Bromhexine

Product Name: Bromhexine

Physical & Chemical Properties:

Pharmacology

Pharmacokinetics:
Bromhexine hydrochloride is rapidly absorbed from the gastrointestinal tract and undergoes extensive first-pass metabolism in the liver. Its oral bioavailability is stated to be only about 20%. It is widely distributed to body tissues and is highly bound to plasma proteins. About 85 to 90% of a dose is excreted in the urine mainly as metabolites. It has a terminal elimination half-life of up to about 12 hours. Bromhexine crosses the blood brain barrier and small amounts cross the placenta.

Pharmacodynamics/Mechanism of action:
Bromhexine is an oral mucolytic agent with a low level of associated toxicity. Bromhexine acts on the mucus at the formative stages in the glands, within the mucus-secreting cells. Bromhexine disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces a less viscous mucus, which is easier to expectorate.

Indications:
This section must contain the indications of the product as specified in the ARTG. If the indications are not specified in the ARTG (e.g. for a non-validated grandfathered product), the indications must be as specified on the product label.

Contraindications:
Bromhexine is contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to bromhexine hydrochloride (or any of the other ingredients in the product).

Precautions:
Since mucolytics may disrupt the gastric mucosal barrier, bromhexine should be used with caution in patients with a history of gastric ulceration.

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

Use in pregnancy:
Category A: Bromhexine has been taken by a large number of pregnant women and women of child bearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.

Lactation:
It is not known whether bromhexine is excreted in breast milk or whether it has a harmful effect on the breastfeeding infant. Therefore, it is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.

Interaction with other medicines:
There are no known significant interactions with other medicines.

Adverse reactions:
Gastrointestinal side effects may occur occasionally with bromhexine and a transient rise in serum aminotransferase values has been reported. Other reported adverse effects include headache, vertigo (dizziness), sweating and allergic reactions.