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MEDICINE MONOGRAPH CODE: [6.5] ID: TIP-MED-000095

Hydrocortisone

Active Ingredient / Scientific Identity: Hydrocortisone • Class: Short-Acting Physiological Corticosteroid (Balanced 1:1 Glucocorticoid & Mineralocorticoid Activity)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Hydrocortisone ([6.5] | ID: TIP-MED-000095) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/6-5-hydrocortisone/
Generic / Entity NameHydrocortisone ([6.5])
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassShort-Acting Physiological Corticosteroid (Balanced 1:1 Glucocorticoid & Mineralocorticoid
Available Dosage FormsOral Uncoated Scored Tablets: 5 mg, 10 mg, 20 mg; Lyophilised Powder for IV/IM Injection: 100 mg, 200 mg, 500
Regulatory ClassificationSchedule H & Schedule G Prescription Drug ('Caution: It is dangerous to take this pre
Key Warning & Review DateRenal & Hepatic: Physiological replacement doses are safe and essential in CKD and 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

Hydrocortisone (TIP-MED-000095, Reference Code [6.5]) is classified under Thyroid, Pituitary, Adrenal & Hormonal Medicines (Ch 06) as a Short-Acting Physiological Corticosteroid (Balanced 1:1 Glucocorticoid & Mineralocorticoid Activity). 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:
Representative Indian Market Examples (Edition 2.7 Ch 06 [6.5], p. 74): Oral Replacement Tablets: Hisone (Samarth—5 mg, 10 mg, 20 mg), Cort-S; Parenteral Emergency Injection (Hydrocortisone Sodium Succinate): Primacort 100 mg / 200 mg (Macleods), Efcorlin (GSK) — Strengths & Dosage Forms: Oral Uncoated Scored Tablets: 5 mg, 10 mg, 20 mg; Lyophilised Powder for IV/IM Injection: 100 mg, 200 mg, 500 mg vials
Representative Indian Market Examples (Edition 2.7 Ch 06 [6.5], p. 74): Oral Replacement Tablets: Hisone (Samarth—5 mg, 10 mg, 20 mg), Cort-S; Parenteral Emergency Injection (Hydrocortisone Sodium Succinate): Primacort 100 mg / 200 mg (Macleods), Efcorlin (GSK) — Strengths & Dosage Forms: Oral Uncoated Scored Tablets: 5 mg, 10 mg, 20 mg; Lyophilised Powder for IV/IM Injection: 100 mg, 200 mg, 500 mg vials
Dosage Forms & Available Strengths:
Oral Uncoated Scored Tablets: 5 mg, 10 mg, 20 mg; Lyophilised Powder for IV/IM Injection: 100 mg, 200 mg, 500 mg vials
Routes: Oral / Parenteral / Topical as specified by formulation

3. Mechanism of Action & Pharmacodynamics

Short-Acting Physiological Corticosteroid (Balanced 1:1 Glucocorticoid & Mineralocorticoid Activity) acting on target receptor/enzyme pathways in Thyroid, Pituitary, Adrenal & Hormonal Medicines (Ch 06): clinical efficacy is mediated via Short-Acting Physiological Corticosteroid (Balanced 1:1 Glucocorticoid & Mineralocorticoid Activity) for Oral: Physiological hormone replacement in primary adrenal insufficiency (Addison's disease), secondary/pituitary adrenal insufficiency (Sheehan's syndrome, post-pituitary surgery), and congenital adrenal hyperplasia (CAH). Parenteral IV/IM: Acute adrenal crisis, refractory septic shock, status asthmaticus, severe anaphylaxis adjunct..

