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Authoritative Clinical Reference
Schedule H
Oral, Parenteral, Ophthalmic
Form Strengths
Oral Tablets 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg
Oral Dispersible Tablets 5 mg, 10 mg, 20 mg
Oral Syrup/Suspension 5 mg/5 mL, 15 mg/5 mL
Injection (Prednisolone Sodium Phosphate) 20 mg/mL, 30 mg/mL (for IV/IM use)
Eye Drops 0.5%, 1% w/v
Eye Ointment 0.5% w/w
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Parameter Details
Starting dose 40–60 mg orally once daily (or in 2 divided doses)
Titration Not applicable for short courses
Usual maintenance dose Not applicable (short-term use only)
Maximum dose 60 mg/day
Duration 5–10 days
Clinical notes No taper required if duration <14 days. Give in morning to reduce insomnia. If oral route not feasible, use Prednisolone sodium phosphate 1 mg/kg IV/IM daily (max 60 mg).
Parameter Details
Starting dose 0.5–1 mg/kg/day orally in single or divided doses
Titration Taper gradually based on clinical and serological response; reduce by 5–10 mg every 1–2 weeks once stable
Usual maintenance dose 5–10 mg/day
Maximum dose 80 mg/day
Duration Long-term; guided by disease activity
Clinical notes Initiate steroid-sparing agents (e.g., azathioprine, mycophenolate) early. Monitor for cushingoid features and adrenal suppression.
Parameter Details
Starting dose 40–60 mg orally once daily
Titration Taper by 5 mg/week once clinical remission achieved
Usual maintenance dose Not recommended for maintenance; transition to steroid-sparing agents
Maximum dose 60 mg/day
Duration 4–8 weeks
Clinical notes In hospitalized patients unable to take orally, consider IV methylprednisolone. Plan transition to 5-ASA or immunomodulators.
Parameter Details
Starting dose 1 mg/kg/day orally (max 80 mg/day)
Titration Continue full dose for 8–12 weeks, then taper over 6–8 weeks
Usual maintenance dose 5–10 mg/day or alternate-day dosing as guided by relapse pattern
Maximum dose 80 mg/day
Duration Initial course 4–6 months; maintenance as needed
Clinical notes Frequent relapsers may require steroid-sparing agents (cyclophosphamide, tacrolimus, rituximab). Monitor for steroid toxicity.
Parameter Details
Starting dose 10–20 mg orally once daily
Titration Taper to lowest effective dose as DMARDs take effect (usually over 4–8 weeks)
Usual maintenance dose 5–7.5 mg/day (if long-term use unavoidable)
Maximum dose 20 mg/day for bridge therapy
Duration Short-term until DMARDs effective
Clinical notes Not disease-modifying; use as bridge only. Initiate calcium + vitamin D supplementation. Consider bisphosphonate if prolonged use anticipated.
Parameter Details
Starting dose 30–40 mg orally once daily
Titration Not applicable
Usual maintenance dose Not applicable (short-term use)
Maximum dose 40 mg/day
Duration 3–7 days
Clinical notes No taper required for courses <7 days. Address underlying cause.
Parameter Details
Starting dose 10–100 mg IV initially
Titration 5–60 mg IV/IM every 6–8 hours based on clinical response
Usual maintenance dose Individualized; transition to oral when feasible
Maximum dose 100 mg/dose (initial)
Duration Transient use until cause-specific treatment initiated
Clinical notes Dexamethasone often preferred for cerebral edema due to minimal mineralocorticoid activity. Use prednisolone if dexamethasone unavailable.
Secondary Indications — Adults (Off-label)
Indication Dose Duration Notes
PAEDIATRIC DOSING (Specialist Only)
⚠️ Not recommended below 1 year of age except under paediatric specialist supervision.
