FLUIBRON ® Ambroxol

FLUIBRON ® is a drug based on Ambroxol hydrochloride

THERAPEUTIC GROUP: Mucolytics

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications FLUIBRON ® Ambroxol

FLUIBRON ® is indicated in the symptomatic treatment of bronchopulmonary pathological manifestations characterized by hypersecretion of thick and viscous mucus.

Mode of action FLUIBRON ® Ambroxol

FLUIBRON ® is a drug based on Ambroxol, an active ingredient counted among the mucolytics, but actually equipped with numerous other biological activities.

Taken orally this active principle is rapidly and almost completely absorbed by the enteric mucosa, reaching in a few minutes the plasma peak, and subsequently concentrating mainly at the pulmonary level where it performs its therapeutic action.

Following a half-life estimated between 7 and 12 hours and a hepatic metabolism supported by cytochromial enzymes including CYP3A4, Ambroxol is rapidly excreted in the urine as glucoronate metabolites.

Its therapeutic activity, effective in the course of respiratory diseases, is due to the multiple biological activities that can be synthesized in the antioxidant and anti-inflammatory action, important in protecting the respiratory mucosa from the oxidative and inflammatory insult present in these conditions, and in the balancing action both on ciliary activity, and on the biochemical composition of mucus.

All this translates into greater effectiveness in eliminating sputum, which appears to be more fluid and less viscous.

Studies carried out and clinical efficacy

THE AMBROXOLO IN THE PREVENTION OF PULMONARY EVENTS IN PREMATURATIONS

Zhongguo Dang Dai Er Ke Za Zhi. 2010 Nov; 12 (11): 858-63.

Work demonstrating that the early use of Ambroxol can reduce the risk of respiratory distress syndrome and the relative risk of lung infection in premature infants.

AMBROXOLO REDUCES POST-OPERATIVE PULMONARY COMPLICATIONS

Neurocrit Care. 2012 Apr; 16 (2): 267-72. doi: 10.1007 / s12028-011-9642-4.

Study that demonstrates how the administration of high doses of Ambroxol can be effective in reducing postoperative pulmonary complications, improving oxygenation capacity, therefore the relative clinical picture.

AMBROXOL IN THE PROTECTION OF INFECTIONS FROM PSEUDOMONAS AEURIGINOSA

Arch Med Sci. 2011 Jun; 7 (3): 405-13. doi: 10.5114 / aoms.2011.23403. Epub 2011 Jul 11.

An interesting experimental study conducted on rats, which demonstrates how Ambroxol can be effective in protecting the body from Pseudomonas aeuriginosa infection, improving the chemical composition of bronchopulmonary secretions.

Method of use and dosage

FLUIBRON ®

Ambroxol hydrochloride 30 mg tablets;

Ambroxol hydrochloride 30 mg oral solution powder;

Syrup 15 mg of Ambroxol hydrochloride per 5 ml of product;

Solution to be atomized at 0.75% of Ambroxol hydrochloride.

The choice of the dosage and formulation of FLUIBRON ® to be used is the responsibility of the physician after having carefully evaluated the patient's general health conditions and the severity of his clinical picture.

As a general rule it is advisable to subdivide the entire dosage into 3 different administrations, possibly spaced from each other by about 8 hours, and preferably taken after meals.

In adults the daily dose should not exceed 90 mg of Ambroxol hydrochloride.

Warnings FLUIBRON ® Ambroxol

FLUIBRON ® therapy should be preceded by a careful medical examination, aimed at assessing the prescriptive appropriateness and the possible presence of conditions incompatible with the use of Ambroxol, such as for example severe liver and kidney diseases or peptic ulcer.

Therefore, in these patients it would be advisable to proceed with great caution in administering FLUIBRON ®.

Rarely, the use of mucolytics has been followed by severe hypersensitivity reactions to the drug, which can however be traced to the presence of underlying pathological conditions, for which, however, treatment must be suspended.

PREGNANCY AND BREASTFEEDING

The aforementioned contraindications to the use of FLUIBRON ® also extend to pregnancy and the subsequent period of breastfeeding, given the ability of Ambroxol to easily permeate both the placental barrier and the breast filter, thus exposing itself to the fetus and infant in concentrations pharmacologically relevant.

Interactions

Although they are not clinically relevant interactions, it should be remembered that Ambroxol therapy could lead to increased concentrations of certain antibiotics in bronchopulmonary secretions and saliva.

Contraindications FLUIBRON ® Ambroxol

The use of FLUIBRON ® is contraindicated in patients who are hypersensitive to the active substance or to one of its excipients, in patients with gastro-duodenal ulcer, in patients suffering from severe liver and kidney diseases and in small patients under the age of 2 years.