Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Mean and range of total body clearance and half-life of theophylline related to age and altered physiological states.¶ Population characteristicsTotal body clearance.mean (range)††(mL/kg/min)Half-lifemean (range)††(hr)¶For various North American patient populations from literature reports. Different rates of elimination and consequent dosage requirements have been observed among other peoples.Clearance represents the volume of blood completely cleared of theophylline by the liver in one minute. Clinically significant drug interactions with theophylline. DrugType of InteractionEffect.Refer to for further information regarding table.Average effect on steady state theophylline concentration or other clinical effect for pharmacologic interactions.
Manifestations of theophylline toxicity.Percentage of patients reported with sign or symptomAcute Overdose(Large Single Ingestion)Chronic Overdosage(Multiple Excessive Doses)Sign/SymptomStudy 1(n=157)Study 2(n=14)Study 1(n=92)Study 2(n=102).These data are derived from two studies in patients with serum theophylline concentrations 30 mcg/mL. In the first study (Study #1 - Shanon, Ann Intern Med 1993;119:1161-67), data were prospectively collected from 249 consecutive cases of theophylline toxicity referred to a regional poison center for consultation. In the second study (Study #2 - Sessler, Am J Med 1990;88:567-76), data were retrospectively collected from 116 cases with serum theophylline concentrations 30 mcg/mL among 6000 blood samples obtained for measurement of serum theophylline concentrations in three emergency departments. Children (1-15 years) and adults (16-60 years) without risk factors for impaired clearance. Titration StepChildren 45 kg and adults1. Starting Dosage12-14 mg/kg/day up toa maximum of 300 mg/daydivided Q4-6 hrs.300 mg/day divided Q6-8 hrs.2.
After 3 days, iftolerated, increasedose to:16 mg/kg/day up to amaximum of 400 mg/daydivided Q4-6 hrs.400 mg/day divided Q6-8 hrs.3. After 3 more days,if tolerated, increasedose to:20 mg/kg/dayup to a maximumof 600 mg/daydivided Q4-6 hrs.600 mg/day divided Q6-8 hrs.C. Dosage adjustment guided by serum theophylline concentration.
Peak Serum ConcentrationDosage Adjustment¶ Dose reduction and/or serum theophylline concentration measurement is indicated whenever adverse effects are present, physiologic abnormalities that can reduce theophylline clearance occur (e.g., sustained fever), or a drug that interacts with theophylline is added or discontinued (see ).30 mcg/mLTreat overdose as indicated (see recommendations for chronic overdosage). If theophylline is subsequently resumed, decrease dose by at least 50% and recheck serum concentration after 3 days to guide further dosage adjustment.How is Elixophyllin SuppliedElixophyllin Elixir (Theophylline Oral Solution, USP) is a clear red solution with a mixed fruit flavor.
Each tablespoonful (15 mL) contains 80 mg theophylline anhydrous.Elixophyllin Elixir (Theophylline Oral Solution, USP) is available in bottles of473 mL NDC 70408-644-34RECOMMENDED STORAGEStore at 25 oC (77 oF); excursions permitted to 15 o - 30 oC (59 o - 86 oF) see USP Controlled Room Temperature.Dispense in a tight, light-resistant container. Avoid exposure to excessive heat.Manufactured by:Nostrum Laboratories, Inc.Bryan, Ohio 43506Iss.: 1T04NDC 70408-644-34Elixophyllin® ELIXIR(Theophylline Oral Solution, USP)(THEOPHYLLINE ANHYDROUS)80 mg / 15 mLRx only16 OUNCES(473 mL).
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