Brand Name

Terbutaline

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FDA approval date: June 26, 2001
Form: Injection, Tablet

What is Terbutaline?

For people living with asthma or chronic lung diseases, few things are more frightening than struggling to catch a breath. Coughing, wheezing, or chest tightness can make daily life unpredictable and exhausting. Terbutaline is a medication designed to bring relief and restore control. It helps open the airways, making breathing easier and more comfortable for those affected by asthma, bronchitis, or other breathing disorders. 

Terbutaline belongs to a group of drugs called beta₂-adrenergic agonists. These medications work by relaxing the muscles in the airways, allowing more air to move in and out of the lungs. It can be used as a bronchodilator to manage or prevent bronchospasm (narrowing of the airways) in conditions such as asthma, emphysema, and chronic bronchitis. While newer inhalers have become more common, terbutaline remains an important treatment option, especially for patients who need short-term or oral bronchodilator therapy. 

What does Terbutaline do? 

Terbutaline helps relieve and prevent bronchospasm, the tightening of airway muscles that makes it hard to breathe. It is prescribed for people with asthma, chronic obstructive pulmonary disease (COPD), or other lung disorders where airways become constricted. 

When taken as directed, terbutaline helps: 

  • Reduce coughing, wheezing, and shortness of breath 
     
  • Improve airflow and oxygen delivery 
     
  • Make it easier to perform daily activities without feeling breathless 

Terbutaline works as a rescue or maintenance medication, depending on how it is prescribed. For some patients, it’s used as a short-term treatment to stop sudden breathing problems. For others, especially those who cannot use inhalers effectively, it may be taken regularly in oral form to maintain airway openness. 

Studies and clinical experience have shown that terbutaline effectively increases lung function within minutes of use and continues to provide relief for several hours (NIH, 2024). Its quick onset makes it a reliable choice for managing acute symptoms when used under medical supervision. 

How does Terbutaline work? 

Terbutaline works by stimulating beta₂ receptors located in the smooth muscles of the airways. These receptors respond by relaxing the muscles, causing the airways to widen, a process known as bronchodilation. 

In asthma or COPD, inflammation and muscle tightening reduce the diameter of the airways, trapping air in the lungs and making it difficult to exhale. By activating these receptors, terbutaline helps reverse this narrowing, allowing air to flow freely. 

This mechanism provides rapid relief from shortness of breath, wheezing, and chest tightness. Clinically, it’s valuable because it restores airflow quickly and helps prevent severe asthma attacks or COPD flare-ups that might otherwise require emergency care. 

Additionally, terbutaline has mild effects on other parts of the body, such as relaxing uterine muscles, which is why it was once used in hospitals to delay premature labor. However, this use is now limited and generally avoided outside specific, short-term medical settings due to potential side effects. 

Terbutaline side effects 

Like all medications, terbutaline can cause side effects, though many are mild and temporary. Because it stimulates beta receptors throughout the body, some effects are related to increased heart rate and nervous system activity. 

Common side effects include: 

  • Shakiness or tremors (especially in the hands) 
     
  • Nervousness or restlessness 
     
  • Headache 
     
  • Dizziness 
     
  • Rapid heartbeat or palpitations 

Less common but serious side effects may include: 

  • Chest pain or irregular heartbeat 
     
  • Severe dizziness or fainting 
     
  • Muscle cramps or weakness 
     
  • Allergic reactions such as rash, swelling, or difficulty breathing 

If any of these serious effects occur, patients should seek medical attention immediately. 

Terbutaline should be used with caution in people who have: 

  • Heart disease or arrhythmias 
     
  • High blood pressure 
     
  • Diabetes (since it may raise blood sugar levels) 
     
  • Seizure disorders or overactive thyroid 

Your healthcare provider will assess your medical history to determine whether terbutaline is safe and appropriate for you. Most people tolerate the medication well, and any side effects often decrease as the body adjusts to treatment. 

Terbutaline dosage 

Terbutaline comes as tablets, injections, or inhalation solutions, chosen based on patient need. Tablets are for maintenance, inhalers for quick relief, and injections for emergencies. Dosage is physician-adjusted; do not self-increase to avoid side effects like irregular heartbeat. 

