Fluifort

Carbocysteine lysine monohydrate.

100 ml of FLUIFORT Syrup contains Carbocysteine Lysine Salt Monohydrate, equivalent to Carbocysteine Lysine Salt 9 g.

Pharmacology: Therapeutic Properties: FLUIFORT (Carbocysteine Lysine Salt Monohydrate) is a muco-regulator which exerts a specific metabolic action on the serous and mucous cells of the respiratory epithelium. It has no effect on the mucus itself.
The main demonstrated effect of FLUIFORT is the increase of sialomucin contents in the mucus, restoring the proper sialo- to fucomucin proportion. This directly results in restored physiological mucus viscosity, elasticity and adhesion, and indirectly in restoring mucus hydration and mucociliary clearance.
The salification of Carbocysteine with Lysine results in greater solubility and biological availability, which allows to decrease the number of daily administrations while maintaining the wanted effects, and with an increase of the post-dosing effect typical of metabolic agents.
Once the metabolic mechanism is activated - that is, after one or a few days of administration, depending on the specific condition of the patient - it remains in effect even in the absence of drug administration (post-dosing carry-over effect).
Pharmacokinetics: Carbocysteine Lysine Salt Monohydrate has a greater water solubility and hence improved bio-availability. Therefore it is possible to administer FLUIFORT once daily in adults and twice daily in children.
The active ingredient is rapidly and completely absorbed after oral administration (plasma half-life 1.5 hour). It is mainly excreted via the urinary route; 30-60% is excreted unmodified; the remainder in the form of various metabolites. Bio-availability studies have shown that up to 17.5% of the administered dose can be found in the bronchial secretions.

FLUIFORT is a muco-regulator having mucolytic and fluidifying effect.
FLUIFORT is effective in conditions with either hyperviscous or hypoviscous mucus.
FLUIFORT is indicated for the treatment of acute and chronic disorders of the upper and lower respiratory tract, such as chronic obstructive pulmonary disorders (COPD) and the prevention of acute exacerbations associated with chronic obstructive bronchitis.
FLUIFORT is also indicated for the treatment of ear, nose and throat (ENT) disorders, such as pharyngitis, tonsillitis, laryngitis, rhinitis, rhinopharyngitis, otitis, sinusitis.

Adults: 30 ml (equivalent to Carbocysteine Lysine Salt 2.7 g) once daily or 15 ml twice daily.
Children: Not recommended in neonates and infants.
1 to 5 years of age: 2.5 ml twice daily.
Over 5 years of age: 5 ml twice daily.
Administration in children should be done under careful medical monitoring.
The dosage may be increased to administration three times daily (t.i.d.) in both children and adults according to medical prescription.

In case of overdosage with enhancement of side effects, gastric lavage may be useful, followed by additional treatment under medical supervision. No specific antidote exists.

History of ascertained hypersensitivity to the product; gastric or duodenal ulcer.

When treating diabetic patients or in case of low-calorie diets it should be considered that FLUIFORT Syrup contains sucrose.

Although the product is neither teratogenic nor mutagenic, and did not appear to have negative effects on the reproductive function in animal studies, it is not recommended for use during the first trimester of pregnancy. As it is not known whether carbocysteine is excreted in milk, its use during lactation is not advised.

The clinical trials and pharmacovigilance initiatives conducted after commercialisation show that FLUIFORT is well tolerated.
Occasionally, gastrointestinal symptoms such as gastralgia, nausea, diarrhoea, mild to moderate and transient dizziness, and very rarely skin rashes have been reported. These side effects disappear upon reduction of the dosage.

No incompatibilities are known between FLUIFORT and the most commonly used medications for the treatment of disorders of the upper and lower airways.

Store in a cool, dry place (25°C).

Cough & Cold Preparations

R05CB03 - carbocisteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

NDD