Terbutaline (Monograph)
Drug class: Selective beta-2-Adrenergic Agonists
VA class: RE103
CAS number: 23031-32-5
Warning
A standardized concentration for this drug has been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. The drug is included in a standard concentration list which may apply to an IV or oral compounded liquid formulation. For additional information, see the ASHP website [Web].
Warning
- Preterm Labor
-
Injection is not FDA labeled for and is contraindicated for prolonged tocolysis (beyond 48–72 hours).198 210 Oral tablets are not FDA labeled for and are contraindicated for acute or maintenance tocolysis.199 210 Do not use terbutaline sulfate (injection or oral tablets) for maintenance tocolysis, particularly in the outpatient or home setting.198 199 210 (See Preterm Labor under Cautions and Preterm Labor under Uses.)
-
Serious, sometimes fatal adverse effects, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia,124 130 197 198 199 201 210 reported after administration in pregnant women.161 198 199 210 Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration.130 198 199 197 (See Preterm Labor under Cautions.)
Introduction
Bronchodilator; relatively selective, short-acting β2-adrenergic agonist.198 199 c
Uses for Terbutaline
Bronchospasm in Asthma
Symptomatic management or prevention of bronchospasm in patients with reversible, obstructive airway disease (e.g., asthma).198 199
Some experts suggest use of oral β2-adrenergic agonist therapy principally in patients unable to use inhaled bronchodilators (e.g., young children).183 Other experts do not recommend oral β2-agonists for relief of acute asthma symptoms.209 Oral administration associated with slower onset of action and increased incidence of adverse effects.167 183
Sub-Q terbutaline reserved for prehospital management of severe asthma exacerbations when inhaled β2-selective agents are not readily available.175 209 Sub-Q terbutaline not used routinely for treatment of severe exacerbations of asthma in hospitalized patients.209 No proven advantage of sub-Q administration compared with oral inhalation (no longer commercially available in US). 209
Bronchospasm in COPD
Symptomatic management of reversible bronchospasm associated with chronic bronchitis and emphysema.198 199 c
Inhaled β2-adrenergic agonists preferred over oral β2-adrenergic agonist therapy for treatment of COPD;191 192 long-acting inhaled bronchodilators more effective and convenient than short-acting agents.192 Oral β2-adrenergic agonist use associated with slower onset of action and increased incidence of adverse effects compared with inhaled therapy.191 192
Role of oral β2-adrenergic agonists in treatment of COPD limited.191 192
Preterm Labor
Has been used for acute IV† [off-label] or sub-Q therapy in selected women to inhibit uterine contractions in preterm labor† [off-label] (tocolysis) and prolong gestation when beneficial.108 109 110 111 115 116 117 118 119 120 121 122 123 124 125 126 188 197
Manufacturers and FDA warn that injection is not FDA labeled for and is contraindicated for prolonged tocolysis (beyond 48–72 hours), because of the potential for serious maternal cardiac effects and death.198 210 (See Preterm Labor under Cautions.)
Manufacturers and FDA also warn that oral tablets are not FDA labeled for and are contraindicated for acute or maintenance tocolysis, because efficacy not proven and safety concerns similar to injection.199 201 210 (See Preterm Labor under Cautions.)
Do not use terbutaline sulfate (injection or oral tablets) for maintenance tocolysis, particularly in the outpatient or home setting.198 199 200 201 210 (See Preterm Labor under Cautions.)
However, available data suggest that acute β-adrenergic agonist treatment may forestall labor for 48 hours,108 111 119 120 121 122 123 124 126 188 197 providing time for patients to be transferred to other (e.g., tertiary-care) facilities and/or receive corticosteroids to increase fetal lung maturation.124 125 126 188 189 197 211 213 Any other potential benefits of such drugs in prolonging pregnancy are unclear.124 125 126 188
ACOG states that because of conflicting results, there is no clear first-line tocolytic agent.188
Terbutaline Dosage and Administration
Administration
Administer orally or sub-Q.198 199
Has been administered IV† [off-label] to inhibit uterine contractions in preterm labor† [off-label] (tocolysis).109 117 124 197 Administration of sub-Q injection preparation by other routes (e.g., IV) or methods not recommended by manufacturer.198 (See Preterm Labor under Cautions.)
