Theophylline in 5% Dextrose Injection Flexible Plastic Container
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Theophylline 5% Dextrose Injection Flexible
Theophylline 5% Dextrose Injection Flexible
- Clinician Information:
Theophylline in 5% Dextrose Injection Flexible Plastic Container Side Effects Center
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.
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Theophylline in 5% Dextrose Injection Flexible Plastic Container FDA Prescribing Information: Side Effects
Adverse reactions associated with theophylline are generally mild when serum theophylline concentrations are < 20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When 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).
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|
(Large Single Ingestion)
(Multiple Excessive Doses)
|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|
| * 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 Theophylline in 5% Dextrose Injection Flexible Plastic Container (Theophylline in 5% Dextrose Injection Flexible Plastic Container) »
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