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Terbutaline

Pronunciation

Pronunciation

(ter BYOO ta leen)

Index Terms

  • Brethaire
  • Brethine
  • Bricanyl
  • Terbutaline Sulfate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection, as sulfate:

Generic: 1 mg/mL (1 mL)

Tablet, Oral, as sulfate:

Generic: 2.5 mg, 5 mg

Pharmacologic Category

  • Antidote, Extravasation
  • Beta2 Agonist

Pharmacology

Relaxes bronchial and uterine smooth muscle by action on beta2-receptors with less effect on heart rate

Absorption

33% to 50%

Metabolism

Hepatic to inactive sulfate conjugates

Excretion

Urine (60% as unchanged drug); feces

Onset of Action

Oral: 30 to 45 minutes; SubQ: 6 to 15 minutes; Inhalation: 5 minutes (maximum effect: 15 to 60 minutes)

Time to Peak

Serum: SubQ: 0.5 hours

Duration of Action

Oral: 4 to 8 hours; Oral inhalation: 3 to 6 hours; SubQ: 1.5 to 4 hours

Half-Life Elimination

5.7 hours (range: 2.9 to 14 hours)

Protein Binding

25%

Use: Labeled Indications

Asthma/Bronchospasm: Bronchodilator in reversible airway obstruction and bronchial asthma

Use: Unlabeled

Injection: Tocolytic agent (short-term [≤72 hours]) prevention or management of preterm labor; management of extravasation of sympathomimetic vasoconstrictors (based on limited case reports)

Contraindications

Hypersensitivity to terbutaline, sympathomimetic amines, or any component of the formulation

Injection: Additional contraindications: Prolonged (>72 hours) prevention or management of preterm labor

Oral: Additional contraindications: Prevention or treatment of preterm labor

Bricanyl Turbuhaler [Canadian product]: Hypersensitivity to sympathomimetic amines; history of tachyarrhythmias; as tocolytic in patients at risk of premature labor or threatened abortion.

Dosing: Adult

Asthma/bronchospasm:

Oral: 5 mg/dose every 6 hours 3 times/day; if side effects occur, reduce dose to 2.5 mg every 6 hours; not to exceed 15 mg in 24 hours.

SubQ:

Manufacturer’s labeling: 0.25 mg/dose; may repeat in 15 to 30 minutes (maximum: 0.5 mg/4-hour period)

Off-label dose: 0.25 mg/dose; may repeat every 20 minutes for 3 doses (maximum: 0.75 mg/1-hour period) (NAEPP 2007)

Inhalation: Bricanyl Turbuhaler [Canadian product]: One inhalation; if not effective after 5 minutes may repeat dose. If second dose is not effective, consult healthcare provider immediately. Additional doses may be administered however >6 inhalations in a 24 hour period should not be needed. Note: If adequate relief is not obtained with previously effective dose, or if effects of inhalation last <3 hours, patient should be reassessed promptly; may indicate worsening asthma.

Extravasation management, sympathomimetic vasoconstrictors (off-label use; based on limited case reports): SubQ:

Large extravasations: Infiltrate extravasation area using a solution of 1 mg diluted in 9 mL (total volume: 10 mL) of 0.9% sodium chloride; volume of terbutaline solution administered varied from 3 to 10 mL (Stier 1999).

Small/distal extravasations: Infiltrate extravasation area using a solution of 1 mg diluted in 1 mL (total volume: 2 mL) of 0.9% sodium chloride; volume of terbutaline solution administered varied from 0.5 to 1 mL (Stier 1999).

Premature labor (acute; short-term [≤72 hours] tocolysis; off-label use):

IV: 2.5 to 5 mcg/minute; increased gradually every 20 to 30 minutes by 2.5 to 5 mcg/minute up to a maximum of 25 mcg/minute; decrease to the lowest effective dose once contractions are controlled (Mackeen 2014; Travis 1993).

