Terbutaline Sulfate

Drug overview for TERBUTALINE SULFATE (terbutaline sulfate):

Generic name: TERBUTALINE SULFATE (ter-BYOO-ta-leen)
Drug class: Beta-Adrenergic Agents
Therapeutic class: Respiratory Therapy Agents

Terbutaline sulfate is a synthetic sympathomimetic amine that stimulates beta-adrenergic receptors less selectively than relatively selective beta2-agonists (e.g., albuterol).

No enhanced Uses information available for this drug.

DRUG IMAGES

TERBUTALINE SULF 1 MG/ML VIAL

The following indications for TERBUTALINE SULFATE (terbutaline sulfate) have been approved by the FDA:

Indications:
Exacerbation of chronic obstructive pulmonary disease
Status asthmaticus

Professional Synonyms:
Acute severe asthma attack
Acute severe asthma
Acutely deteriorating chronic obstructive pulmonary disease
Asthma with status asthmaticus
Exacerbation of COPD
Severe asthma exacerbation

The following dosing information is available for TERBUTALINE SULFATE (terbutaline sulfate):

Dosing
Administration
Dosing Information
Generic

The usual adult oral dosage of terbutaline sulfate is 5 mg 3 times daily administered at approximately 6-hour intervals while the patient is awake. The total dosage of terbutaline sulfate in adults should not exceed 15 mg within a 24-hour period. If disturbing adverse effects occur, dosage may be reduced to 2.5

mg 3 times daily.

The recommended dosage of terbutaline sulfate in children 12-15 years of age is 2.5 mg orally 3 times daily; the total dosage of terbutaline sulfate should not exceed 7.5 mg within a 24-hour period.

The usual subcutaneous dose of terbutaline sulfate in adults and adolescents 12 years of age and older is 0.25 mg injected into the lateral deltoid area. If substantial clinical improvement does not occur within 15-30 minutes, a second dose of 0.25

mg may be administered. If the patient fails to respond within another 15-30 minutes, other therapeutic measures should be considered. The manufacturer states that the total dosage of terbutaline sulfate should not exceed 0.5

mg subcutaneously within a 4-hour period.

In hospitalized children or adolescents older than 12 years of age with an asthma exacerbation, 0.25 mg of terbutaline sulfate every 20 minutes for a total of 3 doses has been suggested by some clinicians. 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.

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.

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. For acute tocolytic therapy, IV terbutaline sulfate 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 the desired effects are achieved. 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.

Terbutaline sulfate injection should not be used for prolonged tocolysis (beyond 48-72 hours). (See Uses: Preterm Labor and Cautions: Adverse Effects.)

For acute tocolytic therapy in the management of preterm labor+, subcutaneous terbutaline sulfate at a dosage of 0.25 mg every 0.3-3 hours has been recommended.

If pulse rate exceeds 120 beats/minute, terbutaline sulfate therapy should be temporarily discontinued. (See Cautions: Adverse Effects.)Terbutaline sulfate injection should not be used for prolonged tocolysis (beyond 48-72 hours). (See Uses: Preterm Labor and Cautions: Adverse Effects.)

Terbutaline sulfate is administered orally or subcutaneously (usually into the lateral deltoid area). Terbutaline sulfate also has been used IV+ in selected patients to inhibit uterine contractions in preterm labor+ (tocolysis). The drug also has been administered by IV infusion+ for the emergency treatment of acute asthma exacerbations in young children.

However, administration of parenteral terbutaline sulfate by routes or methods other than subcutaneous injection (e.g., IV) is not recommended by the manufacturer.

