Prednisolone - Drug Monograph

Comprehensive information about Prednisolone including mechanism, indications, dosing, and safety information.

Introduction

Prednisolone is a synthetic glucocorticoid medication belonging to the corticosteroid class. It is a potent anti-inflammatory and immunosuppressive agent widely used in clinical practice for managing various inflammatory, allergic, and autoimmune conditions. As an intermediate-acting corticosteroid, prednisolone provides effective therapeutic benefits while maintaining a favorable balance between potency and side effect profile.

Mechanism of Action

Prednisolone exerts its effects through multiple mechanisms. It diffuses across cell membranes and binds to cytoplasmic glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex binds to glucocorticoid response elements on DNA, modulating gene transcription. Prednisolone:

  • Inhibits phospholipase A2, reducing prostaglandin and leukotriene synthesis
  • Suppresses inflammatory cytokine production (IL-1, IL-2, IL-6, TNF-α)
  • Impairs neutrophil and macrophage migration to inflammation sites
  • Reduces capillary permeability and edema
  • Decreases lymphocyte proliferation and antibody production
  • Alters lymphocyte circulation patterns

Indications

FDA-Approved Indications:
  • Inflammatory disorders (rheumatoid arthritis, polymyalgia rheumatica)
  • Allergic conditions (severe asthma, allergic rhinitis)
  • Dermatological diseases (psoriasis, severe eczema)
  • Ophthalmic inflammation
  • Hematologic disorders (autoimmune hemolytic anemia, ITP)
  • Neoplastic diseases (leukemias, lymphomas)
  • Endocrine disorders (adrenal insufficiency)
  • Gastrointestinal diseases (ulcerative colitis, Crohn's disease)
  • Nephrotic syndrome
  • Organ transplantation rejection prophylaxis
Off-label Uses:
  • COVID-19 pneumonia (in specific clinical scenarios)
  • Acute gout attacks
  • Sarcoidosis
  • Thyroid eye disease

Dosage and Administration

General Dosing Principles:
  • Individualize dosage based on condition severity and patient response
  • Use lowest effective dose for shortest duration possible
  • Administer with food to minimize GI upset
Standard Adult Dosing:
  • Anti-inflammatory: 5-60 mg daily in divided doses
  • Rheumatoid arthritis: 5-7.5 mg daily
  • Asthma: 40-60 mg daily initially, tapered to lowest effective dose
  • Adrenal insufficiency: 4-5 mg/m² daily
Special Populations:
  • Geriatric: Start at lower end of dosing range due to increased susceptibility to side effects
  • Hepatic impairment: May require dose adjustment due to altered metabolism
  • Renal impairment: No significant adjustment needed
  • Pediatric: 0.1-2 mg/kg/day in divided doses (based on condition)
Administration Routes:
  • Oral tablets (most common)
  • Ophthalmic solutions
  • Topical preparations
  • Intra-articular injections (as prednisolone acetate)

Pharmacokinetics

Absorption: Well absorbed from GI tract (bioavailability 80-90%) Distribution: Volume of distribution: 0.5-0.8 L/kg; Crosses placenta and enters breast milk Protein Binding: 90-95% bound to transcortin and albumin Metabolism: Hepatic via CYP3A4 to inactive metabolites Elimination: Half-life: 2-4 hours; Duration of action: 18-36 hours; Excretion: Primarily renal (metabolites)

Contraindications

  • Systemic fungal infections
  • Known hypersensitivity to prednisolone or components
  • Live virus vaccinations during immunosuppressive therapy
  • Active untreated infections (relative contraindication)
  • Idiopathic thrombocytopenic purpura (for IM administration)

Warnings and Precautions

Boxed Warning:
  • Corticosteroids may cause serious and fatal infections
  • May exacerbate hypertension and diabetes
  • Can cause psychiatric reactions including steroid psychosis
Additional Precautions:
  • Adrenal suppression with long-term use
  • Increased infection risk (bacterial, fungal, viral, parasitic)
  • Gastrointestinal perforation risk in patients with GI disorders
  • Ophthalmic effects (cataracts, glaucoma)
  • Osteoporosis and avascular necrosis
  • Growth suppression in children
  • Hyperglycemia and diabetes mellitus
  • Fluid and electrolyte disturbances
  • Myopathy and muscle weakness

