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The pharmacokinetics of theophylline vary widely among similar patients and cannot be predicted by agesexbody weight or other demographic characteristicsIn additioncertain concurrent illnesses and alterations in normal physiologysee Table Iand co-administration of other drugssee Table IIcan significantly alter the pharmacokinetic characteristics of theophyllineWithin-subject variability in metabolism has also been reported in some studiesespecially in acutely ill patientsIt isthereforerecommended that serum theophylline concentrations be measured frequently in acutely ill patientse.gat 24-hr intervalsand periodically in patients receiving long-term therapye.gat 6-12 month intervalsMore frequent measurements should be made in the presence of any condition that may significantly alter theophylline clearancesee PRECAUTIONSLaboratory Tests

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This is not a complete list of all side effects that may occurIf you have questions about side effectscontact your health care providerCall your doctor for medical advice about side effectsTo report side effects to the appropriate agencyplease read the Guide to Reporting Problems to FDA.

Serum Concentrations at Steady State After multiple doses of immediate-release theophyllinesteady state is reached in 30-65 hoursaverage 40 hoursin adultsAt steady stateon a dosage regimen with 6-hour intervalsthe expected mean trough concentration is approximately 60of the mean peak concentrationassuming a mean theophylline half-life of 8 hoursThe difference between peak and trough concentrations is larger in patients with more rapid theophylline clearanceIn patients with high theophylline clearance and half-lives of about 4-5 hourssuch as children age 1 to 9 yearsthe trough serum theophylline concentration may be only 30of peak with a 6-hour dosing intervalIn these patients a slow release formulation would allow a longer dosing interval8-12 hourswith a smaller peak/trough difference.

Gastrointestinal decontamination Oral activated charcoal0.5 g/kg up to 20 g and repeat at least once 1-2 hours after the first doseis extremely effective in blocking the absorption of theophylline throughout the gastrointestinal tracteven when administered several hours after ingestionIf the patient is vomitingthe charcoal should be administered through a nasogastric tube or after administration of an antiemeticPhenothiazine antiemetics such as prochlorperazine or perphenazine should be avoided since they can lower the seizure threshold and frequently cause dystonic reactionsA single dose of sorbitol may be used to promote stooling to facilitate removal of theophylline bound to charcoal from the gastrointestinal tractSorbitolhowevershould be dosed with caution since it is a potent purgative which can cause profound fluid and electrolyte abnormalitiesparticularly after multiple dosesCommercially available fixed combinations of liquid charcoal and sorbitol should be avoided in young children and after the first dose in adolescents and adults since they do not allow for individualization of charcoal and sorbitol dosingIpecac syrup should be avoided in theophylline overdosesAlthough ipecac induces emesisit does not reduce the absorption of theophylline unless administered within 5 minutes of ingestion and even then is less effective than oral activated charcoalMoreoveripecac induced emesis may persist for several hours after a single dose and significantly decrease the retention and the effectiveness of oral activated charcoal.

Severe toxicity from theophylline overdose is a relatively rare eventIn one health maintenance organizationthe frequency of hospital admissions for chronic overdosage of theophylline was about 1 per 1000 person-years exposureIn another studyamong 6000 blood samples obtained for measurement of serum theophylline concentrationfor any reasonfrom patients treated in an emergency department7were in the 20-30 mcg/mL range and 3were30 mcg/mLApproximately two-thirds of the patients with serum theophylline concentrations in the 20-30 mcg/mL range had one or more manifestations of toxicity while90of patients with serum theophylline concentrations30 mcg/mL were clinically intoxicatedSimilarlyin other reportsserious toxicity from theophylline is seen principally at serum concentrations30 mcg/mL.

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