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for TERBUTALINE SULFATE (terbutaline sulfate):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 5 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Ergot Alkaloids/Sympathomimetics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of ergot alkaloids and sympathomimetics may result in additive or synergistic effect on peripheral blood vessels. CLINICAL EFFECTS: Concurrent use of ergot alkaloids and sympathomimetics may result in increased blood pressure due to peripheral vasoconstriction. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: When possible, avoid the concurrent use of ergot alkaloids and sympathomimetics. If concurrent use is warranted, monitor blood pressure and for signs of vasoconstriction. Decreasing the dose of one or both drugs may be necessary. DISCUSSION: There have been reports of severe vasoconstriction resulting in gangrene in patients receiving intravenous ergonovine with dopamine or norepinephrine.	DIHYDROERGOTAMINE MESYLATE, ERGOLOID MESYLATES, ERGOMAR, ERGOTAMINE TARTRATE, ERGOTAMINE-CAFFEINE, METHYLERGONOVINE MALEATE, METHYSERGIDE MALEATE, MIGERGOT, MIGRANAL, TRUDHESA
Selected Inhalation Anesthetic Agents/Sympathomimetics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The exact mechanism is unknown. The anesthetics produce conduction changes that increase impulse re-entry into the myocardial tissue.(1) The anesthetics' ability to precipitate arrhythmias is enhanced by elevated arterial blood pressure, tachycardia, hypercapnia, and/or hypoxia, events that stimulate the release of endogenous catecholamines.(1) CLINICAL EFFECTS: Concurrent use of inhalation anesthetic agents and sympathomimetics may result in ventricular arrhythmias or sudden blood pressure and heart rate increase during surgery.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Monitor blood pressure and avoid use of sympathomimetics in patients being treated with anesthetics on the day of surgery.(2) Intravenous use of epinephrine during surgery with halothane and related halogenated general anesthetics should be strongly discouraged. When intravenous epinephrine is necessary, nitrous oxide anesthesia supplemented with ether, muscle relaxants, or opioids should be used instead of halothane.(3,4) Epinephrine may safely be used subcutaneously with the following precautions: the patient is adequately ventilated to prevent hypoxia or respiratory acidosis; the total dose of epinephrine is limited to 100 mcg/10 minute period or 300 mcg/hour in adults, 3.5 mcg/Kg in infants, 2.5 mcg/Kg in children up to two years of age, and 1.45 mcg/Kg in children over two years of age; a minimum effective concentration of anesthetic is maintained; the drugs are not co-administered in patients with hypertension or other cardiovascular disorders; and the cardiac rhythm is continuously monitored during and after injection.(3-10) If arrhythmias occur after the administration of the epinephrine, the drugs of choice are lidocaine or propranolol, depending on the type of arrhythmia.(1) DISCUSSION: Administration of epinephrine during halothane anesthesia may may lead to serious ventricular arrhythmias.(3-6,11-18) This has occurred when epinephrine was administered intravenously,(6) when it was administered with lidocaine as a dental block,(11,14) or when it was administered supraperiosteally.(5) Norepinephrine has been shown to interact with halothane in a manner similar to epinephrine.(1) In two case reports, patients were given terbutaline (0.25 to 0.35 mg) for wheezing following induction of anesthesia with halothane. One patient's heart rate increased from 68 to 100 beats/minute, and the ECG showed premature ventricular contractions and bigeminy, while the other patient developed multiple unifocal premature ventricular contractions and bigeminy. The arrhythmias resolved in both patients following lidocaine administration.(19) Although not documented, isoproterenol causes effects on the heart similar to terbutaline(20) and would probably interact with halothane in a similar manner. Other inhalation anesthetics that increase the incidence of arrhythmias with epinephrine include chloroform,(20) methoxyflurane,(20) and enflurane.(12) A similar interaction may be expected between the other inhalation anesthetics and sympathomimetics.	DESFLURANE, FORANE, ISOFLURANE, SEVOFLURANE, SUPRANE, TERRELL, ULTANE
