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Terbutaline (Terbutaline Sulfate) - Summary

 
 



TERBUTALINE SUMMARY

Terbutaline sulfate USP, the active ingredient of terbutaline sulfate tablets, USP is a beta-adrenergic agonist bronchodilator available as tablets of 2.5 mg (2.05 mg of the free base) and 5 mg (4.1 mg of the free base) for oral administration. Terbutaline sulfate is ±-alpha-[(tert -butylamino)methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt).

Terbutaline sulfate tablets, USP are indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.


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NEWS HIGHLIGHTS

Published Studies Related to Terbutaline

Continuous infusions of terbutaline in asthma - a review. [2011.10]
CONCLUSION: Although some findings are encouraging, they are drawn from small observational studies done at a time when the standard management of asthma was quite different from today. No randomized controlled trials exist for the use of CSIT, which remains off-license for the treatment of asthma in the United Kingdom. Clearly, prospective well-powered studies are required to fully ascertain its potential benefits and safety profile-something that is unlikely to occur given that the use of CSIT remains low and appears to be declining.

Improvement of fertility in artificially inseminated ewes following vaginal treatment with misoprostol plus terbutaline sulphate. [2010.12]
The effect of vaginal administration of misoprostol plus terbutaline sulphate 6 h prior to artificial insemination (AI) upon the site of AI (vaginal or cervical) and fertility was studied using a total of 87 estrous synchronized Serra da Estrela ewes (control n = 42 and treated n = 45)... Although needing confirmation, it was hypothesized that drugs might have induced local secretory modifications leading to an increase of cervical ability to retain more viable spermatozoa for fertilization.

The effect of terbutaline on the absorption of pulmonary administered insulin in subjects with asthma. [2010.03]
AIM: To investigate the effect of prior administration of a bronchodilator on the absorption of inhaled insulin in people with asthma treated with inhaled corticosteroids... CONCLUSIONS: In people with asthma and reversible bronchoconstriction, the administration of a bronchodilator prior to administration of inhaled insulin led to increased absorption of insulin, whereas no effect on insulin absorption in subjects without significant reversibility could be detected.

Bromotyrosines in sputum proteins and treatment effects of terbutaline and budesonide in asthma. [2009.10]
BACKGROUND: Inhaled corticosteroids are widely used in the treatment of persistent asthma, usually combined with inhaled beta2-agonists. Previous research suggests that short-acting beta2-agonists (SABAs) may downregulate the anti-inflammatory effects of inhaled corticosteroids, thereby increasing asthma morbidity. OBJECTIVE: To determine whether 3-bromotyrosine and 3,5-dibromotyrosine levels, specific markers of eosinophil activation, reflect treatment effects on airway inflammation of inhaled corticosteroids and SABAs and support previous conclusions... CONCLUSIONS: 3-Bromotyrosine and 3,5-dibromotyrosine levels reflect treatment effects in asthma and support previous findings that SABAs impair the anti-inflammatory effects of inhaled corticosteroids. In addition to eosinophil numbers and eosinophil cationic protein levels, these modified tyrosine residues provide useful information about the inflammatory state of the airways.

A randomized, controlled trial of nebulized terbutaline for the first acute bronchiolitis in infants less than 12-months-old. [2009.03]
BACKGROUND: Despite the common clinical practice, the available evidence on the efficacy of bronchodilators therapy for bronchiolitis is conflicting. The aim of this study is to evaluate the efficacy of nebulized terbutaline in bronchiolitis as measured by improvement in clinical score, oxygen saturation or reduction in duration of hospitalization... CONCLUSION: Nebulized terbutaline therapy does not appear effective in treating moderately ill infants with the first acute bronchiolitis.

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Clinical Trials Related to Terbutaline

Terbutaline Concentrations in Blood and Urine [Not yet recruiting]
The purpose of this study is to assess the blood and urine concentrations of terbutaline and to evaluate the difference between inhaled and oral terbutaline in order to distinguish treatment with terbutaline from doping with terbutaline in a doping control.

Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma [Completed]
Study No. 001 about Budesonide/Formoterol use in ASthMA sponsored by Agenzia Italiana del FArmaco (Italian Drug Agency) (AIFA-ASMA-BF-001) The aim of the study is to verify whether asthma not controlled by low doses inhaled corticosteroids, thus in need for step up therapy, can be equally controlled by guidelines recommended regular bid treatment with long acting beta agonist/inhaled corticosteroid (ICS/LABA) combination or the symptom driven use of an ICS/LABA combination in the absence of maintenance therapy. The study is designed to be able to evaluate the non inferiority of regular placebo plus prn inhaled budesonide/formoterol (experimental treatment) versus regular, twice daily 160/4. 5 mcg inhaled budesonide/formoterol combination plus prn inhaled terbutaline (guidelines recommended treatment).

Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3 [Recruiting]
A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to moderate asthma

Study to Evaluate is ECV Success is Improved and the Side Effects Reduced With the Use of IV NTGL Versus Terbutaline [Terminated]
Breech presentation of a term pregnancy is a common occurrence. A procedure known as external cephalic version (ECV) is frequently used by obstetricians to turn the baby into the vertex position prior to delivery in order to avoid a cesarean section and the associated risks. Medications to relax the uterus, known as tocolytics, are used in conjunction with the procedure as they have been shown to improve the success rate of ECV, but with inconsistent, varying results.

A Pilot Study to Evaluate the Safety of Terbutaline in Children With Type 1 Diabetes [Completed]
The purpose of the study is to gain experience with the use of terbutaline in children with T1D and to determine that there is not a frequent serious, unexpected, uncontrollable effect on short-term glycemic control. Some information also will be obtained with regard to whether terbutaline, in the dosing being used in the study, is sufficiently well tolerated to expect that adherence will be satisfactory in a large randomized trial. In addition, this pilot study will provide data on the accuracy of a continuous glucose monitor during terbutaline use to verify that the drug does not impact on sensor function.

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Reports of Suspected Terbutaline Side Effects

Maternal Exposure During Pregnancy (12)Lactic Acidosis (7)Attention Deficit/hyperactivity Disorder (6)Gastrooesophageal Reflux Disease (5)Cleft LIP and Palate (5)Asthma (4)Chorioamnionitis (4)Congenital Central Nervous System Anomaly (4)Developmental Delay (4)Patent Ductus Arteriosus (4)more >>


Page last updated: 2011-12-09

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