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Theophylline is safe and effective for the approved indications in pediatric patientsThe maintenance dose of theophylline must be selected with caution in pediatric patients since the rate of theophylline clearance is highly variable across the age range of neonatesto adolescentssee CLINICAL PHARMACOLOGYTable IWARNINGSand DOSAGE AND ADMINISTRATIONTable VDue to the immaturity of theophylline metabolic pathways in infants under the age of one yearparticular attention to dosage selection and frequent monitoring of serum theophylline concentrations are required when theophylline is prescribed to pediatric patients in this age group.

The patientor parent/care givershould be instructed to seek medical advice whenever nauseavomitingpersistent headacheinsomnia or rapid heart beat occurs during treatment with theophyllineeven if another cause is suspectedThe patientor parent/care givershould be instructed to contact their clinician if they develop a new illnessespecially if accompanied by a persistent feverif they experience worsening of a chronic illnessif they start or stop smoking cigarettes or marijuanaor if another clinician adds a new medication or discontinues a previously prescribed medicationPatients should be instructed to inform all clinicians involved in their care that they are taking theophyllineespecially when a medication is being added or deleted from their treatmentPatients should be instructed to not alter the dosetiming of the doseor frequency of administration without first consulting their clinicianIf a dose is missedthe patient should be instructed to take the next dose at the usually scheduled time and to not attempt to make up for the missed dose.

In patients with chronic obstructive pulmonary diseaseCOPDclinical studies have shown that theophylline decreases dyspneaair trappingthe work of breathingand improves contractility of diaphragmatic muscles with little or no improvement in pulmonary function measurements.

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.

Refer to PRECAUTIONSDrug Interactions for further information regarding table.

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