Terbutaline (oral)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Black Box Warning
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Warning:Tocolysis
See full prescribing information for complete Boxed Warning.
Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration
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Overview
Terbutaline (oral) is a Beta-2 adrenergic agonist, bronchodilator and sympathomimetic that is FDA approved for the treatment of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include palpitations, tachyarrhythmia, headache, seizure, tremor and nervousness.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The usual oral dose of terbutaline sulfate tablets for adults is 5 mg administered at approximately six-hour intervals, three times daily, during the hours the patient is usually awake. If side effects are particularly disturbing, the dose may be reduced to 2.5 mg three times daily, and still provide a clinically significant improvement in pulmonary function. The total dose within 24 hours should not exceed 15 mg.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Terbutaline in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Terbutaline in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Terbutaline sulfate tablets is not recommended for use in children below the age of 12 years. A dosage of 2.5 mg three times daily is recommended for children 12-15 years of age. The total dose within 24 hours should not exceed 7.5 mg. If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Terbutaline in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Terbutaline in pediatric patients.
Contraindications
Tocolysis
Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis.
Hypersensitivity
Terbutaline sulfate is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any components of this drug product.
Warnings
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Warning:Tocolysis
See full prescribing information for complete Boxed Warning.
Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. In particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration
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Deterioration of Asthma
Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of terbutaline sulfate tablets, USP than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
Use of Anti-Inflammatory Agents
The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.
Cardiovascular Effects
Terbutaline sulfate tablets, USP, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of terbutaline sulfate tablets, USP at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, terbutaline sulfate tablets, USP, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Seizures
There have been rare reports of seizures in patients receiving terbutaline; seizures did not recur in these patients after the drug was discontinued.
Adverse Reactions
Clinical Trials Experience
Adverse reactions observed with terbutaline sulfate tablets, are similar to those commonly seen with other sympathomimetic amines. All of these reactions are generally transient in nature and usually do not require treatment. The frequency of these side effects appears to diminish with continued therapy.
The following table lists the adverse reactions seen in 199 patients treated with terbutaline sulfate tablets during six double-blind crossover studies and four double-blind parallel studies (short- and long-term) performed in the United States. Percent Incidence of Adverse Reactions (Total Daily Dosage Range 5-15 mg) -Study sample size N=199.
Nervous System
Cardiovascular
- Palpitations
- Tachycardia
- Extrasystoles ventricular
Digestive
Body as a Whole
[*[Sweating]]
Postmarketing Experience
There is limited information regarding Terbutaline (oral) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Terbutaline (oral) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Terbutaline (oral) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Terbutaline (oral) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Terbutaline (oral) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Terbutaline (oral) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Terbutaline (oral) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Terbutaline (oral) in geriatric settings.
Gender
There is no FDA guidance on the use of Terbutaline (oral) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Terbutaline (oral) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Terbutaline (oral) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Terbutaline (oral) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Terbutaline (oral) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Terbutaline (oral) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Terbutaline (oral) Administration in the drug label.
Monitoring
There is limited information regarding Terbutaline (oral) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Terbutaline (oral) and IV administrations.
Overdosage
There is limited information regarding Terbutaline (oral) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Terbutaline (oral) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Terbutaline (oral) Mechanism of Action in the drug label.
Structure
There is limited information regarding Terbutaline (oral) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Terbutaline (oral) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Terbutaline (oral) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Terbutaline (oral) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Terbutaline (oral) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Terbutaline (oral) How Supplied in the drug label.
Storage
There is limited information regarding Terbutaline (oral) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Terbutaline (oral) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Terbutaline interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Terbutaline (oral) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Terbutaline (oral) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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| Clinical data | |
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| Pregnancy category |
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| Routes of administration | SQ, Oral, Inhaled |
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| Legal status | |
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| Pharmacokinetic data | |
| Metabolism | GI tract (oral), liver; CYP450: unknown |
| Elimination half-life | urine 90% (60% unchanged), bile/faeces; Half-life: 3-4h |
| Identifiers | |
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| CAS Number | |
| PubChem CID | |
| DrugBank | |
| E number | {{#property:P628}} |
| ECHA InfoCard | {{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value). |
| Chemical and physical data | |
| Formula | C12H19NO3 |
| Molar mass | 225.284 g/mol |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]
For patient information, click here
Overview
Terbutaline (trade names Brethine, Bricanyl, or Brethaire) is a β2-adrenergic receptor agonist, used as a fast-acting bronchodilator (often used as a short-term asthma treatment) and as a tocolytic to delay premature labour. The inhaled form of terbutaline starts working within 15 minutes and can last up to 6 hours.
Terbutaline as a treatment for premature labour is an off-label use not approved by the FDA. It is a pregnancy category 'B' medication and is routinely prescribed to stop contractions.
Side Effects
Maternal - tachycardia, nervousness, tremors, headache and possible pulmonary edema. Fetal - tachycardia and hypoglycemia. Terbutaline is preferred over Ritodrine because it has minimal effects on blood pressure.
References
- Pages with script errors
- E number from Wikidata
- ECHA InfoCard ID from Wikidata
- Articles without EBI source
- Chemical pages without ChemSpiderID
- Articles without KEGG source
- Articles without InChI source
- Articles without UNII source
- Articles containing unverified chemical infoboxes
- Beta-adrenergic agonists
- Tocolytics
- Asthma
- Drugs
- Pulmonology