Beta-2 Agonists/Non-Cardioselective Beta-Blockers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Non-cardioselective beta-blockers and beta-2 agonists may antagonize the effects of each other. CLINICAL EFFECTS: Diminished response to either the beta-agonist, beta-blocker, or both may occur. Beta-blockers may also induce bronchospasm. PREDISPOSING FACTORS: Patients receiving beta-2 agonists for the treatment of asthma may be more at risk for bronchospasm. PATIENT MANAGEMENT: If possible, avoid beta-blocker therapy in asthmatic patients requiring beta-2 agonist therapy. If beta-blocker therapy is required, use a cardio-selective beta-blocker. For timolol ophthalmic drops, counsel patients to apply pressure to the inner corner of the eye after administration to prevent systemic absorption. Monitor patients for decreased effects of either agent, such as increased need for/use of beta-2 agonists or increased heart rate or blood pressure. DISCUSSION: Many patients with asymptomatic or mild reactive airways disease tolerate beta-blockers well. Most patients with COPD do not have bronchospastic component to their illness and may be given beta-blockers. Heart failure treatment guidelines recommend beta-blockers in the presence of COPD. Non-selective beta-blockers have been shown to have a negative effect on lung function (FEV1) and airway hyperresponsiveness (AHR) in patients with asthma and COPD.(1) An open-label study using the nonselective beta blocker nadolol showed no effect on salbutamol in 10 patients with mild asthma not on controller therapy.(2) A study in 8 healthy men showed that long acting propranolol (160 mg) only effected airway dilation at the 200 mcg salbutamol dose. The 800 mcg and 1600 mcg dose were unaffected. However, penbutolol prevented any significant airway dilation with all doses of salbutamol.(3) In a double blind, three-way, crossover study, 44% (7/16 patients) of patients taking metoprolol showed a greater than 20% decrease in FEV1 compared to 19% (3 patients) after dilevalol and 6% (1 patient) after placebo. Dilevalol and metoprolol significantly inhibited isoproterenol response compared to placebo.(4) A double-blind, randomized, crossover study in 10 asthmatic patients showed that intravenous propranolol produced marked symptomatic bronchoconstriction. Only a slight but significant inhibition of bronchomotor sensitivity to isoproterenol was noted during esmolol infusion.(5) In 18 patients with reversible bronchial asthma, labetalol caused a significant increase in FEV1 and metoprolol caused a significant decrease in FEV1. Concurrent administration of isoproterenol and labetalol caused a further increase in FEV1. The effect of isoproterenol was decreased by metoprolol (100, 200mg).(6) In one study propranolol (0.06mg/kg IV) was shown to almost completely block the effects of isoproterenol in asthmatics. Metoprolol (0.12mg/kg IV) did not affect isoproterenol.(7) Studies have shown that cardioselective beta-blockers are safe for patients with asthma and COPD.(8,9,10) Nebivolol and celiprolol significantly decreased FEV1. Inhalation of albuterol (up to 800mcg) significantly improved FEV1, but the values after nebivolol and celiprolol administration were lower than the initial values.(11) Administration of metoprolol did not cause any respiratory problems in 9 asthmatic patients. There was no significant difference between the metoprolol and placebo groups in the respiratory response to an isoproterenol aerosol in 24 asthmatic patients.(12) Eight male asthmatic patients were given 10 mg bisoprolol, 20 mg bisoprolol, and 100 mg metoprolol. Both bisoprolol and metoprolol caused bronchoconstriction measured by a significant fall in PEFR (peak expiratory flow rate). Terbutaline was able to reverse bronchoconstriction in all patients.(13) A double blind, placebo-controlled study analyzed the use of atenolol 100mg, metoprolol 100mg, or acebutolol 400 mg in 8 asthmatic patients before and after exercise. All three drugs reduced significantly FEV1 and PEFR. Administration of terbutaline improved all respiratory indices.(14) A double-blind crossover trial in 10 asthmatic patients showed that a single IV dose of atenolol 3mg caused slight impairment of ventilatory function. A dose of salbutamol by inhalation was able to reverse the bronchial effect of atenolol.(15) Propranolol (80mg/day), oxprenolol (80mg/day), atenolol (100mg/day), and celiprolol 200mg/day were given to 10 asthmatic patients in a randomized, crossover design with a two week washout period between each drug. The non-beta 1 selective beta blockers (propranolol, oxprenolol) caused a significant reduction in FEV1 and inhibited the bronchodilator response to inhaled salbutamol. Atenolol and celiprolol (beta1 selective beta blockers) did not significantly affect respiratory function or antagonize salbutamol effects.(16) A double blind, randomized, within patient, placebo-controlled study compared the cardioselective beta-blocker atenolol to the non-selective propranolol. Atenolol caused a significantly less drop in FEV1 compared to propranolol. The effect of isoprenaline plus the beta blockers were also studied. Both atenolol and propranolol effected isoprenaline FEV1 dose response curves but the greatest displacement was seen with propranolol.