Prednisolone (20mg)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

Prednisolone is a synthetic glucocorticoid, a potent anti-inflammatory and immunosuppressant agent. It is the active metabolite of prednisone, converted in the liver. In the Indian context, it is a cornerstone therapy for a wide range of inflammatory, allergic, autoimmune, and neoplastic conditions. Its 20mg strength is typically used for moderate to severe disease states, initial high-dose therapy, or as part of pulse therapy protocols.

OnsetDurationBioavailability
Rapid. Pharmacological effects begin within 1-2 hours of oral administration.Intermediate-acting glucocorticoid. Biological half-life is 18-36 hours, allowing for once-daily or alternate-day dosing.High, approximately 80-90% after oral administration.

2. Mechanism of Action

Prednisolone binds to intracellular glucocorticoid receptors (GR), forming a complex that translocates to the nucleus. This complex modulates gene transcription, leading to increased synthesis of anti-inflammatory proteins (lipocortin-1, IL-10) and decreased synthesis of pro-inflammatory mediators (cytokines, chemokines, adhesion molecules, enzymes like COX-2).

3. Indications & Uses

  • Severe allergic conditions (anaphylaxis, angioedema)
  • Rheumatic disorders (Rheumatoid Arthritis, SLE, Polymyositis)
  • Severe asthma and COPD exacerbations
  • Autoimmune diseases (Autoimmune Hepatitis, Ulcerative Colitis, Crohn's disease)
  • Dermatological conditions (Pemphigus vulgaris, Severe psoriasis, Exfoliative dermatitis)
  • Nephrotic syndrome
  • Cerebral edema (tumor-related)
  • Prevention of graft rejection in organ transplantation

4. Dosage & Administration

Adult Dosage: Highly variable. For severe diseases: 20-60mg/day in single or divided doses. Maintenance: Lowest possible dose, often 5-15mg/day. Pulse therapy: Up to 1g/day IV, oral equivalent used in high doses (e.g., 60-100mg/day) for short periods.

Administration: Take with or immediately after food to minimize gastric irritation. Single daily doses should be taken in the morning (8 AM) to coincide with the body's natural cortisol rhythm and reduce HPA axis suppression. Do not stop abruptly after >2 weeks of therapy.

5. Side Effects

Common side effects may include:

  • Increased appetite, weight gain
  • Insomnia, mood swings
  • Fluid retention, edema
  • Dyspepsia, heartburn
  • Acne, hirsutism
  • Easy bruising
  • Moon face

6. Drug Interactions

DrugEffectSeverity
WarfarinAltered INR (increase or decrease); monitor closelyMajor
Phenytoin, Phenobarbital, RifampicinIncreased metabolism of prednisolone via CYP3A4 induction, reducing its efficacyMajor
Ketoconazole, Itraconazole, ClarithromycinInhibits CYP3A4, increasing prednisolone levels and toxicity riskMajor
NSAIDs (e.g., Ibuprofen, Diclofenac)Increased risk of GI ulceration and bleedingMajor
Diuretics (e.g., Furosemide, Hydrochlorothiazide)Enhanced potassium loss, severe hypokalemiaMajor
Antidiabetics (Insulin, Metformin)Prednisolone causes hyperglycemia; may require dose adjustment of antidiabeticsModerate
Vaccines (Live-attenuated: MMR, Varicella, OPV)Reduced immune response; risk of vaccine-induced infectionContraindicated

7. Patient Counselling

  • DO take with food or milk.
  • DO take single daily doses in the morning (8 AM).
  • DO NOT stop the medicine suddenly if taken for more than 2 weeks.
  • DO inform all doctors and dentists about your steroid use before any procedure.
  • DO carry a Steroid Alert Card.
  • DO NOT take live vaccines (e.g., MMR, chickenpox) without consulting your doctor.
  • DO monitor weight, blood sugar, and blood pressure regularly if on long-term therapy.

8. Toxicology & Storage

Overdose: Acute: Severe fluid and electrolyte disturbances (hypertension, edema, hypokalemia, metabolic alkalosis), psychosis, convulsions, hyperglycemia. Chronic: Cushingoid state, severe immunosuppression, osteoporosis, myopathy.

Storage: Store below 30°C in a cool, dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date printed on the pack.