Terbutaline (Monograph)
Drug class: Selective beta-2-Adrenergic Agonists
Warning
- Tocolysis
-
Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. 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.
-
Terbutaline sulfate injection has not been approved and should not be used for prolonged tocolysis (beyond 48-72 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.
Introduction
Short-acting β2-agonist bronchodilator (SABA); synthetic sympathomimetic amine.
Uses for Terbutaline
Bronchospasm
Used orally and sub-Q for prevention and reversal of bronchospasm in patients ≥12 years of age with asthma and reversible bronchospasm associated with COPD, including bronchitis and emphysema (oral and sub-Q injection).
Global Initiative for Asthma (GINA) guidelines state that oral bronchodilators (e.g., oral short-acting β2-adrenergic agonists [SABA], theophylline) have a higher risk of adverse events than inhaled bronchodilators and are no longer recommended for asthma management. Sub-Q terbutaline is generally reserved for prehospital management of severe asthma exacerbations when inhaled SABA agents are not readily available.
GINA guidelines state that IV terbutaline† [off-label] (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 initial emergency department management of asthma exacerbations in children ≤5 years of age† [off-label] .
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline states that inhaled bronchodilators are recommended over oral bronchodilators; terbutaline is not mentioned in the most recent (2025) guidelines.
Preterm Labor
Has been used for acuteIV† [off-label] or sub-Q therapy in selected women to inhibit uterine contractions in preterm labor (tocolysis)† [off-label] and prolong gestation when beneficial.
Manufacturers warn that the injection formulation is not FDA labeled and is contraindicated for prolonged tocolysis (beyond 48–72 hours), because of potential for serious maternal adverse reactions, including death.
Manufacturers also warn that the oral tablets are not FDA labeled and are contraindicated for acute or maintenance tocolysis, because of potential for serious maternal adverse reactions, including death.
Do not use injection or oral tablets for maintenance tocolysis, particularly in the outpatient or home setting.
ACOG mentions terbutaline as one of several possible tocolytic agents. Use of terbutaline sulfate or other tocolytics may effectively delay delivery for up to 48 hours, but no direct benefit of tocolytic therapy on neonatal outcomes observed. Primary goal 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).
Extravasation
Has been used sub-Q for treatment of vasopressor extravasation† [off-label] .
Terbutaline Dosage and Administration
General
Pretreatment Screening
-
Screen for cardiovascular disorders, hyperthyroidism, diabetes, and convulsive disorders.
-
Check baseline BP.
-
Screen for current or past use of beta-blockers, non-potassium sparing diuretics, monoamine oxidase inhibitors, and tricyclic antidepressants.
Patient Monitoring
-
Monitor BP, heart rate, and cardiac symptoms in patients with cardiovascular disorders, including coronary insufficiency, cardiac arrhythmias, and hypertension.
-
Monitor potassium in patients taking concomitant non-potassium sparing diuretics.
Administration
Administer orally or sub-Q.
Has been administered IV† for emergency department management of asthma exacerbation in children ≤5 years of age when recommended inhalation treatment not possible.
Has been administered IV† to inhibit uterine contractions in preterm labor† (tocolysis).
Administration of injection preparation by other routes (e.g., IV) or methods other than sub-Q not recommended by manufacturer.
Oral Administration
Administer orally 3 times daily during waking hours, at approximately 6-hour intervals.
Sub-Q Administration
Inject into lateral deltoid area.
IV Administration†
Standardize 4 Safety
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. 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. For additional information on S4S (including updates that may be available), see [Web].
dosing units differ from concentration units
Patient Population |
Concentration Standards |
Dosing Units |
---|---|---|
Pediatric patients (<50 kg) |
1 mg/mL |
mcg/kg/min |
Dosage
Available as terbutaline sulfate; dosage expressed in terms of the sulfate salt.
Pediatric Patients
Prevention and Reversal of Bronchospasm Associated with Asthma, Bronchitis, and Emphysema
Oral
Children or adolescents 12–15 years of age: 2.5 mg 3 times daily. Do not exceed total dosage of 7.5 mg within a 24-hour period.
Sub-Q
Adolescents ≥12 years of age: Administer a dose of 0.25 mg. Repeat dose (0.25 mg) if substantial clinical improvement does not occur within 15–30 minutes. If no response within another 15–30 minutes, consider other therapeutic measures. Donot exceed total dosage of 0.5 mg within a 4-hour period.
