Terbutaline sulfate, a synthetic sympathomimetic amine, is a short-acting β2-agonist bronchodilator (SABA).12, 198, 199
Terbutaline sulfate is used orally and subcutaneously for the prevention and reversal of bronchospasm in patients 12 years of age or older with asthma and for reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema.198, 199
Controlled clinical studies have shown that terbutaline relieves bronchospasm and increases pulmonary function in COPD, producing an increase of 15% or more in forced expiratory volume in 1 second (FEV1) and forced mid-expiratory flow between 25% and 75% of forced vital capacity (FEF25-75%).198, 199 Terbutaline has also demonstrated clinically significant decreases in airway and pulmonary resistance.199 In studies comparing terbutaline to ephedrine, both drugs maintained substantial improvements in pulmonary function for up to 3 months of treatment.199
A randomized controlled trial compared subcutaneous terbutaline to nebulized albuterol for out-of-hospital treatment of respiratory distress secondary to asthma or COPD exacerbations in adults.252 Both treatments resulted in substantial improvements in respiratory symptoms; however, albuterol was associated with greater improvements in patient-rated dyspnea symptoms and increased rates of overall subjective improvement.252
A randomized controlled trial compared IV terbutaline† to saline placebo in 49 pediatric patients 2-17 years of age who were admitted to the intensive care unit for severe asthma exacerbations.250 All patients received high-dose nebulized albuterol, ipratropium bromide, and systemic corticosteroids in addition to the study intervention.250 Terbutaline did not significantly improve clinical asthma severity scores over the first 24 hours of treatment compared to placebo, although there was a numeric trend toward improvement in the terbutaline group.250 Another randomized controlled trial compared IV theophylline, IV terbutaline, and a combination of IV theophylline and IV terbutaline in 40 children 3-15 years of age who had impending respiratory failure secondary to status asthmaticus; all patients additionally received IV methylprednisolone and continuous nebulized albuterol.251 In this study, clinical outcomes were similar between the treatment groups, although more patients receiving the combination of IV theophylline and IV terbutaline reported nausea as an adverse effect.251
The Global Initiative for Asthma (GINA) publishes an annual guideline on asthma management .12 The GINA guidelines provide evidence-based recommendations for the management of asthma in adults, adolescents, and children.12 The guideline states that all patients with asthma should be evaluated for symptom control, risk of future exacerbations, treatment issues (e.g., inhaler technique and adherence), and comorbidities.12 A stepwise approach to treatment is recommended where specific drugs are added or adjusted up or down through a series of steps to achieve symptom control while keeping the patient on the lowest effective treatment.12 Drugs used in the management of asthma include inhaled corticosteroids (ICS) used alone or in combination with formoterol or other long-acting beta agonists (LABA), short-acting β2-adrenergic agonists (SABA), long-acting muscarinic agonists (LAMA), leukotriene receptor antagonists, azithromycin, oral corticosteroids, and biologic agents.12 Oral bronchodilators (e.g., oral SABA, theophylline) have a higher risk of adverse events than inhaled bronchodilators and are no longer recommended for asthma management.12 The GINA guidelines state that IV terbutaline† (administered as an initial IV bolus dose followed by continuous IV infusion) may be used as an alternative to inhaled SABA (if inhalation is not possible) for the initial emergency department management of asthma exacerbations in children ≤5 years of age†.12
Subcutaneous terbutaline generally is reserved for prehospital management of severe asthma exacerbations when inhaled SABA agents are not readily available.209
