Salbutamol

Registered South African indications:

• Severe bronchospasm
• Status asthmaticus (sol)

Contraindications

International manufacturer recommendations

• Hypersensitivity to the active ingredient or any of its excipients
• Use to arrest uncomplicated premature labour or threatened abortion (Non-IV salbutamol formulations)

South African manufacturer recommendations

• Hypersensitivity to the active ingredient or any of its excipients
• Managing premature labour or threatened abortion

Cautions

International manufacturer recommendations

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Only or main treatment in patients with severe or unstable asthma
• Increase in dosage or frequency
• Underlying severe heart disease
  - Ischaemic heart disease
  - Arrhythmia
  - Severe heart failure
• Thyrotoxicosis
• Hypokalaemia
• Acute severe asthma
• Diabetic mellitus
• Hypoxia
• Coadministration with other sympathomimetic medicines
• Coadministration with xanthine derivatives, corticosteroids, diuretics
• Coadministration of nebulised salbutamol with nebulised anticholinergics

South African manufacturer recommendations

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Thyrotoxicosis
• Cardiovascular disorders
  - Ischaemic heart disease
  - Angina pectoris
  - Tachycardia
  - Dysrhythmias
  - Hypertension
• Increase in dosage or frequency
  - Excessive dosing
• Acute severe asthma
• Hypokalaemia
• Hypoxia
• Presence of acidosis
• Coadministration with other sympathomimetic medicines
• Coadministration with xanthine derivatives, corticosteroids, diuretics
• Coadministration with beta-blockers
• Coadministration with other medicines that cause hypokalaemia and cardiac dysrhythmias

Forms avail. in SA and covered in this monograph: neb, sol

Dosages below include:

• International manufacturer recommendations
• South African manufacturer recommendations

International manufacturer recommendations

Management of chronic bronchospasm unresponsive to conventional therapy
Acute severe asthma

• Inhaled (neb): 2.5-5mg, 6hrly; Max: 40mg/24hrs
• Intermittent admin: Undiluted: Inhaled (sol): 10mg (2ml), as a nebulised soln over 3-5min; For dose up to 10mg, nebulise until aerosol generation ceases
• Intermittent admin: Diluted: Inhaled (sol): 2.5-5mg, as a nebulised soln until aerosol generation ceases (approx. 10min)
• Continuous admin: Inhaled (sol): Dilute to 50-100μg/ml (1-2ml sol made up to 100ml with diluent); Admin at a rate of 1-2mg per 60min

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Inhaled (neb): Up to 40mg/day can be given under strict medical supervision in hospital

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Inhaled (sol): See additional prescribing points for dilution directions

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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

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South African manufacturer recommendations

Severe bronchospasm (Additional agent required)
- With oxygen from an oxygen cylinder to which a flow gauge and appropriate face mask is attached

• Inhaled (neb): 2.5-5mg, up to 6hrly

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If prolonged delivery time is desired, (>10min) dilution with sterile normal saline may be required

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Status asthmaticus (Additional agent may be required)
- With intermittent positive-pressure ventilation, usually with oxygen enriched air
Severe bronchospasm (Additional agent may be required)
- Where intermittent positive-pressure ventilation is necessary, e.g. acute exacerbations of chronic bronchitis, severe bronchial asthma, bronchiectasis and lung infection

• Undiluted: Inhaled (sol): 10mg (2ml), as a nebulised soln over 3-5min, up to 6hrly
• Diluted: Inhaled (sol): 2.5-5mg, as a nebulised soln until aerosol generation ceases (approx. 10min), up to 6hrly

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Inhaled (sol): See additional prescribing points for dilution directions

Paed. forms avail. in SA and covered in this monograph: neb, sol

Paed. dosages below include:

• International manufacturer recommendations
• South African manufacturer recommendations

International manufacturer recommendations

Management of chronic bronchospasm unresponsive to conventional therapy
Acute severe asthma

Younger than 4 years

• Not recommended for use

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Other pharmaceutical forms may be more appropriate for administration in children under 4 years old

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Between 4-11 years

• Inhaled (neb): 2.5-5mg, up to 6hrly
• Intermittent admin: Diluted: Inhaled (sol): 2.5-5mg, as a nebulised soln until aerosol generation ceases (approx. 10min), up to 6hrly

12 years and older

• See adult dosage

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Infants under 18 months old: Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxia may occur supplemental oxygen therapy should be considered

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Salbutamol nebuliser solution is designed to be used undiluted. However, if prolonged delivery time (>10min) is required, then dilution with sodium chloride solution (0.9%w/v) for nebulisation or sterile sodium chloride injection (normal saline) may be required

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Inhaled (sol): See additional prescribing points for dilution directions

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South African manufacturer recommendations

Severe bronchospasm (Additional agent required)
- With oxygen from an oxygen cylinder to which a flow gauge and appropriate face mask is attached

Younger than 20 months

• No information available

Between 20 months - 6 years

• Inhaled (neb): 2.5mg, up to 6hrly

Between 6-12 years

• Inhaled (neb): 2.5-5mg, up to 6hrly

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The same mode of administration is applicable to children (a paediatric face mask must be used)

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No paediatric dosing information available in SA manufacturer recommendations for inhaled (sol)

Pregnancy

International manufacturer recommendations

• Caution
• Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus
• As with the majority of drugs, 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 foetus at very high dose levels

South African manufacturer recommendations

• Caution
• Safety in pregnant women has not been established

Breastfeeding

International manufacturer recommendations

• Caution 
• As salbutamol is probably secreted in breast milk, its use in breastfeeding 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 

