From the FDA Drug Label
Table V. Dosing initiation and titration (as anhydrous theophylline).
- A. Infants < 1 year old. Initial Dosage. Premature Neonates: < 24 days postnatal age; 1 mg/kg every 12 hr ≥ 24 days postnatal age; 1.5 mg/kg every 12 hr
Full term infants and infants up to 52 weeks of age: Total daily dose (mg) = [(0.2 x age in weeks)+5. 0] x (Kg body Wt).
up to age 26 weeks; divide dose into 3 equal amounts administered at 8 hour intervals.
26 weeks of age; divide dose into 4 equal amounts administered at 6 hour intervals.
- B. Children (1 to 15 years) and adults (16 to 60 years) without risk factors for impaired clearance. Use In Patients With Impaired Renal Function Titration StepChildren < 45 kgChildren > 45 kg and adults 1 Starting Dosage12 to 14 mg/kg/day up to a maximum of 300 mg/day divided Q4 to 6 hrs300 mg/day divided Q6 to 8 hrs
The recommended IV dose of Deriphylline (theophylline) for pediatric patients is as follows:
- For infants < 1 year old:
- Premature neonates: 1 mg/kg every 12 hours if < 24 days postnatal age, and 1.5 mg/kg every 12 hours if ≥ 24 days postnatal age.
- Full-term infants: Total daily dose (mg) = [(0.2 x age in weeks) + 5.0] x (Kg body weight), divided into 3-4 equal amounts administered at 6-8 hour intervals.
- For children 1-15 years old: 12-14 mg/kg/day up to a maximum of 300 mg/day, divided into 4-6 equal amounts administered at 4-6 hour intervals. It is essential to monitor serum theophylline concentrations and adjust the dose accordingly to maintain a peak steady-state concentration of 10-15 mcg/mL 1.
From the Research
The recommended IV dose of Deriphylline (theophylline) for pediatric patients varies by age, with a loading dose of 6 mg/kg given slowly over 20-30 minutes, followed by a maintenance dose of 0.8-1.0 mg/kg/hour for children 1-9 years old, and a reduced maintenance dose of 0.7-0.8 mg/kg/hour for children 9-16 years old, as supported by 2.
Key Considerations
- For children 1-9 years old, the loading dose is 6 mg/kg, followed by a maintenance dose of 0.8-1.0 mg/kg/hour.
- For children 9-16 years old, the loading dose remains 6 mg/kg, but the maintenance dose is reduced to 0.7-0.8 mg/kg/hour.
- Neonates and infants under 1 year require lower doses due to decreased clearance, typically 0.5 mg/kg/hour.
Therapeutic Monitoring and Adjustments
Therapeutic drug monitoring is essential as theophylline has a narrow therapeutic index, with target serum concentrations of 10-20 μg/mL, as noted in 3. Doses should be adjusted based on serum levels, clinical response, and the presence of side effects. Factors affecting theophylline metabolism include liver function, cardiac status, and concurrent medications.
Administration and Monitoring
Administration should be done via infusion pump to ensure accurate dosing, and patients should be monitored for respiratory rate, heart rate, and signs of toxicity during treatment, as emphasized in 4. Common side effects include tachycardia, nausea, vomiting, and seizures at toxic levels.
Special Considerations
The presence of upper respiratory tract infections (URTI) may reduce theophylline clearance, and a correction factor of 60% may be recommended to adjust the dose rate during an URTI, as suggested by 2.