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Bronchodilator Pregnancy: UK SPC 4.6, verbatim: 'Administration of medicinal products during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. As with the majority of medicinal products, there is little published evidence of the safety of salbutamol in the early stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the fetus at very high dose levels.' Note also the UK contraindication that 'Non-IV formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion' (SPC 4.3). US label 8.1: 'There are no randomized clinical studies of use of albuterol sulfate during pregnancy. Available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. There are, however, clinical considerations in pregnant women with asthma. Administration of albuterol sulfate HFA to mice and rabbits during the period of organogenesis revealed evidence of adverse developmental outcomes (cleft palate in mice, delayed ossification in rabbits) at less than the maximum recommended human daily inhaled dose.' A pregnancy exposure registry for asthma medications is available (MotherToBaby). BREAST-FEEDING (UK SPC 4.6): 'As salbutamol is probably secreted in breast milk, its use in nursing mothers requires careful consideration. It is not known whether salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.' FERTILITY: 'There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals.'

Salbutamol (Albuterol)

Brand names: Ventolin, Salamol, Bricanyl

Salbutamol (albuterol) is a short-acting beta-2 agonist (SABA) used as a reliever inhaler in asthma and COPD and for acute bronchospasm.

Adult dose

Dose: Nebulised (UK SPC, adults including the elderly): 2.5 mg to 5 mg salbutamol up to four times a day. Metered-dose inhaler (US label; each actuation delivers 108 mcg albuterol sulfate, equivalent to 90 mcg albuterol base, from the mouthpiece): 2 inhalations every 4 to 6 hours - 'For some patients, 1 inhalation every 4 hours may be sufficient.' For prevention of exercise-induced bronchospasm: 2 inhalations 15 to 30 minutes before exercise.
Route: Inhalation by two routes. NEBULISED (UK SPC 4.2): 'Salbutamol nebuliser solutions are for inhalation use only, to be breathed in through the mouth, under the direction of a physician, using a suitable nebuliser. The solution should not be injected or swallowed.' METERED-DOSE INHALER (US label 2.3): 'Albuterol Sulfate HFA should be administered by the orally inhaled route only.' SCOPE NOTE: the intravenous route listed on this page is not dosed in either fetched label, so no IV figure is given.
Frequency: Nebulised: up to four times a day. Metered-dose inhaler: every 4 to 6 hours for bronchospasm; a single dose 15 to 30 minutes before exercise for prevention of exercise-induced bronchospasm.
Max: Nebulised route, adults: up to 40 mg per day. UK SPC 4.2 verbatim: 'Up to 40 mg per day can be given under strict medical supervision in hospital.' Metered-dose inhaler: no numeric daily ceiling is stated - the US label caps frequency instead (section 2.1: 'More frequent administration or a greater number of inhalations is not recommended') and warns in section 5.5 'Excessive use may be fatal. Do not exceed recommended dose.'
SCOPE: covers the page's primary routes - nebulised and metered-dose inhalation for bronchospasm - from the two fetched labels; the intravenous route is NOT covered and no IV dose is published. VERBATIM UK SPC 4.2 (nebuliser solution): 'Adults (including the elderly): 2.5 mg to 5 mg salbutamol up to four times a day. Up to 40 mg per day can be given under strict medical supervision in hospital.' DILUTION: 'Salbutamol nebulisers solutions are intended to be used undiluted. However, if prolonged delivery time (more than 10 minutes) is required, the solution may be diluted with sterile normal saline.' The product this dose comes from is 'Salbutamol 1mg/ml nebuliser solution' - check the strength of the nebules actually in use before drawing a volume, as other strengths are marketed. VERBATIM US LABEL (metered-dose inhaler), section 2.1: 'Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a greater number of inhalations is not recommended.' Section 2.2: 'Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 15 to 30 minutes before exercise.' Section 3 pins the strength that makes an inhalation count meaningful: 'Inhalation aerosol: 108 mcg of albuterol sulfate (90 mcg of albuterol base) from the mouthpiece per actuation.' PRIMING (US label 2.3): 'Prime Albuterol Sulfate HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime Albuterol Sulfate HFA, release 4 sprays into the air away from the face, shaking well before each spray.' CLEANING: 'At least once a week, wash the actuator with warm water and let it air-dry completely.' OVERUSE (UK SPC 4.4): 'Overuse of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and mortality. Patients who take more than twice a week “as needed” salbutamol, not counting prophylactic use prior to exercise, should be re-evaluated.' 'Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma.' No acute-severe-asthma, back-to-back nebulisation or hyperkalaemia regimen appears in either fetched label - those uses are not sourced here.

Paediatric dose

Route: Nebulised inhalation (UK SPC) or oral inhalation from a metered-dose aerosol (US label)
Frequency: Nebulised: up to four times a day. Metered-dose inhaler: every 4 to 6 hours
AGE-BANDED, NOT PER-KILOGRAM - both labels give flat doses by age, so no per-kg value is published and the weight calculator is deliberately left inactive. VERBATIM UK SPC 4.2 (nebuliser solution): 'Children aged 12 years and over: Dose as per adult population. Children aged 4-11 years: 2.5 mg to 5 mg up to four times a day. Other pharmaceutical forms may be more appropriate for administration in children under 4 years old.' INFANTS: 'Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxia may occur supplemental oxygen therapy should be considered.' VERBATIM US LABEL (metered-dose inhaler, section 2.1): 'Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation repeated every 4 to 6 hours', each actuation delivering 108 mcg albuterol sulfate (90 mcg albuterol base); section 8.4: 'The safety and effectiveness of albuterol sulfate HFA in pediatric patients younger than 4 years have not been established.' HOME NEBULISER WARNINGS (UK SPC 4.2, verbatim): 'Private purchase of nebuliser devices for use at home to deliver rescue therapy for the acute treatment of asthma in children and adolescents is not recommended.' 'Only specialists in respiratory medicine should initiate and clinically manage use of nebulisers and associated nebulised medicines at home for acute treatment of asthma in children and adolescents.' 'Children should be trained in the correct use of their device to deliver rescue therapy and use should be supervised by a responsible adult.' 'Urgent medical assistance should be sought if worsening asthma symptoms are not relieved by rescue medicines, even if there is short-term recovery following use of prescribed nebulised medication.' No paediatric maximum daily dose is stated separately - the 40 mg per day figure appears under the adult heading only, so it is not repeated here. Verify every paediatric figure against a children's formulary and current national asthma guidance before use.

