July 24, 2016
Recommended Topic Related To:

Theophylline in 5% Dextrose

"The US Food and Drug Administration (FDA) has expanded the indication for the short-acting beta-agonist albuterol sulfate inhalation powder (ProAir RespiClick, Teva) to children aged 4 to 11 years, the company announced today.

"...

A A A

Theophylline 5% Dextrose Injection Excel




Theophylline in 5% Dextrose Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/8/2016

Theophylline 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 such as emphysema and chronic bronchitis. Theophylline in 5% Dextrose Injection is available in generic form. Common side effects of Theophylline in 5% Dextrose Injection include:

  • nausea
  • vomiting (may include blood in vomit)
  • abdominal pain
  • diarrhea
  • headache
  • insomnia
  • low blood potassium
  • high blood sugar
  • heart palpitations
  • irregular heartbeat
  • nervousness
  • tremors
  • disorientation,or
  • seizures

    Theophylline is administered intravenously and the dose is individualized based on the patients, age, body weight, and other factors. Theophylline may interact with 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 human infants. Consult your doctor before breastfeeding.

    Our Theophylline in 5% Dextrose Injection 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 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)

    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.


    Women's Health

    Find out what women really need.

    Related Drugs
    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