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Terbutaline Injection (Terbutaline Sulfate Injection) - Summary




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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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 [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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Page last updated: 2008-03-26

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