Dr. Paul Answers Your Questions About Asthma. Watch The Video

Terbutaline Sulfate

Pronunciation

Class: Selective beta-2-Adrenergic Agonists
VA Class: RE103
CAS Number: 23031-32-5

Warning(s)

  • 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 Sulfate

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

Slideshow: Asthma: 10 Things You Need To Do To Keep It In Check

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 or sub-Q therapy in selected women to inhibit uterine contractions in preterm labor (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 Sulfate Dosage and Administration

Administration

Administer orally or sub-Q.198 199

Has been administered IV to inhibit uterine contractions in preterm labor (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
Oral

Children 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-Q

Hospitalized children ≤12 years of age 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.208 209

Adults

Bronchospasm
Asthma
Oral

5 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-Q

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 adults with asthma exacerbation: 0.25 mg every 20 minutes for a total of 3 doses suggested by some clinicians.208 209

COPD
Oral

5 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-Q

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

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
Oral

Children 12–15 years of age: Maximum 7.5 mg within a 24-hour period.199

Sub-Q

Children ≥12 years of age: Maximum: 0.5 mg within a 4-hour period.198

Adults

Bronchospasm
Asthma
Oral

Maximum 15 mg within a 24-hour period.199

Sub-Q

Maximum 0.5 mg within a 4-hour period.198

COPD
Oral

Maximum 15 mg within a 24-hour period.199

Sub-Q

Maximum 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-Q

Injection 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 Sulfate

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

Interactions for Terbutaline Sulfate

Specific Drugs

Drug

Interaction

Comments

Antidepressants, tricyclic

Potentiation of vascular effects198 199

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

Use concomitantly with caution198 199

MAO inhibitors

Potentiation of vascular effects198 199

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 Sulfate 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

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextrose 5% in water

Sodium chloride 0.45 or 0.9%

Drug Compatibility
Admixture CompatibilityHID

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

  • Decreases resistance of airways.198 199 c

  • 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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Terbutaline Sulfate

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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Brethine 2.5MG Tablets (AAIPHARMA): 90/$45.99 or 270/$119.97

Terbutaline Sulfate 1MG/ML Solution (APP PHARMACEUTICAL): 1/$15.99 or 3/$24.97

Terbutaline Sulfate 2.5MG Tablets (GLOBAL PHARMACEUTICAL CORP): 90/$44.99 or 270/$125.98

Terbutaline Sulfate 5MG Tablets (GLOBAL PHARMACEUTICAL CORP): 90/$47.99 or 270/$125.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions January 27, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. Geigy. Brethaire (terbutaline sulfate) inhalation aerosol prescribing information. Summit, NJ; 1995 Nov.

101. Joseph X, Whitehurst VE, Bloom S et al. Enhancement of cardiotoxic effects of beta-adrenergic bronchodilators by aminophylline in experimental animals. Fundam Appl Toxicol. 1981; 1:443-7. [PubMed 6136445]

102. Anon. Interactions between methyl xanthines and beta adrenergic agonists. FDA Drug Bull. 1981; 11:19-20. [PubMed 6119269]

103. Kelly HW. Controversies in asthma therapy with theophylline and the β2-adrenergic agonists. Clin Pharm. 1984; 3:386-95. [IDIS 187701] [PubMed 6147224]

104. Walker SB, Kradjan WA, Bierman CW. Bitolterol mesylate. A beta-adrenergic agent: chemistry, pharmacokinetics, pharmacodynamics, adverse effects and clinical efficacy in asthma. Pharmacotherapy. 1985; 5:127-37. [IDIS 393481] [PubMed 3895171]

105. Hampson NB, Mueller MP. Cooling of metered-dose inhalers decreases pressure output from canisters. N Engl J Med. 1989; 320:321. [IDIS 250265] [PubMed 2563147]

106. Lourenco RV, Cotromones E. Clinical aerosols: I. Characterization of aerosols and their diagnostic uses. Arch Intern Med. 1982; 142:2163-92. [PubMed 6753780]