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) publishes an annual guideline on the comprehensive management of COPD.25 Risk reduction strategies such as smoking cessation and vaccinations are key components of COPD management.25 Pharmacologic therapy is used to reduce symptoms, reduce the frequency and severity of exacerbations, and improve overall health status.25 Drugs that are used for maintenance treatment of COPD include SABA, LABA, short-acting muscarinic antagonists (SAMA), LAMA, ensifentrine, methylxanthines, roflumilast, and mucolytic agents.25 Choice of therapy should be individualized based on availability, cost, adverse effects, and clinical benefits of the drugs in relation to the patient's severity of symptoms and risk for exacerbations.25 The GOLD guideline states that inhaled bronchodilators (e.g., LABA and LAMA) used on a regular basis are central to symptom management in COPD; inhaled bronchodilators are recommended over oral bronchodilators.25 Terbutaline is not mentioned in the most recent (2025) GOLD guidelines.25
Terbutaline sulfate has been used IV† or subcutaneously in selected patients to inhibit uterine contractions in preterm labor (tocolysis)† and thus prolong gestation when such prolongation of intrauterine life would be expected to benefit pregnancy outcome.108, 109, 110, 115, 116, 117, 118, 119, 120, 121, 122, 123, 125, 126, 128, 129, 188, 253 The American College of Obstetricians and Gynecologists (ACOG) considers terbutaline to be one of several possible tocolytic agents.188 Because of conflicting results, there is no clear first-line tocolytic agent.188 The manufacturer of terbutaline sulfate injection warns that the drug is not FDA labeled for and should not be used for prolonged tocolysis (beyond 48-72 hours), and is contraindicated for such use, because of the potential for serious maternal cardiac effects and death.198 The manufacturer of oral terbutaline sulfate also warns that oral terbutaline is not FDA labeled for and should not be used for acute or maintenance tocolysis, and is contraindicated for such use, because it has not been shown to be effective and has similar safety concerns as terbutaline sulfate injection.199, 254 Terbutaline sulfate (injection or oral tablets) should not be used for maintenance tocolysis, particularly in the outpatient or home setting.198, 199, 200, 254, 255
While use of terbutaline sulfate or other tocolytics may effectively delay delivery for up to 48 hours, tocolytics have not been shown to have a direct benefit on neonatal outcomes;108, 109, 110, 115, 116, 117, 118, 119, 120, 121, 122, 123, 126, 188 therefore, the primary goal of tocolytic therapy is to allow time for transport to a tertiary facility and/or allow time for administration of other therapies that improve neonatal outcomes (i.e., antenatal corticosteroids, magnesium sulfate).125, 126, 188, 188
Terbutaline sulfate has been used subcutaneously as an alternative to phentolamine for the treatment of vasopressor extravasation†.256
Terbutaline sulfate is administered orally or subcutaneously (usually into the lateral deltoid area).198, 199
108 Terbutaline sulfate also has been used IV† in selected patients to inhibit uterine contractions in preterm labor† (tocolysis).109, 110, 115, 116, 117, 118, 119, 120, 121, 122, 123, 125, 126, 187, 188
The drug also has been administered by IV infusion† for the emergency treatment of acute asthma exacerbations in young children.12 However, administration of parenteral terbutaline sulfate by routes or methods other than subcutaneous injection (e.g., IV) is not recommended by the manufacturer.198
Terbutaline oral tablets are available as 2.5 and 5 mg scored tablets.199 Administer orally 3 times daily during waking hours, at approximately 6-hour intervals.199
.Store the tablets in a light-resistant container at 20-25°C.199
Terbutaline solution for injection is available as a 1 mg/mL solution.198 The manufacturer states that the drug should not be administered as an IV infusion.198 Prior to administration, inspect the solution for particulate matter and/or discoloration.198 Do not use if the solution is discolored.198 Discard unused portion after single patient use.198
Store the vial in its original carton protected from light at 20-25°C.198
Standardized concentrations for IV terbutaline have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care.249 Multidisciplinary expert panels were convened to determine recommended standard concentrations.249 Because recommendations from the S4S panels may differ from the manufacturer's prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label.249 For additional information on S4S (including updates that may be available), see [Web].249
Patient Population | Concentration Standards | Dosing Unitsa |
|---|---|---|
Pediatric patients (<50 kg) | 1 mg/mL | mcg/kg/min |
aDosing units differ from concentration units.
