BISOLVON

What it is

Bromhexine hydrochloride is a mucolytic. It has been shown to enhance the transport of mucus by reducing its viscosity and by activating the ciliated epithelium (mucociliary clearance). Bisolvon is available in multiple formulations. Bisolvon Chesty Oral Liquid contains 4 mg/5mL of bromhexine hydrochloride, Bisolvon Chesty Kids Oral Liquid contains 4 mg/5mL of bromhexine hydrochloride, Bisolvon Chesty Forte Oral Liquid contains 8 mg/5mL of bromhexine hydrochloride, and Bisolvon Chesty Forte Tablets contain 8 mg per tablet of bromhexine hydrochloride.

Approved indications

— Use as a mucolytic to break down mucus and help clear the chest in conditions accompanied by excessive mucus secretions, such as in the common cold, influenza, infections of the respiratory tract or in other conditions where excess mucus is produced.

Dosing overview

For Bisolvon Chesty Oral Liquid and Bisolvon Chesty Kids Oral Liquid, adults and children 12 years and over take 10 mL (8 mg) three times a day when necessary, which may be increased to 20 mL (16 mg) three times a day for the first seven days. Children 6–11 years take 10 mL (8 mg) three times a day when necessary. For Bisolvon Chesty Forte Oral Liquid, adults and children 12 years and over take 5 mL (8 mg) three times a day when necessary, which may be increased to 10 mL (16 mg) three times a day for the first seven days. Children 6–11 years take 5 mL (8 mg) three times a day when necessary. For Bisolvon Chesty Forte Tablets, adults and children 12 years and over take one tablet (8 mg) three times a day when necessary, which may be increased to two tablets (16 mg) three times a day for the first seven days. Children 6–11 years take one tablet (8 mg) three times a day when necessary.

Key safety warnings

Very rare reports of severe skin lesions such as Stevens Johnson Syndrome and toxic epidermal necrolysis (TEN) in temporal association with the administration of bromhexine have been reported, mostly explained by the patient's underlying disease or concomitant medication. During the early phase of Stevens-Johnson Syndrome or TEN, a patient may first experience non-specific influenza-like prodromes such as fever, aching body, rhinitis, cough and sore throat, which may lead to symptomatic treatment with cough and cold medication. If new skin or mucosal lesions occur, medical advice should be sought immediately and treatment with bromhexine should be discontinued as a precaution. Bisolvon Chesty Oral Liquid and Bisolvon Chesty Kids Oral Liquid contain at least 2.5 g of maltitol in each 5 mL and up to 2.4 g of sorbitol per maximum recommended daily dose of 60 mL. Products containing maltitol and sorbitol may have a laxative effect or cause diarrhoea in some people, which is more likely if several products containing maltitol, sorbitol or related substances are consumed simultaneously. Patients with rare hereditary fructose intolerance should not take these products. Bisolvon Chesty Forte Tablets contain 444 mg of lactose per maximum recommended daily dose. Patients with rare hereditary galactose intolerance or galactosaemia should not take this product.

Contraindications

Bisolvon Chesty should not be used in patients known to be hypersensitive to bromhexine or any other excipients of the formulation.

Regulatory history

Bisolvon Chesty Forte Tablets (AUST R 125375) were first approved on 25 January 2006. Bisolvon Chesty Forte Oral Liquid (AUST R 133204) were first approved on 23 November 2006. Bisolvon Chesty Oral Liquid (AUST R 133244) were first approved on 27 November 2006. Bisolvon Chesty Kids Oral Liquid (AUST R 182576) were first approved on 28 April 2011.