Active Ingredient: Theophylline
Theophylline is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 4.6 milligrams theophylline, over the duration of 30 minutes. Afterwards, intravenous, 0.4 milligrams theophylline, hourly.
Loading dose of intravenous theophylline: 4.6 mg/kg, calculated on the basis of ideal body weight and administered over 30 minutes, on average, will produce maximum post-distribution serum concentration of 10 mcg/mL with a range of 6–16 mcg/mL. When a loading dose becomes necessary in the patient who has already received theophylline, estimation of the serum concentration based upon the history is unreliable, and an immediate serum level determination is indicated. The loading dose can then be determined as follows:
D=(Desired C−Measured C) (V)
Where D is the loading dose, C is the serum theophylline concentration, and V is the volume of distribution. The mean volume of distribution can be assumed to be 0.5 L/kg and the desired serum concentration should be conservative (e.g., 10 mcg/mL) to allow for the variability in the volume of distribution. A loading dose should not be given before obtaining a serum theophylline concentration if the patient has received any theophylline in the previous 24 hours.
A serum concentration obtained 30 minutes after an intravenous loading dose, when distribution is complete, can be used to assess the need for and size of subsequent loading doses, if clinically indicated, and for guidance of continuing therapy. Once a serum concentration of 10 to 15 mcg/mL has been achieved with the use of a loading dose(s), a constant intravenous infusion is started. The rate of administration is based upon mean pharmacokinetic parameters for the population and calculated to achieve a target serum concentration of 10 mcg/mL.
Initiation of a constant intravenous theophylline infusion of 0.4 mg/kg/hr at the completion of the loading dose, on average, will result in a steady-state concentration of 10 mcg/mL with a range of 7–26 mcg/mL.
For:
Intravenous, 4.6 milligrams theophylline per kilogram of body weight, over the duration of 30 minutes. Afterwards, intravenous, between 0.5 milligrams theophylline per kilogram of body weight and 0.8 milligrams theophylline per kilogram of body weight, hourly.
Loading dose: 4.6 mg/kg administered over 30 minutes.
Initial theophylline infusion rates following an appropriate loading dose:
| Patient population | Age | Theophylline infusion rate (mg/kg/hr)*† |
|---|---|---|
| Neonates | Postnatal age up to 24 days | 1 mg/kg every 12 hours/‡ |
| Young children | 1–9 years | 0.8 |
| Older children | 9–12 years | 0.7 |
| Adolescents (cigarette or marijuana smokers) | 12–16 years | 0.7 |
| Adolescents (nonsmokers) | 12–16 years | 0.5§ |
* To achieve a target concentration of 10 mcg/mL. Aminophylline = theophylline/0.8. Use ideal body weight for obese patients.
† Lower initial dosage may be required for patients receiving other drugs that decrease theophylline clearance (e.g., cimetidine).
§ Not to exceed 900 mg/day, unless serum levels indicate the need for a larger dose.
¶ Not to exceed 400 mg/day, unless serum levels indicate the need for a larger dose.
For:
Regimen A: Intravenous, 4.6 milligrams theophylline, over the duration of 30 minutes. Afterwards, intravenous, 1 milligrams theophylline, once every 12 hours.
Regimen B: Intravenous, 4.6 milligrams theophylline, over the duration of 30 minutes. Afterwards, intravenous, 1.5 milligrams theophylline, once every 12 hours.
Loading dose: 4.6 mg/kg administered over 30 minutes.
Initial theophylline infusion rates following an appropriate loading dose:
| Patient population | Age | Theophylline infusion rate (mg/kg/hr)*† |
|---|---|---|
| Neonates | Postnatal age up to 24 days | 1 mg/kg every 12 hours/‡ |
| Postnatal age beyond 24 days | 1.5 mg/kg every 12 hours/‡ |
* To achieve a target concentration of 10 mcg/mL. Aminophylline = theophylline/0.8. Use ideal body weight for obese patients.
† Lower initial dosage may be required for patients receiving other drugs that decrease theophylline clearance (e.g., cimetidine).
‡ To achieve a target concentration of 7.5 mcg/mL for neonatal apnea.
For:
$d time(s) per day every $document.frequencyDenominator day(s)
Loading dose: 4.6 mg/kg administered over 30 minutes.
Initial theophylline infusion rates following an appropriate loading dose:
| Patient population | Age | Theophylline infusion rate (mg/kg/hr)*† |
|---|---|---|
| Infants | 6–52 weeks old | mg/kg/hr=(0.008) (age in weeks) + 0.21 |
* To achieve a target concentration of 10 mcg/mL. Aminophylline = theophylline/0.8. Use ideal body weight for obese patients.
† Lower initial dosage may be required for patients receiving other drugs that decrease theophylline clearance (e.g., cimetidine).
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