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Authoritative Clinical Reference
Schedule H
Oral, Intravenous (IV), Intramuscular (IM), Topical, Rectal
Form Strengths Available
Tablets 5 mg, 10 mg, 20 mg
Injection (Hydrocortisone sodium succinate) 100 mg/vial, 250 mg/vial (lyophilized powder for reconstitution)
Topical cream/ointment 0.5%, 1%, 2.5%
Rectal preparations Enema 100 mg/60 mL (limited availability); Suppositories (limited availability)
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Parameter Recommendation
Starting dose 15–20 mg/day orally in divided doses
Titration Adjust based on clinical response, fatigue levels, electrolytes, and postural BP
Usual maintenance dose 15–25 mg/day in 2–3 divided doses (typically 10–15 mg morning, 5 mg afternoon ± 2.5–5 mg evening)
Maximum dose 30 mg/day (higher doses suggest over-replacement or stress dosing need)
Clinical notes Morning dose should be largest to mimic physiological cortisol rhythm; most patients require concurrent fludrocortisone (50–200 mcg/day) for mineralocorticoid replacement
Parameter Recommendation
Starting dose 10–15 mg/day orally in divided doses
Titration Adjust based on clinical response
Usual maintenance dose 10–20 mg/day in 2–3 divided doses
Maximum dose 25 mg/day
Clinical notes Fludrocortisone usually NOT required (aldosterone secretion preserved); lower doses often sufficient compared to primary AI
Parameter Recommendation
Starting dose 100 mg IV bolus stat
Titration Not applicable in acute phase
Usual maintenance dose 50–100 mg IV every 6–8 hours for first 24–48 hours, then taper based on clinical stability
Maximum dose 400 mg/day in first 24 hours
Clinical notes Concurrent aggressive IV fluid resuscitation with 0.9% saline (1–2 L in first hour); identify and treat precipitant (infection, trauma, surgery); switch to oral when stable and tolerating feeds
Flow for Adrenal Crisis Management:
text
Suspected Adrenal Crisis
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IV access + Blood for cortisol (do NOT wait for results)
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Hydrocortisone 100 mg IV stat
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0.9% NaCl 1 L IV over 1 hour (then continue resuscitation)
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Hydrocortisone 50–100 mg IV every 6–8 hours
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Once stable (24–48 hrs): Halve IV dose daily → Convert to oral
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Resume maintenance oral dose + fludrocortisone (if primary AI)
Parameter Recommendation
Starting dose 15–25 mg/day orally in 2–3 divided doses
Titration Guided by 17-hydroxyprogesterone, androstenedione, testosterone levels, and clinical signs
Usual maintenance dose 15–25 mg/day; reverse circadian dosing may be used (higher evening dose)
Maximum dose 30 mg/day
Clinical notes Balance between adrenal suppression and avoiding Cushingoid features; often requires fludrocortisone; monitor for over-treatment (weight gain, striae, osteoporosis)
Parameter Recommendation
Starting dose 200 mg/day IV
Titration Not applicable
Usual maintenance dose 200 mg/day as continuous infusion OR 50 mg IV every 6 hours
Maximum dose 200 mg/day
Duration Continue until vasopressors weaned; then taper over 2–3 days or stop abruptly if used <7 days
Clinical notes Per Surviving Sepsis Campaign and ISCCM protocols; no ACTH stimulation test required before initiation; most benefit in patients requiring escalating vasopressors despite adequate fluid resuscitation
Parameter Recommendation
Starting dose 200 mg IV stat
Titration Not applicable
Usual maintenance dose 100 mg IV every 6–8 hours for 24–48 hours
Maximum dose 400 mg/day