Primary Indications — Paediatric
Phase Dose Duration
Induction 2 mg/kg/day orally (max 60 mg/day) in single or divided doses 6 weeks
Consolidation 1.5 mg/kg (max 40 mg) on alternate days 6 weeks
Taper Gradual reduction over next 4–6 weeks As tolerated
Parameter Details
Starting dose 2 mg/kg/day (max 60 mg/day)
Titration Shift to alternate-day after 6 weeks induction
Usual maintenance dose 0.5–1 mg/kg alternate days in frequent relapsers
Maximum dose 60 mg/day
Monitoring Growth parameters, blood pressure, blood glucose, weight, ophthalmology review if prolonged therapy
Clinical notes Based on IAP Nephrotic Syndrome Guidelines. Consider steroid-sparing agents for frequent relapsers or steroid-dependent cases.
Parameter Details
Starting dose 1–2 mg/kg/day orally (max 60 mg/day)
Titration Not applicable
Usual maintenance dose Not applicable (short-term use)
Maximum dose 60 mg/day
Duration 3–5 days
Clinical notes No taper required for courses <7 days. Oral prednisolone as effective as IV methylprednisolone for most cases.
Parameter Details
Starting dose 0.5–1 mg/kg/day orally in single or divided doses
Titration Taper as DMARDs become effective
Usual maintenance dose Aim for discontinuation
Maximum dose 60 mg/day
Duration Short-term bridge (4–8 weeks)
Clinical notes Specialist-guided. Monitor growth velocity. Use with DMARDs.
Secondary Indications — Paediatric (Off-label)
Indication Dose Duration Notes
Autoimmune Hepatitis 2 mg/kg/day orally (max 60 mg), then gradual taper Months to years OFF-LABEL. SPECIALIST ONLY. Based on Indian paediatric gastroenterology practice.
Paediatric Crohn's Disease Flare 1 mg/kg/day orally (max 40 mg), taper over 8–12 weeks 8–12 weeks OFF-LABEL. SPECIALIST ONLY. Transition to steroid-sparing therapy.
Infantile Spasms (if ACTH unavailable) 2–4 mg/kg/day orally in 2–3 divided doses 2–4 weeks, then taper OFF-LABEL. SPECIALIST ONLY. Based on paediatric neurology practice.
| eGFR (ml/min/1.73m²) | Recommendation |
|---|
Mild to severe impairment No dose adjustment required
Dialysis (HD/PD) Not significantly dialyzed; no supplemental dose needed
Note: Use lowest effective dose in nephrotic syndrome relapses. Monitor for fluid retention and hypertension, which may be exacerbated in renal impairment.
| Severity | Recommendation |
|---|---|
| Mild impairment (Child-Pugh A) | Use with caution; no specific dose reduction. Monitor glucose and electrolytes. |
| Moderate impairment (Child-Pugh B) | Use lowest effective dose; enhanced systemic effects possible due to reduced metabolism. |
| Severe impairment (Child-Pugh C) | Avoid unless essential; risk of enhanced toxicity. Specialist supervision recommended. |
Parameter Details
Risk category Use with caution; generally considered low-risk, especially after 1st trimester
Indian guidance May be used when benefit outweighs risk (e.g., SLE flare, severe asthma, autoimmune disease)
Preferred alternatives Prednisolone preferred over dexamethasone/betamethasone for maternal conditions (lower fetal exposure due to placental metabolism)
When it may be used Life-threatening maternal conditions, autoimmune diseases, severe asthma exacerbations
Monitoring Maternal: blood glucose, blood pressure. Fetal: growth monitoring if prolonged use; neonatal adrenal function if high doses near delivery
Parameter Details
Compatibility Compatible with breastfeeding at doses ≤40 mg/day
Drug levels in milk Low to moderate; minimal infant exposure at usual doses
Preferred alternatives Prednisolone preferred over longer-acting steroids
Timing advice Administer immediately after breastfeeding to minimize infant exposure
Infant monitoring Growth, feeding pattern; signs of adrenal suppression only if prolonged high doses (>40 mg/day)
Parameter Recommendation
Starting dose Same as adults, but aim for lowest effective dose
Titration Slower titration; assess response carefully before dose increases