4. Therapeutic Indications & Evidence-Supported Uses

  • Oral: Physiological hormone replacement in primary adrenal insufficiency (Addison's disease), secondary/pituitary adrenal insufficiency (Sheehan's syndrome, post-pituitary surgery), and congenital adrenal hyperplasia (CAH)
  • Parenteral IV/IM: Acute adrenal crisis, refractory septic shock, status asthmaticus, severe anaphylaxis adjunct

🇮🇳 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: Chronic Oral Adrenal Replacement: Typically 15 mg to 25 mg/day divided into 2 or 3 physiological doses to mimic circadian rhythm: e.g., 10 mg upon waking (07:00 AM) and 5 mg in the mid-afternoon (02:00–04:00 PM) (or 10 mg morning + 5 mg noon + 5 mg at 5 PM). (Note: 20 mg Hydrocortisone = 5 mg Prednisolone = 0.75 mg Dexamethasone). Follow endocrinologist prescription.

Administration & Meal Timing: Oral tablets: Take with food or milk. | Split Circadian Dosing: Larger dose (2/3) immediately in the morning, smaller dose (1/3) in the early-to-mid afternoon (not later than 04:00–05:00 PM, to avoid nocturnal cortisol excess and insomnia).

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Metabolism & Biotransformation:
Renal & Hepatic: Physiological replacement doses are safe and essential in CKD and liver disease.
Elimination & Renal Adjustment:
Renal & Hepatic: Physiological replacement doses are safe and essential in CKD and liver disease.
Hepatic Impairment Considerations:
Renal & Hepatic: Physiological replacement doses are safe and essential in CKD and liver disease.

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • Never omit or abruptly discontinue in adrenal insufficiency! In patients with panhypopituitarism (both cortisol and thyroid deficiency), Hydrocortisone MUST be started BEFORE Levothyroxine (giving levothyroxine first accelerates cortisol clearance and triggers fatal adrenal crisis!).

Key Clinical Precautions: Renal & Hepatic: Physiological replacement doses are safe and essential in CKD and liver disease.

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • At physiological replacement doses (15–20 mg/day), minimal adverse effects; excessive replacement causes weight gain, hypertension, peripheral oedema, mild hyperglycaemia, and bone loss.
  • Addisonian Adrenal Crisis if doses are missed or not doubled during febrile illness, vomiting, trauma, or surgery (presents with profound shock, severe vomiting, abdominal pain, hyponatraemia, hyperkalaemia, and hypoglycaemia); peptic ulceration or opportunistic infection at supraphysiological doses.
Serious / Dose-Limiting Adverse Effects:
  • Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.

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

  • CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, phenobarbitone) accelerate hydrocortisone metabolism and can precipitate acute adrenal crisis unless replacement dose is doubled! NSAIDs increase GI ulcer risk
  • Diuretics increase hypokalaemia

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: Mandatory 'Steroid Sick-Day Rules' for Adrenal Insufficiency Patients: 1. Rule of Doubling: During any intercurrent fever (>38°C), infection, tooth extraction, or moderate physical stress, double the daily oral hydrocortisone dose (e.g., from 10-0-5 mg to 20-0-10 mg) until recovery. 2. Emergency Injection Rule: If the patient develops vomiting or severe diarrhoea and cannot keep oral Hisone tablets down, they MUST receive an immediate 100 mg Intramuscular/IV Hydrocortisone injection (Primacort) and hospital care within 1–2 hours—delay is fatal! 3. Always carry a Steroid Emergency Alert Card in the wallet.
  • Meal & Clock Timing Instruction: Oral tablets: Take with food or milk. (Split Circadian Dosing: Larger dose (2/3) immediately in the morning, smaller dose (1/3) in the early-to-mid afternoon (not later than 04:00–05:00 PM, to avoid nocturnal cortisol excess and insomnia).)
  • Missed Dose Protocol: Take immediately upon remembering! Never skip a replacement dose.
  • Geriatric Dispensing Pearl: Many elderly CGHS patients who have taken chronic oral or indigenous/unlabelled steroid powders for arthritis or asthma develop secondary adrenal suppression; ensure any patient on Hisone replacement understands sick-day doubling.

Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Oral Uncoated Scored Tablets: 5 mg, 10 mg, 20 mg; Lyophilised Powder for IV/IM Injection: 100 mg, 200 mg, 500 mg vials

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 Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 06 [6.5] (p. 74)

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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Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/6-5-hydrocortisone/, 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.