Clinical notes Always give AFTER adrenaline (first-line); role is to prevent biphasic reactions and late-phase inflammation; not a substitute for adrenaline; antihistamines given concurrently
Parameter Recommendation
Starting dose 100 mg IV stat
PAEDIATRIC DOSING (Specialist Only)
⚠️ Age and Safety Statement
Primary Paediatric Indications
Parameter Infants & Young Children Older Children/Adolescents
Starting dose 10–15 mg/m²/day in 3 divided doses 10–15 mg/m²/day in 3 divided doses
Titration Adjust based on 17-OHP, androstenedione, growth velocity Adjust based on hormonal control and growth
Usual maintenance dose 10–15 mg/m²/day divided TDS 10–15 mg/m²/day divided TDS
Maximum dose 20 mg/m²/day (higher suggests need for review) 25 mg/m²/day
Clinical notes Divided TDS to mimic diurnal rhythm; highest dose in morning; fludrocortisone required in salt-wasting forms
Monitoring in CAH:
Parameter Recommendation
Starting dose 8–10 mg/m²/day orally in 3 divided doses
Titration Based on clinical response, energy levels, electrolytes
Usual maintenance dose 8–12 mg/m²/day in 2–3 divided doses
Maximum dose 15 mg/m²/day
Clinical notes Physiological replacement; avoid over-treatment; fludrocortisone usually required
| Age Group | Dose (mcg/kg/day) | Typical Total Daily Dose | Clinical Notes |
|---|
Neonates / Infants <1 year 25 mg IV stat 25–30 mg/m²/day in divided doses
1–5 years 50 mg IV stat 50–100 mg/m²/day in divided doses
6–12 years 50–100 mg IV stat 50–100 mg/m²/day in divided doses
12 years / Adolescents 100 mg IV stat 100 mg every 6–8 hours
Clinical notes: Concurrent IV 0.9% saline with dextrose; monitor glucose closely in infants; transition to oral maintenance once stable
Parameter Recommendation
Starting dose 4 mg/kg IV stat (max 100 mg)
Titration Not applicable
Usual maintenance dose 4 mg/kg IV every 6 hours (max 100 mg/dose)
Maximum dose 400 mg/day
Duration Usually 24–48 hours IV, then switch to oral prednisolone
Clinical notes Per IAP guidelines; oral prednisolone preferred if tolerated; IV for severe/life-threatening exacerbations
Situation Dose
Minor febrile illness Double or triple oral maintenance dose
Vomiting / Unable to take oral IM hydrocortisone: Infants 25 mg, Children 50 mg, Adolescents 100 mg; seek immediate medical care
Minor procedures 25–50 mg IV at induction
Major surgery 50–100 mg/m² IV at induction, then 50–100 mg/m²/day in divided doses for 24–48 hours
Secondary Paediatric Indications (Off-label)
Indication Dose Duration Notes
Ulcerative colitis (distal/rectal) Rectal enema 25–50 mg at bedtime 2–4 weeks OFF-LABEL; Paediatric GI specialist only
Severe croup (alternative to dexamethasone) 10 mg/kg IV (max 100 mg) Single dose OFF-LABEL; Dexamethasone preferred; use when dexamethasone unavailable
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| eGFR (ml/min/1.73m²) | Recommendation |
| eGFR (ml/min/1.73m²) | Recommendation |
| Haemodialysis | Not significantly dialysed; give after dialysis if timing relevant |
| Peritoneal dialysis | No adjustment; monitor for fluid retention |
Clinical Note: Hydrocortisone has significant mineralocorticoid activity causing sodium and water retention; monitor for fluid overload and hypertension in patients with impaired renal function.
| Severity | Recommendation |
|---|---|
| Mild impairment (Child-Pugh A) | No dose adjustment required |
| Moderate impairment (Child-Pugh B) | Use with caution; standard doses acceptable; monitor for prolonged effect |
| Severe impairment (Child-Pugh C) Consider dose reduction (start at lower end of range) | ; monitor closely for fluid retention and prolonged steroid effects; specialist supervision recommended |
Clinical Note: Hydrocortisone is metabolised hepatically; impaired clearance may lead to accumulation and increased adverse effects.
