PREDO 5/MG TAB 30/TAB

Indications

Approved Uses

Systemic corticosteroid for suppression of inflammation/allergy and for replacement therapy in adrenocortical insufficiency; used across many conditions (e.g., asthma/COPD exacerbations, rheumatoid/autoimmune diseases, dermatologic and ocular inflammation, inflammatory bowel disease, nephrotic syndrome, hematologic immune disorders, and certain malignancies) per local label/clinical use.

Off-Label Uses

Common off-label uses include Bell’s palsy and cluster headache; other uses depend on local protocols (e.g., adjunct in Pneumocystis jirovecii pneumonia, croup) and COVID-19 protocols typically prefer dexamethasone rather than prednisolone.

Dosage & Administration

Dosing by Condition

Dosing is individualized by indication and severity; typical adult initial total daily dose ranges 5-60 mg/day (single morning dose or divided), then taper to the lowest effective dose; pediatric dosing is weight-based (commonly ~0.14-2 mg/kg/day in divided doses) per indication-specific guidelines.

Initial Dose

5-60mg per day, depending on the severity of the condition. [10, 31]

Maintenance Dose

2.5-15mg/day (lowest effective dose)

Maximum Dose

Varies by indication; typical adult range 5-60 mg/day, but short-term high-dose regimens may use ~80-100 mg/day or higher in severe disease under specialist direction (no single universal maximum).

Dose Adjustment Notes

Taper gradually after prolonged therapy to avoid adrenal insufficiency; use the lowest effective dose; increase dose temporarily during significant physiologic stress (e.g., surgery, severe infection) in patients on chronic therapy; no routine renal dose adjustment, and hepatic impairment may increase exposure-use caution and monitor.

How to Take

Oral: take with food or milk to reduce gastrointestinal irritation; swallow with water; if once daily, take in the morning (after breakfast) to better match circadian cortisol and reduce insomnia; follow prescriber directions and do not stop abruptly after prolonged use.

Side Effects

Common Side Effects

Increased appetite, weight gain, fluid retention/edema, insomnia, mood changes, dyspepsia/indigestion, hyperglycemia, hypertension, acne, increased sweating, headache.

Side Effect Frequency

Common/very common (especially dose- and duration-dependent): increased appetite, weight gain, hyperglycemia, dyspepsia/GI upset, insomnia, mood changes, fluid retention/edema and hypertension; with longer-term use: osteoporosis, adrenal suppression, cataract/glaucoma, myopathy, skin thinning/bruising, and increased infection risk; rare but serious: peptic ulcer/GI bleeding, psychosis, avascular necrosis, opportunistic infections.

Safety & Warnings

Contraindications

Systemic fungal infection; hypersensitivity to prednisolone (or excipients); administration of live/live-attenuated vaccines in patients receiving immunosuppressive doses of systemic corticosteroids.

Warnings & Precautions

Key precautions: increased infection risk/masking of infection (consider TB/strongyloides risk assessment before long-term therapy); avoid live vaccines at immunosuppressive doses; monitor BP, glucose, weight/edema, electrolytes, and eye health with prolonged use; use caution in diabetes, hypertension, heart failure, peptic ulcer disease, osteoporosis, glaucoma/cataracts, and psychiatric history; taper after prolonged/high-dose use; monitor growth in children; consider bone protection for long-term therapy and provide a steroid card/medical alert for chronic use.

Age Restriction

No absolute minimum age; can be used in pediatrics (including infants/neonates) only when clearly indicated and under specialist supervision; monitor growth with prolonged therapy.

Drug Interactions

Drug Interactions

Key interactions: NSAIDs (↑ GI ulcer/bleed risk); warfarin/anticoagulants (variable INR effect-monitor); antidiabetics (↓ glycemic control); CYP3A4 inhibitors e.g., ketoconazole/macrolides (↑ prednisolone exposure); CYP3A4 inducers e.g., rifampicin/phenytoin/carbamazepine (↓ exposure); diuretics/amphotericin B (↑ hypokalemia); ciclosporin (↑ levels/toxicity both ways); live vaccines (avoid/contraindicated at immunosuppressive doses).

