PREDO 25MG 30 TAB

Indications

Approved Uses

Broadly indicated for conditions requiring systemic corticosteroid anti-inflammatory/immunosuppressive therapy, including severe allergic reactions, asthma/COPD exacerbations, rheumatic/autoimmune diseases (e.g., RA, SLE), dermatologic inflammatory diseases, hematologic immune cytopenias, nephrotic syndrome, inflammatory bowel disease (UC/Crohn’s), certain neurologic relapses (e.g., MS relapse), and as glucocorticoid replacement in adrenocortical insufficiency when appropriate.

Off-Label Uses

Common off-label/adjunct uses include Bell’s palsy, acute multiple sclerosis relapse, adjunctive therapy for Pneumocystis jirovecii pneumonia with hypoxemia, and adjunctive therapy in certain severe inflammatory conditions (e.g., pericarditis in selected cases); COVID-19 treatment is guideline-based with dexamethasone preferred, while prednisolone may be used as an alternative only when equivalent glucocorticoid dosing is required and dexamethasone is unavailable.

Dosage & Administration

Dosing by Condition

Typical oral prednisolone ranges (adults) vary by indication: many inflammatory/allergic conditions 5-60 mg/day (often once daily); acute asthma/COPD exacerbation commonly 40-60 mg/day for ~5-7 (up to 14) days; pediatric acute asthma/allergy often 1-2 mg/kg/day (max 60 mg/day) for ~3-5 days; longer-term autoimmune diseases use the lowest effective dose with tapering per response.

Initial Dose

10-20mg/day for mild-moderate conditions; 40-60mg/day for severe inflammatory or autoimmune conditions

Maintenance Dose

Adjusted to the lowest dose that maintains an adequate clinical response.

Maximum Dose

Children: 0.14-2 mg/kg/day (max 60 mg/day); Adults: 5-60 mg/day depending on condition

Children's Dosage

0.5-2mg/kg/day (max 40-60mg/day) depending on indication; nephrotic syndrome: 60mg/m²/day; croup: single dose 1-2mg/kg; taper required for courses >7 days

Dose Adjustment Notes

Dose must be individualized to indication and response; use the lowest effective dose for the shortest duration; taper gradually after prolonged therapy or high doses to prevent adrenal insufficiency; patients on chronic therapy may require stress-dose steroids during major illness/surgery.

How to Take

Oral prednisolone 25 mg tablet: take exactly as prescribed; take with food or milk to reduce GI irritation; if once daily, take in the morning (with breakfast) to better align with circadian cortisol and reduce HPA-axis suppression; swallow with water (do not crush unless clinician advises).

Side Effects

Common Side Effects

Common: increased appetite and weight gain, insomnia, mood changes, dyspepsia/indigestion, fluid retention/edema, hyperglycemia, hypertension, acne and increased sweating; headache and stomach discomfort can occur.

Side Effect Frequency

Common/very common (dose- and duration-dependent): increased appetite, weight gain, fluid retention/edema, hyperglycemia, insomnia, mood changes, dyspepsia. Important less common/serious risks (more likely with higher dose/longer use): hypertension, hypokalemia, increased infection risk, peptic ulcer/GI bleeding, adrenal suppression, osteoporosis/fractures, cataract/glaucoma, avascular necrosis, and steroid-induced psychosis.

Safety & Warnings

Contraindications

Contraindicated in systemic fungal infections and in patients with hypersensitivity to prednisolone/excipients; avoid administration of live vaccines in patients receiving immunosuppressive corticosteroid doses.

Warnings & Precautions

Key precautions: increased infection risk and masking of symptoms; avoid live vaccines at immunosuppressive doses; monitor glucose, blood pressure, weight/edema, and electrolytes; bone protection for long-term therapy (calcium/vitamin D ± other therapy as indicated); psychiatric monitoring; GI risk (consider gastroprotection if high risk); ophthalmic monitoring with prolonged use; and taper after prolonged/high-dose courses (consider steroid card for extended therapy).

Age Restriction

No absolute minimum age; prednisolone can be used in pediatrics (including neonates) when clinically indicated, with specialist oversight and careful monitoring.

Drug Interactions

Drug Interactions

Clinically important interactions include: NSAIDs (↑ GI ulcer/bleed), warfarin/anticoagulants (variable INR effect), antidiabetics (↑ glucose/↓ effect), CYP3A4 inducers e.g., rifampicin/phenytoin/carbamazepine (↓ prednisolone exposure), CYP3A4 inhibitors e.g., azoles/macrolides (↑ exposure), diuretics/amphotericin B (↑ hypokalaemia), ciclosporin (↑ levels/toxicity both ways), and live vaccines (risk of disseminated infection at immunosuppressive doses).