SubQ: 0.25 mg every 20 minutes to 3 hours; hold for pulse >120 beats per minute. Terbutaline has not been approved for and should not be used for prolonged tocolysis (beyond 48 to 72 hours) (ACOG 159 2016; Hearne 2000).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Asthma/bronchospasm:

Oral: Children and Adolescents:

<12 years: Initial: 0.05 mg/kg/dose 3 times/day, increased gradually as required; maximum: 0.15 mg/kg/dose 3 to 4 times/day or a total of 5 mg/24 hours

12 to 15 years: 2.5 mg every 6 hours 3 times/day; not to exceed 7.5 mg in 24 hours

>15 years: 5 mg/dose every 6 hours 3 times/day; if side effects occur, reduce dose to 2.5 mg every 6 hours; not to exceed 15 mg in 24 hours

SubQ: Children and Adolescents:

<12 years: 0.005 to 0.01 mg/kg/dose to a maximum of 0.4 mg/dose every 15 to 20 minutes for 3 doses; may repeat every 2 to 6 hours as needed

≥12 years: Refer to adult dosing.

Inhalation: Bricanyl Turbuhaler [Canadian product]: Children ≥6 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Reconstitution

For extravasation management (off-label use): Using vial for injection, dilute 1 mg with 9 mL (total volume: 10 mL) (large extravasation site) or 1 mg with 1 mL (total volume: 2 mL) (small/distal extravasation site) of 0.9% sodium chloride (Stier 1999).

Extemporaneously Prepared

A 1 mg/mL oral suspension may be made with tablets. Crush twenty-four 5 mg tablets in a mortar and reduce to a fine powder. Add 5 mL purified water USP and mix to a uniform paste; mix while adding simple syrup, NF in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of simple syrup, NF sufficient to make 120 mL. Label "shake well" and "refrigerate". Stable for 30 days.

Nahata MC, Pai VB, and Hipple TF, Pediatric Drug Formulations, 5th ed, Cincinnati, OH: Harvey Whitney Books Co, 2004.

Administration

IV: Use infusion pump.

Oral: Administer around-the-clock to promote less variation in peak and trough serum levels

Inhalation: Bricanyl Turbuhaler [Canadian product]: After removing lid, patient should hold inhaler upright and turn blue grip as far as it will go in one direction then turn it back to original position. Clicking sound indicates that inhaler is ready for use. Patient should exhale fully but not into the inhaler and then place mouthpiece gently between teeth, close lips around inhaler and inhale deeply. Inhaler should be removed from mouth prior to exhaling. Instruct patients to rinse mouth with water after each inhalation as some medication may stick to the inside of the mouth and throat. If inhaler is dropped or shaken, or if patient exhales into the inhaler after a dose is loaded, the dose will be lost and a new dose should be loaded and inhaled. Outside of mouthpiece should be cleaned once weekly with a dry tissue. Instruct patient to keep inhaler dry. First appearance of red mark in dose indicator (window underneath mouthpiece) indicates that 20 doses remain. When red mark reaches bottom of dose indicator no doses remain and Turbuhaler should be discarded.

SubQ: Extravasation management, sympathomimetic vasopressors (off-label use): Stop vesicant infusion immediately and disconnect IV line (leave needle/cannula in place); gently aspirate extravasated solution from the IV line (do NOT flush the line); remove needle/cannula; elevate extremity. Infiltrate extravasation area with terbutaline solution 1 mg diluted with 9 mL (large extravasation site) or 1 mg diluted with 1 mL (small/distal extravasation site) of 0.9% sodium chloride into extravasation site (Stier 1999).

Compatibility

Stable in D5W, 1/2NS, NS.

Storage

Store injection at room temperature; do not freeze. Protect from heat and light. Use only clear solutions. Store powder for inhalation (Bricanyl® Turbuhaler [Canadian availability]) at room temperature between 15°C and 30°C (58°F and 86°F).

