Schedule H

Oral, Intravenous (IV), Intramuscular (IM), Topical, Ophthalmic, Intra-articular

• Tablets: 0.5 mg, 0.75 mg, 4 mg

• Injection: 4 mg/mL (1 mL, 2 mL ampoules), 8 mg/2 mL

• Eye drops: 0.1% (5 mL, 10 mL)

• Eye ointment: 0.1%

• Topical cream/ointment: 0.05%, 0.1%

• Inhalation solution/Respules: Limited availability in India

Fixed-Dose Combinations (FDCs) Available:

• Dexamethasone + Neomycin + Polymyxin B (ophthalmic)

• Dexamethasone + Chloramphenicol (ophthalmic)

• Dexamethasone + Ciprofloxacin (ophthalmic/otic)

• Dexamethasone + Clotrimazole (topical)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. COVID-19 (Hospitalised Patients Requiring Supplemental Oxygen)

Per ICMR/AIIMS COVID-19 Management Guidelines

Parameter Dose

Starting dose 6 mg IV or oral once daily

Titration Not applicable — fixed dose regimen

Usual maintenance dose 6 mg once daily

Maximum dose 6 mg/day

Duration: 5–10 days (up to 10 days or until discharge, whichever is earlier)

Clinical Notes:

• Proven mortality benefit in RECOVERY trial; endorsed by ICMR and AIIMS

• Use ONLY in patients requiring oxygen (SpO2 <94% on room air) or on ventilatory support

• Do NOT use in mild COVID-19 without hypoxia — may worsen outcomes

• May be given IV initially, switching to oral when stable

• Monitor for secondary infections, hyperglycaemia

1. Cerebral Oedema (Associated with Brain Tumours, CNS Infections, Head Injury)

Loading Dose:

Parameter Dose

Starting dose 10 mg IV stat (or 8–12 mg)

Titration Not applicable for loading

Maintenance:

Parameter Dose

Starting dose 4 mg IV every 6 hours

Titration Taper based on clinical response once oedema controlled

Usual maintenance dose 4 mg IV/oral every 6–8 hours

Maximum dose 24 mg/day (higher doses rarely needed)

Duration: 5–14 days depending on aetiology; taper over 5–7 days once improvement noted

Clinical Notes:

• Effective for vasogenic oedema (tumours, infections); less effective for cytotoxic oedema (stroke)

• Begin taper as soon as clinically feasible to minimise steroid adverse effects

• Switch to oral route when patient able to take orally

• For bacterial meningitis: see specific dosing under indications

1. Acute Asthma Exacerbation / Severe COPD Exacerbation

Parameter Dose

Starting dose 4–8 mg IV/IM every 8–12 hours

Titration Not applicable — short-term use

Usual maintenance dose 4–8 mg IV/IM twice daily initially; then 4 mg oral once or twice daily

Maximum dose 16 mg/day

Duration: IV for 48–72 hours; oral switch and taper over 5–7 days

Clinical Notes:

• Prednisolone 40–50 mg/day oral often preferred for asthma exacerbations (more evidence)

• Dexamethasone useful when IV route required or patient cannot swallow

• Equivalent anti-inflammatory dose: 6 mg dexamethasone ≈ 40 mg prednisolone

• No taper needed if course ≤5 days

1. Chemotherapy-Induced Nausea and Vomiting (CINV) — Prophylaxis and Treatment

High Emetogenic Chemotherapy (HEC):

Parameter Dose

Starting dose 12–20 mg IV/oral before chemotherapy (Day 1)

Titration Not applicable

Usual maintenance dose 8 mg oral once or twice daily (Days 2–4)

Maximum dose 20 mg on Day 1; 8 mg twice daily on subsequent days

Moderate Emetogenic Chemotherapy (MEC):

Parameter Dose

Starting dose 8–12 mg IV/oral before chemotherapy

Titration Not applicable

Usual maintenance dose 4–8 mg oral once daily (Days 2–3)

Maximum dose 12 mg/day

Clinical Notes:

• Use in combination with 5-HT3 antagonists (ondansetron) ± NK1 antagonists (aprepitant)

• Single-dose regimens may be sufficient for some protocols

PAEDIATRIC DOSING (Specialist Only)

⚠️ Steroid use in neonates should be under specialist supervision only due to risks of neurodevelopmental effects, infections, and adrenal suppression.

