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Short-acting β2-agonist (SABA) Pregnancy: Section 4.6, bronchospasm indication, verbatim: 'Although no teratogenic effects have been observed in animals or in patients, Bricanyl should only be administered with caution during the first trimester of pregnancy.' BREAST-FEEDING: 'Terbutaline is secreted into breast milk, but any effects on the infant are unlikely at therapeutic doses. Transient hypoglycaemia has been reported in newborn preterm infants after maternal beta 2-agonist treatment.' PREMATURE LABOUR: 'Bricanyl solution for injection is contraindicated for the treatment of premature labour before the gestational age of week 22.' US labelling adds that oral terbutaline sulfate is not approved and should not be used for acute or maintenance tocolysis, and that serious adverse reactions including death have been reported after administration of terbutaline sulfate to pregnant women (maternal increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia; increased fetal heart rate and neonatal hypoglycemia may occur).

Terbutaline sulfate

Brand names: Bricanyl

Terbutaline sulfate is the salt form of the short-acting beta-2 agonist terbutaline, used as a bronchodilator for reversible airways obstruction in asthma and related conditions. It is formulated for inhalation and for subcutaneous or intravenous use.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Bronchodilation, when a rapid therapeutic response is required: 0.25-0.5 mg, up to four times a day.
Route: Subcutaneous, intramuscular or slow intravenous bolus - 'The preferred routes will usually be subcutaneous or intramuscular. When given as an i.v. bolus the injection must be made slowly noting patient response.' Source product is Bricanyl Injection 0.5 mg/ml, so 0.25-0.5 mg equates to 0.5-1 ml OF THAT STRENGTH.
Frequency: Up to four times a day
Verbatim section 4.2, For bronchodilation: 'When a rapid therapeutic response is required, Bricanyl can be administered by any of the three standard parenteral routes: subcutaneous, intramuscular, or i.v. bolus ... Adults : 0.5 - 1 ml (0.25 - 0.5 mg) up to four times a day.' 'The dosage should be individualised.' ELDERLY: 'Dosage as for adults.' BRONCHODILATOR INFUSION, same indication (verbatim): 'By infusion : 3 - 5 ml (1.5 - 2.5 mg) in 500 ml 5% dextrose, saline or dextrose/saline given by continuous intravenous infusion at a rate of 10 - 20 drops (0.5 - 1 ml) per minute for 8 to 10 hours. A corresponding reduction in dosage should be made for children.' INHALED ROUTE NOT COVERED: this page also lists an inhaled dose; the fetched source is an injection licence and contains no inhaled posology, so no inhaled figure is published here. TOCOLYSIS DELIBERATELY NOT REPRODUCED: the same SPC contains a regimen 'In the short term management of uncomplicated premature labour' - a specialist obstetric indication, initiated only by obstetricians/physicians experienced in tocolytic agents, in facilities equipped for continuous maternal and foetal monitoring, with ECG monitoring throughout, a stated dilution, a maternal heart-rate ceiling and a 48-hour duration limit. Those numbers are inseparable from those safeguards, so they are not carried onto this respiratory page - read them from the SPC or from the obstetric record. The US label additionally states: 'Oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis.' maxDose IS DELIBERATELY EMPTY: section 4.2 states no maximum for the adult parenteral bronchodilator dose. The only 'maximum' cues anywhere in the section belong to something else - the paediatric 0.3 mg ceiling (see paedDose), the tocolysis infusion RATE ceiling, and a maternal HEART-RATE ceiling - and none of them may cap this dose. US CROSS-CHECK, DIFFERENT ROUTE (oral tablets, US labelling, not the dose above): '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 ... The total dose within 24 hours should not exceed 15 mg.'

Paediatric dose

Dose: 0.01 mg/kg
Route: Subcutaneous, intramuscular or slow intravenous bolus (Bricanyl Injection 0.5 mg/ml)
Frequency: Not restated for children in section 4.2; the adult bronchodilator regimen in the same paragraph is 'up to four times a day'
Max: Maximum 0.3 mg total
Concentration: 0.5 mg/ml
Bronchodilation only. Verbatim section 4.2, Paediatric population: 'Children 2 - 15 years : 0.01 mg/kg body weight to a maximum of 0.3 mg total.' The SPC then prints its own worked table, which this record reproduces so the calculator can be checked against it: under 3 years, average weight 10 kg (22 lb) - 0.1 mg = 0.2 ml; 3 years, 15 kg (33 lb) - 0.15 mg = 0.3 ml; 6 years, 20 kg (44 lb) - 0.2 mg = 0.4 ml; 8 years, 25 kg (55 lb) - 0.25 mg = 0.5 ml; 10 years and over, 30 kg and over (66 lb+) - 0.3 mg = 0.6 ml. concentration = 0.5 because the source product is Bricanyl Injection 0.5 mg/ml (0.5 mg per millilitre); every volume above is specific to that strength. For the bronchodilator infusion the SPC says only 'A corresponding reduction in dosage should be made for children' and gives no paediatric infusion figure. NO PAEDIATRIC TOCOLYTIC USE - the tocolysis regimen in this SPC is a maternal regimen. US labelling (oral tablets, different route): '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.' Verify any paediatric dose against a children's formulary before administration.

Dose adjustments

Renal

No renal dose adjustment is given anywhere in the fetched sections - section 4.2 has no renal-impairment posology and the truncated section 4.4 contains none in the retrieved text. The US label states only that 'dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function'.