Drug Interactions

AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Monitor therapy

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cocaine: May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification

Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Nervousness, restlessness

Endocrine & metabolic: Serum glucose increased, serum potassium decreased

Neuromuscular & skeletal: Trembling

1% to 10%:

Cardiovascular: Tachycardia, hypertension, pounding heartbeat

Central nervous system: Dizziness, lightheadedness, drowsiness, headache, insomnia

Gastrointestinal: Dry mouth, nausea, vomiting, bad taste in mouth

Neuromuscular & skeletal: Muscle cramps, weakness

Miscellaneous: Diaphoresis

<1% (Limited to important or life-threatening): Arrhythmia, cardiac arrest (preterm labor), chest pain, hyperglycemia (preterm labor), hypokalemia (preterm labor), hypotension (preterm labor), paradoxical bronchospasm, myocardial infarction (preterm labor), myocardial ischemia (preterm labor), pulmonary edema (preterm labor)

ALERT: U.S. Boxed Warning

Prolonged tocolysis:

Terbutaline has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). In particular, terbutaline 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 to pregnant women. In mothers, 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.

Warnings/Precautions

Concerns related to adverse effects:

• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response.

• Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm) have been reported.

• Serious effects/fatalities: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Disease-related concerns:

• Asthma: Appropriate use: When used as a bronchodilator, optimize anti-inflammatory treatment before initiating maintenance treatment with terbutaline. Do not use as a component of chronic therapy without an anti-inflammatory agent. Only the mildest form of asthma (Step 1 and/or exercise-induced) would not require concurrent use based upon asthma guidelines.

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia or hypertension or HF); beta-agonists may cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta2-agonists may also increase risk of arrhythmias.

• Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose.

• Glaucoma: Use with caution in patients with glaucoma; may elevate intraocular pressure.

• Hyperthyroidism: Use with caution in hyperthyroidism; may stimulate thyroid activity.

• Hypokalemia: Use with caution in patients with hypokalemia or taking concomitant drugs that cause hypokalemia; beta2-agonists may decrease serum potassium.

• Preterm labor: [US Boxed Warning]: Terbutaline is not FDA approved for and should not be used for prolonged tocolysis (>48 to 72 hours). Use for maintenance tocolysis should not be done in the outpatient setting. Adverse events observed in pregnant women include arrhythmias, increased heart rate, hyperglycemia (transient), hypokalemia, myocardial ischemia, and pulmonary edema. Heart rate may be increased in the fetus and hypoglycemia may occur in the neonate. Oral terbutaline is contraindicated for acute or chronic use in the management of preterm labor.

• Seizures: Use with caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation.

Other warnings/precautions:

• Patient information: Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use may indicate deterioration of asthma, and treatment must not be delayed.

Monitoring Parameters

Serum potassium, glucose; intake/output; heart rate, blood pressure, respiratory rate; chest pain, shortness of breath; monitor for signs and symptoms of pulmonary edema (when used as a tocolytic); monitor FEV1, peak flow, and/or other pulmonary function tests (when used as bronchodilator). If used for extravasation management, monitor and document extravasation site.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Terbutaline crosses the placenta; umbilical cord concentrations are ~11% to 48% of maternal blood levels.

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, pre-eclampsia, preterm birth, low birth weight infants). Terbutaline is not recommended for the treatment of asthma during pregnancy; inhaled beta2-receptor agonists are preferred (NAEPP 2005).

[US Boxed Warning]: Terbutaline is not FDA approved for and should not be used for prolonged tocolysis (>48 to 72 hours). Use for maintenance tocolysis should not be done in the outpatient setting. Adverse events observed in pregnant women include arrhythmias, increased heart rate, hyperglycemia (transient), hypokalemia, myocardial ischemia, and pulmonary edema. Heart rate may be increased in the fetus and hypoglycemia may occur in the neonate. Terbutaline has been used in the management of preterm labor. Tocolytics may be used for the short-term (48 hour) prolongation of pregnancy to allow for the administration of antenatal steroids and should not be used prior to fetal viability or when the risks of use to the fetus or mother are greater than the risk of preterm birth (ACOG 159 2016).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue or tremors. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat), breathing attack, angina, tachycardia, arrhythmia, severe anxiety, severe dizziness, passing out, severe headache, seizures, difficulty breathing, wheezing, or cough (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating, and advising patients.

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