Drug Interactions

Significant Interactions:
  • Anticoagulants: Altered anticoagulant effect
  • Antidiabetic agents: Reduced hypoglycemic efficacy
  • CYP3A4 inducers (phenytoin, rifampin): Reduced prednisolone efficacy
  • CYP3A4 inhibitors (ketoconazole): Increased prednisolone levels
  • NSAIDs: Increased GI ulcer risk
  • Diuretics: Enhanced potassium wasting
  • Live vaccines: Reduced vaccine efficacy, increased adverse reactions
  • Cardiac glycosides: Increased digitalis toxicity risk

Adverse Effects

Common (≥1%):
  • Insomnia
  • Weight gain
  • Fluid retention
  • Mood changes
  • Increased appetite
  • Dyspepsia
  • Hyperglycemia
  • Cushingoid appearance
Serious (<1%):
  • Adrenal insufficiency
  • Severe infections
  • Osteoporosis fractures
  • Avascular necrosis
  • Peptic ulcer disease
  • Pancreatitis
  • Psychiatric disorders
  • Ophthalmic complications
  • Anaphylaxis

Monitoring Parameters

Baseline Assessment:
  • Complete medical history and physical examination
  • Blood pressure
  • Blood glucose
  • Electrolytes (especially potassium)
  • Bone density (if long-term therapy anticipated)
  • Ophthalmologic examination
Ongoing Monitoring:
  • Clinical response assessment
  • Blood pressure regularly
  • Blood glucose (especially in diabetics)
  • Weight changes
  • Signs of infection
  • Mood and psychological status
  • Growth parameters in children
  • Bone density annually for long-term therapy
Post-Therapy Monitoring:
  • Assess for adrenal insufficiency after discontinuation
  • Monitor for disease flare-ups

Patient Education

Key Points to Discuss:
  • Take exactly as prescribed; do not stop abruptly
  • Report any signs of infection (fever, sore throat)
  • Monitor for weight gain and swelling
  • Be aware of potential mood changes
  • Regular follow-up appointments are essential
  • Carry medical alert identification
  • Avoid live vaccines during therapy
  • Report any vision changes
  • Maintain adequate calcium and vitamin D intake
  • Inform all healthcare providers about prednisolone use
Administration Instructions:
  • Take with food to reduce stomach upset
  • Do not crush or chew delayed-release tablets
  • If missed dose, take as soon as remembered unless close to next dose
  • Never double dose

References

1. Liu D, et al. A practical guide to the monitoring and management of the complications of systemic corticosteroid therapy. Allergy, Asthma & Clinical Immunology. 2013;9(1):30. 2. Fardet L, et al. Corticosteroid-induced clinical adverse events: incidence, risk factors and management. Drug Safety. 2007;30(10):897-909. 3. Prednisolone [package insert]. U.S. Food and Drug Administration. 4. Barnes PJ. Anti-inflammatory actions of glucocorticoids: molecular mechanisms. Clinical Science. 1998;94(6):557-572. 5. Coutinho AE, Chapman KE. The anti-inflammatory and immunosuppressive effects of glucocorticoids, recent developments and mechanistic insights. Molecular and Cellular Endocrinology. 2011;335(1):2-13. 6. American College of Rheumatology. Guidelines for glucocorticoid-induced osteoporosis prevention. Arthritis Care & Research. 2017;69(8):1095-1110. 7. Strehl C, et al. Defining conditions where long-term glucocorticoid treatment has an acceptably low level of harm to facilitate implementation of existing recommendations: viewpoints from an EULAR task force. Annals of the Rheumatic Diseases. 2016;75(6):952-957.

Medical Disclaimer

The information provided in this article is for educational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

The content on MedQuizzify is designed to support, not replace, the relationship that exists between a patient and their healthcare provider. If you have a medical emergency, please call your doctor or emergency services immediately.

How to Cite This Article

admin. Prednisolone - Drug Monograph. MedQuizzify [Internet]. 2025 Sep 10 [cited 2025 Sep 10]. Available from: http://medquizzify.pharmacologymentor.com/blog/drug-monograph-prednisolone

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