Theochron (theophylline anhydrous)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Theophylline, a xanthine derivative, directly relaxes smooth muscle of the respiratory tract, producing relief of bronchospasm and increasing flow rates and vital capacity.

USES: Theophylline is used to treat lung diseases such as asthma and COPD (bronchitis, emphysema). It must be used regularly to prevent wheezing and shortness of breath. This medication belongs to a class of drugs known as xanthines.

It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. It also decreases the lungs' response to irritants. Controlling symptoms of breathing problems can decrease time lost from work or school.

This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden breathing problems. If sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.

Generic name: theophylline anhydrous
Pronunciation: (thee-OF-i-lin)

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Theochron:

  • Chronic Obstructive Pulmonary Disease With Bronchospasms
  • Mild Persistent Asthma
  • Pulmonary Emphysema

Also known as: Bronchospasm Associated With Copd, Emphysematous Lung Disease.

Dosing

Dosage of theophylline in children younger than 1 year of age, particularly in premature and term neonates, must be carefully individualized. Elimination of the drug in children younger than 1 year of age, especially in neonates, generally appears to be reduced. Because of potential toxicity, use of the drug in children younger than 1 year of age should be carefully considered and, if used, the initial and maintenance dosages (particularly the latter) should be conservative. Maintenance dosage should not be exceeded and therapy with the drug should not be continued unless the drug is well tolerated and clinically beneficial. Recommended initial maintenance dosages for neonates and infants for the treatment of bronchospasm are shown in the following table:

Table 8. Recommended Dosage Titration for Children <1 Year of Age using Immediate-Release Preparations

Age Dosage Titration Premature neonates <24 days Initially, 1 mg/kg every 12 hours. postnatal age Adjust dosage to maintain a peak steady-state serum concentration of 5-10 mcg/mL Premature neonates >=24 days Initially, 1.5 mg/kg every 12 hours. postnatal age Adjust dosage to maintain a peak steady-state serum concentration of 5-10 mcg/mL Full-term infants <26 weeks of age ((0.2 x age in weeks) + 5) x body weight (kg) = total daily dosage (mg); administer in 3 equally divided doses every 8 hours. Adjust dose to maintain a peak steady-state serum concentration of 5-10 mcg/mL in neonates or 10-15 mcg/mL in older infants Infants 26-52 weeks of age ((0.2 x age in weeks) + 5) x body weight (kg) = total daily dosage (mg); administer in 4 equally divided doses every 6 hours. Adjust dosage to maintain a peak steady-state serum concentration of 10-15 mcg/mL

Drug interactions

Theophylline increases excretion of lithium and may decrease its therapeutic effectiveness. Higher doses of lithium may be required during concurrent administration of theophylline. The direct stimulatory effect of theophylline on the myocardium may enhance the sensitivity and toxic potential of the cardiac glycosides. Theophylline may exhibit synergistic toxicity with ephedrine and other sympathomimetics and, when administered concomitantly, these agents may further predispose the patient to the development of cardiac arrhythmias.

Theophylline may enhance the effects of the oral anticoagulants by increasing plasma prothrombin and factor V, but therapeutic theophylline dosages will probably have little or no effect on anticoagulant response.

Cimetidine, high-dose allopurinol (e.g., 600 mg daily), oral contraceptives, propranolol, ciprofloxacin, erythromycin, and troleandomycin may increase serum theophylline concentrations by decreasing theophylline's hepatic clearance. Rifampin may decrease serum theophylline concentrations by increasing theophylline's hepatic clearance. Concomitant theophylline and phenytoin administration can result in decreased serum concentrations of either or both agents by increasing hepatic metabolism.

Methotrexate may decrease clearance of theophylline; plasma theophylline concentrations should be monitored in patients receiving theophylline concomitantly with methotrexate.

There is some evidence from animal studies that concomitant administration of a beta-adrenergic agonist (e.g., isoproterenol) and a theophylline derivative (e.g., aminophylline) may produce increased cardiotoxic effects. Although such an interaction has not been established in humans, a few reports have suggested that such a combination may have the potential for producing cardiac arrhythmias. Further accumulation of clinical data is needed to determine whether this potential interaction exists in humans.

Contraindications

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Adverse reactions

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Precautions

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ICD codes

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Last reviewed · Source: First Databank (FDB) drug data