Composition

 active ingredient carbocisteine

Paediatric syrup: each 5 ml contains 100 mg.

 excipients:

Paediatric syrup: methyl paraben, propylparaben, glycerin, sorbitol 70%,caramel colour, tutti frutti flavour,sodium hydroxide, purified water.

therapeutic indications: 

carbocisteine ( active ingredient ) is a mucolytic agent for the therapy of respiratory tract disorders characterized by excessive viscous mucus including chronic obstructive Airways disease.

 posology and method of administration

adults Including the elderly

•  dosage is raised upon an  initial daily dosage of 2250 mg carbocisteine in divided doses, Reducing to 1500 mg  daily in divided doses when a satisfactory response is obtained e.g. 15 ml three times daily reducing to 10 ml three times a day.

children:

• The normal daily dosage is 20 mg/kg body weight in divided doses.
• It is recommended that this is achieved with Carbolase pediatric syrup.
• children 2-5 years: 2.5 -5 ml four times daily.
• children 5-12 years: 10 ml three times daily.
• pediatric syrup and adult syrup are for oral administration.

Contraindications:

pediatric syrup:

• Carbolase  paediatric is contraindicated for use in children less than 2 years age.(Postmarketing reports of it’s  side effects  showed   that the use of all mucolytic  as carbocisteine  May  worsen the expected Respiratory manifestations  and the side effects outweigh the benefits of its usage for children less than  two years old).
• hypersensitivity to the active substance or to any of the excipients..

  special warning and precautions for use

 a patient  with rare hereditary  problems of fructose intolerance, glucose-galactose malabsorption should not take this medicine. 

Interactions with other medicinal products and other forms of interaction

none stated

  Effects on  ability to drive and use machines

The medicinal product has no or negligible influence on the ability to drive and use machines

 pregnancy  and  lactation

•  Although tests  in  mammalian species  have revealed no  teratogenic effects,  Carbolase  is not recommended during the first trimester of pregnancy.
•  use in lactation:  effects not known.

Undesired effects

•  immune system disorders: there have been reports of anaphylactic  reactions in fixed drug eruption.
• Skin and subcutaneous tissue disorders:  there have been reports  of skin rashes and allergic skin eruption.
• Gastrointestinal disorders: there  have been rare reports of gastrointestinal bleeding during treatment with Carbolase.

 overdose

•  gastric lavage may be  beneficial, followed by observation.
• Gastrointestinal Is the most likely symptom of Carbolase  overdose..

pharmacological reports

Pharmacodynamic properties 

• carbocisteine  (S-carboxymethyl L-cystine)  has been shown in normal bronchitic  animal models  to  fake the nature and  amount of mucus glycoprotein  which is secreted by  the respiratory tract.
• An increase  in the acid neutral glycoprotein ratio of the mucus and a transformation of serous cells to mucus cells is known to be the initial response to irritation and will normally be followed by hypersecretion.
• The administration of  carbocisteine to animals exposed to  irritants indicates  that the glycoprotein  that is  secreted  remains  normal;  administration after exposure indicates that return to normal is accelerated.
•  Studies in humans have demonstrated that  carbocisteine  reduces goblet cell hyperplasia.
• Carbocisteine can therefore be  admistreated to have a role in the management of disorders characterized by abnormal mucus. 

pharmacokinetic properties 

• Carbocisteine Is rapidly absorbed from the GI tract.
• Bioavailability being low ( less than 10% of the taken dose). TC max in blood and in mucous membrane  1.5 – 2 hours, therapeutic concentration is preserved in blood within 8 hours. It is longer of all detained in blood, liver and middle ear. High concentration of the drug is accumulated in bronchial secretions (17.5% of taken dose). It is metabolized in the liver (having the effect of “first passage” through the liver). It is excreted by kidneys (60-90% – unchanged, the rest – in the form of metabolites). T ½ is 2-3.5 hours. Full excretion occurs in 3 days.

Shelf life

• Carbolase syrup (pediatric and adults): 36 months.
• store at a temperature not exceeding 30 ℃.
• Manufactured by : AMRIYA , Egypt.

Product information

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