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. Closely monitor the child and adjust dosage according to response.
Adults
Prevention and Reversal of Bronchospasm Associated with Asthma, Bronchitis, and Emphysema
Oral
5 mg 3 times daily, given approximately every 6 hours during waking hours. If disturbing adverse effects occur, reduce dosage to 2.5 mg 3 times daily. Do not exceed total dosage of 15 mg within a 24-hour period.
Sub-Q
Administer a dose of 0.25 mg. Repeat dose (0.25 mg) if substantial clinical improvement does not occur within 15–30 minutes. If no response within another 15–30 minutes, consider other therapeutic measures. Do not exceed total dosage of 0.5 mg within a 4-hour period.
Preterm Labor†
IV†
Carefully adjust rate and duration of infusion according to patient’s response as indicated by uterine response, maternal BP, and maternal and fetal heart rates.
For acute tocolytic therapy, has been initiated at a dosage of 2.5–20 mcg/minute. Dosage may be increased gradually as tolerated at 10- to 20-minute intervals until desired effects achieved. Effective maximum dosages have ranged from 17.5–30 mcg/minute, although higher maximum dosages (e.g., 70–80 mcg/minute) used cautiously in some patients.
Injection is contraindicated for prolonged tocolysis (beyond 48–72 hours).
Sub-Q
0.25 mg every 0.3–3 hours has been recommended.
Temporarily discontinue if pulse rate is >120 bpm.
Injection is contraindicated for prolonged tocolysis† (beyond 48–72 hours).
Special Populations
Hepatic Impairment
No specific dosage recommendations.
Renal Impairment
No specific dosage recommendations.
Geriatric Patients
No specific dosage recommendations. Select dose with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.
Cautions for Terbutaline
Contraindications
-
Prolonged or maintenance tocolysis (terbutaline injection).
-
Acute or maintenance tocolysis (terbutaline tablets).
-
Hypersensitivity to sympathomimetic amines or any component of the drug product.
Warnings/Precautions
Warnings
Prolonged Tocolysis
Oral terbutaline sulfate not approved and should not be used for acute or maintenance tocolysis. Terbutaline injection not been approved and should not be used for prolonged tocolysis (beyond 48-72 hours). (See Boxed Warning.) In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting.
Serious adverse reactions, including death, 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.
Other Warnings/Precautions
Deterioration of Asthma
Asthma and/or bronchospasm may deteriorate. If higher than usual doses of terbutaline are required, re-evaluate patient for asthma destabilization and consider need for corticosteroid treatment.
Use of Anti-Inflammatory Agents
Anti-inflammatory agents are a mainstay of asthma treatment. Avoid terbutaline monotherapy and give early consideration to adding anti-inflammatory agents.
Cardiovascular Effects
Effects on BP, heart rate, and the ECG can occur. Use with caution in patients with cardiovascular disorders.
Seizures
Seizures reported rarely.
Hypokalemia
Hypokalemia may occur; generally transient and does not require supplementation.
Diabetes and Ketoacidosis
Large doses of IV terbutaline† may aggravate preexisting diabetes and ketoacidosis.
Hyperthyroidism
Use with caution in patients with hyperthyroidism. r198, r199
Specific Populations
Pregnancy
No adequate and well-controlled studies in pregnant women. Adverse behavioral and developmental changes reported in animal studies with sub-Q terbutaline administered during late stage of pregnancy and lactation period.
Do not use oral terbutaline for acute or maintenance tocolysis nor terbutaline injection for prolonged tocolysis (beyond 48-72 hours).
Terbutaline crosses the placenta. Restrict use for relief of bronchospasm during labor to women in whom benefits clearly outweigh risks.
Lactation
Unknown whether terbutaline is excreted in human milk. Administer to nursing women only if potential benefits outweigh possible risk to infant.
Pediatric Use
Safety and efficacy not established in children <12 years of age. However, has been used in children as young as 2 years of age for treatment of asthma exacerbations.
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.
Common Adverse Effects
Most common adverse effects (≥1%) of terbutaline sulfate tablets: nervousness, tremor, somnolence, dizziness, anxiety, insomnia, palpitations, tachycardia, ventricular extrasystoles, vasodilation, nausea, dry mouth, headache, asthenia, and sweating.
Most common adverse effects (≥2%) of terbutaline sulfate injection: tremor, nervousness, dizziness, headache, drowsiness, palpitations, tachycardia, dyspnea, nausea/vomiting, flushed feeling, and sweating.
