PREDO 15/MG/5/ML SYRUP 120ML

Indications

Approved Uses

Systemic corticosteroid therapy for severe inflammatory, allergic, autoimmune, and immunologic conditions (e.g., severe allergic states, dermatologic diseases, rheumatic disorders, respiratory diseases such as asthma exacerbations, hematologic disorders, neoplastic diseases, edematous states such as nephrotic syndrome, and endocrine disorders including adrenocortical insufficiency) as clinically indicated.

Dosage & Administration

Dosing by Condition

General systemic prednisolone dosing: Adults commonly 5-60 mg/day (single morning dose or divided) depending on indication; pediatrics commonly 0.14-2 mg/kg/day (or 4-60 mg/m²/day) depending on indication; short courses for acute asthma/croup are typically in the 1-2 mg/kg/day range (max often 40-60 mg/day) for ~3-5 days per pediatric respiratory guidelines.

Initial Dose

Adults: 20-60mg/day orally in single or divided doses; Children: 1-2mg/kg/day

Maintenance Dose

Adults: 5-15mg/day; Children: lowest effective dose, typically 0.1-0.5mg/kg/day

Maximum Dose

For acute asthma in children, 1-2 mg/kg/day (up to 60 mg/day); dosing is tailored to the specific condition and patient response.

Children's Dosage

1-2mg/kg/day (max 40-60mg/day depending on indication); for croup: single dose 0.15-0.6mg/kg; for asthma exacerbation: 1-2mg/kg/day for 3-5 days

Dose Adjustment Notes

Dose is individualized to indication and response; adjust for changes in disease activity or stress (infection, surgery/trauma) which may require temporary increases; taper gradually after prolonged/repeated courses to prevent adrenal insufficiency-alternate-day regimens may be considered in selected long-term indications.

How to Take

Shake well before each dose; measure with an oral syringe/marked measuring device; give by mouth with food or milk to reduce GI upset; if once daily, give in the morning when feasible; follow prescribed duration and do not stop abruptly if used for more than a few days/longer courses.

How to Prepare

No reconstitution required-ready-to-use oral syrup; shake well before each dose and measure with an oral syringe/medicine spoon.

Side Effects

Common Side Effects

Increased appetite/weight gain, mood changes (irritability/euphoria), insomnia, dyspepsia/nausea, fluid retention/edema, hyperglycemia, acne/sweating; headache can occur.

Side Effect Frequency

Common: increased appetite, weight gain, mood changes/irritability, insomnia, dyspepsia/nausea, fluid retention, elevated blood pressure, hyperglycemia. Less common but serious (risk increases with higher dose/longer duration): serious infection, GI ulcer/bleed, adrenal suppression, osteoporosis/fracture, cataract/glaucoma, psychosis, avascular necrosis, growth suppression in children.

Safety & Warnings

Contraindications

Hypersensitivity to prednisolone/prednisolone sodium phosphate or any excipient; systemic fungal infection. (Live vaccines are contraindicated in patients receiving immunosuppressive doses; active/untreated TB is a major warning/precaution rather than an absolute contraindication.)

Warnings & Precautions

Key precautions: avoid abrupt discontinuation after prolonged/high-dose use (taper); increased infection risk and masking of infection-screen/manage latent TB and consider varicella/measles exposure management; monitor BP, weight/edema, glucose, and electrolytes; caution in peptic ulcer disease, osteoporosis, glaucoma/cataracts, psychiatric history, and heart failure; monitor growth in children on long-term therapy; stress-dose may be needed during surgery/acute illness; avoid live vaccines during immunosuppressive dosing.

Age Restriction

No absolute minimum age; may be used in pediatrics (including infants) when clinically indicated under specialist/physician supervision.

Drug Interactions

Interaction Severity

MAJOR: Live vaccines (avoid with immunosuppressive doses/prolonged therapy); mifepristone (antagonizes glucocorticoid effect-avoid/contraindicated in chronic steroid therapy). MODERATE: Strong CYP3A4 inducers (rifampin, phenytoin) ↓ prednisolone exposure; strong CYP3A4 inhibitors (ketoconazole) ↑ exposure; NSAIDs/aspirin ↑ GI ulcer/bleed risk; warfarin-INR effect variable; antidiabetic agents-reduced glucose control; diuretics/amphotericin-↑ hypokalemia; cyclosporine-↑ levels/toxicity both ways.