Special considerations Higher risk of: osteoporotic fractures, hyperglycaemia, hypertension, delirium, muscle wasting, skin thinning, infections, delayed wound healing
Monitoring Bone density (DEXA), blood glucose, blood pressure, cognitive status
Prophylaxis Consider calcium + vitamin D ± bisphosphonate for prolonged use
Interacting Drug Effect Recommendation
NSAIDs (including aspirin) Markedly increased risk of GI ulceration and bleeding Avoid combination if possible; if essential, use PPI prophylaxis
Rifampicin Hepatic enzyme induction reduces prednisolone efficacy by 50–65% Increase prednisolone dose (may need to double); monitor clinical response
Live vaccines (BCG, OPV, MMR, Varicella) Risk of disseminated infection; impaired vaccine response Contraindicated during high-dose therapy (≥20 mg/day for ≥14 days)
Ketoconazole CYP3A4 inhibition increases prednisolone levels Monitor for steroid toxicity; consider dose reduction
Ritonavir and other strong CYP3A4 inhibitors Increased steroid exposure; risk of Cushing syndrome and adrenal suppression Avoid combination if possible
Interacting Drug Effect Recommendation
Antidiabetic agents (insulin, OHAs) Steroid-induced hyperglycaemia reduces efficacy Monitor blood glucose; adjust antidiabetic dose as needed
Antihypertensives Fluid retention may worsen BP control Monitor blood pressure; adjust antihypertensive if needed
Warfarin Variable effect on INR (usually increased) Monitor INR closely during initiation and dose changes
Cyclosporine Mutual enhancement of toxicity; increased seizure risk Monitor cyclosporine levels; watch for neurotoxicity
Phenytoin, carbamazepine, phenobarbital Enzyme induction reduces steroid efficacy May need increased prednisolone dose
Diuretics (loop, thiazides) Additive hypokalaemia Monitor potassium levels
Fluoroquinolones Increased tendon rupture risk Use with caution; counsel patient
Adverse Effect Clinical Action
Adrenal suppression/crisis Gradual taper mandatory if used >14 days; stress-dose steroids during illness/surgery
Osteonecrosis (avascular necrosis of femoral head) Discontinue if hip/joint pain develops; MRI for diagnosis
Severe infections (including TB reactivation) Screen for latent TB before prolonged therapy; high index of suspicion for atypical infections
Peptic ulcer perforation/GI bleeding Immediate surgical consultation if suspected
Steroid-induced psychosis May require dose reduction or antipsychotic therapy
Proximal myopathy Consider dose reduction; physiotherapy
Posterior subcapsular cataract Ophthalmology referral for prolonged use
Glaucoma Monitor IOP in at-risk patients
Phase Parameters
Baseline Blood pressure, blood glucose (fasting), weight, height (children), LFTs, lipid profile, serum electrolytes, TB screening (Mantoux/IGRA in high-risk), bone density (DEXA if prolonged use anticipated)
During therapy Blood glucose (weekly if diabetic or at-risk), blood pressure, weight, symptoms of infection, mood changes, GI symptoms
Long-term (>3 months) DEXA scan, ophthalmology review (cataract, glaucoma), growth monitoring in children, HbA1c
Tapering Gradual taper if used >14 days to avoid adrenal crisis; assess for symptoms of adrenal insufficiency
| Formulation | Approximate Price (per tablet) |
|---|---|
| Tablets 5 mg ₹0.50–₹2 per tablet | |
| Tablets 10 mg ₹1–₹3 per tablet | |
| Tablets 20 mg ₹2–₹5 per tablet | |
| Tablets 40 mg ₹4–₹8 per tablet | |
| Syrup 5 mg/5 mL (60 mL) ₹20–₹45 per bottle | |
| Injection 30 mg/mL ₹30–₹70 per ampoule | |
| Eye drops 1% (5 mL) ₹25–₹60 per bottle |
Note: Not under NLEM price control as of 2023. Government supply prices significantly lower.
Prednisolone; glucocorticoid; corticosteroid; asthma; nephrotic syndrome; autoimmune diseases; SLE; rheumatoid arthritis; immunosuppression; adrenal suppression; tapering; paediatrics; pregnancy-caution
RxIndia v1.0 — 13 Jun 2025
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