South African manufacturer recommendations

• Caution 
• Safety in breastfeeding women has not been established

Fertility

International manufacturer recommendations

• There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals

South African manufacturer recommendations

• No information available

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

International manufacturer recommendations

• No dose adjustment recommended 

South African manufacturer recommendation

• Caution; no information available

Porphyria Information

• Not porphyrinogenic (NP) 

Drugs in Sport

• Permitted - No warnings 

Central Nervous System Disorders

• Tremor
• Headache
• Hyperactivity

Cardiovascular Disorders

• Tachycardia
• Palpitations
• Cardiac arrhythmia
  - Atrial fibrillation
  - Supraventricular tachycardia
  - Extrasystoles
• Myocardial ischemia
• Peripheral vasodilation

Respiratory Disorders

• Paradoxical bronchospasm

Gastrointestinal Disorders

• Mouth and throat irritation

Endocrine and Metabolic Disorders

• Hypokalaemia (potentially serious hypokalaemia may result from beta₂-agonist therapy)
• Lactic acidosis

Musculoskeletal Disorders

• Muscle cramps

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
  - Angioedema
  - Urticaria
  - Bronchospasm
  - Hypotension
  - Collapse

• Non-selective beta blocking agents
• Propanolol

• Pulmonary function tests
  - Forced expiratory volume (FEV1)
  - Peak flow
• Blood pressure
• Heart rate
• Serum glucose
• Serum potassium
• Serum creatinine

Specific cases may require

• Serum lactate

Additional observations

• CNS stimulation
• Asthma symptoms
• Arterial or capillary blood gases

Administration directions

Nebulising solution

• Salbutamol nebuliser solution must only be used by inhalation, to be breathed in through the mouth and must not be injected or swallowed
• Salbutamol nebuliser solution is designed to be used undiluted. However, for a prolonged delivery time (more than 10min) dilution with sodium chloride solution (0.9% w/v) for nebulisation or sterile sodium chloride injection (normal saline) may be necessary

Respirator solution

• Salbutamol respirator solution is 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
• Salbutamol respirator solution may be administered intermittently or continuously
• The nebulised solution may be inhaled through a face mask, “T” piece or via an endotracheal tube. Intermittent positive pressure ventilation (IPPV) may be used, but is rarely necessary
• When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air
• As many nebulisers operate on a continuous flow basis, it is likely that nebulised medicine will be released into the local environment. Salbutamol respirator solution should therefore be administered in a well-ventilated room, particularly in hospitals when several patients may be using nebulisers at the same time

Intermittent administration

Adults

• Salbutamol respirator solution 0.5ml (2.5mg of salbutamol) should be diluted to a final volume of 2ml with sterile normal saline. This may be increased to 1ml (5mg of salbutamol) diluted to a final volume of 2.5ml. The resulting solution is inhaled from a suitably driven nebuliser until aerosol generation ceases. Using a correctly matched nebuliser and driving source this should take about 10 minutes
• Salbutamol respirator solution may be used undiluted for intermittent administration. For this, 2ml of salbutamol respirator solution (10mg of salbutamol) is placed in the nebuliser and the patient allowed to inhale the nebulised solution until bronchodilation is achieved. This usually takes 3-5 minutes
• Some adult patients may require higher doses of salbutamol up to 10mg, in which case nebulisation of the undiluted solution may continue until aerosol generation ceases

Paediatric population

• The same mode of administration for intermittent administration is also applicable to children
• The minimum starting dosage for children under the age of 12 years is 0.5ml (2.5mg of salbutamol) diluted to 2-2.5 ml with sterile normal saline
• Some children (over the age of 18 months) may, however, require higher doses of salbutamol up to 5mg. Intermittent treatment may be repeated up to four times daily

Continuous administration

• Salbutamol respirator solution is diluted with sterile normal saline to contain 50-100micrograms of salbutamol per ml, (1-2ml solution made up to 100ml with diluent). The diluted solution is administered as an aerosol by a suitably driven nebuliser. The usual rate of administration is 1-2mg per hour

Salbutamol is a selective β₂-adrenoceptor agonist. At therapeutic doses it acts on the β₂-adrenoceptors of bronchial muscle. Salbutamol provides short-acting (4-6hr) bronchodilation with a fast onset (within 5mins) in reversible airways obstruction

Nebulising solution (per 2.5ml) 2.5mg 

• Asthavent Respules (Cipla Medpro)
• Ventolin Nebules (GSK) originator
• Salbu-Neb 2.5 (Arrow)

Nebulising solution (per 2.5ml) 5.0mg

• Ventolin Solution (GSK) originator
• Salbu-Neb 5 (Arrow)

Solution (per ml) 5mg

• Venteze Respirator Solution (Pharmacare) originator
• Ventolin Respirator Solution (GSK) originator

Also available in the following forms: Inhaler, accuhaler, syrup, tablet and injection.

COMBINATION PREPARATIONS

Salbutamol/ Ipratropium bromide anhydrous

Solution U.D.V (per 2.5ml) 2.5mg/0.5mg

• Combivent U.D.V (Ingelheim) originator

Solution (per 2.5ml) 2.5mg/0.5mg

• Sabax Combined (Adcock) 

Solution U.D.V (per 2.5ml) 3mg/0.5mg

• Co-iprasal Solution (Arrow)

Inhaler 100μg/20μg

• Duolin Hfa (Cipla)