Doctors monitor heart rate, blood pressure, and blood sugar in older adults or those with chronic illnesses during terbutaline treatment to ensure effectiveness and prevent complications. Adherence to dosage and follow-up appointments is crucial for safe and effective treatment adjustments. 

Does Terbutaline have a generic version? 

Yes. Terbutaline is available as a generic medication approved by the U.S. Food and Drug Administration (FDA). Generic terbutaline contains the same active ingredient, strength, and quality as brand-name versions such as Brethine and Bricanyl (available in some countries). 

Generic drugs are safe, effective, and often cheaper, increasing treatment accessibility. Patients can confidently use prescribed generic versions. In the U.S., terbutaline is mainly available as tablets and injections; inhalants are less common now due to newer options. 

Conclusion 

Terbutaline remains a valuable and reliable bronchodilator for managing asthma, COPD, and other breathing disorders. By relaxing the airway muscles, it provides quick relief from symptoms like wheezing and breathlessness, helping patients breathe more freely and comfortably. 

Terbutaline remains important for acute symptom control and when inhalers aren’t suitable. Used correctly under medical supervision, it is safe and effective. Open communication with your healthcare provider is key. Report side effects, follow dosing, and ask questions. With proper use, terbutaline can significantly improve breathing and confidence. 

References 

  1. Mayo Clinic. (2024). Terbutaline (oral route, injection route) drug information. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Terbutaline: Uses, side effects, and precautions. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. U.S. Food and Drug Administration (FDA). (2023). Terbutaline sulfate drug label information. Retrieved from https://www.accessdata.fda.gov 
     
  1. National Institutes of Health (NIH). (2024). Beta-agonist bronchodilators in asthma and COPD treatment. Retrieved from https://www.nih.gov 
     