Primary Indications

1. Croup (Laryngotracheobronchitis)

Parameter Dose

Starting dose 0.15–0.6 mg/kg oral/IM as single dose

Titration Not applicable — single dose usually sufficient

Usual maintenance dose Not applicable

Maximum dose 12 mg (single dose)

Clinical Notes:

• Single dose highly effective; repeat dosing rarely needed

• 0.6 mg/kg is standard dose in most IAP/Indian protocols

• If unable to tolerate oral: give IM or use nebulised budesonide as alternative

• Onset of action: 1–2 hours; may use nebulised adrenaline for immediate relief in severe cases

1. Acute Severe Asthma / Bronchospasm

Parameter Dose

Starting dose 0.15–0.3 mg/kg IV/IM/oral

Titration Not applicable for acute use

Usual maintenance dose 0.15–0.3 mg/kg/day in 1–2 divided doses

Maximum dose 6 mg/dose; 12 mg/day

Duration: 3–5 days; no taper needed for short course

Clinical Notes:

• Prednisolone 1–2 mg/kg/day oral often preferred (more paediatric data)

• Dexamethasone useful when IV required or if vomiting

• Single-dose or 2-day dexamethasone regimens increasingly used for acute asthma

1. Bacterial Meningitis (Adjunctive)

Parameter Dose

Starting dose 0.15 mg/kg IV

Titration Not applicable

Usual maintenance dose 0.15 mg/kg IV every 6 hours

Maximum dose 10 mg every 6 hours (adult equivalent)

Duration: 4 days; give before or with first antibiotic dose

Clinical Notes:

• Start BEFORE or WITH first antibiotic dose — delayed administration reduces benefit

• Best evidence for S. pneumoniae and H. influenzae type b meningitis

• Per IAP and ICMR guidelines

1. Congenital Adrenal Hyperplasia (CAH) — Replacement Therapy

Parameter Dose

Starting dose 0.25–0.5 mg/m²/day oral in 1–2 divided doses

Titration Adjust based on 17-OHP levels, growth, bone age

Usual maintenance dose 0.25–0.5 mg/m²/day

Maximum dose Individualised; avoid over-replacement

Clinical Notes:

• Hydrocortisone preferred in growing children (less growth-suppressive)

• Dexamethasone may be used in post-pubertal patients or those with poor compliance (once-daily dosing)

• Add fludrocortisone if salt-wasting form

• Specialist (Paediatric Endocrinology) supervision mandatory

1. Chemotherapy Protocols (Leukaemia, Lymphoma)

Parameter Dose

Starting dose Protocol-specific (typically 6–10 mg/m²/day)

Titration Per protocol

Usual maintenance dose Protocol-specific

Maximum dose Protocol-specific (may exceed usual limits)

Clinical Notes:

• Used in induction, consolidation phases of ALL protocols

• Specialist (Paediatric Oncology) supervision mandatory

• Monitor for hyperglycaemia, infections, mood changes, myopathy

Age-Based Dosing Reference (Croup/Asthma):

Age/Weight Single Dose (Croup) Asthma Dose (Daily)

6–12 months 1–2 mg 1–1.5 mg/day

1–2 years 2–3 mg 1.5–2 mg/day

Note: Monitor for fluid retention and electrolyte disturbances (hypokalaemia) in patients with renal impairment on long-term therapy.

Note: Dexamethasone is hepatically metabolised via CYP3A4. Significant hepatic impairment may prolong half-life and increase toxicity risk.