Parameter Details
Risk Category Relatively safe; preferred corticosteroid in pregnancy when glucocorticoid required
Rationale Extensively metabolised by placental 11β-hydroxysteroid dehydrogenase; minimal fetal exposure compared to dexamethasone/betamethasone
Preferred Alternatives Prednisolone (also extensively metabolised by placenta)
When May Be Used Adrenal insufficiency (essential); severe asthma; autoimmune flares requiring systemic steroids
Monitoring Maternal: BP, blood glucose; Fetal: growth monitoring if prolonged use; Neonatal: observe for adrenal suppression if high maternal doses near delivery
Special Considerations Use stress dosing during labour in women on chronic replacement therapy
Parameter Details
Compatibility Compatible with breastfeeding at physiological replacement doses
Milk Levels Low; minimal transfer into breast milk
Preferred Alternatives Prednisolone (equally acceptable)
Infant Monitoring Growth and weight gain if maternal dose >20 mg/day for prolonged periods; observe for signs of adrenal suppression (rare)
Recommendations Physiological replacement doses safe; high-dose courses (>40 mg/day for >3 weeks) warrant monitoring infant
Parameter Recommendation
Recommended starting dose Use lowest effective dose; start at lower end of dosing range
Titration Slower titration; monitor closely for adverse effects
Extra risks Osteoporosis and fractures (consider bone protection); Hyperglycaemia (may unmask or worsen diabetes); Hypertension and fluid retention (cardiac risk); Proximal myopathy; Skin fragility and poor wound healing; Cognitive effects (confusion, delirium); Increased infection susceptibility
Monitoring More frequent BP, glucose, electrolyte monitoring; bone density if prolonged use anticipated
Interacting Drug Effect Mechanism Recommendation
Rifampicin Marked reduction in hydrocortisone efficacy Strong CYP3A4 induction; accelerates cortisol metabolism Increase hydrocortisone dose by 2–3 fold during rifampicin therapy; monitor for adrenal insufficiency
Phenytoin / Phenobarbital / Carbamazepine Reduced hydrocortisone efficacy CYP3A4 induction May need to increase hydrocortisone dose; monitor clinical response
Ketoconazole / Itraconazole Increased hydrocortisone levels and effects CYP3A4 inhibition + direct adrenal enzyme inhibition Monitor for Cushingoid features; consider dose reduction
Live vaccines (BCG, OPV, MMR, Varicella, Yellow Fever) Risk of disseminated infection Immunosuppression from steroids AVOID during high-dose systemic therapy; defer vaccination until 3 months after stopping high-dose steroids
Warfarin Unpredictable INR changes Altered vitamin K-dependent factor synthesis Monitor INR closely when starting, stopping, or changing hydrocortisone dose
Ritonavir Increased hydrocortisone exposure Strong CYP3A4 inhibition Use with caution; monitor for steroid toxicity
Mifepristone Antagonises glucocorticoid effects Glucocorticoid receptor antagonist Avoid concurrent use in adrenal insufficiency
Interacting Drug Effect Recommendation
NSAIDs Increased risk of GI bleeding and ulceration Use PPI prophylaxis if co-prescription necessary; avoid prolonged concurrent use
Thiazide / Loop diuretics Enhanced hypokalaemia Monitor potassium; supplement if needed
Digoxin Hypokalaemia increases digoxin toxicity risk Monitor potassium and digoxin levels
Oral antidiabetics / Insulin Reduced glycaemic control May need to increase antidiabetic doses; monitor blood glucose frequently
Methotrexate Increased haematological toxicity risk Monitor FBC more frequently
Fluoroquinolones Increased risk of tendinopathy Counsel about tendon symptoms; consider alternatives
Antihypertensives Reduced antihypertensive efficacy May need to uptitrate antihypertensive dose; monitor BP
