Recommended Topic Related To:

Theophylline in 5% Dextrose Injection Flexible Plastic Container

"The U.S. Food and Drug Administration will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing "...

Theophylline 5% Dextrose Injection Flexible

Theophylline in 5% Dextrose Injection Flexible Plastic Container Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Theophylline 200, 400 and 800 mg in 5% Dextrose Injection is a methylxanthine used as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include nausea, vomiting, headache, insomnia, diarrhea, irritability, restlessness, muscle tremors, and increased urination.

Dosage of Theophylline is determined by a physician. Theophylline may interact with a wide variety of drugs, including but not limited to, adenosine, adrenaline-like drugs, allopurinol, aminoglutethimide, antiarrhythmics, anti-seizure drugs, benzodiazepines, beta-blockers, birth control pills, cimetidine, digoxin, disulfiram, fluvoxamine, interferon, isoproterenol, methotrexate, moricizine, pentoxifylline, rifampin, St John's wort, sulfinpyrazone, tacrine, thiabendazole, ticlopidine, verapamil, zileuton, tobacco or marijuana smoking, caffeine, and alcohol. Tell your doctor all medications and supplements you use. During pregnancy, Theophylline should be used 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 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.

Theophylline in 5% Dextrose Injection Flexible Plastic Container 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 ≥ 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 Theophylline in 5% Dextrose Injection Flexible Plastic Container (Theophylline in 5% Dextrose Injection Flexible Plastic Container) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Allergies & Asthma

Improve treatments & prevent attacks.

Related Drugs
Health Resources
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations

NIH talks about Ebola on WebMD