Oral Administration
Administer orally 3 times daily during waking hours, at approximately 6-hour intervals.199
Sub-Q Administration
For solution and drug compatibility information, see Compatibility under Stability.
Inject into lateral deltoid area.198
Dosage
Available as terbutaline sulfate; dosage expressed in terms of sulfate salt.198 199
Pediatric Patients
Bronchospasm
Asthma
OralChildren or adolescents 12–15 years of age: 2.5 mg 3 times daily.199 Do not exceed total dosage of 7.5 mg within a 24-hour period.199
Sub-QHospitalized children ≤12 years of age† [off-label] with 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
Children or adolescents ≥12 years of age: 0.25 mg recommended by manufacturer.198 Repeat dose (0.25 mg) if substantial clinical improvement does not occur within 15–30 minutes.198 If no response within another 15–30 minutes, consider other therapeutic measures.198 Manufacturer states total dosage should not exceed 0.5 mg within a 4-hour period.198
Hospitalized children or adolescents >12 years of age with asthma exacerbation: 0.25 mg every 20 minutes for a total of 3 doses suggested by some clinicians.209
Adults
Bronchospasm
Asthma
Oral5 mg 3 times daily, given approximately every 6 hours during waking hours.199 If disturbing adverse effects occur, reduce dosage to 2.5 mg 3 times daily.199 Do not exceed total dosage of 15 mg within a 24-hour period.199
Sub-Q0.25 mg recommended by manufacturer.198 Repeat dose (0.25 mg) if substantial clinical improvement does not occur within 15–30 minutes.198 If no response within another 15–30 minutes, consider other therapeutic measures.198 Manufacturer states total dosage should not exceed 0.5 mg within a 4-hour period.198
Hospitalized adults with asthma exacerbation: 0.25 mg every 20 minutes for a total of 3 doses suggested by some clinicians.209
COPD
Oral5 mg 3 times daily, given approximately every 6 hours during waking hours.199 If disturbing adverse effects occur, reduce dosage to 2.5 mg 3 times daily.199 Do not exceed total dosage of 15 mg within a 24-hour period.199
Sub-Q0.25 mg recommended by manufacturer.198 Repeat dose (0.25 mg) if substantial clinical improvement does not occur within 15–30 minutes.198 If no response within another 15–30 minutes, consider other therapeutic measures.198 Manufacturer states total dosage should not exceed 0.5 mg within a 4-hour period.198
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.108 109 110 111 114 115 117 118 124 126
For acute tocolytic therapy, has been initiated at a dosage of 2.5–20 mcg/minute.108 110 111 114 115 117 118 126 Dosage may be increased gradually as tolerated at 10- to 20-minute intervals until desired effects achieved.108 109 110 111 114 115 117 118 126 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.108 109 110 111 114 115 117 118 126
Injection is contraindicated for prolonged tocolysis (beyond 48–72 hours).198 210 (See Preterm Labor under Cautions and Preterm Labor under Uses.)
Sub-Q
0.25 mg every 0.3–3 hours has been recommended.188
Temporarily discontinue if pulse rate is >120 bpm.188
Injection is contraindicated for prolonged tocolysis† (beyond 48–72 hours).198 210 (See Preterm Labor under Cautions and Preterm Labor under Uses.)
Prescribing Limits
Pediatric Patients
Bronchospasm
Asthma
OralChildren 12–15 years of age: Maximum 7.5 mg within a 24-hour period.199
Sub-QChildren ≥12 years of age: Maximum: 0.5 mg within a 4-hour period.198
Adults
Bronchospasm
Asthma
OralMaximum 15 mg within a 24-hour period.199
Sub-QMaximum 0.5 mg within a 4-hour period.198
COPD
OralMaximum 15 mg within a 24-hour period.199
Sub-QMaximum 0.5 mg within a 4-hour period.198
Preterm Labor†
IV†Effective maximum dosages have ranged from 17.5–30 mcg/minute; higher maximum dosages (e.g., 70–80 mcg/minute) used cautiously in some patients.108 109 110 111 114 115 117 118 126
Injection is contraindicated for prolonged tocolysis (beyond 48–72 hours).198 210 (See Preterm Labor under Cautions and Preterm Labor under Uses.)
Sub-QInjection is contraindicated for prolonged tocolysis (beyond 48–72 hours).198 210 (See Preterm Labor under Cautions and Preterm Labor under Uses.)
