Terbutaline (oral)

Terbutaline (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

Disclaimer

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Black Box Warning

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

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)

There is limited information regarding Terbutaline (oral) FDA-Labeled Indications and Dosage (Adult) in the drug label.

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)

There is limited information regarding Terbutaline (oral) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

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

There is limited information regarding Terbutaline (oral) Contraindications in the drug label.

Warnings

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

There is limited information regarding Terbutaline (oral) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Terbutaline (oral) Clinical Trials Experience in the drug label.

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.

Terbutaline (oral)

Clinical data
Pregnancy category	B
Routes of administration	SQ, Oral, Inhaled
ATC code	R03AC03 (WHO) R03CC03 (WHO)
Legal status
Legal status	UK: POM (Prescription only)
Pharmacokinetic data
Metabolism	GI tract (oral), liver; CYP450: unknown
Elimination half-life	urine 90% (60% unchanged), bile/faeces; Half-life: 3-4h
Identifiers
IUPAC name 5-(1-hydroxy-2-tert-butylamino-ethyl)benzene-1,3-diol
CAS Number	23031-25-6
PubChem CID	5403
DrugBank	APRD00589
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C12H19NO3
Molar mass	225.284 g/mol

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Clinical Trials
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]

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

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