SUMMARY
Theophylline in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Theophylline, Anhydrous, USP in 5% Dextrose Injection. It contains no antimicrobial agents. Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste.
Intravenous theophylline is indicated 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.
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NEWS HIGHLIGHTS
Published Studies Related to Theophylline Injection
Pharmacokinetics of an extended-release theophylline product in cats. [2007.09.15]
OBJECTIVE: To evaluate the pharmacokinetics of a brand of extended-release theophylline tablets and capsules in healthy cats. DESIGN: Randomized 3-way crossover study... CONCLUSIONS AND CLINICAL RELEVANCE: Daily administration of the brand of theophylline tablets and capsules used in this study at 15 mg/kg (6.8 mg/lb) and 19 mg/kg (8.6 mg/lb), respectively, maintained plasma concentrations within the desired therapeutic range in healthy cats.
Theophylline does not potentiate the effects of a low dose of dexamethasone in horses with recurrent airway obstruction. [2006.11]
REASONS FOR PERFORMING STUDY: Theophylline has been shown to have corticosteroid-sparing effects for the treatment of human asthma. A similar effect, if present in horses, would allow diminishing the dose of corticosteroids administered to equine patients with inflammatory airway diseases... CONCLUSIONS AND POTENTIAL RELEVANCE: Oral theophylline for 7 days did not improve the effects of a low dose of dexamethasone for the treatment of horses with RAO.
Prophylaxis of contrast material-induced nephropathy in patients in intensive care: acetylcysteine, theophylline, or both? A randomized study. [2006.06]
PURPOSE: To prospectively compare the protective effect of acetylcysteine, theophylline, and both agents combined in patients who are admitted to the intensive care unit with at least one risk factor for contrast material-induced nephropathy and who receive at least 100 mL of iodinated contrast medium... CONCLUSION: For prophylaxis of contrast-induced nephropathy in patients who are admitted to the intensive care unit and who receive 100 mL or more of contrast medium, theophylline is superior to acetylcysteine. Copyright (c) RSNA, 2006.
Efficacy and safety of intravenous theophylline administration for treatment of mild acute exacerbation of bronchial asthma. [2005.09]
CONCLUSION: These results suggest that IAT is useful for patients with mild acute exacerbation of bronchial asthma and is safe if serum theophylline concentrations are measured.
Population pharmacokinetics of caffeine and its metabolites theobromine, paraxanthine and theophylline after inhalation in combination with diacetylmorphine. [2005.01]
The stimulant effect of caffeine, as an additive in diacetylmorphine preparations for study purposes, may interfere with the pharmacodynamic effects of diacetylmorphine. In order to obtain insight into the pharmacology of caffeine after inhalation in heroin users, the pharmacokinetics of caffeine and its dimethylxanthine metabolites were studied...
Clinical Trials Related to Theophylline Injection
Rosiglitazone Versus Theophylline in Asthmatic Smokers [Completed]
Asthmatic smokers display a blunted response to both inhaled and oral corticosteroid
treatments and are at increased risk for exacerbations and near fatal asthma. The prevalence
of smoking in asthmatics runs between 20-30%. Therefore, new, more efficacious treatments are
required.
Recent work has demonstrated a mechanism which may explain steroid resistance. A commonly
used drug called theophylline can reverse this steroid resistance in laboratory studies.
Another commonly used drug, rosiglitazone can reverse smoking induced lung inflammation in
laboratory studies.
The investigators aim to study the effects of these drugs on smoking asthmatics' lung
function and other parameters including quality of life and asthma control.
Effects of Low-Dose Theophylline During Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [Completed]
Molecular mechanisms of COPD exacerbations and the modulating effect of low dose theophylline
on that inflammation are elucidated in this project. NF-kappa B-dependent pathway and
acetylation status of nuclear histones are to be studied. Design: controlled, prospective and
randomized study with or without theophylline, a potent HDAC activator. Objectives: 1) To
determine NF-kB activation, histone deacetylase (HDAC) and histone acetyl-transferase (HAT)
activity in sputum macrophages and blood monocytes during an episode of exacerbation and 3
months later, once stability is achieved. To correlate these measurements with inflammatory
and oxidative stress markers and with pulmonary function and clinical variables. 2) To
assess the effect of theophylline on previous molecular, functional and clinical data.
Method: 25 patients with COPD will be recruited during an episode of exacerbation requiring
hospitalization. NF-kB activation, HDAC and HAT activity, markers of inflammation and
oxidative stress will be determined with specific assays. These determinations will be
repeated once the patient is stable and compared with smokers and non smoker controls with
normal lung function
Acetylcysteine, Theophylline, and a Combination of Both in the Prophylaxis of Contrast-Induced Nephropathy [Completed]
Several studies demonstrated a significant reduction of contrast-induced nephropathy (CIN;
definition: increase in serum creatinine of >=0. 5mg/dl and/or >=25% increase within 48h after
contrast-medium) by acetylcysteine (A) or theophylline (T). However, the results are
contradictory. Therefore, it was the aim of our double-blind study to compare the effects of
A, T, a combination of A and T (A+T), and placebo (P).
Theophylline in Treating Cancer Patients With Shortness of Breath [Active, not recruiting]
RATIONALE: Theophylline may help to relieve shortness of breath in patients who have cancer.
It is not yet known whether theophylline is more effective than no further treatment for
shortness of breath.
PURPOSE: Randomized phase III trial to determine the effectiveness of theophylline in
treating shortness of breath in patients who have cancer.
Theophylline in Treating Patients With In Situ, Stage I, or Stage II Chronic Lymphocytic Leukemia [Completed]
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of theophylline in treating patients who
have in situ, stage I, or stage II chronic lymphocytic leukemia.
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