Interaction Severity

MAJOR: live vaccines (avoid with immunosuppressive doses), mifepristone (antagonizes glucocorticoid effect). MODERATE/clinically significant: strong CYP3A inducers (rifampin, carbamazepine, phenytoin) ↓ prednisolone exposure; strong CYP3A inhibitors (ketoconazole/itraconazole, some macrolides like clarithromycin) ↑ exposure; NSAIDs ↑ GI ulcer/bleed risk; warfarin-variable effect (monitor INR); antidiabetic agents-hyperglycemia (monitor/adjust); diuretics/amphotericin B ↑ hypokalemia risk; cyclosporine-mutual level changes/toxicity risk.

Food Interaction

Take with food or milk to reduce gastrointestinal irritation/upset.

Special Populations

Children

0.5-2mg/kg/day (max 40-60mg/day) depending on indication; nephrotic syndrome: 60mg/m²/day; croup: single dose 1-2mg/kg; taper required for courses >7 days

Kidney Impairment

No specific dose adjustment is recommended; use with caution in severe renal impairment and monitor for fluid retention, blood pressure, and electrolytes.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled 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), high doses, or repeated courses; taper gradually under medical supervision.

Overdose

Acute overdose is usually managed with supportive care (GI upset, fluid retention, hypertension, hyperglycaemia, mood/psychiatric effects may occur); chronic excessive exposure can cause Cushingoid features and adrenal suppression-seek urgent medical advice for large ingestions or severe symptoms.

Patient Counseling

Take PREDO (prednisolone) exactly as prescribed; take with food or milk to reduce stomach upset. If taking once daily, take in the morning (with breakfast) to better match natural cortisol rhythm and reduce insomnia. Do not stop suddenly-if used for more than a few days or at higher doses, it must be tapered to avoid adrenal insufficiency. Seek medical advice promptly for signs of infection (fever, sore throat) because corticosteroids can mask/worsen infections; avoid close contact with chickenpox/measles if non-immune. If you have diabetes, monitor blood glucose more frequently (may increase). Report black/tarry stools or severe abdominal pain (GI bleeding/ulcer risk), new/worsening mood changes, significant swelling/rapid weight gain, or vision changes. Avoid live vaccines during systemic prednisolone therapy (especially at immunosuppressive doses); tell healthcare providers you are taking a steroid and carry a steroid card/alert if on prolonged therapy.

Monitoring Requirements

Monitor based on dose/duration and comorbidities: blood pressure, blood glucose (especially diabetes), weight/edema, electrolytes (notably potassium), signs of infection; for long-term therapy monitor bone health (BMD/osteoporosis risk), eye exams/intraocular pressure/cataracts, and HPA-axis suppression; monitor growth in children.

Pharmacology

Mechanism of Action

Prednisolone is a synthetic glucocorticoid that binds intracellular glucocorticoid receptors to alter gene transcription, decreasing pro-inflammatory cytokines and eicosanoid production (via lipocortin/PLA2 inhibition) and suppressing immune cell function; it also reduces leukocyte migration and capillary permeability.

Onset of Action

Oral prednisolone is absorbed with peak plasma concentrations in about 1-2 hours; clinical anti-inflammatory benefit may begin within hours but can take longer depending on the condition.

Duration of Effect

Intermediate-acting glucocorticoid: biologic effect typically lasts about 18-36 hours.

Half-Life

Plasma elimination half-life about 2 to 4 hours; biological (pharmacodynamic) half-life about 18 to 36 hours (intermediate-acting glucocorticoid).

Bioavailability

Approximately 80% to 100% (high oral bioavailability).

Metabolism

Hepatic metabolism (primarily CYP3A4) to inactive metabolites; prednisolone is the active metabolite of prednisone.

Excretion

Primarily renal excretion, mainly as inactive metabolites (glucuronide/sulfate conjugates); only a small fraction is excreted unchanged.

Protein Binding

About 70% to 90% protein bound (albumin and corticosteroid-binding globulin/transcortin), and binding is concentration-dependent.

Product Information

Available Dosage Forms

For this SFDA-registered product: oral tablet (25 mg) in blister pack of 30 tablets; other prednisolone dosage forms exist in general (e.g., oral solutions/syrups, injectable salts, ophthalmic preparations) but are not this specific product.

Composition per Dose

Each tablet: 25mg prednisolone

Generic Availability

Yes

OTC Alternatives

No OTC alternative provides equivalent systemic corticosteroid effect; for mild allergy symptoms, OTC antihistamines (e.g., cetirizine, loratadine) may help, and for mild pain/inflammation OTC NSAIDs may help if appropriate, but they are not substitutes for prednisolone when a steroid is indicated.

Symptom Target

Allergy, Cough, Inflammation

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 01-07-2026