Bromhexine

Registered South African indications:

• Symptomatic relief of cough, associated with non-purulent excessive sputum production

Contraindications

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Caution

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Severe hepatic impairment
• Elderly
• History of peptic ulceration
• Asthma

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

South African registered indications and dosages

Symptomatic relief of cough, associated with non-purulent excessive sputum production

• Oral (sol): 5-10ml, 3 times daily
• Inhaled (sol): 4ml, twice daily; Admin. inhalation from a respirator

For inhaled solution: Warm the solution to prevent the possible occurrence of an initial irritating cough. If the preparation is used in the presence of bronchospasm, a bronchodilator should first be administered
The solution may be diluted 1:1 with physiological saline solution. Use immediately after dilution in order to avoid precipitation

Treatment duration: Determined on an individual basis depending on the response. Should not be taken for more than 5 days without medical advice

Notify patients of an expected increase in the flow of secretions

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

South African registered indications and dosages

Symptomatic relief of cough, associated with non-purulent excessive sputum production

Oral (sol)

• Younger than 10 years: 2.5-5ml, 3 times daily
• Older than 10 years: See adult dosage

Inhaled (sol)

• Younger than 2 years: 5 drops, twice daily
• Between 2-6 years: 10 drops, twice daily
• Between 6-12 years: 1ml, twice daily
• Older than 12 years: 2ml, twice daily

Bromhexine is not recommended in children below 2 years and must not be given to children under 2 years except under medical supervision

For inhaled solution: Warm the solution to prevent the possible occurrence of an initial irritating cough. If the preparation is used in the presence of bronchospasm, a bronchodilator should first be administered
The solution may be diluted 1:1 with physiological saline solution. Use immediately after dilution in order to avoid precipitation
Administer inhalation from a respirator

Treatment duration: Determined on an individual basis depending on the response. Should not be taken for more than 5 days without medical advice

Notify patients of an expected increase in the flow of secretions

Pregnancy

• Caution
• There is no data on the use of bromhexine in pregnant women. The effects, if any, on the developing foetus are unknown. Until more information is available, bromhexine should only be used during pregnancy if the maternal condition justifies the potential risk to the foetus

Breastfeeding

• Caution
• Available evidence and/or expert consensus is inconclusive or is inadequate for determining infant risk when used during breastfeeding

Renal Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no dose adjustment recommended
  Use is not recommended

Hepatic Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no dose adjustment recommended
  Use is not recommended

Elderly

• Caution; no dose adjustment recommended
  Use is not recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Sweating

Respiratory Disorders

• Bronchospasm

Gastrointestinal Disorders

• Heartburn
• Anorexia
• Nausea and vomiting
• Diarrhoea

Hepatobiliary Disorders

• Transient rise in serum aminotransferase

Skin and Subcutaneous Tissue Disorders

• Skin rash
• Angioedema
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Allergic reaction
• Anaphylaxis

No information available 

None routine

Bromhexine is a derivative of the herbal active ingredient vasicine. It reduces mucus viscosity and activates the ciliated epithelium. 

Solution (per 5ml) 10mg 

• Bisolvon 0.2% (Ingelheim) originator

COMBINATION PREPARATIONS

Bromhexine hydrochloride/ Orciprenaline sulphate

Syrup (per 5ml) 4mg/5mg

• Adco-Linctopent (Adcock)
• Bronkese Compound Linctus (Pharmacare)
• Flemeze Bronchodilatory Syrup (Johnson & Johnson) originator
• Bisolvon Linctus DA (Ingelheim) originator