• Known hypersensitivity to dexamethasone or any corticosteroid

• Systemic fungal infections (unless being treated with specific antifungals)

• Cerebral malaria (may worsen outcome)

• Administration of live or live-attenuated vaccines during immunosuppressive doses

• Untreated systemic bacterial, viral, or parasitic infections (unless corticosteroid is part of treatment protocol)

• Idiopathic thrombocytopenic purpura (IM injection contraindicated)

• Herpes simplex keratitis (for ophthalmic use)

• Diabetes mellitus — may significantly worsen glycaemic control; monitor blood glucose

• Hypertension — may exacerbate; monitor BP

• Heart failure — fluid retention may worsen symptoms

• Osteoporosis or risk factors for bone loss — consider bone protection if prolonged use

• Peptic ulcer disease or history of GI bleeding — increased risk of GI complications

• Psychiatric disorders (depression, psychosis, mania) — may precipitate or exacerbate

• Glaucoma — may increase intraocular pressure

• Myasthenia gravis — initial worsening possible before improvement

• Thyroid disorders — may alter thyroid function tests

• Active or latent tuberculosis — may reactivate; screen before prolonged use

• Strongyloides infection risk (endemic areas/immigrants) — screen before high-dose steroids

• Concurrent anticoagulant therapy — increased bleeding risk

• Recent myocardial infarction — myocardial rupture reported

• Immunocompromised patients — increased infection risk

• Children — growth suppression with prolonged use

• Abrupt withdrawal after prolonged use — risk of adrenal crisis

Parameter Information

Overall Safety Use only if benefit outweighs risk; crosses placenta

Risk First trimester: possible slight increase in orofacial cleft risk (data inconclusive); later pregnancy: generally well-tolerated short courses

Preferred Alternatives Prednisolone or prednisone preferred for long-term use (greater placental metabolism, less fetal exposure)

Specific Indication Fetal lung maturation (24–34 weeks): 6 mg IM every 12 hours × 4 doses; alternative to betamethasone

When Use May Be Justified Severe maternal illness (asthma, ARDS, COVID-19); fetal lung maturation; obstetric specialist supervision

Monitoring Maternal: blood glucose, BP, signs of infection; Fetal: growth if chronic exposure; Neonatal: glucose, adrenal function after maternal exposure

Parameter Information

Compatibility Generally compatible with breastfeeding for short courses

Expected Drug Level in Milk Low (corticosteroids present in small amounts)

Risk to Infant Minimal with short-term maternal use; theoretical risk of adrenal suppression with high-dose prolonged exposure

Preferred Alternatives Prednisolone may be preferred (more data; greater maternal metabolism)

Infant Monitoring Growth, feeding, signs of adrenal insufficiency (rare) with prolonged high-dose maternal therapy

Recommendation Short courses acceptable; for prolonged high-dose use, consider alternatives or monitor infant

Parameter Recommendation

Starting dose Use lowest effective dose (typically lower end of dose range)

Titration Slower titration and taper; elderly more susceptible to adverse effects

Increased Risks Osteoporosis and fractures; hyperglycaemia and new-onset diabetes; hypertension; fluid retention and heart failure exacerbation; infections (including reactivation TB); delirium and psychiatric disturbance; GI bleeding (especially with NSAIDs); myopathy; cataracts; skin fragility

Additional Precautions Consider bone protection (calcium, vitamin D, bisphosphonate) for courses >3 months; monitor glucose; use PPI if GI risk factors; avoid NSAIDs if possible

Interacting Drug Mechanism Effect Management

Rifampicin, Rifabutin Strong CYP3A4 induction Significantly reduced dexamethasone levels and efficacy (may need 2–3× dose) Increase dexamethasone dose; monitor clinical response; consider alternative steroid

Phenytoin, Carbamazepine, Phenobarbital CYP3A4 induction Reduced dexamethasone efficacy May need dose increase; monitor response

Ketoconazole, Itraconazole CYP3A4 inhibition Increased dexamethasone levels and toxicity Use with caution; monitor for steroid adverse effects; reduce dose if necessary