(17) The pulmonary effects of celiprolol 200 mg, celiprolol 400mg, propranolol 40mg, atenolol 100 mg were evaluated in 34 asthmatic patients. Propranolol and atenolol caused significant reductions in pulmonary function. Propranolol pretreatment caused a significant reduction in the effect of the bronchodilator. Celiprolol did not antagonize the bronchodilators.(18) A double-blind, placebo controlled, randomized, crossover design study studied the effects of propranolol 80mg or celiprolol 200 or 400mg on pulmonary function. Propranolol produced a significant decrease in FEV1 and FVC. Celiprolol and placebo had similar results. The effect of aerosolized terbutaline was also measured. Even at supratherapeutic doses, terbutaline was unable to restore pulmonary function parameters to baseline levels after treatment with propranolol. Terbutaline caused further bronchodilation after administration of celiprolol.(19) Eleven asthmatic patients showed significant bronchoconstriction in small airways after propranolol 40mg and pindolol 2.5mg in a double blind, randomized trial. Large airways only showed bronchoconstriction with propranolol. Terbutaline 0.5mg subcutaneous was given after pretreatment with propranolol and pindolol. The bronchodilator effect of terbutaline on large airways was diminished after both propranolol and timolol.(20)	BETAPACE, BETAPACE AF, BETIMOL, BRIMONIDINE TARTRATE-TIMOLOL, CARVEDILOL, CARVEDILOL ER, COMBIGAN, COREG, COREG CR, CORGARD, COSOPT, COSOPT PF, DORZOLAMIDE-TIMOLOL, HEMANGEOL, INDERAL LA, INDERAL XL, INNOPRAN XL, ISTALOL, LABETALOL HCL, LABETALOL HCL-WATER, NADOLOL, PINDOLOL, PROPRANOLOL HCL, PROPRANOLOL HCL ER, PROPRANOLOL-HYDROCHLOROTHIAZID, SOTALOL, SOTALOL AF, SOTALOL HCL, SOTYLIZE, TIMOLOL, TIMOLOL MALEATE, TIMOLOL-BIMATOPROST, TIMOLOL-BRIMONI-DORZOL-BIMATOP, TIMOLOL-BRIMONIDIN-DORZOLAMIDE, TIMOLOL-DORZOLAMIDE-BIMATOPRST, TIMOPTIC OCUDOSE
Selected Direct-Acting Sympathomimetics/Tricyclic Compounds SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Unknown. However, it is speculated that direct-acting sympathomimetic amines have an enhanced effect due to tricyclic blockage of norepinephrine reuptake. CLINICAL EFFECTS: Increased effect of direct acting sympathomimetics. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Consider avoiding the concurrent use of direct-acting sympathomimetics and tricyclic compounds. If concurrent use of direct-acting sympathomimetics and tricyclic compounds is warranted, the initial dose of the sympathomimetic should be lowered and the patient should be monitored for adverse cardiovascular effects. Use of tricyclic compounds and other sympathomimetics should be approached with caution. DISCUSSION: Epinephrine and other direct-acting sympathomimetic amines exert enhanced cardiovascular effects (e.g., arrhythmias, hypertension, and tachycardia) in individuals concurrently receiving or previously treated with tricyclic antidepressants. Other direct and mixed acting sympathomimetic amines have also been reported to interact with tricyclic antidepressants. These include norepinephrine, phenylephrine, dopamine, and methoxamine. Protriptyline, amitriptyline, and desipramine have also been reported to interact with direct-acting sympathomimetics.	AMITRIPTYLINE HCL, AMOXAPINE, ANAFRANIL, CHLORDIAZEPOXIDE-AMITRIPTYLINE, CLOMIPRAMINE HCL, DESIPRAMINE HCL, DOXEPIN HCL, IMIPRAMINE HCL, IMIPRAMINE PAMOATE, NORPRAMIN, NORTRIPTYLINE HCL, PAMELOR, PERPHENAZINE-AMITRIPTYLINE, PROTRIPTYLINE HCL, SILENOR, TRIMIPRAMINE MALEATE
Iobenguane I 123/Agents that Affect Catecholamines SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells.(1) CLINICAL EFFECTS: Compounds that reduce catecholamine uptake or that deplete catecholamine stores may interfere with imaging completed with iobenguane.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discuss the use of agents that affect catecholamines. Discontinue drugs that reduce catecholamine uptake or deplete catecholamine stores prior to imaging with iobenguane. Before imaging with iobenguane, discontinue agents that affect catecholamines for at least 5 biological half-lives, as clinically tolerated.(1) DISCUSSION: Many agents may reduce catecholamine uptake or deplete catecholamine stores.(1) Examples include: - CNS stimulants or amphetamines (e.g. cocaine, methylphenidate, dextroamphetamine) - norepinephrine and dopamine reuptake inhibitors (e.g. phentermine) - norepinephrine and serotonin reuptake inhibitors (e.g. tramadol) - monoamine oxidase inhibitors (e.g. phenelzine, linezolid) - central monoamine depleting drugs (e.g. reserpine) - non-select beta adrenergic blocking drugs (e.g. labetalol) - alpha agonists or alpha/beta agonists (e.g. pseudoephedrine, phenylephrine, ephedrine, phenylpropanolamine, naphazoline) - tricyclic antidepressants or norepinephrine reuptake inhibitors (e.g. amitriptyline, bupropion, duloxetine, mirtazapine, venlafaxine) - botanicals that may inhibit reuptake of norepinephrine, serotonin or dopamine (e.g. ephedra, ma huang, St. John's Wort, yohimbine)	ADREVIEW