Dose adjustments

Renal

Not stated - neither fetched label gives a renal dose adjustment for salbutamol by any inhaled route. The US label's only related statement is in section 8.5 (Geriatric Use): 'In general, 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, and of concomitant disease or other drug therapy.'

Hepatic

Not stated - neither fetched label gives a hepatic dose adjustment. The same US label section 8.5 sentence quoted under renal adjustment is the only mention of hepatic function.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

For oral inhalation only. ( 2 ) Treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation every 4 to 6 hours. For some patients, 1 inhalation every 4 hours may be sufficient. ( 2.1 ) Prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation 15 to 30 minutes before exercise. ( 2.2 ) Priming information: Prime Albuterol Sulfate HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime Albuterol Sulfate HFA, release 4 sprays into the air away from the face, shaking …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2024-12-31. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • Hypersensitivity to salbutamol or to any of the excipients (UK SPC 4.3). US label section 4: 'Albuterol Sulfate HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients'
  • UK SPC 4.3, verbatim: 'Non-IV formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion'
  • Not a contraindication but a route restriction (UK SPC 4.4): 'Salbutamol nebuliser solution must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed'
  • Caution, not contraindication (UK SPC 4.4): 'Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis'; and 'Salbutamol nebuliser solutions should be used with care in patients known to have received large doses of other sympathomimetic medicinal' products [sentence truncated at the source-fetch limit]
  • Caution, not contraindication (US label section 5.4/5.7): 'Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular or convulsive disorders'

Side effects

  • Common (UK SPC 4.8): tremor, headache, tachycardia
  • Uncommon (UK SPC 4.8): palpitations, mouth and throat irritation, muscle cramps
  • Rare (UK SPC 4.8): hypokalaemia - 'Potentially serious hypokalaemia may result from beta 2 agonist therapy'; sleep disturbances; peripheral vasodilatation
  • Very rare (UK SPC 4.8): hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse; insomnia; hyperactivity; cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles; paradoxical bronchospasm
  • Not known (UK SPC 4.8): lactic acidosis; myocardial ischaemia (reported spontaneously in post-marketing data)
  • Most common adverse reactions with the metered-dose inhaler, incidence at or above 3% (US label section 6): throat irritation, viral respiratory infections, upper respiratory inflammation, cough, and musculoskeletal pain
  • Life-threatening paradoxical bronchospasm (US label 5.1): 'If paradoxical bronchospasm occurs following dosing with Albuterol Sulfate HFA, it should be discontinued immediately and alternative therapy should be instituted... paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister'
  • Hypokalaemia and changes in blood glucose (US label 5.7, 5.8)

Monitoring

  • Serum potassium in acute severe asthma (UK SPC 4.4, verbatim): 'Potentially serious hypokalaemia has been reported in patients taking beta-2-agonist therapy. Particular caution is advised in patients with acute severe asthma as hypokalaemia may be potentiated in hypoxic patients and those treated with xanthine derivatives, steroids, diuretics. In these groups of patients serum potassium levels should be monitored'
  • Lung function and regular clinical review (UK SPC 4.4): 'Severe asthma requires regular medical assessment, including lung-function testing, as patients are at risk of severe attacks and even death'
  • Escalating reliever use as a marker of losing control (UK SPC 4.4): 'Increasing use of bronchodilators, in particular short-acting inhaled beta 2-agonists to relieve symptoms indicates deterioration of asthma control and patients should be warned to seek medical advice as soon as possible.' 'The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective or more inhalations than usual are required'
  • Reassess patients using reliever more than twice a week (UK SPC 4.4) for 'daytime symptoms, night-time awakening, and activity limitation due to asthma... as these patients are at risk for overuse of salbutamol'
  • US label 5.2: 'Need for more doses of Albuterol Sulfate HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment'
  • Do not let the reliever displace anti-inflammatory treatment (UK SPC 4.4): 'Patients who are prescribed regular anti-inflammatory therapy (e.g., inhaled corticosteroids) should be advised to continue taking their anti-inflammatory medication even when symptoms decrease'; US label 5.3: 'Albuterol Sulfate HFA is not a substitute for corticosteroids'

Clinical monograph

How it works

It stimulates beta-2 adrenoceptors in airway smooth muscle, producing rapid bronchodilation.

Prescribing in practice

  • It relieves symptoms but does not treat the underlying inflammation — frequent or escalating use is a marker of poor control and a prompt to review and step up preventer therapy.
  • Tremor and palpitations are common; high or nebulised doses can cause hypokalaemia and tachycardia.
  • In acute severe asthma, high-dose use needs monitoring (including potassium).

Monitoring

Track reliever frequency as a marker of control; in acute high-dose use monitor heart rate and potassium.

Counselling the patient

  • This is your reliever — if you need it often (e.g. three or more times a week), get a review.
  • Check your inhaler technique and carry it for emergencies.

Evidence & guidelines

The standard reliever in asthma and COPD (BTS/SIGN, NICE); overuse is a recognised risk marker.

Reference: BTS/SIGN Asthma 2023; NICE; 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.