Prevention and Reversal of Bronchospasm Associated with Asthma, Bronchitis, and Emphysema
Oral: The recommended dosage of terbutaline sulfate in children 12-15 years of age is 2.5 mg orally 3 times daily; do not exceed a total dosage of 7.5 mg within a 24-hour period.199
Subcutaneous:The usual subcutaneous dose of terbutaline sulfate in adolescents 12 years of age and older is 0.25 mg injected into the lateral deltoid area.198 If substantial clinical improvement does not occur within 15-30 minutes, a second dose of 0.25 mg may be administered.198 If the patient fails to respond within another 15-30 minutes, consider other therapeutic measures.198 Do not exceed 0.5 mg subcutaneously within a 4-hour period.198 In hospitalized children 12 years of age or younger† with an acute asthma exacerbation, 0.01 mg/kg has been given every 20 minutes for a total of 3 doses, then every 2-6 hours as needed.209
IV:For initial emergency department management of asthma exacerbations in children ≤5 years of age†, terbutaline has been given as an IV bolus dose† of 2 mcg/kg over 5 minutes, followed by continuous IV infusion† of 5 mcg/kg/hour.12 Closely monitor the child and adjust dosage according to response.12
Prevention and Reversal of Bronchospasm Associated with Asthma, Bronchitis, and Emphysema
Oral:The usual adult oral dosage of terbutaline sulfate is 5 mg administered 3 times daily at approximately 6-hour intervals while the patient is awake.199 Do not exceed a total dosage of 15 mg within a 24-hour period.199 If disturbing adverse effects occur, consider reducing the dosage to 2.5 mg 3 times daily.199
Subcutaneous:The usual subcutaneous dosage of terbutaline sulfate in adults is 0.25 mg injected into the lateral deltoid area.198 If substantial clinical improvement does not occur within 15-30 minutes, a second dose of 0.25 mg may be administered.198 If the patient fails to respond within another 15-30 minutes, consider other therapeutic measures.198 The manufacturer states that the total dosage of terbutaline sulfate should not exceed 0.5 mg subcutaneously within a 4-hour period.198
IV:For use as a tocolytic agent in the management of preterm labor†, the rate and duration of IV† infusions of terbutaline sulfate should be carefully adjusted according to the patient's response as indicated by uterine response, maternal blood pressure, and maternal and fetal heart rates.108, 109, 110, 114, 115, 117, 118, 126 For acute tocolytic therapy, IV terbutaline sulfate has been initiated at a dosage of 2.5-20 mcg/minute.110, 114, 115, 117, 118, 126, 128, 129 Dosage may be increased gradually as tolerated at 10- to 20-minute intervals until the desired effects are achieved.108, 109, 110, 114, 115, 117, 118, 126, 128, 129 Effective maximum dosages have ranged from 17.5-30 mcg/minute, although higher maximum dosages (e.g., 70-80 mcg/minute) have been used cautiously in some patients.108, 109, 110, 114, 115, 117, 118, 126 Terbutaline sulfate injection should not be used for prolonged tocolysis (beyond 48-72 hours).198
Subcutaneous:For acute tocolytic therapy in the management of preterm labor†, subcutaneous terbutaline sulfate at a dosage of 0.25 mg every 20 minutes to 3 hours has been recommended.187, 188 If pulse rate exceeds 120 beats/minute, terbutaline sulfate therapy should be temporarily discontinued.187, 188 Terbutaline sulfate injection should not be used for prolonged tocolysis (beyond 48-72 hours).198
The manufacturer makes no dosage recommendations for patients with hepatic impairment.198, 199
The manufacturer makes no dosage recommendations for patients with renal impairment.198, 199
The manufacturer makes no specific dosage recommendations for geriatric patients.198, 199 In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.198, 199
A boxed warning is included in the prescribing information for terbutaline sulfate regarding its use for tocolysis.198, 199 Oral terbutaline has not been approved for and should not be used for acute or maintenance tocolysis;199 injectable terbutaline has not been approved for and should not be used for prolonged tocolysis (beyond 48-72 hours).198 In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting.198, 199 Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women.198, 199 In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia.198, 199 Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration.198, 199
Other Warnings and Precautions
Asthma may deteriorate acutely over a period of hours or chronically over several days or longer.198, 199 If the patient needs more doses of terbutaline sulfate than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment (e.g., corticosteroids).198, 199
Exacerbation of bronchospasm has been reported after terbutaline administration.198, 199
Use of Anti-inflammatory Agents
The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients.198, 199 Avoid terbutaline monotherapy; early consideration should be given to adding anti-inflammatory agents (e.g., corticosteroids).198, 199