There are 1 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Methacholine/Beta-Agonists; Anticholinergics; Theophylline SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway.(1) CLINICAL EFFECTS: The result of the methacholine challenge test may not be accurate.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The following drugs should be held before a methacholine challenge for the the duration indicated:(1) - short-acting beta-agonists: 6 hours - long-acting beta-agonists: 36 hours - short-acting anti-cholinergics: 12 hours - long-acting anti-cholinergics: at least 168 hours (7 days) - oral theophylline: 12-48 hours DISCUSSION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway and cause inaccurate test results.	METHACHOLINE CHLORIDE, PROVOCHOLINE

Drug Interaction

Drug Names

Methacholine/Beta-Agonists; Anticholinergics; Theophylline

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway.(1)

CLINICAL EFFECTS: The result of the methacholine challenge test may not be accurate.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The following drugs should be held before a methacholine challenge for the the duration indicated:(1) - short-acting beta-agonists: 6 hours - long-acting beta-agonists: 36 hours - short-acting anti-cholinergics: 12 hours - long-acting anti-cholinergics: at least 168 hours (7 days) - oral theophylline: 12-48 hours

DISCUSSION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway and cause inaccurate test results.

METHACHOLINE CHLORIDE, PROVOCHOLINE

The following contraindication information is available for TERBUTALINE SULFATE (terbutaline sulfate):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 3 contraindications. Absolute contraindication.

