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Terbutaline Injection (Terbutaline Sulfate Injection) - Summary

 
 



SUMMARY

TERBUTALINE SULFATE INJECTION USP

Terbutaline sulfate USP, the active ingredient of terbutaline sulfate injection, is a beta-adrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration. Each milliliter of solution contains 1 mg of terbutaline sulfate USP (0.82 mg of the free base), sodium chloride for isotonicity, and hydrochloric acid for adjustment to a target pH of 4. Terbutaline sulfate is ()-α-[(tert -butylamino)methyl]-3,5-dihydroxybenzyI alcohol sulfate (2:1) (salt).

Terbutaline sulfate injection is 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 Injection

Terbutaline versus nifedipine for prolongation of pregnancy in patients with preterm labor. [2008.01]
Objective: To compare the effectiveness, safety, and possible adverse effects of terbutaline and nifedipine in prolonging pregnancy beyond 48 h. Methods: A randomized controlled trial was conducted with 174 pregnant women admitted with preterm labor randomized into 2 groups, which were given terbutaline (95 patients) and nifedepine (79 patients), respectively...

Safety and efficacy of oral nifedipine versus terbutaline injection in preterm labor. [2007.11]
CONCLUSION: The safety and efficacy of nifedipine compares with that of terbutaline for treatment of preterm labor.

Efficacy and tolerance of high-dose inhaled ipratropium bromide vs. terbutaline in intubated premature human neonates. [2007]
BACKGROUND: There is insufficient data to reliably assess the benefit of bronchodilators in ventilated premature neonates. OBJECTIVES: To compare the efficacy/tolerance of inhaled ipratropium bromide (IB) vs. terbutaline (T) and to describe factors associated with their efficacy... CONCLUSION: High doses of bronchodilators are required in ventilated neonates, but the positive response rate was <50%. Their long-term benefit remains to be proven. Copyright (c) 2007 S. Karger AG, Basel.

Management of uterine hyperstimulation with concomitant use of oxytocin and terbutaline. [2006.08]
The purpose of this study was to evaluate the efficacy of the concomitant use of subcutaneous terbutaline and oxytocin for the management of uterine hyperstimulation. Patients in active labor receiving intravenous oxytocin who developed uterine hyperstimulation were randomly assigned to receive either oxytocin discontinuation or administration of subcutaneous terbutaline while maintaining the oxytocin infusion...

Randomized comparison of intravenous nitroglycerin and subcutaneous terbutaline for external cephalic version under tocolysis. [2004.12]
OBJECTIVE: The purpose of this study was to compare the efficacy and safety of intravenous nitroglycerin with that of subcutaneous terbutaline as a tocolytic agent for external cephalic version at term... CONCLUSION: Compared with intravenous nitroglycerin, subcutaneous terbutaline was associated with a significantly higher rate of successful external cephalic version at term.

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Clinical Trials Related to Terbutaline Injection

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 [Recruiting]
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 Symbicort As-Needed or Bricanyl As-Needed or Pulmicort Once Daily + Bricanyl As-Needed in Asthma Patients [Not yet recruiting]
1. The primary objective of this study is:

- To evaluate the magnitude of the protective effect of the combination of

budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma

2. The secondary objectives of this study are:

- To evaluate the magnitude of the protective effect of the combination of

budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma

- To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and

regular use of budesonide + terbutaline as-needed as terms of adverse event

Trial of Terbutaline for the Treatment of Status Asthmaticus in Children [Completed]
Although widely used for the treatment of pediatric status asthmaticus, intravenous terbutaline has potentially significant side effects; may not improve outcomes; and may increase Intensive Care Unit (ICU) length of stay. This study is designed to test the efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or placebo will be titrated according to severity of illness as quantified by a validated clinical asthma score. Differences in outcomes between the study groups, such as length of stay, hospital costs, and lung function will be compared.

Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement [Not yet recruiting]
Labor pain is a major factor in making the placement of an epidural catheter difficult. The epidural, once in place and dosed, eventually decreases the parturient's pain. To achieve this goal as fast and safely as possible it would be helpful to have a parturient who can tolerate and co-operate with the placement of the epidural catheter.

Briefly stopping contractions, the cause of labor pain, could be the key to achieve this goal.

This study will evaluate the safety, efficacy and duration of the drug terbutaline for this purpose.

more trials >>


Page last updated: 2008-03-26

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