Ritonavir, Cobicistat Strong CYP3A4 inhibition Markedly increased dexamethasone exposure; Cushing syndrome risk Avoid if possible; if essential, reduce dexamethasone dose significantly; monitor closely

Live Vaccines (BCG, OPV, MMR, Varicella, Yellow Fever) Immunosuppression Risk of disseminated vaccine infection Avoid live vaccines during high-dose immunosuppressive therapy and for 3 months after

NSAIDs Additive GI toxicity Significantly increased risk of peptic ulceration and GI bleeding Avoid combination if possible; if essential, co-prescribe PPI; monitor for GI symptoms

Warfarin and other Vitamin K Antagonists Unclear mechanism; variable effect on INR May increase or decrease anticoagulant effect Monitor INR closely when starting, stopping, or changing dexamethasone dose

Interacting Drug Effect Management

Insulin, Oral Antidiabetics Corticosteroids antagonise glucose-lowering effect Monitor blood glucose frequently; adjust antidiabetic doses as needed

Antihypertensives Corticosteroids may reduce efficacy (fluid retention, vasoconstriction) Monitor BP; may need antihypertensive dose adjustment

Diuretics (Thiazides, Loop) Additive hypokalaemia Monitor potassium; supplement if needed

Digoxin Steroid-induced hypokalaemia may increase digoxin toxicity Monitor potassium and digoxin levels

Amphotericin B Additive hypokalaemia Monitor potassium closely; supplement as needed

Fluoroquinolones (Ciprofloxacin, Levofloxacin) Increased risk of tendon rupture Use with caution; advise patient to report tendon pain

Cyclosporine, Tacrolimus Mutual inhibition of metabolism; possible additive immunosuppression Monitor drug levels; watch for toxicity of both agents

Aspirin (Anti-inflammatory doses) Additive GI bleeding risk; steroids may increase aspirin clearance Co-prescribe PPI; monitor for GI symptoms; may need aspirin dose adjustment

Oestrogens / Oral Contraceptives May increase corticosteroid effect (reduced clearance) Monitor for steroid adverse effects

Neuromuscular Blocking Agents (Pancuronium, Vecuronium) May enhance or prolong neuromuscular blockade Use with caution in ICU setting

Short-term Use (<2 weeks):

• Hyperglycaemia

• Insomnia

• Increased appetite, weight gain

• Mood changes (euphoria, irritability, anxiety)

• Dyspepsia, gastritis

• Fluid retention, facial flushing

• Increased energy/restlessness

Long-term Use:

• Cushingoid features (moon face, buffalo hump, central obesity)

• Skin thinning, easy bruising, striae

• Muscle weakness (proximal myopathy)

• Hypertension

• Hypokalaemia

• Immunosuppression, increased infection risk

• Acne

• Hirsutism

• Menstrual irregularities

Adverse Effect Clinical Action

Adrenal Suppression / Adrenal Crisis (on abrupt withdrawal after prolonged use) Never stop abruptly after >7–10 days use; taper gradually; stress-dose steroids during illness/surgery

Peptic Ulcer with Haemorrhage/Perforation Consider PPI prophylaxis in high-risk patients; discontinue if severe GI symptoms; endoscopy if bleeding

Avascular Necrosis (Osteonecrosis) (especially femoral head) High-dose/prolonged use; investigate hip pain; MRI for diagnosis; orthopaedic referral

Severe Infections / TB Reactivation / Opportunistic Infections Screen for latent TB before prolonged use; maintain high suspicion for infection (fever may be masked)

Hyperglycaemia / New-Onset Diabetes / DKA Monitor glucose; treat with insulin if needed; may require admission in severe cases

Severe Psychiatric Reactions (psychosis, severe depression, mania, suicidal ideation) May require dose reduction or discontinuation; psychiatric consultation

Posterior Subcapsular Cataract / Glaucoma Ophthalmologic evaluation for chronic use; may need treatment

Osteoporotic Fractures Bone protection for prolonged use; DEXA scan; treat osteoporosis

Growth Suppression in Children Use lowest effective dose; alternate-day therapy if possible; monitor growth

