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Theophylline Injection (Theophylline Injection) - 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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Published Studies Related to Theophylline Injection

Prevention of contrast-induced acute kidney injury by theophylline in elderly patients with chronic kidney disease. [2010.09.29]
Although the optimal strategy for preventing contrast-induced acute kidney injury (CI-AKI) has not yet been established, the current strategy focuses on adequate periprocedural hydration, the use of a low amount of low or iso-osmolar contrast medium, and the application of adjunctive therapies, including hemofiltration, hemodialysis and drugs...

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.

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Clinical Trials Related to Theophylline Injection

The Effect of Theophylline in the Treatment of Bronchiectasis [Completed]
Theophylline was well recommended in the treatment of chronic obstructive pulmonary disease (COPD) and asthma. However, there is no supporting evidence for their efficacy in the treatment of bronchiectasis. Our hypothesis is that theophylline will play a role in bronchiectasis. Our purpose is to examine the efficacy and safety of 24 weeks treatment with theophylline in subjects with non-cystic fibrosis bronchiectasis.

Theophylline and Steroids in Chronic Obstructive Pulmonary Disease (COPD) Study [Recruiting]
The aim of this multi-centre, double blind, randomised, controlled trial (DBRCT) is to assess the effect of low dose theophylline, singly and in combination with low dose oral prednisone, on COPD (Chronic Obstructive Pulmonary Disease) exacerbations, quality of life and secondary clinical outcomes compared with usual therapy and placebo over 48 weeks of treatment. Approximately 2400 symptomatic patients with COPD will be recruited in China for comparison of low dose theophylline versus placebo and low dose theophylline + low dose prednisone The primary end-point for this study is the difference between the three treatment groups in

- COPD exacerbation rate

- Time to first severe exacerbation requiring hospitalisation or death

The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis [Completed]
The purpose of this study is to examine the efficacy and safety of 24 weeks treatment with theophylline plus low-dose formoterol-budesonide in subjects with bronchiectasis.

Drug Interaction Study of Colchicine and Theophylline [Completed]
Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe substrate. When the two are co-administered the potential exists for a clinically significant drug interaction. This study aims to determine the effect of steady-state colchicine on the pharmacokinetics of theophylline administered as a single dose. A secondary goal is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the entire study period.

A Phase I Dose Escalation Study of Erlotinib in Combination With Theophylline [Recruiting]
This study is to determine the use of theophylline in patients with NSCLC and advanced solid malignancies and whether treatment with theophylline will help lower or diminish the side effect of diarrhea in patients taking erlotinib. Patients will be enrolled in one of two parts of the study to verify the lowest dose of theophylline that is effective and the highest dose of erlotinib that can be tolerated with theophylline. If this study shows that theophylline is able to inhibit erlotinib induced diarrhea, it will help demonstrate that patients using the tyrosine kinase inhibitor (TKIs), erlotinib, can use it effectively at higher doses without experiencing severe diarrhea.

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Page last updated: 2010-10-05

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