Terbutaline Sulfate: Brands, Price & Uses in Bangladesh

Terbutaline Sulfate is a selective beta-2 adrenergic agonist bronchodilator. Its uses are classified below by strength of evidence:

FDA-approved / established uses

• Bronchial asthma: Prevention and reversal of bronchospasm in patients with reversible airway obstructive disease (asthma).
• Chronic bronchitis and emphysema: Relief of bronchospasm associated with chronic obstructive pulmonary conditions where a reversible bronchospastic component is present.

Locally marketed dosage forms

• In Bangladesh, Terbutaline Sulfate is also available as an oral syrup and as a nebulizer (respirator) solution used for acute relief of bronchospasm under medical supervision, in addition to tablet and injection forms.

Well-known off-label use (not an FDA-approved indication)

• Tocolysis (uterine relaxation) in preterm labor: Terbutaline Sulfate has long been used off-label, in hospital settings only, to acutely relax uterine smooth muscle and delay preterm labor for a short period. Per the boxed warning, Terbutaline Sulfate must NOT be used for prolonged tocolysis (beyond 48-72 hours) or for outpatient/oral maintenance tocolysis, due to the risk of serious maternal cardiac events and death.

Bronchospasm / asthma - oral tablets (patients 12 years and older)

Acute bronchospasm - subcutaneous injection

0.25 mg injected subcutaneously into the lateral deltoid area. If significant clinical improvement does not occur within 15-30 minutes, a second dose of 0.25 mg may be given. Total dose should not exceed 0.5 mg within a 4-hour period. Requires medical supervision.

Acute bronchospasm - nebulizer (respirator) solution

Where available (as in Bangladesh), the 5 mg/2 mL nebulizer solution is administered via a nebulizer as directed by the physician, typically diluted with normal saline, for acute relief of bronchospasm; frequency and dose should follow the prescriber's instructions and product labeling.

Tocolysis (off-label; specialist/hospital use only)

Acute, short-term tocolysis with Terbutaline Sulfate (subcutaneous or intravenous, under continuous maternal and fetal monitoring) has been used historically to arrest preterm labor. Per the boxed warning, use must not exceed 48-72 hours, and Terbutaline Sulfate must never be used as an oral or outpatient maintenance tocolytic. This use requires an obstetric specialist in a hospital setting.

Administration

Oral tablets and syrup may be taken with or without food. Injection is for subcutaneous use only, administered by or under the supervision of a healthcare professional. Nebulizer solution is for inhalation via a nebulizer device only and must not be swallowed or injected.

Terbutaline Sulfate commonly causes expected pharmacologic effects related to beta-adrenergic stimulation; some effects are more serious and require prompt medical attention.

Common

• Tremor (fine skeletal muscle tremor, especially of the hands) - a very common, dose-related effect.
• Nervousness, restlessness, anxiety.
• Tachycardia (fast heart rate), palpitations.
• Headache, dizziness.
• Sweating, muscle cramps.
• Nausea, dry mouth.

Less common / serious

• Significant tachyarrhythmias or other cardiac arrhythmias, chest pain/angina - see Precautions and Warnings.
• Hypokalemia (low blood potassium) - see Precautions and Warnings.
• Hyperglycemia (raised blood sugar).
• Paradoxical bronchospasm (worsening of wheeze immediately after a dose) - rare, but requires discontinuation and alternative therapy if it occurs.
• With tocolytic use: maternal pulmonary edema and serious maternal cardiac events (see boxed warning under Contraindications and Pregnancy and Lactation).