107. Geigy. Brethine (terbutaline sulfate) injection prescribing information. Summit, NJ; 1995 Dec.

108. Beall MH, Edgar BW, Paul RH et al. A comparison of ritodrine, terbutaline, and magnesium sulfate for the suppression of preterm labor. Am J Obstet Gynecol. 1985; 153:854-9. [IDIS 211026] [PubMed 4073155]

109. Kosasa TS, Busse R, Wahl N et al. Long-term tocolysis with combined intravenous terbutaline and magnesium sulfate: a 10-year study of 1000 patients. Obstet Gynecol. 1994; 84:369-73. [IDIS 334072] [PubMed 8058233]

110. Caritis SN, Toig G, Heddinger LA et al. A double-blind study comparing ritodrine and terbutaline in the treatment of preterm labor. Am J Obstet Gynecol. 1984; 150:7-14. [IDIS 190677] [PubMed 6383045]

111. Travis BE, McCullough JM. Pharmacotherapy of preterm labor. Pharmacotherapy. 1993; 13:28-36. [IDIS 311789] [PubMed 8437965]

112. Angel JL, O’Brien WF, Knuppel RA et al. Carbohydrate intolerance in patients receiving oral tocolytics. Am J Obstet Gynecol. 1988; 159:726-6.

113. Schreyer P, Caspi E, Snir E et al. Metabolic effects of intramuscular and oral administration of ritodrine in pregnancy. Obstet Gynecol. 1981; 57:730-3. [IDIS 133043] [PubMed 7231825]

114. Finley J, Katz M, Rojas-Perez M et al. Cardiovascular consequences of β-agonist tocolysis: an echocardiographic study. Obstet Gynecol. 1984; 64:787-91. [IDIS 192747] [PubMed 6150456]

115. Ingemarsson I, Bengtsson B. A five-year experience with terbutaline for preterm labor: low rate of severe side effects. Obstet Gynecol. 1985; 66:176-80. [IDIS 203655] [PubMed 4022480]

116. Main EK, Main DM, Gabbe SG. Chronic oral terbutaline tocolytic therapy is associated with maternal glucose intolerance. Am J Obstet Gynecol. 1987; 157:644-7. [IDIS 316527] [PubMed 3631165]

117. Parilla BV, Dooley SL, Minogue JP et al. The efficacy of oral terbutaline after intravenous tocolysis. Am J Obstet Gynecol. 1993; 169:965-9. [IDIS 321361] [PubMed 8238158]

118. How HY, Hughes SA, Vogel RL et al. Oral terbutaline in the outpatient management of preterm labor. Am J Obstet Gynecol. 1995; 173:1518-22. [IDIS 357322] [PubMed 7503194]

119. Adkins RT, Van Hooydonk JE, Bressman PL et al. Prevention of preterm birth: early detection and aggressive treatment with terbutaline. South Med J. 1993; 86:157-64. [IDIS 311292] [PubMed 8240475]

120. Allbert JR, Johnson C, Roberts WE et al. Tocolysis for recurrent preterm labor using a continuous subcutaneous infusion pump. J Reprod Med. 1994; 39:614-8. [IDIS 334689] [PubMed 7996525]

121. Fischer JR, Kaatz BL. Continuous subcutaneous infusion of terbutaline for suppression of preterm labor. Clin Pharm. 1991; 10:292-6. [IDIS 279763] [PubMed 2032446]

122. Lam F, Gill P, Smith M et al. Use of the subcutaneous terbutaline pump for long-term tocolysis. Obstet Gynecol. 1988; 72:810-3. [IDIS 311381] [PubMed 3173932]

123. Perry KG Jr, Morrison JC, Rust OA et al. Incidence of adverse cardiopulmonary effects with low-dose continuous terbutaline infusion. Am J Obstet Gynecol. 1995; 173:1273-7. [IDIS 355651] [PubMed 7485336]

124. American College of Obstetricians and Gynecologists (ACOG) Committee on Technical Bulletins. Preterm labor. Technical Bulletin No. 206. Washington, DC: American College of Obstetricians and Gynecologists; 1995 Jun.

