Salbutamol

Registered South African indications:

• Bronchospasm associated with bronchial asthma
• Emphysema
• Chronic obstructive bronchitis

Contraindications

South African recommendations

• Hypersensitivity to salbutamol or to any of the other excipients
• Concurrent use with beta-blocking medicines
• Hyperthyroidism
• Cardiac disease
• Prevention of premature labour associated with toxaemia of pregnancy or ante partum haemorrhage
• Threatened abortion during first and second trimesters of pregnancy
• Concurrent use with monoamine oxidase inhibitors (MAOIs)

Recommendations in other jurisdictions

• Hypersensitivity to the active substance or any of the excipients listed
• Non-IV formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Elderly
• Underlying severe cardiac disease
• Severe or unstable asthma
• Ischaemic cardiac disease
• Arrhythmias
• Severe cardiac failure
• Thyrotoxicosis
• Hypokalaemia
• Diabetes Mellitus
• Ketoacidosis
• Loss of efficacy
• Controlled sodium diet

Forms avail. in SA and covered in this monograph: syr, tab

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Bronchospasm associated with bronchial asthma
Emphysema
Chronic obstructive bronchitis

• Oral (syr): 2-4mg, 6-8hrly; Increase up to 8mg/dose if required
• Oral (tab): 2-4mg, 6-8hrly

Indications and dosages registered in other jurisdictions

Asthma
Bronchospasm
- Relief of bronchospasm in bronchial asthma of all types
Reversible airways obstruction

• Oral (syr): Minimum initial dose: 2mg, 8hrly; Usual effective dose: 4mg, 6-8hrly; Increase up to 8mg, 6-8hrly if required; Max: 32mg/24hrs

Paed. forms avail. in SA and covered in this monograph: syr, tab

Paed. dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Bronchospasm associated with bronchial asthma
Emphysema
Chronic obstructive bronchitis

Oral (syr)

• Younger than 2 years: Not established for use
• Between 2-6 years: 1-2mg, 6-8hrly
• Older than 6 years: 2mg, 6-8hrly

Oral (tab)

• Younger than 2 years: Not established for use
• Between 2-6 years: 1-2mg, 6-8hrly
• Between 6-12 years: 2mg, 6-8hrly
• Older than 12 years: See adult dosage

Indications and dosages registered in other jurisdictions

Asthma
Bronchospasm
- Relief of bronchospasm in bronchial asthma of all types
Reversible airways obstruction

Oral (syr)

• Younger than 2 years: Not established for use
• Between 2-6 years: Minimum initial dose: 1mg, 8hrly; Increase to 2mg, 6-8hrly if required 
• Between 6-12 years: Minimum initial dose: 2mg, 8hrly; Increase to 2mg, 6hrly if required
• Older than 12 years: Minimum initial dose: 2mg, 8hrly; Increase to 4mg, 6-8hrly if required

Salbutamol is well tolerated by children so that, if necessary, these doses may be cautiously increased to the maximum dose

Pregnancy

• Caution
• Administration of salbutamol during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus
• There is little published evidence of salbutamol's safety 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

Breastfeeding

• Caution
• 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

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; dose adjustment recommended
• Oral (syr, tab): 2mg, 6-8hrly; Max: 8mg, 8hrly

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

•  Prohibited - In-and-out of competition

Central Nervous System Disorders

• Tremor
• Headache
• Hyperactivity
• Fear
• Anxiety
• Restlessness
• Insomnia
• Tremor
• Confusion
• Irritability
• Psychosis
• Dizziness
• Fainting

Cardiovascular Disorders

• Hypertension
• Cerebral haemorrhage
• Tachycardia
• Palpitations
• Cardiac arrhythmias
• Atrial fibrillation
• Extrasystoles
• Myocardial ischaemia
• Peripheral vasodilatation
• Angina
• Hypotension
• Flushing

Respiratory Disorders

• Bronchospasm
• Pulmonary oedema
• Dyspnoea

Gastrointestinal Disorders

• Hypersalivation

Genitourinary Disorders

• Urinary retention

Endocrine and Metabolic Disorders

• Hypokalaemia
• Altered glucose metabolism
• Decreased appetite

Musculoskeletal Disorders

• Muscle cramps
• Muscle tension
• Weakness

Skin and Subcutaneous Tissue Disorders

• Angiooedema
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions

• Non-selective beta blockers
• Propranolol
• Monoamine oxidase inhibitors
• Corticosteroids
• Halogenated anaesthetics
• Potassium-depleting agents
• Cardiac glycosides
• Quinidine
• Tricyclic antidepressants

None routine. Specific cases may require

• Vital signs
• Electrolytes
• Blood glucose
• Serum potassium
• Lung function

• Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma
  requires regular medical assessment including lung function testing as patients are at risk of severe attacks and even
  death
• Patients should be warned that if either the usual relief with salbutamol preparations is diminished or the usual duration
  of action reduced, they should not increase the dose or its frequency of administration, but should seek medical advice
• Increasing use of bronchodilators to relieve symptoms indicates deterioration of asthma control. In this situation patients should be reassessed and consideration given to the need for increased anti-inflammatory therapy

Salbutamol is a selective beta-2 agonist which acts on the beta-2 adrenoceptors of the bronchial muscle. At therapeutic doses it provides short-acting bronchodilation (4-6 hours) in reversible airways obstruction. Stimulation results in relaxation of bronchial smooth muscle in the lungs, increased vital capacity, decreased residual volume and reduced airway resistance. Salbutamol has little or no effect on cardiac receptors.

Tablets 2mg

• Venteze- 2 (Pharmacare)

Tablets 4mg

• Venteze- 4 (Pharmacare)

Syrup (per 5ml) 2mg

• Asthavent syrup (Cipla)
• Vari-Salbutamol (LeBasi)
• Venteze syrup (Pharmacare)
• Ventolin (GSK) originator

Also available in the following forms: Solution, injection, accuhaler, inhaler and nebulising solution.

COMBINATION PREPARATIONS

Salbutamol/ Bromohexine hydrochloride

Syrup (per 5ml) 2.41mg/4mg

• Duro-Tuss Linctus (iNova) originator