Finished product reference

Bromhexine Hydrochloride

Solution · Oral · 4 mg/5mL · 120 mL

List code
52436
Pharmacologic class
Mucolytic

What it is and how it works

Bromhexine, a synthetic derivative of vasicine, depolymerises mucopolysaccharide fibres and increases the production of serous bronchial secretions, reducing sputum viscosity and improving mucociliary clearance. Its active metabolite is ambroxol.

Indications

Acute and chronic bronchopulmonary diseases associated with abnormal or viscous mucus secretion and impaired mucus transport.

Dosage and administration (summary)

Oral: adults 8–16 mg three times daily. Injection: typically 4–8 mg two to three times daily by slow intravenous injection or infusion, or intramuscularly, according to the product.

Contraindications

Hypersensitivity to bromhexine; rare hereditary conditions incompatible with excipients (e.g. galactose intolerance for tablets).

Warnings and precautions

Severe cutaneous adverse reactions (erythema multiforme, Stevens–Johnson syndrome, toxic epidermal necrolysis, AGEP) have been reported; discontinue at the first sign of rash or mucosal lesions. Use with caution in patients with a history of peptic ulcer, severe hepatic or renal impairment, and impaired cough reflex (risk of secretion accumulation). Gastrointestinal upset is common.

Pregnancy

Avoid in pregnancy, especially in the first trimester, as a precaution.

Storage and supply

Store below 25 °C, protected from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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