What is the recommended dose of omnacortil (prednisolone) per kilogram body weight in children?

Omnacortil (Prednisolone) Dosing in Children

For most pediatric conditions requiring corticosteroid therapy, the recommended dose of omnacortil (prednisolone) is 2 mg/kg/day (maximum 60 mg/day) or 60 mg/m²/day as a single daily dose, based on the specific condition being treated. 1, 2, 3

Standard Dosing by Body Weight vs. Body Surface Area

The dosing can be calculated using either method, though they may yield different results:

• Weight-based dosing: 2 mg/kg/day for initial therapy (maximum 60 mg/day) 1, 2, 3
• BSA-based dosing: 60 mg/m²/day for initial therapy 1, 2
• Important caveat: For significantly overweight children, dose based on ideal body weight rather than actual weight to avoid unnecessary steroid exposure 2, 4

Weight-based dosing may result in relative underdosing in smaller children compared to BSA-based calculations, which can increase the risk of frequent relapses in conditions like nephrotic syndrome. 5 When weight-based dosing was compared to theoretical BSA-based dosing, children with frequent relapses had significantly higher underdosing percentages (16.6% vs 8.7%, p=0.03). 5

Condition-Specific Dosing Regimens

Nephrotic Syndrome (First Episode)

• Initial phase: 60 mg/m²/day or 2 mg/kg/day (maximum 60 mg/day) as a single daily dose for 4-6 weeks 1, 2
• Continuation phase: 40 mg/m²/day or 1.5 mg/kg/day (maximum 40 mg) on alternate days for 2-5 months with gradual tapering 1, 2
• Total duration: At least 12 weeks of therapy 1

Nephrotic Syndrome (Relapses)

• Infrequent relapses: 60 mg/m²/day or 2 mg/kg/day (maximum 60 mg/day) until remission for at least 3 days, then 40 mg/m²/day or 1.5 mg/kg/day on alternate days for at least 4 weeks 1, 2
• Frequent relapses/steroid-dependent: Daily prednisolone until remission for 3 days, followed by alternate-day dosing for at least 3 months at the lowest effective dose 1, 2
• During viral infections: Increase to daily dosing at the same dose taken on alternate days for 7 consecutive days to reduce relapse risk (reduces relapse rate from 48% to 18%, p=0.014) 6

Acute Asthma Exacerbations

• Dose: 1-2 mg/kg/day (maximum 50-60 mg/day) as a single daily dose 7
• Duration: Continue until peak expiratory flow reaches 80% of personal best or symptoms resolve (typically 3-10 days) 3

Autoimmune Hepatitis

• Initial therapy: 1-2 mg/kg/day (maximum 60 mg/day) for 2 weeks 2
• Maintenance: Taper over 6-8 weeks to 0.1-0.2 mg/kg/day or 5 mg/day 2

Administration Timing and Frequency

Single daily dosing in the morning is strongly preferred over divided doses to minimize hypothalamic-pituitary-adrenal (HPA) axis suppression. 2, 7, 8

• Single morning dosing results in less HPA suppression (83% vs 100%, p=0.02) and longer time to first relapse (median 131 vs 28 days, p=0.002) compared to divided dosing 8
• Single daily dosing mimics physiologic cortisol secretion patterns 7
• The FDA label mentions divided doses (3-4 times daily) for initial dosing ranges of 0.14-2 mg/kg/day, but this conflicts with more recent guideline recommendations favoring single daily dosing 3

Critical Dosing Considerations

Maximum Doses

• Daily maximum: 60 mg/day for most conditions 1, 2, 3
• Alternate-day maximum: 40 mg per dose 1, 2
• In specific cases, up to 80 mg may be considered, though this is uncommon 2

Tapering Principles

• Never stop abruptly after long-term therapy 3
• For alternate-day therapy, use the lowest dose that maintains remission without major adverse effects 1
• Specific tapering schedules vary by condition but generally involve reducing by 25-33% at appropriate intervals 7

Monitoring and Safety

Regular assessment for steroid-related adverse effects is essential, especially with prolonged use. 2, 4

Common side effects include:

• Cushingoid features, growth deceleration, weight gain, hypertension, and gastric irritation 7
• Growth suppression is unique to children and is minimized by alternate-day dosing 9
• Cosmetic changes occur in 80% of patients after 2 years of treatment 4

Consider corticosteroid-sparing agents for children who develop steroid-related adverse effects, particularly those with frequent relapses or steroid dependence. 1, 4

Additional monitoring recommendations:

• Baseline and annual bone mineral density testing for long-term therapy 2, 4
• Growth monitoring in all children on prolonged therapy 2
• Calcium and vitamin D supplementation during steroid therapy 7