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Respiratory Drug Data - A-Z (English)

Drug Class Description

Carbocisteine ATC code: RO5CB03

Generic Name

Carbocisteine

Drug Description

Capsules: Carbocisteine 375 mg Syrup: Each 5 ml of oral solution contains 250 mg of Carbocisteine. Also contains 2 g of sucrose, 70 mg of ethanol (1.6% v/v), 7.5 mg of methyl parahydroxybenzoate (E218) and 33 mg of sodium (1.4 mmol). Paediatric Syrup: Carbocisteine 125 mg/5 ml.

Presentation

Capsules: Yellow, size 1 capsules marked “MUCODYNE 375” in black and containing a white to off-white powder or friable plug. Syrup: A clear amber coloured syrupy liquid Paediatric Syrup: A rosy brown to red brown mobile liquid Paediatric Syrup: Carbocisteine 125 mg/5 ml.

Indications

Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease.

Adult Dosage

Capsules and syrup:

Adults including the elderly:

Dosage is based upon an initial daily dosage of 2250mg carbocisteine in divided doses, reducing to 1500mg daily in divided doses when a satisfactory response is obtained e.g. two capsules three times a day reducing to one capsule four times a day, for normal syrup 15ml tds. reducing to 10ml tds.

 

Child Dosage

The capsule and syrup formulations are not recommended for children. The normal daily dosage is 20mg/kg bodyweight in divided doses. It is recommended that this is achieved with Mucodyne Paediatric Syrup.

Mucodyne capsules and Syrup are for oral administration.

Paediatric Syrup:

Children 5 - 12 years: 10 ml three times daily.

Children 2 - 5 years: 2.5 - 5 ml four times daily.

Mucodyne Paediatric Syrup is for oral administration.

Elderly Dosage

Adults including the elderly:

Dosage is based upon an initial daily dosage of 2250mg carbocisteine in divided doses, reducing to 1500mg daily in divided doses when a satisfactory response is obtained e.g. two capsules three times a day reducing to one capsule four times a day, for normal syrup 15ml tds. reducing to 10ml tds.

Contra Indications

Capsules and Syrup:

Hypersensitivity to the active substance(s) or to any of the excipients.

Use in patients with active peptic ulceration.

Paediatric syrup:

Mucodyne paediatric is contraindicated for use in children less than 2 years age.

Hypersensitivity to the active substance or to any of the excipients.

Special Precautions

Capsules:

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

Syrup and Paediatric syrup:

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Interactions

None stated.

Adverse Reactions

Capsules, Syrup and Paediatric Syrup:

Immune System Disorders

There have been reports of anaphylactic reactions and fixed drug eruption.

Skin and subcutaneous tissue disorders

There have been reports of skin rashes and allergic skin eruptions.

Capsules and Syrup:

Gastrointestinal disorders

There have been rare reports of gastrointestinal bleeding occurring during treatment with Mucodyne.

Owner

sanofi-aventis

Drug Availability

(POM)

Updated

04 November 2011

Drug Languages: en it fr de es no nl pt se

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Mucodyne Capsules, Syrup and Paediatric Syrup