Interaction Severity

MAJOR: live vaccines (avoid with immunosuppressive doses/prolonged therapy). MODERATE/CLINICALLY SIGNIFICANT: NSAIDs/aspirin (GI ulcer/bleed), warfarin (INR changes), antidiabetics (hyperglycemia), strong CYP3A inducers e.g., rifampicin (reduced effect), strong CYP3A inhibitors e.g., azoles (increased exposure), diuretics/amphotericin B (hypokalemia), cyclosporine (mutual toxicity), fluoroquinolones (tendon rupture risk). MINOR: antacids may reduce absorption if taken simultaneously (separate dosing).

Food Interaction

Take with food or milk to reduce gastrointestinal irritation; otherwise no specific food restrictions.

Special Populations

Kidney Impairment

No dose adjustment required; use with caution in significant renal impairment due to fluid retention, hypertension, and electrolyte effects.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

Do not stop abruptly after prolonged therapy (typically >2-3 weeks) or high-dose/repeated courses; taper gradually under medical supervision.

Overdose

Acute overdose is usually not life-threatening; may cause GI upset, fluid retention, hypertension, hyperglycemia, mood changes, and electrolyte disturbances; chronic excessive dosing can cause Cushingoid features and adrenal suppression-management is supportive with monitoring (glucose, BP, electrolytes) and medical evaluation.

Patient Counseling

Take with food or milk; take in the morning (single daily dosing) to reduce insomnia/HPA-axis disruption; do not stop abruptly-taper if used beyond a short course; report signs of infection and avoid exposure to chickenpox/measles if non-immune; avoid live vaccines during systemic therapy (and follow clinician advice on timing); monitor blood glucose if diabetic; watch for mood/psychiatric changes, GI upset/bleeding, swelling/weight gain, and vision changes; carry a steroid card/alert if on prolonged or high-dose therapy.

Monitoring Requirements

If prolonged/high-dose therapy: monitor blood pressure, blood glucose, weight, electrolytes (especially potassium), signs of infection, and for long-term use bone health (BMD/osteoporosis risk), eye exams (cataract/glaucoma), growth in children, and adrenal suppression/HPA-axis recovery when tapering.

Pharmacology

Mechanism of Action

Binds intracellular glucocorticoid receptors to alter gene transcription, decreasing pro-inflammatory cytokines/mediators; induces lipocortin to inhibit phospholipase A2, reducing arachidonic-acid-derived prostaglandins and leukotrienes, producing anti-inflammatory and immunosuppressive effects.

Onset of Action

Clinical onset is typically within a few hours; peak plasma levels occur in ~1-2 hours after oral dosing, while maximal anti-inflammatory benefit may take longer depending on condition.

Duration of Effect

Biologic effect typically lasts about 12-36 hours (intermediate-acting glucocorticoid).

Half-Life

Plasma elimination half-life ~2-4 hours (biologic effect duration is longer).

Bioavailability

Approximately 70-90% (commonly cited ~80%).

Metabolism

Primarily hepatic metabolism (CYP3A4 and reduction/oxidation pathways), with interconversion with prednisone via 11β-hydroxysteroid dehydrogenase; metabolites are then conjugated.

Excretion

Primarily renal excretion as inactive metabolites (mainly glucuronide and sulfate conjugates), with a small fraction excreted unchanged.

Protein Binding

High protein binding ~70-90% (to albumin and corticosteroid-binding globulin/transcortin), concentration-dependent.

Product Information

Available Dosage Forms

For this SFDA-registered product: oral tablet 5 mg (blister pack of 30).

Composition per Dose

Each tablet: 5mg prednisolone

Generic Availability

Yes

OTC Alternatives

No true OTC alternative to oral prednisolone (systemic corticosteroid); for mild self-limited allergic symptoms, OTC non-sedating antihistamines (e.g., cetirizine, loratadine) may be used, and for minor pain/fever OTC analgesics (e.g., paracetamol/ibuprofen) may be used if appropriate, but these are not therapeutic substitutes for systemic steroid indications.

Symptom Target

Inflammation, allergy, autoimmune conditions, adrenocortical insufficiency

Sedating

No

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