Hepatic

No hepatic dose adjustment is given anywhere in the fetched sections. The US label notes only the same general caution for elderly patients with decreased hepatic, renal or cardiac function. Rare reports of elevations in liver enzymes appear in the US adverse-reaction list.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Paediatric weight-based calculator

Bronchodilation only. Verbatim section 4.2, Paediatric population: 'Children 2 - 15 years : 0.01 mg/kg body weight to a maximum of 0.3 mg total.' The SPC then prints its own worked table, which this record reproduces so the calculator can be checked against it: under 3 years, average weight 10 kg (22 lb) - 0.1 mg = 0.2 ml; 3 years, 15 kg (33 lb) - 0.15 mg = 0.3 ml; 6 years, 20 kg (44 lb) - 0.2 mg = 0.4 ml; 8 years, 25 kg (55 lb) - 0.25 mg = 0.5 ml; 10 years and over, 30 kg and over (66 lb+) - 0.3 mg = 0.6 ml. concentration = 0.5 because the source product is Bricanyl Injection 0.5 mg/ml (0.5 mg per millilitre); every volume above is specific to that strength. For the bronchodilator infusion the SPC says only 'A corresponding reduction in dosage should be made for children' and gives no paediatric infusion figure. NO PAEDIATRIC TOCOLYTIC USE - the tocolysis regimen in this SPC is a maternal regimen. US labelling (oral tablets, different route): '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.' Verify any paediatric dose against a children's formulary before administration.

Verify in a children's formulary

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • US labelling: contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of the drug product
  • Section 4.4 warning, not a section 4.3 contraindication: 'Due to the positive inotropic effect of the beta 2-agonists, these drugs should not be used in patients with hypertrophic cardiomyopathy'
  • US labelling: oral terbutaline sulfate has not been approved and should not be used for acute or maintenance tocolysis
  • The remaining section 4.3 contraindications in this SPC are specific to the treatment of premature labour (a different indication from this page) - among them gestational age under 22 weeks, pre-existing ischaemic heart disease or significant risk factors for it, threatened abortion in the first and second trimester, any condition in which prolongation of pregnancy is hazardous, intrauterine foetal death, pulmonary hypertension and left ventricular outflow tract obstruction such as aortic stenosis

Side effects

  • Very common: tremor; headache
  • Common: tachycardia; palpitations; hypokalaemia; muscle spasms
  • Rare: lactic acidosis - reported with high therapeutic doses of parenteral and nebulised short-acting beta-agonist therapy, mainly in patients being treated for an acute asthma exacerbation
  • Frequency not known: hypersensitivity reactions including angioedema, bronchospasm, hypotension and collapse
  • Frequency not known: arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia and extrasystoles; myocardial ischaemia
  • Frequency not known: peripheral vasodilation; sleep disorder and behavioural disturbances such as agitation and restlessness
  • Frequency not known: paradoxical bronchospasm - 'In rare cases, through unspecified mechanisms, paradoxical bronchospasm may occur, with wheezing immediately after inhalation. This should be immediately treated with a rapid-onset bronchodilator. Bricanyl therapy should be discontinued'
  • Frequency not known: nausea; mouth and throat irritation; urticaria; rash
  • Section 4.8 is truncated at the source-fetch limit and its preterm-labour table was only partly retrieved - this list must not be treated as complete

Monitoring

  • Serum potassium - 'Potentially serious hypokalaemia may result from beta 2-agonist therapy. Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia ... It is recommended that serum potassium levels are monitored in such situations'
  • Blood glucose - 'Due to the hyperglycaemic effects of beta 2-agonists, additional blood glucose controls are recommended initially in diabetic patients'
  • Continuing effectiveness of the dose regimen - 'If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice', and consideration given to additional therapy including increased dosages of anti-inflammatory medication
  • Consider lactic acidosis as a contributing factor in patients not adequately responding to acute therapy
  • Cardiac symptoms - patients with underlying severe heart disease (ischaemic heart disease, arrhythmia or severe heart failure) should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease; dyspnoea and chest pain may be of either respiratory or cardiac origin
  • Caution in thyrotoxicosis (as for all beta 2-agonists)

Clinical monograph

How it works

The drug selectively activates beta-2 adrenoceptors on bronchial smooth muscle, increasing cyclic AMP and relaxing the airways to relieve bronchospasm.

Prescribing in practice

  • Rising reliever requirement indicates poor asthma control and should prompt urgent review of preventer treatment rather than dose escalation alone.
  • Caution applies in ischaemic heart disease, arrhythmias, hyperthyroidism and diabetes, with awareness of hypokalaemia compounded by steroids, xanthines and diuretics.
  • Parenteral and high nebulised doses may produce tremor, tachycardia and hypokalaemia, warranting monitoring in acute severe asthma.

Monitoring

Monitor symptom control, reliever use and, with high-dose or parenteral therapy, serum potassium and heart rate.

Counselling the patient

  • Use only for symptom relief and seek help promptly if breathlessness is not controlled.
  • Tremor and palpitations can occur shortly after a dose and typically pass.

Evidence & guidelines

As a long-established SABA salt, terbutaline sulfate has well-characterised bronchodilator efficacy supporting its reliever role in UK practice.

Reference: BTS/SIGN; MHRA; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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