Clinical medicine profile
Terbutaline 1.25mg/Bromhexine 4mg/Ammonium Chloride 50mg/Menthol 0.75mg/5mL
Beta-2 adrenergic agonist (bronchodilator)
- Route
- INHALATION / ORAL / NEB / IV (rare)
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
WARNING: TOCOLYSIS 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. [see Contraindications, Tocolysis . ]
Contraindications
- CONTRAINDICATIONS 1.
- Tocolysis Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis. [see Boxed Warning: Tocolysis . ] 2.
- Hypersensitivity Terbutaline sulfate is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.
Precautions
- WARNINGS 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 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, 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 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, 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.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
DOSAGE AND ADMINISTRATION Adults The usual oral dose of terbutaline sulfate 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. Children Terbutaline sulfate 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.
Pediatric Use Terbutaline sulfate is not recommended for patients under the age of 12 years because of insufficient clinical data to establish safety and effectiveness (see DOSAGE AND ADMINISTRATION ).
Low for inhaled; monitor electrolytes if continuous nebs.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Low clinical concern for inhaled therapy.
Use, effects & interactions
Indications
INDICATIONS AND USAGE Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
Adverse effects
- ADVERSE REACTIONS Adverse reactions observed with terbutaline sulfate 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 to 15 mg) Terbutaline N=199 Reaction % Nervous System Nervousness 35.0 Tremor 15.0 Somnolence 5.5 Dizziness 3.5 Anxiety 1.0 Insomnia 1.5 Cardiovascular Palpitations 5.0 Tachycardia 3.5 Extrasystoles ventricular 1.5 Vasodilations 1.0 Digestive Nausea 3.0 Dry mouth 1.5 Body as a Whole Headache 7.5 Asthenia 2.0 Skin and Appendages Sweating 1.0 The following adverse effects each occurred in fewer than 1% of patients: hallucinations, rash, paresthesia, hypertonia, (muscle cramps), vomiting.
- There have been rare reports of elevations in liver enzymes and of hypersensitivity vasculitis.
Drug interactions
Open multi-drug checker ↗- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Terbutaline 1.25mg/Bromhexine 4mg/Ammonium Chloride 50mg/Menthol 0.75mg/5mL.
- Confirm combination SmPC for exact dosing.
Mechanism & disposition
Stimulate airway smooth muscle beta-2 receptors, increasing cAMP and causing bronchodilation.
Read complete mechanism
Stimulate airway smooth muscle beta-2 receptors, increasing cAMP and causing bronchodilation. Also improve mucociliary clearance and may stabilise mast cells. SABA for rescue; LABA for maintenance with ICS.
Minutes (SABA)
3–6 h SABA; 12 h LABA
INHALATION / ORAL / NEB / IV (rare)
half-life of terbutaline was approximately 3.4 hours. In comparison to oral dosing, subcutaneous administration of 0.5 mg of terbutaline sulfate to 17 healthy, adult, male subjects resulted in a mean (SD) peak plasma terbutaline concentration of 9.6 (3.6) ng/mL, which was observe...
of terbutaline was approximately 3.4 hours. In comparison to oral dosing, subcutaneous administration of 0.5 mg of terbutaline sulfate to 17 healthy, adult, male subjects resulted in a mean (SD) peak plasma terbutaline concentration of 9.6 (3.6) ng/mL, which was observed at a med...
Pregnancy, lactation & diet
Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies of terbutaline sulfate in pregnant women. Published animal studies show that rat offspring exhibit alterations in behavior and brain development, including decreased cellular proliferation and differentiation when dams were treated subcutaneously with terbutaline during the late stage of pregnancy and lactation period. Terbutaline exposures in rat dams were approximately 6.5 times the common human dose in adults of 15 mg/day, on a mg/m 2 basis. 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 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. [See Boxed Warning: Tocolysis and Contraindications, Tocolysis . ] In animal embryofetal developmental studies, no teratogenic effects were observed in offspring when pregnant rats and rabbits received terbutaline sulfate at oral doses up to 50 mg/kg/day, approximately 32 and 65 times, respectively, the maximum recommended daily oral dose for adults, on a mg/m 2 basis. Terbutaline sulfate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers It is not known whether this drug is excreted in human milk. Therefore, terbutaline sulfate should be used during nursing only if the potential benefit justifies the possible risk to the newborn.
Brands & loaded prices
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Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.