Terbutaline sulfate, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms.198, 199 Significant changes in systolic and diastolic blood pressure have been observed and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.198, 199 Although such effects are uncommon after administration of terbutaline sulfate at recommended doses, if they occur, the drug may need to be discontinued.198, 199 In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression.198, 199 The clinical significance of these findings is unknown.198, 199 Therefore, terbutaline sulfate, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, including coronary insufficiency, cardiac arrhythmias, and hypertension.198, 199
There have been rare reports of seizures in patients receiving terbutaline; seizures did not recur in these patients after the drug was discontinued.198, 199
Beta-adrenergic agonists may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.198, 199 The decrease is usually transient and does not require supplementation.198, 199
Large doses of IV terbutaline sulfate† have been reported to aggravate preexisting diabetes and ketoacidosis.198, 199
Terbutaline, as with all sympathomimetic amines, should be used with caution in patients with hyperthyroidism.198, 199
There are no adequate and well-controlled studies of terbutaline sulfate in pregnant women.198, 199 Published animal studies in rats showed alterations in behavior and brain development in the offspring, including decreased cellular proliferation and differentiation, when dams were treated subcutaneously with terbutaline during the late stage of pregnancy and lactation period.198, 199
Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis.199 Terbutaline injection has not been approved and should not be used for prolonged tocolysis (beyond 48-72 hours).198 In particular, terbutaline sulfate should not be used for tocolysis in the outpatient or home setting.198, 199 Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women.198, 199 In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia.198, 199 Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration.198, 199
Terbutaline crosses the placenta.198, 199 After administration of a single IV dose of terbutaline to 22 women in late pregnancy who required elective Cesarean section due to clinical reasons, umbilical blood levels of terbutaline were found to range from 11-48% of the maternal blood levels.198, 199 Because of the potential for beta-agonist interference with uterine contractility, use of terbutaline sulfate for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.198, 199
It is not known whether terbutaline is excreted in human milk.198, 199 The drug should be used during nursing only if the potential benefit justifies the possible risk to the infant.198, 199
The manufacturer does not recommend terbutaline sulfate for patients younger than 12 years of age because of insufficient clinical data to establish safety and effectiveness.198, 199
Clinical studies of terbutaline sulfate did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger subjects.198, 199 Other reported clinical experience has not identified differences in responses between the elderly and younger patients.198, 199 In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease.198, 199
The manufacturer reports that no clinical pharmacokinetic studies have been conducted in special populations.198, 199
The manufacturer reports that no clinical pharmacokinetic studies have been conducted in special populations.198, 199
The most common adverse effects of terbutaline sulfate tablets reported in ≥1% of patients include nervousness, tremor, somnolence, dizziness, anxiety, insomnia, palpitations, tachycardia, ventricular extrasystoles, vasodilation, nausea, dry mouth, headache, asthenia, and sweating.199
The most common adverse effects of terbutaline sulfate injection reported in ≥2% of patients include tremor, nervousness, dizziness, headache, drowsiness, palpitations, tachycardia, dyspnea, nausea/vomiting, flushed feeling, and sweating.198
Terbutaline should not be administered concurrently with other sympathomimetic agents because of the possibility of additive adverse cardiovascular effects;198, 199 however, an aerosol bronchodilator of the adrenergic stimulant type may be used to relieve acute bronchospasm in patients receiving chronic oral terbutaline therapy.199
Monoamine Oxidase (MAO) Inhibitors and Tricyclic Antidepressants
Administer terbutaline sulfate with extreme caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, since the action of terbutaline on the vascular system may be potentiated.198, 199
Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta agonists, such as terbutaline, but may produce severe bronchospasm in asthmatic patients.198, 199 Therefore, patients with asthma should not normally be treated with beta-blockers.198, 199 However, under certain circumstances (e.g., as prophylaxis after myocardial infarction) there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma.198, 199 In this setting, cardioselective beta blockers could be considered, although they should be administered with caution.198, 199
The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded.198, 199 Although the clinical significance of these effects is not known, use caution when beta-agonists are co-administered with non-potassium sparing diuretics.198, 199
Terbutaline sulfate is a short-acting β2-agonist bronchodilator (SABA).12, 198, 199 In vitro and in vivo pharmacologic studies have demonstrated that terbutaline exerts a preferential effect on beta2 -adrenergic receptors.198, 199 While it is recognized that beta2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta2-receptors in the human heart, existing in a concentration of 10-50%.198, 199 The precise function of these receptors has not been established.198, 199 In controlled clinical studies in patients given terbutaline sulfate orally, proportionally greater changes occurred in pulmonary function parameters than in heart rate or blood pressure.199 While this suggests a relative preference for the beta-receptors in man, the usual cardiovascular effects commonly associated with other sympathomimetic agents were also observed with terbutaline sulfate.198, 199 Additionally, controlled clinical studies in patients given terbutaline subcutaneously have not revealed a preferential beta-adrenergic effect.198
The pharmacologic effects of beta-adrenergic agonists, including terbutaline, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic 3', 5'-adenosine monophosphate (cAMP).198, 199 Increased cAMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.198, 199
Controlled clinical studies have shown that terbutaline sulfate administered orally or subcutaneously relieves bronchospasm in patients with chronic obstructive pulmonary disease (COPD) by significantly increasing pulmonary function (e.g., an increase of 15% or more in forced expiratory volume in one second [FEV1]).198, 199 After administration of terbutaline sulfate, a measurable change in flow rate usually occurs within 30 minutes after oral administration and within 5 minutes after subcutaneous injection.198, 199 A clinically significant improvement in pulmonary function occurs within 60-120 minutes after oral administration and within 15 minutes after subcutaneous injection.198, 199 The maximum effect usually occurs within 120-180 minutes after oral administration and within 30-60 minutes after subcutaneous administration.198, 199 Terbutaline sulfate also produces a clinically significant decrease in airway and pulmonary resistance, which persists for 4 hours or longer after oral administration and between 1.5-4 hours after subcutaneous administration.198, 199 Significant bronchodilator action (as measured by airway resistance, forced expiratory flow or peak expiratory flow rate) has also been demonstrated for up to 8 hours in some studies with oral terbutaline.199 In studies comparing the effectiveness of terbutaline sulfate with that of ephedrine for up to 3 months, both drugs maintained a significant improvement in pulmonary function throughout this period of treatment.198, 199
Following oral administration of terbutaline sulfate 5 mg tablets or terbutaline sulfate 5 mg solution in 17 healthy adult male subjects, peak plasma concentrations were observed at median (range) times of 2 (1-3) and 1.5 (0.5-3.0) hours after dosing.199 After oral administration of terbutaline 51-62 mcg/kg to 3 healthy male subjects, peak plasma concentrations were observed 1-3 hours later.199 After 3 days only 30-50% of the dose was recovered from urine and the remainder from feces, which may indicate poor absorption.199 After an oral dose of terbutaline sulfate in asthmatic patients, the elimination half-life of the drug was approximately 3.4 hours.199
After subcutaneous administration of terbutaline sulfate 0.5 mg in healthy adult male subjects, peak plasma concentrations were observed at a median (range) time of 0.5 (0.08-1.0) hours after dosing.198 The mean terminal half-life in 9 of the 17 subjects was 5.7 hours.198 Elimination half-life of the drug in 10 of 14 patients was approximately 2.9 hours after subcutaneous administration, but the other 4 patients had longer elimination half-lives (between 6-14 hours).198 About 90% of the drug was excreted in the urine at 96 hours after subcutaneous administration, approximately 60% of which was unchanged drug.198 The sulfate conjugate is a major metabolite of terbutaline.198, 199
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 2.5 mg* | ||
5 mg* | Terbutaline Sulfate Tablets | |||
Parenteral | Injection, for subcutaneous use only | 1 mg/mL* |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
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