125. Macones GA, Berlin M, Berlin JA. Efficacy of oral beta-agonist maintenance therapy in preterm labor: a meta-analysis. Obstet Gynecol. 1995; 85:313-7. [IDIS 341822] [PubMed 7824252]

126. King JF, Grant A, Keirse MJ et al. Beta-mimetics in preterm labour: an overview of the randomized controlled trials. Br J Obstet Gynaecol. 1988; 95:211-22. [IDIS 305430] [PubMed 2897207]

127. Canadian Preterm Labor Investigators Group. Treatment of preterm labor the beta-adrenergic agonist ritodrine. N Engl J Med. 1992; 327:308-12. [IDIS 299344] [PubMed 1620169]

128. Wilkins IA, Lynch L, Mehalek KE et al. Efficacy and side effects of magnesium sulfate and ritodrine as tocolytic agents. Am J Obstet Gynecol. 1988; 159:685-9. [IDIS 246807] [PubMed 3048103]

129. Astra USA, Inc. Yutopar (ritodrine hydrochloride) injection prescribing information dated April 1995. In: Physicians’ desk reference. 51st ed. Montvale, NJ; Medical Economics Company Inc; 1997:566-7.

130. CibaGeneva. Brethine (terbutaline sulfate) tablets prescribing information. In: Physicians’ desk reference. 50th ed. Montvale, NJ: Medical Economics Company Inc; 1997:831.2.

131. Meyer JM, Wenzel CL, Kradjan WA. Salmeterol: a novel, long-acting beta 2-agonist. Ann Pharmacother. 1993; 27:1478-87. [IDIS 323106] [PubMed 7905757]

132. Brogden RN, Faulds D. Salmeterol xinafoate: a review of its pharmacological properties and therapeutic potential in reversible obstructive airways disease. Drugs. 1991; 42:895-912. [PubMed 1723379]

133. Kelly HW. Issues and advances in the pharmacotherapy of asthma. J Clin Pharm Ther. 1992; 17:271-81. [IDIS 304352] [PubMed 1361192]

134. Lipworth BJ. Risks versus benefits of inhaled β2-agonists in the management of asthma. Drug Safety. 1992; 7:54-70. [PubMed 1346963]

135. Sears MR, Taylor DR, Print CG et al. Regular inhaled beta-agonist treatment in bronchial asthma. Lancet. 1990; 336:1391-6. [IDIS 275192] [PubMed 1978871]

136. Anon. Warnings from the CSM. Int Pharm J. 1991; 5:247-8.

137. Spitzer WO, Sussa S, Ernst P et al. The use of β-agonists and the risk of death and near death from asthma. N Engl J Med. 1992; 326:501-6. [IDIS 291894] [PubMed 1346340]

138. Palmer JBD, Jenkins MM. β2-agonists in asthma. Lancet. 1991; 337:43. [IDIS 275815] [PubMed 1670660]

139. Dahl R. β2-agonists in asthma. Lancet. 1991; 337:43. [IDIS 275815] [PubMed 1670660]

140. Löfdahl CG, Svedmyr N. Beta agonists—friends or foes? Eur Respir J. 1991; 4:1161-5. Editorial.

141. Kamada AK, Spahn JD, Blake KV. Salmeterol: its place in asthma management. Ann Pharmacother. 1994; 28:1100-2. [IDIS 335815] [PubMed 7803888]

142. Wanner A. Is the routine use of inhaled β-adrenergic agonists appropriate in asthma treatment? Yes. Am J Respir Crit Care Med. 1995; 151:597-9. [IDIS 344522] [PubMed 7881643]

143. Sears MR. Is the routine use of inhaled β-adrenergic agonists appropriate in asthma treatment? No. Am J Respir Crit Care Med. 1995; 151:600-1. [IDIS 344523] [PubMed 7881644]

144. Lai CKW, Twentyman OP, Holgate ST. The effect of an increase in inhaled allergen dose after rimiterol hydrobromide on the occurrence and magnitude of the late asthmatic response and the asssociated change in nonspecific bronchial responsiveness. Am Rev Respir Dis. 1989; 140:917-23. [IDIS 310468] [PubMed 2572192]

