Theophylline in 5% Dextrose
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Theophylline 5% Dextrose Injection Excel
Theophylline in 5% Dextrose 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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Theophylline in 5% Dextrose FDA Prescribing Information: Side Effects
(Adverse Reactions)
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 ¡Ý15 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). Hypercalcemia has been reported in a patient with hyperthyroid disease at therapeutic theophylline concentrations (see OVERDOSAGE).
Table IV. Manifestations of theophylline toxicity.*
| Sign/Symptom | Percentage of patients reported with sign or symptom | |||
| Acute Overdose (Large Single Ingestion) |
Chronic Overdosage (Multiple Excessive Doses) |
|||
| 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 lntern 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. |
||||
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
Read the entire FDA prescribing information for Theophylline in 5% Dextrose (Theophylline in Dextrose Excel Container) »
Additional Theophylline 5% Dextrose Injection Excel Information
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