Food Interaction

Take with food or milk to reduce gastrointestinal irritation; avoid excessive liquorice intake (glycyrrhizin) which can worsen hypokalemia/hypertension risk, especially with corticosteroids.

Special Populations

Breastfeeding

Caution

Children

1-2mg/kg/day (max 40-60mg/day depending on indication); for croup: single dose 0.15-0.6mg/kg; for asthma exacerbation: 1-2mg/kg/day for 3-5 days

Elderly

Use the lowest effective dose; increased risk of osteoporosis, hypertension, hyperglycemia, and infection; consider calcium and vitamin D supplementation; monitor bone density with long-term use

Storage & Patient Advice

Storage Conditions

Store below 25°C. Keep away from direct sunlight. Do not freeze. Keep out of reach of children. Shelf life: 24 months from manufacture date.

Preparation Instructions

No reconstitution required-ready-to-use oral syrup; shake well before each dose and measure with an oral syringe/medicine spoon.

Missed Dose

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

Stopping the Medicine

Do not stop abruptly after more than ~1-2 weeks of systemic therapy or after high-dose/repeated courses; taper gradually per prescriber to prevent adrenal insufficiency/withdrawal.

Overdose

Acute overdose is usually managed with supportive care; possible effects include GI upset, agitation/mood changes, hypertension, hyperglycemia, and fluid/electrolyte disturbances. Chronic excessive dosing can cause Cushingoid features and adrenal suppression; seek urgent medical advice/poison center and monitor glucose, BP, and electrolytes.

Patient Counseling

Take exactly as prescribed; do not stop abruptly if used for more than a few days-taper only under medical advice. Take with food or milk to reduce GI upset. Prefer morning dosing (or split dosing if prescribed) to reduce insomnia and mimic natural cortisol rhythm. Seek medical advice promptly for fever/sore throat or other infection signs (steroids can mask infection). If diabetic, monitor blood glucose more closely. Avoid close contact with chickenpox/measles and seek urgent advice if exposed. Avoid live vaccines while on immunosuppressive doses; tell healthcare providers before surgery/serious illness (may need stress-dose steroids). With prolonged therapy, carry a steroid card/medical alert and attend monitoring (BP, glucose, weight, eye checks, bone protection as appropriate).

Monitoring Requirements

If prolonged/high-dose therapy: monitor blood pressure, weight/edema, blood glucose, electrolytes (especially potassium), signs of infection and adrenal suppression; in longer courses monitor growth in children, bone health (fracture risk/BMD), and perform eye exams (cataract/glaucoma) as clinically indicated.

Pharmacology

Mechanism of Action

Binds intracellular glucocorticoid receptors to alter gene transcription, decreasing pro-inflammatory cytokines/mediators; induces lipocortin to inhibit phospholipase A2 and downstream prostaglandin/leukotriene synthesis; reduces capillary permeability and immune cell trafficking.

Half-Life

Plasma (elimination) half-life ~2-4 hours; biological (pharmacodynamic) half-life ~18-36 hours.

Metabolism

Prednisolone sodium phosphate is hydrolyzed by phosphatases to prednisolone; prednisolone is primarily hepatically metabolized (largely via CYP3A4 and reductive pathways) to inactive metabolites.

Product Information

Available Dosage Forms

For this SFDA-registered product: Oral syrup (bottle).

Composition per Dose

Each 5ml: 15mg prednisolone as prednisolone sodium phosphate (equivalent to 3mg/ml)

Generic Availability

Yes

OTC Alternatives

No OTC alternative for systemic corticosteroid therapy; OTC antihistamines (e.g., loratadine, cetirizine) for mild allergic symptoms only

Symptom Target

Severe inflammatory, allergic, autoimmune, and immunologic conditions

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 10-08-2026