145. Suissa S, Ernst P, Boivin JF et al. A cohort analysis of excess mortality in asthma and the use of inhaled beta-agonists. Am J Respir Crit Care Med. 1994; 149(3 Part 1):604-10. [IDIS 327105] [PubMed 8118625]

146. O’Connor BJ, Aikman SL, Barnes PJ. Tolerance to the nonbronchodilator effects of inhaled beta 2-agonists in asthma. N Engl J Med. 1992; 327:1204-8. [IDIS 304091] [PubMed 1357551]

147. Cockcroft DW, McParland CP, Britto SA et al. Regular inhaled salbutamol and airway responsiveness to allergen. Lancet. 1993; 342:833-7. [IDIS 320479] [PubMed 8104272]

148. Mullen ML, Mullen B, Carey M. The association between β-agonist use and death from asthma: a meta-analytic integration of case-control studies. JAMA. 1993; 270:1842-5. [IDIS 320909] [PubMed 8105113]

149. Reviewers’ comments (personal observations) on Salmeterol Xinafoate 12:12.

150. National Institutes of Health, National Heart, Lung, and Blood Institute. Global Initiative for asthma: global strategy for asthma management and prevention NHLBI/WHO Workshop Report. Bethesda, MD: National Institutes of Health. 1995 Jan:77-100. NIH/NHLBI Publication No. 95-3659.

151. Devoy MAB, Fuller RW, Palmer JBD. Are there any detrimental effects of the use of inhaled long-acting β2-agonists in the treatment of asthma? Chest. 1995; 107:1116-24.

152. McFadden ER Jr. Perspectives in β2-agonist therapy: vox clamantis in deserto vel lux in tenebris? J Allergy Clin Immunol. 1995; 95:641-51.

153. Crane J, Burgess C, Pearce N et al. Asthma deaths in New Zealand. BMJ. 1992; 304:1307. [IDIS 296806] [PubMed 1606438]

154. Crane J, Pearce N, Flatt A et al. Prescribed fenoterol and death from asthma in New Zealand, 1981-83: case-control study. Lancet. 1989; 1:917-22. [IDIS 254874] [PubMed 2565417]

155. Löfdahl CG, Svedmyr N. Beta agonists—friends or foes? Eur Respir J. 1991; 4:1161-5. Editorial.

156. Sisson MC. Preventing preterm labor. Is trebutaline our best option? AWHONN Lifelines. 1997; 1:42-6.

157. Allbert JR, Johnson C, Roberts WE et al. Tocolysis for recurrent preterm labor using a continuous subcutaneous infusion pump. J Reprod Med. 1994; 39:614-8. [IDIS 334689] [PubMed 7996525]

158. Moise KJ, Sala DJ, Zurawin RK et al. Continuous subcutaneous terbutaline pump therapy for premature labor: safety and efficacy. South Med J. 1992; 85:255-60. [IDIS 293256] [PubMed 1546349]

159. Wenstrom KD, Weiner CP, Merrill D et al. A placebo-controlled randomized trial of the terbutaline pump for prevention of preterm delivery. Am J Perinatol. 1997;14:87-91.

160. Perry KG, Morrison JC, Rust OA et al. Incidence of adverse cardiopulmonary effects with low dose continuous terbutaline infusion. Am J Obset Gynecol. 1995;173:1273-7.

161. Nightingale SL. Dear healthcare provider letter concerning proper use of terbutaline. Rockville, MD: US Food and Drug Administration; 1997 Nov 13.

162. Hudgens DR, Conradi SE. Sudden death associated with terbutaline sulfate Am J Obstet Gynecol. 1993;169:120-1.

163. Lindenbaum C, Ludmir J, Teplick FB et al. Maternal glucose intolerance and the subcutaneous terbutaline pump. Am J Obstet Gynecol. 1992: 166: 925-8. (IDIS 293989)

164. Adkins RT. Terbutaline pump treatment of premature labor. South Med J. 1993; 86: 1076. [IDIS 311292] [PubMed 8240475]

165. National Asthma Education and Prevention Program. Expert panel report II: guidelines for the diagnosis and management of asthma. 1997 Feb.

166. National Asthma Education Program. Executive summary: guidelines for the diagnosis and management of asthma. NIH Publ. No.94-3042A. Washington, DC: US Government Printing Office; 1994 Jul.