Contraindication List
Compression of umbilical cord
Myocardial ischemia
Placental abruption

There are 5 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Cardiac arrhythmia
Chronic myocardial ischemia
Hypertension
Hypokalemia
Pulmonary edema

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Diabetes mellitus
Hyperthyroidism
Ketoacidosis
Seizure disorder

The following adverse reaction information is available for TERBUTALINE SULFATE (terbutaline sulfate):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 10 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Acute myocardial infarction Cardiac arrhythmia Chest pain Hyperglycemia Hypertension Hypokalemia Myocardial ischemia Paradoxical bronchospasm Pulmonary edema Tachycardia

There are 10 less severe adverse reactions.

More Frequent	Less Frequent
Nervousness Tremor	Cramps Dizziness Drowsy General weakness Hyperhidrosis Insomnia Nausea Vomiting

Rare/Very Rare
None.

The following precautions are available for TERBUTALINE SULFATE (terbutaline sulfate):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Although there are no adequate and controlled studies to date in humans, terbutaline sulfate has been associated with alterations in behavior and brain development, including decreased cellular proliferation and differentiation, in rat offspring when terbutaline was administered subcutaneously to dams during the late stage of the pregnancy and lactation period. Terbutaline exposures in rat dams were approximately 6.5 times the human exposure of an oral adult dosage of terbutaline sulfate 15 mg daily (on a mg/m2 basis) and approximately 24-48 times the human exposure of a subcutaneous adult dosage of terbutaline sulfate 2-4 mg daily (on a mg/m2 basis).

In embryofetal developmental studies, teratogenic effects were not observed in offspring when pregnant rats and rabbits received terbutaline sulfate at oral dosages up to 50 mg/kg daily (approximately 32 and 65 times, respectively, the maximum recommended oral dosage for adults on a mg/m2 basis; approximately 810 and 1600 times, respectively, the maximum recommended subcutaneous dosage for adults on a mg/m2 basis). Terbutaline sulfate injection is not FDA labeled for and should not be used for prolonged tocolysis (beyond 48-72 hours), and is contraindicated for such use. Oral terbutaline sulfate is not FDA labeled for and should not be used for acute or maintenance tocolysis, and is contraindicated for such use.

Terbutaline sulfate (injection or oral tablets) should not be used for maintenance tocolysis, particularly in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate in pregnant women. Such adverse reactions in pregnant women include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia.

In addition, increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration of terbutaline. The manufacturers state that terbutaline should be used with caution in pregnant women when needed for relief of bronchospasm during labor and only when the potential benefits are expected to clearly outweigh the possible risks. The manufacturers also state that terbutaline should be used during pregnancy only if the potential benefits justify the potential risks to the fetus.

(See Cautions: Adverse Effects and Uses: Preterm Labor.) Patients should be advised that serious adverse effects, including maternal cardiac effects and death, have been reported after prolonged use of terbutaline to manage preterm labor. Patients should be advised that there are serious situations where a clinician may decide that short-term use of terbutaline injection in the hospital setting may benefit a pregnant woman. Patients should be advised that oral terbutaline should not be used either to treat preterm labor or prevent recurrent preterm labor.

(See Cautions: Adverse Effects and Uses: Preterm Labor.) Patients receiving terbutaline for another condition (e.g., asthma) should be advised to contact their clinician if they are or plan to become pregnant.

Terbutaline is distributed into milk, but in amounts generally considered insufficient to affect nursing infants; however, the drug should be used with caution in nursing women and only if the potential benefits justify the possible risks to the infant.

No enhanced Geriatric Use information available for this drug.

COPD exacerbation
J44.1	Chronic obstructive pulmonary disease with (acute) exacerbation
Status asthmaticus
J45.22	Mild intermittent asthma with status asthmaticus
J45.32	Mild persistent asthma with status asthmaticus
J45.42	Moderate persistent asthma with status asthmaticus
J45.52	Severe persistent asthma with status asthmaticus
J45.902	Unspecified asthma with status asthmaticus