Drug Interactions
Specific Drugs
Drug |
Interaction |
Comments |
---|---|---|
Antidepressants, tricyclic |
Potentiation of vascular effects |
Extreme caution recommended with concomitant therapy or in patients receiving terbutaline ≤2 weeks after discontinuance of tricyclic antidepressants |
β-Adrenergic blocking agents |
Potential antagonism of pulmonary effects resulting in severe bronchospasm in asthmatic patients |
If concomitant therapy required, consider cautious use of cardioselective β-adrenergic blocking agents |
Diuretics, potassium depleting |
Potential for decreased serum potassium concentrations and/or ECG changes, especially when recommended β-adrenergic agonist dosage exceeded |
Use concomitantly with caution |
MAO inhibitors |
Potentiation of vascular effects |
Extreme caution recommended with concomitant therapy or in patients receiving terbutaline ≤2 weeks after discontinuance of MAO inhibitors |
Sympathomimetic agents |
Potential for additive adverse cardiovascular effects |
Concomitant use not recommended Does not preclude use of an inhaled adrenergic agonist bronchodilator to relieve acute bronchospasm during long-term oral terbutaline therapy |
Terbutaline Pharmacokinetics
Absorption
Bioavailability
Oral: About 30-50%.
Sub-Q: Well absorbed.
Onset
Oral: Measurable changes in pulmonary flow rate usually occur within 30 minutes. Substantial clinical improvement in pulmonary function occurs within 1–2 hours. Maximum effects occur within 2–3 hours.
Sub-Q: Measurable changes in expiratory flow rate occur within 5 minutes. Clinically important increases in FEV1 occur within 15 minutes. Maximum effects occur within 30–60 minutes.
Duration
Oral: Clinically important decreases in airway and pulmonary resistance may persist for ≥4 hours.
Sub-Q: Clinically important bronchodilator activity may continue for 1.5–4 hours. Duration of clinical improvement similar to equivalent doses (mg for mg) of epinephrine.
Distribution
Extent
Crosses placenta.
Elimination
Metabolism
Partially metabolized in liver, principally to inactive sulfate conjugate.
Elimination Route
Following oral administration, renal (30–50%) and fecal elimination.
Following sub-Q administration, excreted principally as unchanged drug (60%) in urine.
Half-life
Oral single-dose administration in patients with asthma: Approximately 3.4 hours.
Sub-Q administration: Mean 5.7 hours.
Stability
Storage
Oral
Tablets
Tight, light-resistant containers at 20–25°C.
Parenteral
Solution for Injection
20–25°C. Protect from light by storing in original carton until use.
Actions
-
Short-acting β2-agonist bronchodilator (SABA); synthetic sympathomimetic amine.
-
Exerts preferential effect on β2-adrenergic receptors of sympathetic nervous system.
-
Stimulates production of cyclic adenosine-3′,5′-monophosphate (cAMP), which mediates numerous cellular responses, including bronchial smooth muscle relaxation and inhibition of release of mediators from mast cells in airways.
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Decreases resistance of airways.
Advice to Patients
-
Inform patients of the risk of using terbutaline for tocolysis and during pregnancy.
-
Importance of patients informing their healthcare provider of any underlying cardiovascular, endocrine, or seizure disorder.
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Importance of not using terbutaline more frequently than recommended and to not increase the dose or frequency of terbutaline sulfate without consulting their healthcare provider.
-
Inform patients to seek medical attention immediately if terbutaline becomes less effective for symptomatic relief, their symptoms become worse, and/or they need to use the product more frequently than usual.
-
Inform patients that terbutaline sulfate and other inhaled drugs and asthma medications should be taken only as directed by their physician. Common adverse effects include palpitations, chest pain, rapid heart rate, tremor or nervousness.
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Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Inform patients on the proper administration and use of terbutaline.
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Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (particularly, concomitant or recent use of monoamine oxidase inhibitors and tricyclic antidepressants) and OTC drugs.
-
Inform patients of other important precautionary information.
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.
Preparations
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.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Tablets |
2.5 mg* |
Terbutaline Sulfate Tablets |
|
5 mg* |
Terbutaline Sulfate Tablets |
|||
Parenteral |
Injection, for subcutaneous use only |
1 mg/mL* |
Terbutaline Sulfate Injection |
AHFS DI Essentials™. © Copyright 2025, Selected Revisions August 10, 2025. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.
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