167. National Institutes of Health, National Heart, Lung, and Blood Institute. Global Initiative for asthma: global strategy for asthma management and prevention NHLBI/WHO Workshop Report. Bethesda, MD: National Institutes of Health. 1995 Jan:77-100. NIH/NHLBI Publication No. 95-3659.

168. British Thoracic Society. Guidelines on the management of asthma. Thorax. 1993; 48(2 Suppl):S1-24.

169. Allen & Hanburys. Serevent (salmeterol xinafoate) inhalation aerosol prescribing information. Research Triangle Park, NC; 1994 Dec.

170. Allen & Hanburys. Serevent (salmeterol xinafoate) inhalation aerosol patient instructions. Research Triangle Park, NC; 1994 Feb.

171. Bone RC. Another word of caution regarding a new long-acting bronchodilator. JAMA. 1995; 273:967-8. [IDIS 344245] [PubMed 7884959]

172. Reviewers’ comments (personal observations) on salmeterol.

173. Anon. Warnings from the CSM. Int Pharm J. 1991; 5:247-8.

174. American Thoracic Society. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1995; 152: s77-120.

175. Siafakas NM, Vermeire P, Pride NB et al. Optimal assessment and management of chronic obstructive pulmonary disease (COPD). Eur Respir J. 1995: 8; 1398-1420.

176. Boehringer Ingelheim. Atrovent (ipratropium bromide) inhalation aerosol prescribing information. Ridgefield, CT; 1993 June.

177. Pearlman DS, Chervinsky P, LaForce C et al. A comparison of salmeterol with albuterol in the treatment of mild-to-moderate asthma. N Engl J Med. 1992; 327:1420-5.

178. D’Alonzo GE, Nathan RA, Henochowicz S et al. Salmeterol xinafoate as maintenance therapy compared with albuterol in patients with asthma. JAMA. 1994; 271:1412-6.

179. Drazen JM, Israel E, Boushey HA et al. Comparison of regularly scheduled with as- needed use of albuterol in mild asthma. N Engl J Med. 1996; 335:841-7.

180. National Asthma Education and Prevention Program. Expert panel report: guidelines for the diagnosis and management of asthma-update on selected topics 2002. Bethesda, Md: National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program Coordinating Committee; 2003 Jun. Available from National Heart, Lung, and Blood Institute Information Center, NIH Publication No. 02-5074. Also available from website. Accessed 2004 Sep. 15.

181. Papageorgiou AN, Doray JL, Ardila R et al. Reduction of mortality, morbidity, and respiratory distress syndrome in infants weighing less than 1,000 grams by treatment with betamethasone and ritodrine. Pediatrics. 1989; 83:493-7. [IDIS 252932] [PubMed 2927987]

182. Veterans’ Health Administration Department of Veteran Affairs. The pharmacologic management of chronic obstructive pulmonary disease. Washington, DC: Veterans’ Health Administration; 1999 June. Pharmacy Benefits Management No. 99-0012. Available from website. Accessed Sep. 30, 2002.

183. National Institutes of Health, National Heart, Lung, and Blood Institute. Global Initiative for asthma: global strategy for asthma management and prevention. Bethesda, MD: National Institutes of Health. 2009 Dec. Available from website. Accessed 2010 Sep 23.

184. National Heart, Lung, and Blood Institute/World Health Organization. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Bethesda, MD: National Heart, Lung, and Blood Institute, Global Initiative for Chronic Obstructive Lung Disease, World Health Organization; 2001. Available from website. Accessed Sep. 26, 2002.

185. Boehringer Ingelheim. Atrovent (ipratropium bromide) inhalation aerosol prescribing information. Ridgefield, CT; 1999 Mar.

186. Snow V, Lascher S, Mottur-Pilson C for the Joint Expert Panel of Chronic Obstructive Pulmonary Disease of the American College of Chest Physicians and the American College of Physicians-American Society of Internal Medicine. Evidence base for management of acute exacerbations of chronic obstructive pulmonary disease. Clinical Practice Guideline, pt.1. Ann Intern Med. 2001; 134:595-9. [IDIS 462483] [PubMed 11281744]

187. Veterans’ Health Administration, Department of Veterans’ Affairs. VHA/DOD clinical practice guideline for the management of chronic obstructive pulmonary disease: complete summary. Washington, DC: Veterans’ Health Administration; 1999 Aug.

188. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. Management of preterm labor. Washington, DC; American College of Obstetricians and Gynecologists: 2003 May. Practice Bulletin No. 43.

189. Roberts D, Dalziel S. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2006; 3:CD004454. [PubMed 16856047]

191. American Thoracic Society / European Respiratory Society Task Force. Standards for the diagnosis and management of patients with COPD. Version 1.2, for health professionals. New York, NY: American Thoracic Society, European Respiratory Society; 2005 Sep 8. Available from website. Accessed Aug 10, 2007.

192. National Heart, Lung, and Blood Institute/World Health Organization. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Bethesda, MD: National Heart, Lung, and Blood Institute, Global Initiative for Chronic Obstructive Lung Disease, World Health Organization; 2006 Nov. Available from website. Accessed Jun. 13, 2007.

193. O’Donnell DE, Aaron S, Bourbeau J et al. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease-2003. Can Respir J. 2003; 10(Suppl. A):11A-65A. [PubMed 12861361]

194. Celli BR, Macnee W. Standard for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004; 23:932-46. [PubMed 15219010]

195. American Thoracic Society. Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1995; 152: s77-120.

196. Siafakas NM, Vermeire P, Pride NB et al. Optimal assessment and management of chronic obstructive pulmonary disease (COPD). Eur Respir J. 1995: 8; 1398-1420.

197. Anotayanonth S, Subhedar NV, Garner P et al. Betamimetics for inhibiting preterm labour. Cochrane Database Syst Rev. 2004; :CD004352.

198. Bedford Laboratories. Terbutaline sulfate injection prescribing information. Bedford, OH; 2011 Apr.

199. Global Pharmaceuticals. Terbutaline sulfate tablets prescribing information. Philadelphia, PA; 2011 Feb.

200. Nanda K, Cook LA, Gallo MF et al. Terbutaline pump maintenance therapy after threatened preterm labor for preventing preterm birth. Cochrane Database Syst Rev. 2002; :CD003933.

201. Dodd JM, Crowther CA, Dare MR et al. Oral betamimetics for maintenance therapy after threatened preterm labour. Cochrane Database Syst Rev. 2006; :CD003927.

202. Tafreshi MJ, Weinacker AB. Beta-adrenergic-blocking agents in bronchospastic diseases: a therapeutic dilemma. Pharmacotherapy. 1999; 19(8):974-8. [PubMed 10453968]

205. American Thoracic Society/European Respiratory Society. Standards for the diagnosis and management of patients with COPD: patient version. New York, NY: American Thoracic Society, European Respiratory Society; 2004. Available from website. Accessed Aug 20, 2007.

208. The American Heart Association. Guidelines 2005 for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2005; 112(Suppl I): IV1-211. [PubMed 16314375]

209. National Asthma Education and Prevention Program. Expert panel report III: guidelines for the diagnosis and management of asthma. 2007 Jul. Bethesda, MD: U.S. Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute. Available from website. Accessed Jul 27, 2008.

210. US Food and Drug Administration. FDA drug safety communication: New warnings against use of terbutaline to treat preterm labor. Rockville, MD; 2011 Feb 17. From FDA website. Accessed 2011 Jul 6.

211. Simhan HN, Caritis SN. Prevention of preterm delivery. N Engl J Med. 2007; 357:477-87. [PubMed 17671256]

212. Berkman ND, Thorp JM, Lohr KN et al. Tocolytic treatment for the management of preterm labor: a review of the evidence. Am J Obstet Gynecol. 2003; 188:1648-59. [PubMed 12825006]

213. Sayres WG. Preterm labor. Am Fam Physician. 2010; 81:477-84. [PubMed 20148502]

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1533-4.

c. AHFS Drug Information 2007. McEvoy GK, ed. Terbutaline. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1333-6.

Hide
(web4)