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Theolair

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Theolair

Theolair Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Theolair (theophylline) is a xanthine drug used to treat the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. Common side effects include nausea, vomiting, headache, insomnia, diarrhea, irritability, restlessness, and muscle tremors.

The dose of Theolair is individualized based on patient response. Theolair may interact with adenosine, adrenaline-like drugs, allopurinol, aminoglutethimide, certain antiarrhythmic drugs, anti-seizure drugs, benzodiazepines, beta, birth control pills, cimetidine, digoxin, disulfiram, fluvoxamine, interferon, isoproterenol, methotrexate, moricizine, pentoxifylline, rifampin, St John's wort, sulfinpyrazone, tacrine, thiabendazole, ticlopidine, verapamil, zileuton, cough-and-cold products, diet aids, alcohol, caffeine, and tobacco. Tell your doctor all medications and supplements you use. During pregnancy, Theolair should be sued only if prescribed. This drug passes into breast milk and may cause irritability or other signs of mild toxicity in nursing infants. Consult your doctor before breastfeeding.

Our Theolair (theophylline) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Theolair FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse reactions associated with theophylline are generally mild when peak serum theophylline concentrations are < 20 mcg/ mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum theophylline concentrations exceed 20 mcg/mL, however, theophylline produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal (see OVERDOSAGE). The transient caffeine-like adverse reactions occur in about 50%of patients when theophylline therapy is initiated at doses higher than recommended initial doses (e.g., > 300 mg/day in adults and > 12 mg/kg/day in children beyond 1 year of age). During the initiation of theophylline therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of theophylline therapy at a low dose with subsequent slow titration to a predetermined age-related maximum dose will significantly reduce the frequency of these transient adverse effects (see DOSAGE AND ADMINISTRATION, Table V). In a small percentage of patients ( < 3%of children and < 10%of adults)the caffeine-like adverse effects persist during maintenance therapy, even at peak serum theophylline concentrations within the therapeutic range (i.e., 10-20 mcg/mL). Dosage reduction may alleviate the caffeine-like adverse effects in these patients, however, persistent adverse effects should result in a reevaluation of the need for continued theophylline therapy and the potential therapeutic benefit of alternative treatment.

Other adverse reactions that have been reported at serum theophylline concentrations < 20 mcg/mL include diarrhea, irritability, restlessness, fine skeletal muscle tremors, and transient diuresis. In patients with hypoxia secondary to COPD, multifocal atrial tachycardia and flutter have been reported at serum theophylline concentrations ≥ 15 mcg/mL. There have been a few isolated reports of seizures at serum theophylline concentrations < 20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum theophylline concentrations < 20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum theophylline concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum theophylline concentrations < 20 mcg/mL have generally been milder than seizures associated with excessive serum theophylline concentrations resulting from an overdose (i.e., they have generally been transient, often stopped without anticonvulsant therapy, and did not result in neurological residua).

Table IV. Manifestations of theophylline toxicity.*

  Percentage of Patients Reported With Sign or Symptom
Acute Overdose
(Large Single Ingestion)
Chronic Overdosage
(Multiple Excessive Doses)
Sign/Symptom Study 1
(n=157)
Study 2
(n=14)
Study 1
(n=92)
Study 2
(n=102)
Asymptomatic NR** 0 NR** 6
Gastrointestinal
  Vomiting 73 93 30 61
  Abdominal Pain NR** 21 NR** 12
  Diarrhea NR** 0 NR** 14
  Hematemesis NR** 0 NR** 2
Metabolic/Other
  Hypokalemia 85 79 44 43
  Hyperglycemia 98 NR** 18 NR**
  Acid/base disturbance 34 21 9 5
  Rhabdomyolysis NR** 7 NR** 0
Cardiovascular
  Sinus tachycardia 100 86 100 62
  Other supraventricular tachycardias 2 21 12 14
  Ventricular premature beats 3 21 10 19
  Atrial fibrillation or flutter 1 NR** 12 NR**
  Multifocal atrial tachycardia 0 NR** 2 NR**
  Ventricular arrhythmias with hemodynamic instability 7 14 40 0
  Hypotension/shock NR** 21 NR** 8
Neurologic
  Nervousness NR** 64 NR** 21
  Tremors 38 29 16 14
  Disorientation NR** 7 NR** 11
  Seizures 5 14 14 5
Death 3 21 10 4
* 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. Differences in the incidence of manifestations of theophylline toxicity between the two studies may reflect sample selection as a result of study design (e.g., in Study #1, 48%of the patients had acute intoxications versus only 10% in Study #2) and different methods of reporting results.
** NR =Not reported in a comparable manner.

Read the entire FDA prescribing information for Theolair (Theophylline) »

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