Special Populations
Geriatric Patients
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.198
Cautions for Terbutaline
Contraindications
-
Injection: Prolonged tocolysis† (beyond 48–72 hours); do not use for maintenance tocolysis, particularly in the outpatient or home setting.198 210 (See Preterm Labor under Cautions and Preterm Labor under Uses.)
-
Oral: Acute or maintenance tocolysis; do not use for maintenance tocolysis†, particularly in the outpatient or home setting.199 210 (See Preterm Labor under Cautions and Preterm Labor under Uses.)
-
Known hypersensitivity to sympathomimetic agents or any ingredient in formulation.198 199
Warnings/Precautions
Warnings
Preterm Labor
Serious and sometimes fatal adverse effects, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia,124 130 197 198 199 201 210 reported after administration in pregnant women.161 198 199 210 Increased fetal heart rate and neonatal hypoglycemia also may occur following maternal administration.130 197 198 199
FDA has received postmarketing reports of maternal death and serious cardiovascular events associated with obstetric use.161 210 FDA has concluded that risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged tocolysis with terbutaline injection (beyond 48–72 hours) or receiving acute or prolonged tocolysis with oral terbutaline.198 199 210
Injection is not FDA labeled for and is contraindicated for prolonged tocolysis (beyond 48–72 hours).198 210 Oral tablets are not FDA labeled for and are contraindicated for acute or maintenance tocolysis.199 201 210 Do not use terbutaline sulfate (injection or oral tablets) for maintenance tocolysis, particularly in the outpatient or home setting.198 199 200 201 210 (See Preterm Labor under Uses.)
Report adverse events involving terbutaline to the FDA MedWatch program.210
Acute or Worsening Asthma
Failure to respond to a previously effective dosage of terbutaline may indicate seriously worsening asthma.183 198 199 Reevaluate asthma therapy, giving special consideration to possible need for anti-inflammatory treatment (e.g., corticosteroids).183 198 199 Use of β-adrenergic agents alone not adequate to control mild to severe persistent asthma symptoms.183 209
Cardiovascular Effects
Possible clinically important cardiovascular effects, including changes in BP, heart rate, and ECG (e.g., flattening of the T wave, prolongation of the QTc interval, ST-segment depression).198 199
Cautious use recommended in patients with cardiovascular disorders, including ischemic heart disease, coronary insufficiency, cardiac arrhythmias, and hypertension.198 199 May require drug discontinuance.198 199
Nervous System Effects
Possible CNS stimulation (e.g., nervousness, tremor).183 198 199 c Seizures reported rarely; did not recur following drug discontinuance.198 199
Cautious use recommended in patients with seizure disorders and those unusually responsive to sympathomimetic amines198 199
Sensitivity Reactions
Immediate hypersensitivity reactions and exacerbations of bronchospasm reported.198 199
General Precautions
Endocrine and Metabolic Effects
Large IV† doses may aggravate preexisting diabetes and ketoacidosis.198 199
Use with caution in patients with diabetes mellitus or hyperthyroidism.198 199
Possible hypokalemia;198 199 may increase risk of cardiovascular effects.198 199 Hypokalemia usually transient, not requiring supplementation.198 199
Specific Populations
Pregnancy
Category C.198 199 Restrict use for relief of bronchospasm during labor to women in whom benefits clearly outweigh risks.198 199 (See Preterm Labor under Cautions.)
Lactation
Distributed into milk, but in amounts generally considered insufficient to affect nursing infants.c Administer to nursing women only if potential benefits to woman outweigh possible risk to infant.198 199
Pediatric Use
Safety and efficacy not established in children <12 years of age.198 199
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.198 (See Geriatric Patients under Dosage and Administration.)