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Brand Information

Terbutaline Sulfate (Terbutaline Sulfate)
1DESCRIPTION
Rx only
Formula1.jpg
Terbutaline sulfate USP is a white to gray-white crystalline powder. It is odorless or has a faint odor of acetic acid. It is soluble in water and in 0.1N hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform.
2CLINICAL PHARMACOLOGY
Terbutaline is a beta-adrenergic receptor agonist. In vitro and in vivo pharmacologic studies have demonstrated that terbutaline exerts a preferential effect on beta2-adrenergic receptors. 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 between 10% to 50%. The precise function of these receptors has not been established (see WARNINGS). Controlled clinical studies in patients given terbutaline subcutaneously have not revealed a preferential beta2-adrenergic effect. 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). 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. Controlled clinical studies have shown that terbutaline relieves bronchospasm in acute and chronic obstructive pulmonary disease by significantly increasing pulmonary flow rates (e.g., an increase of 15% or more in FEV1). After subcutaneous administration of 0.25 mg of terbutaline, a measurable change in expiratory flow rate usually occurs within 5 minutes, and a clinically significant increase in FEV1 occurs within 15 minutes. The maximum effect usually occurs within 30 to 60 minutes, and clinically significant bronchodilator activity may continue for 1.5 to 4 hours. The duration of clinically significant improvement is comparable to that observed with equimilligram doses of epinephrine.
Elimination half-life of the drug in 10 of 14 patients was approximately 2.9 hours after subcutaneous administration, but longer elimination half-lives (between 6 to 14 hours) were found in the other 4 patients. About 90% of the drug was excreted in the urine at 96 hours after subcutaneous administration, with about 60% of this being unchanged drug. It appears that the sulfate conjugate is a major metabolite of terbutaline and urinary excretion is the primary route of elimination.
3INDICATIONS & USAGE
Terbutaline Sulfate Injection, USP 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.
4CONTRAINDICATIONS
Prolonged Tocolysis
Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting (see BOXED WARNING: PROLONGED TOCOLYSIS).
Hypersensitivity
Terbutaline sulfate injection is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.
5WARNINGS
Deterioration of Asthma
6PRECAUTIONS
General
Terbutaline, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension, and cardiac arrhythmias; in patients with hyperthyroidism or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure have been seen and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.
Drug Interactions
The concomitant use of terbutaline with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
Terbutaline should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, since the action of terbutaline on the vascular system may be
Beta-Blockers
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. Therefore, patients with asthma should not normally be treated with beta-blockers. 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. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
Diuretics
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. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year study in Sprague-Dawley rats, terbutaline sulfate caused a significant and dose-related increase in the incidence of benign leiomyomas of the mesovarium at dietary doses of 50 mg/kg and above (approximately 810 times the maximum recommended daily subcutaneous (sc) dose for adults on a mg/m2 basis). In a 21-month study in CD-1 mice, terbutaline showed no evidence of tumorigenicity at dietary doses up to 200 mg/kg (approximately 1,600 times the maximum recommended daily sc dose for adults on a mg/m2 basis). The mutagenicity potential of terbutaline has not been determined.
Reproduction studies in rats using terbutaline demonstrated no impairment of fertility at oral doses up to 50 mg/kg (approximately 810 times the maximum recommended daily sc dose for adults on a mg/m2 basis).
Pregnancy: Teratogenic Effect
Pregnancy Category C
There are no adequate and well-controlled studies of terbutaline sulfate in pregnant women. Published animal studies show that rat offspring exhibit alterations in behavior and brain development, including decreased cellular proliferation and differentiation when dams were treated subcutaneously with terbutaline during the late stage of pregnancy and lactation period. Terbutaline exposures in rat dams were approximately 24 to 48 times the common human dose in adults of 2 to 4 mg/day, on a mg/m2 basis. Terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia.
Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration (see BOXED WARNING:
PROLONGED TOCOLYSIS and CONTRAINDICATIONS, Prolonged Tocolysis). In animal embryofetal developmental studies, no teratogenic effects were observed in offspring when pregnant rats and rabbits received terbutaline sulfate at oral doses up to 50 mg/kg/day, approximately 810 and 1600 times, respectively, the maximum recommended daily subcutaneous dose for adults, on a mg/m2 basis. Terbutaline sulfate should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
Use in Labor and Deivery
Because of the potential for beta-agonist interference with uterine contractility, use of terbutaline for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Terbutaline crosses the placenta. After single dose IV administration of terbutaline to 22 women in late pregnancy who were delivered by elective Cesarean section due to clinical reasons, umbilical blood levels of terbutaline were found to range from 11% to 48% of the maternal blood levels.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Therefore, terbutaline should be used during nursing only if the potential benefit justifies the possible risk to the newborn.
Pediatric Use
Terbutaline is not recommended for patients under the age of 12 years because of insufficient clinical data to establish safety and effectiveness.
Geriatric Use
Clinical studies of Terbutaline Sulfate Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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.
7ADVERSE REACTIONS
Adverse reactions observed with terbutaline are similar to those commonly seen with other sympathomimetic agents. All these reactions are transient in nature and usually do not require treatment.
The following table compares adverse reactions seen in patients treated with terbutaline (0.25 mg and 0.5 mg), with those seen in patients treated with epinephrine injection (0.25 mg and 0.5 mg), during eight double-blind crossover studies involving a total of 214 patients.
Note: Some patients received more than one dosage strength of terbutaline and epinephrine. In addition, there were reports of anxiety, muscle cramps, and dry mouth (less than 0.5%). There have been rare reports of elevations in liver enzymes and of hypersensitivity vasculitis with terbutaline administration.
8OVERDOSAGE
The median sc lethal dose of terbutaline in mature rats was approximately 165 mg/kg (approximately 2,700 times the maximum recommended daily sc dose for adults on a mg/m2 basis). The median sc lethal dose of terbutaline in young rats was approximately 2,000 mg/kg (approximately 32,000 times the maximum recommended daily sc dose for adults on a mg/m2 basis). The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Hypokalemia may also occur. There is no specific antidote. Treatment consists of discontinuation of terbutaline together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of terbutaline.
9DOSAGE & ADMINISTRATION
Terbutaline Sulfate Injection, USP should be used only for subcutaneous administration and not intravenous infusion. Sterility and accurate dosing cannot be assured if the vials are not used in accordance with DOSAGE AND ADMINISTRATION.
10HOW SUPPLIED
Image1.jpg
Discard unused portion after single patient use.

Fresenius Kabi
Lake Zurich, IL 60047
451001E
Revised: April 2022
11Sample Package Label
Label1.jpg