Salbutamol Sulphate/ Bromhexine Hydrochloride

Registered South African indications: 

• Relief of cough associated with bronchospasm (wheezing)

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Patients with cardiac dysrhythmias or tachycardia
• Patients receiving monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI's termination

South African recommendations

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment

Effects on ability to drive and use machines

• None known

Salbutamol Sulphate

Caution in the following patients

• Hyperthyroidism: Administer cautiously in thyrotoxicosis
• Myocardial insufficiency
• QT-interval prolongation
• Hypertension
• Diabetes mellitus: Can increase blood glucose levels; diabetic patients should be cautious
• Severe asthma

Asthma management

• Not the only/main treatment for severe or unstable asthma. Consider oral corticosteroids and/or high-dose inhaled corticosteroids

Dosage and frequency

• Increase only on medical advice. Follow a stepwise programme; monitor clinically and with lung function tests

Deteriorating asthma control

• Increasing need for bronchodilators indicates worsening control. Seek medical advice if short-acting relief becomes less effective

Cardiovascular risks

• Possible myocardial ischaemia; patients with severe heart disease should seek medical advice if symptoms worsen

Hypokalaemia risk

• Monitor plasma-potassium in severe asthma, especially with risk factors like hypoxia, acidosis, or concomitant medication use

Dose limitation

• High doses may increase risk of serious side effects; do not exceed maximum dose

Bromhexine Hydrochloride

Peptic ulceration history

• Use with care in patients with history of peptic ulceration

Cough reflex inhibition

• Risk of bronchospasm and respiratory tract infection with antitussive co-administration

Serious respiratory disease

• Patient should consult doctor if symptoms like high fever or prolonged cough occur

Hypersensitivity reactions

• Should be discontinued if reactions occur and doctor consulted

Severe skin reactions

• Rare cases of Stevens Johnson syndrome and toxic epidermal necrolysis (TEN, Lyell's syndrome); discontinue and seek medical advice if new skin/mucous membrane damage appears

Asthmatic patients

• Exercise caution in asthmatic patients

Impaired renal and hepatic function

• Clearance of bromhexine or its metabolites may be reduced in patients with severe hepatic or renal impairment

Forms avail. in SA and covered in this monograph: liq

South African registered indications and dosages

Relief of cough associated with bronchospasm (wheezing)

Salbutamol Sulphate /Bromhexine Hydrochloride
2.41/4 (mg/5ml)

• Oral (liq): 10ml, 3-4 times a day

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Do not exceed the recommended dose

Paed. forms avail. in SA and covered in this monograph: liq

South African registered indications and dosages

Relief of cough associated with bronchospasm (wheezing)

Salbutamol Sulphate /Bromhexine Hydrochloride
2.41/4 (mg/5ml)

• Younger than 2 years: No specific recommendation provided
• Between 2-6 years: Oral (liq): 2.5-5ml, 3-4 times a day
• Between 6-12 years: Oral (liq): 5ml, 3-4 times a day
• Older than 12 years: See adult dosage

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Do not exceed the recommended dose

Pregnancy 

South African recommendations

• Caution
• Safety in pregnancy has not been established
• Salbutamol/ bromhexine may delay onset of labour
• Small amounts of bromhexine cross the placenta

Breastfeeding

South African recommendations

• Caution
• Safety in lactation has not been established

Fertility

South African recommendations

• No information available

South African recommendations

• Caution; no dose adjustment recommended
  Clearance of bromhexine or its metabolites may be reduced in patients with severe renal impairment

South African recommendations

• Caution; no dose adjustment recommended
  Clearance of bromhexine or its metabolites may be reduced in patients with severe hepatic impairment

South African recommendations

• No dose adjustment recommended
  Suitable for elderly

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Salbutamol Sulphate

Immune System Disorders

Less frequent

• Hypersensitivity reactions including:
  • Angioedema
  • Urticaria
  • Paradoxical bronchospasm
  • Hypotension and collapse

Metabolism and Nutrition Disorders

Less frequent

• Hyperglycaemia
• Hypokalaemia (potentiated by concomitant therapy with corticosteroids, diuretics, or xanthines and by hypoxia and acidosis)

Nervous System Disorders

Frequent

• Tremor
• Headache
• Nervous tension

Less frequent

• Hyperactivity

Frequency unknown

• Hallucinations in children
• Restlessness

Cardiac Disorders

Frequent

• Tachycardia due to increased sympathetic effects on the cardiovascular system
• Palpitations

Less frequent

• Cardiac dysrhythmias including:
  • Atrial fibrillation
  • Supraventricular tachycardia
  • Extrasystoles

Frequency unknown

• Myocardial ischaemia

Vascular Disorders

Less frequent

• Peripheral vasodilation with flushing

Frequency unknown

• Hypotension

Musculoskeletal and Connective Tissue Disorders

Frequent

• Muscle cramps

Less frequent

• Feeling of muscle tension

Bromhexine Hydrochloride

Immune System Disorders

Less frequent

• Hypersensitivity

Frequency unknown

• Anaphylactic reactions up to anaphylactic shock

Gastrointestinal Disorders

Less frequent

• Upper abdominal pain
• Nausea
• Vomiting
• Diarrhoea

Hepato-biliary Disorders

Frequency unknown

• Transient rise in serum aminotransferase values

Respiratory, Thoracic and Mediastinal Dysfunction

Frequency unknown

• Bronchospasm

Skin and Subcutaneous Tissue Disorders

Less frequent

• Skin rashes

Frequency unknown

• Angioedema
• Urticaria
• Pruritus

General Disorders and Administration Site Conditions

Frequency unknown

• Headache
• Dizziness
• Sweating

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Salbutamol Sulphate/ Bromhexine Hydrochloride

• Monoamine oxidase inhibitors (MAOIs)

Salbutamol Sulphate

• Sympathomimetics
• Diuretics
• Corticosteroids
• Xanthines
• Theophylline
• Non-selective beta-blocking agents
• Propranolol

Bromhexine Hydrochloride

• Non-steroidal anti-inflammatory drugs (NSAIDs)
• Diclofenac
• Ibuprofen
• Salicylates
• Erythromycin
• Amoxicillin
• Oxytetracycline

None routine. Specific cases may require

• Lung function tests 
• Serum potassium

Salbutamol Sulphate
Salbutamol is a β2-selective adrenergic bronchodilator. It acts by stimulating β2-adrenergic receptors in the lungs to relax bronchial smooth muscle.

Bromhexine Hydrochloride
Bromhexine hydrochloride reduces the viscosity of non-infected secretions from mucous cells in the respiratory tract, in vitro.

COMBINATION PREPARATIONS

Salbutamol Sulphate /Bromhexine Hydrochloride

Liquid (per 5ml) 2.41mg/4mg

• Duro-tuss (iNova) originator