Common Adverse Effects
Oral: Nervousness,199 tremor,199 headache,199 somnolence,199 palpitations,199 dizziness,199 tachycardia,199 nausea.199
Sub-Q: Nervousness,198 drowsiness,198 tremor,198 headache,198 palpitations.198
Drug Interactions
Specific Drugs
Drug |
Interaction |
Comments |
---|---|---|
Antidepressants, tricyclic |
Extreme caution recommended with concomitant therapy or in patients receiving terbutaline ≤2 weeks after discontinuance of tricyclic antidepressants198 199 |
|
β-Adrenergic blocking agents |
Potential antagonism of pulmonary effects resulting in severe bronchospasm in asthmatic patients198 199 |
If concomitant therapy required, consider cautious use of cardioselective β-adrenergic blocking agents without intrinsic sympathomimetic activity (e.g., metoprolol, atenolol, esmolol); 198 199 202 use low dosages initially202 |
Diuretics, potassium depleting |
Potential for decreased serum potassium concentrations and/or ECG changes, especially when recommended β-adrenergic agonist dosage exceeded198 199 |
|
MAO inhibitors |
Extreme caution recommended with concomitant therapy or in patients receiving terbutaline ≤2 weeks after discontinuance of MAO inhibitors198 199 |
|
Sympathomimetic agents |
Potential for additive adverse cardiovascular effects198 199 c |
Concomitant use not recommended198 199 Does not preclude use of an inhaled adrenergic agonist bronchodilator to relieve acute bronchospasm during long-term oral terbutaline therapy199 |
Terbutaline Pharmacokinetics
Absorption
Bioavailability
Oral: About 30-50%.
Sub-Q: Well absorbed.c
Onset
Sub-Q: Measurable changes in expiratory flow rate occur within 5 minutes.198 Clinically important increases in FEV1 occur within 15 minutes.198 Maximum effects occur within 30–60 minutes.198
Oral: Measurable changes in pulmonary flow rate usually occur within 30 minutes.199 Substantial clinical improvement in pulmonary function occurs within 1–2 hours.199 Maximum effects occur within 2–3 hours.199
Duration
Sub-Q: Clinically important bronchodilator activity may continue for 1.5–4 hours.198 Duration of clinical improvement similar to equivalent doses (mg for mg) of epinephrine.198
Oral: Clinically important decreases in airway and pulmonary resistance may persist for ≥4 hours.199
Distribution
Extent
Crosses placenta197 198 199 201 and distributes into milk.c (See Preterm Labor under Cautions.)
Elimination
Metabolism
Partially metabolized in liver, principally to inactive sulfate conjugate.198 199 c
Elimination Route
Following sub-Q administration, excreted principally as unchanged drug (60%) in urine.198 199
Half-life
Sub-Q administration: Mean 5.7 hours.198
Oral single-dose administration in patients with asthma: Approximately 3.4 hours.199
Stability
Storage
Oral
Tablets
Tight, light-resistant containers at 15–30°C.199
Parenteral
Solution for Injection
20–25°C.198 Protect from light by storing in original carton until use.198
Compatibility
Parenteral
Solution CompatibilityHID
Compatible |
---|
Dextrose 5% in water |
Sodium chloride 0.45 or 0.9% |
Drug Compatibility
Compatible |
---|
Aminophylline |
Incompatible |
Bleomycin sulfate |
Actions
-
Stimulates β-adrenergic receptors of sympathetic nervous system with little or no effect on α-adrenergic receptors.198 199 c
-
Less selective than relatively selective β2-agonists (e.g., albuterol).c
-
No apparent preferential β2-adrenergic effect following sub-Q administration in controlled clinical studies.198
-
Stimulates the 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.198 199
-
Relaxes uterine smooth muscle and inhibits uterine contractions.108 109 110 111 115 116 117 118 119 120 121 122 123 124 125 126 188 198 201 c
Advice to Patients
-
Importance of understanding proper storage and administration techniques.199
-
Importance of adherence to dosing schedules, including not exceeding the recommended dose or frequency of use unless otherwise instructed by clinician.199
-
If decreased effectiveness occurs and/or symptoms become worse, contact clinician immediately; do not increase dose or frequency of administration.199
-
Importance of using inhaled or other anti-asthma agents only as directed by clinician.199
-
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.198 199 210
-
Importance of informing patients that serious adverse effects (e.g., maternal cardiac effects, death) reported after prolonged use to manage preterm labor†.210 Importance of informing patients of serious situations where short-term use of the injection in the hospital setting may benefit a pregnant woman.210
-
Importance of informing patients that oral tablets should not be used either to treat preterm labor† or prevent recurrent preterm labor†.210
-
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (e.g., inhaled drugs, other antiasthma agents) and OTC drugs, as well as any concomitant illnesses.198 199
-
Importance of informing patients of other important precautionary information.198 199 (See Cautions.)
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 2024, Selected Revisions March 2, 2022. 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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