Amphotericin B Severe hypokalaemia Monitor potassium closely; supplement aggressively
Salicylates (high-dose) Increased salicylate clearance; toxicity on steroid withdrawal Monitor salicylate levels if dose changed
Isoniazid Reduced isoniazid efficacy (mild) Usually clinically insignificant; no routine adjustment needed
Antacids May reduce oral hydrocortisone absorption Separate administration by 2 hours
Adverse Effect Clinical Notes
Adrenal suppression Occurs with supraphysiological doses >2–3 weeks; requires gradual tapering; may be life-threatening if steroids stopped abruptly
Osteoporosis and pathological fractures Risk with chronic use; vertebral and hip fractures; consider bone protection
Avascular necrosis of femoral head Suspect if hip/groin pain; MRI for diagnosis
Steroid-induced psychosis Dose-related; may occur at any point; requires dose reduction or cessation
Opportunistic infections Reactivation of TB, fungal infections, Strongyloides hyperinfection
Peptic ulcer with perforation/haemorrhage Especially with concurrent NSAIDs
Posterior subcapsular cataracts With prolonged use
Steroid-induced glaucoma Monitor intraocular pressure in susceptible individuals
Growth suppression In children; use minimum effective dose
Cushing's syndrome (iatrogenic) Truncal obesity, moon face, striae, buffalo hump
Hyperglycaemia / New-onset diabetes May require antidiabetic therapy
Severe hypokalaemia Especially with concurrent diuretics; cardiac arrhythmia risk
Anaphylaxis Rare; usually to excipients in injectable preparations; requires immediate discontinuation
| Timing | Parameters |
|---|---|
| Baseline | Weight, BP, fasting glucose, electrolytes (Na, K), bone density (DEXA) if long-term use planned; baseline ophthalmology if high-dose or prolonged use anticipated |
Short-term use (<2 weeks) Blood glucose (especially in diabetics); BP; clinical response
During initiation/dose change Glucose monitoring (particularly first 48–72 hours in hospitalised patients); electrolytes; clinical signs of fluid overload
Long-term use (>3 months) DEXA scan (baseline and every 1–2 years); annual ophthalmology review (cataracts, glaucoma); HbA1c or fasting glucose every 3–6 months; height velocity in children; BP at each visit
Adrenal function ACTH stimulation test if prolonged supraphysiological doses and need to assess adrenal recovery before tapering
Infection surveillance Mantoux/IGRA before starting if high-dose planned in TB-endemic areas; low threshold for investigating infections
Oral Preparations
| Brand Name | Manufacturer | Strengths Available |
|---|---|---|
| Hisone | Samarth Pharma | 5 mg, 10 mg, 20 mg tablets |
Cortef Pfizer (limited availability) 5 mg, 10 mg, 20 mg tablets
Hydrocort Various 10 mg, 20 mg tablets
Injectable Preparations
| Brand Name | Manufacturer | Strengths Available |
|---|---|---|
| Solu-Cortef | Pfizer | 100 mg, 250 mg vials |
Hydrocortisone Sodium Succinate Various (Samarth, Cadila) 100 mg, 250 mg vials
Lycort Lyca Pharma 100 mg vial
Efcorlin GSK/Various 100 mg, 250 mg vials
Topical Preparations
| Brand Name | Manufacturer | Strengths Available |
|---|
Cortisone (cream/ointment) Various 1%
Hydro-C Various 1% cream
Wycort Wyeth (limited) 1% cream
Rectal Preparations
| Formulation | Approximate Price (per tablet) |
|---|---|
| Tablets 10 mg (strip of 10) | ₹40–80 Variable availability |
| Tablets 20 mg (strip of 10) | ₹60–120 |
| Injection 100 mg vial | ₹50–120 |
| Injection 250 mg vial | ₹100–180 |
| Topical cream 1% (15 g) | ₹30–80 |
hydrocortisone; corticosteroid; glucocorticoid; adrenal-insufficiency; Addison-disease; CAH; adrenal-crisis; septic-shock; stress-dosing; NLEM-India; pregnancy-safe; paediatrics; steroid-replacement
RxIndia v1.0 — 27 Jan 2025
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