Myopathy (Steroid Myopathy) Proximal weakness; CK usually normal; reduce dose; physiotherapy

SJS/TEN (rare) Discontinue immediately; dermatology consultation; hospitalisation

Anaphylaxis (rare, especially with IV) Discontinue; emergency management

Short-term use (<2 weeks) Blood glucose (daily if diabetic or hospitalised); BP; clinical assessment for adverse effects

After initiation of prolonged therapy (2–4 weeks) Blood glucose; electrolytes; BP; weight; signs of infection; mood/behaviour

Long-term use (every 1–3 months) Blood glucose/HbA1c; BP; weight; potassium; signs of Cushing syndrome; infections; mood; growth (children); DEXA annually; ophthalmologic examination annually

Before discontinuation Assess HPA axis suppression (if >2 weeks use); plan taper; educate on stress dosing

Tablets:

• Dexona™ (Zydus Cadila) — 0.5 mg, 4 mg

• Decadron™ — 0.5 mg

• Dexameth™ (Cadila) — 0.5 mg

• Wysolone-D™ — 0.5 mg

• Generic dexamethasone — 0.5 mg, 4 mg

Injection:

• Dexona™ Injection (Zydus) — 4 mg/mL

• Decmax™ (Mankind) — 4 mg/mL

• Dexamethasone Injection™ (Various) — 4 mg/mL, 8 mg/2mL

Ophthalmic:

• MaxDex™ Eye Drops — 0.1%

• Dexacort™ Eye Drops — 0.1%

• Various FDCs (Dexamethasone + antibiotic)

Topical:

• Desowen™ (though this is desonide, often confused)

• Various FDC topical preparations

0.5 mg tablet ₹0.80–₹3.00 per tablet —

0.1% eye drops (5 mL) ₹25–₹60 —

Regulatory: Injectable formulation listed under NLEM 2022; NPPA price controlled for scheduled formulations; widely available in government supply

1. COVID-19: oxygen-dependent only — Dexamethasone 6 mg/day reduces mortality in hypoxic COVID-19 patients; do NOT use in mild cases without hypoxia — may be harmful

1. Tapering after prolonged use — HPA axis suppression occurs after >7–10 days of systemic steroids; taper gradually (reduce by 10–20% every few days to weeks depending on duration/dose); abrupt withdrawal may precipitate adrenal crisis

1. Meningitis timing critical — Give dexamethasone BEFORE or WITH the first antibiotic dose; benefit lost if started after antibiotics

1. Equivalent potency — Dexamethasone is ~6–7× more potent than prednisolone; 6 mg dexamethasone ≈ 40 mg prednisolone (anti-inflammatory equivalence)

1. GI protection — Co-prescribe PPI in patients on high-dose steroids, elderly, or those with history of peptic ulcer or concurrent NSAID/anticoagulant use

1. Drug interactions with TB treatment — Rifampicin significantly reduces dexamethasone efficacy; may need 2–3× usual dose to achieve clinical effect in patients on anti-TB therapy

corticosteroid; glucocorticoid; dexamethasone; cerebral-oedema; COVID-19; meningitis; CINV; asthma; croup; adrenal-insufficiency; NLEM-India; HPA-suppression; immunosuppression; Schedule-H

RxIndia v1.1 — 02 Apr 2025

• CDSCO Product Information

• Indian Pharmacopoeia (IP)

• National List of Essential Medicines (NLEM) 2022

• ICMR COVID-19 Management Guidelines

• AIIMS COVID-19 Treatment Protocol

• API Textbook of Medicine

• AIIMS and PGIMER Protocols for Cerebral Oedema

• Harrison's Principles of Internal Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• IAP Guidelines (Croup, Asthma, Meningitis)

• MoHFW National Asthma and COPD Treatment Modules

• RECOVERY Trial (NEJM 2020) — COVID-19 evidence

• DEXA-ARDS Trial — ARDS evidence (off-label)

• European Society of Medical Oncology (ESMO) Antiemetic Guidelines — CINV evidence