & Storage

    Clinical & Laboratory Monitoring: Monitor clinical parameters per parent monograph [6.8].

    Pharmacist Patient Counselling Points:

    • Patient Counselling Checklist: Remember that Defcort 6 mg equals Prednisolone 5 mg and must never be stopped suddenly after >2 weeks; for Florinef, store properly and report ankle swelling or high BP
    • Meal & Clock Timing Instruction: Take in the morning with breakfast (Morning (8:00 AM))
    • Missed Dose Protocol: Take same day as soon as remembered; never miss replacement doses in Addison's disease
    • Geriatric Dispensing Pearl: Fludrocortisone >200 mcg/d in older adults carries a high risk of supine hypertension, hypokalaemia, and heart failure (AGS Beers 2023)

    Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Deflazacort Tablets: 6 mg, 12 mg, 24 mg, 30 mg; Suspension: 6 mg/5 mL (Deflazacort 6 mg = Prednisolone 5 mg). Fludrocortisone Tablets: 100 mcg (0.1 mg)

    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/6-8-c36-fludrocortisone-acetate/, 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.