What are the indications, recommended dosage, and contraindications for prednisolone 5 mg tablets?

INDICATION OF TAB PREDNISOLONE 5 MG AND DOSAGE AND CONTRAINDICATION

Prednisolone 5 mg tablets are indicated for a wide range of inflammatory and autoimmune conditions, with dosing highly variable from 5-60 mg daily depending on disease severity, and are contraindicated in systemic fungal infections and live virus vaccination during immunosuppression.

Indications

Prednisolone is a systemic corticosteroid used for multiple conditions:

Primary Indications

• Autoimmune hepatitis: First-line therapy in combination with azathioprine 1
• Asthma exacerbations: Short-course burst therapy for acute control 2
• Nephrotic syndrome: Initial treatment in children with steroid-sensitive disease 3
• Bullous pemphigoid: Systemic therapy for moderate-to-severe disease 4
• Rheumatoid arthritis: Low-dose long-term therapy to slow radiographic progression 5, 6
• ANCA-associated vasculitis: Induction therapy for renal and pulmonary involvement 7

Additional Uses

• Multiple sclerosis exacerbations
• Inflammatory bowel disease
• Severe allergic reactions
• Various dermatologic, rheumatologic, and hematologic disorders 8

Dosage

Dosing must be individualized based on disease severity, patient age, and response 8. The FDA label emphasizes that "dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient" 8.

Disease-Specific Dosing

Autoimmune Hepatitis:

• Adults: Initial prednisolone 0.5 mg/kg/day (maximum 40 mg/day) as single morning dose, combined with azathioprine 1 mg/kg/day 1
• Taper over 1-3 months to maintenance of 5-10 mg/day 1
• Children: Up to 2 mg/kg/day (maximum 40 mg) initially 1

Asthma Exacerbations:

• Adults: 40-60 mg/day in single or 2 divided doses for 3-10 days 2
• Children: 1-2 mg/kg/day (maximum 60 mg/day) for 3-10 days 2
• No taper needed for courses <1 week 2

Nephrotic Syndrome (Children):

• Initial episode: 60 mg/m²/day (or 2 mg/kg/day, maximum 80 mg) as single daily dose for 4-6 weeks 3
• Followed by alternate-day therapy at 40 mg/m²/day for 4 weeks 3
• Single morning dose preferred over divided dosing (less HPA axis suppression) 9

Bullous Pemphigoid:

• Mild disease: 0.5 mg/kg/day 4
• Taper to minimal therapy (0.1 mg/kg/day) over 4-6 months 4

Rheumatoid Arthritis:

• Low-dose long-term: 5 mg/day or less for maintenance 5, 6
• Even 5 mg daily substantially decreases radiographic damage 5

General Dosing Principles

Initial dosing range: 5-60 mg/day (0.14-2 mg/kg/day in children) depending on condition 8

Maintenance: Reduce to lowest effective dose after achieving response 8

Tapering:

• For courses >1 week but ≤10 days: No taper needed if on concurrent inhaled corticosteroids 2
• For longer courses: Gradual reduction by 2.5-5 mg decrements 10
• Abrupt discontinuation should be avoided after long-term therapy 8

Timing: Single morning dose preferred to minimize HPA axis suppression 8, 9

Contraindications

Absolute Contraindications

• Systemic fungal infections 8
• Known hypersensitivity to prednisolone or formulation components 8

Relative Contraindications (Use with Extreme Caution)

Active infections:

• Tuberculosis (requires prophylaxis/treatment first) 4
• Herpes virus infections, varicella 2
• Strongyloides 2

Metabolic conditions:

• Uncontrolled diabetes mellitus 2
• Severe osteoporosis 2

Cardiovascular:

• Uncontrolled hypertension 2
• Recent myocardial infarction or stroke (within 12 months for certain conditions) 11

Gastrointestinal:

• Active peptic ulcer disease 2

Psychiatric:

• Severe psychiatric conditions 3

Pregnancy considerations:

• Not contraindicated but requires effective birth control if sexually active 11
• Can be used with caution when benefits outweigh risks

Special Precautions

Live vaccines are contraindicated during immunosuppressive therapy (prednisone >20 mg/day for >2 weeks) 4

Vaccination recommendations before starting therapy:

• COVID-19, pneumococcus, influenza, shingles, hepatitis A/B, HPV (if indicated) 1

Monitoring requirements:

• Bone density screening for therapy >3 months 4, 10
• Calcium and vitamin D supplementation 10, 1
• Consider bisphosphonates for osteoporosis prevention in high-risk patients 4
• Pneumocystis jirovecii prophylaxis (optional) 4

Dose-Related Adverse Effects

Doses >2.5 mg/day: Increased fracture risk 12

Doses 5-10 mg/day: Moderate risk of adverse events including fractures, infections, GI bleeding 13

Doses >10-15 mg/day: Significantly increased risk (OR 32.3) of serious adverse events 13

Common side effects include: reversible glucose abnormalities, increased appetite, fluid retention, weight gain, mood changes, hypertension, and with long-term use: adrenal suppression, growth suppression in children, dermal thinning, cataracts, muscle weakness 2, 8