Fluimucil - instructions for use, dose, side effects, contraindications

Excipients: methyl parahydroxybenzoate 1.0 mg; sodium benzoate 1.5 mg; disodium edetate 1.0 mg; carmellose sodium 4.0 mg; sodium saccharinate 0.4 mg; aromatic raspberry 2.5 mg; sodium hydroxide to pH 6.5; water purified to 1.0 ml.

Solution for oral administration 40 mg / ml:

active substance - acetylcysteine 40.0 mg;

Excipients; methylparahydroxybenzoate 1.8 mg; propyl parahydroxybenzoate 0.2 g; disodium edetate 1.0 mg; carmellose sodium 4.0 mg; sorbitol 70% 120.0 mg; sodium saccharinate 0.4 mg; strawberry flavoring 10.0 mg; flavoring pomegranate 2.0 mg; sodium hydroxide to pH 6.5; water purified to 1.0 ml.

Description:

Oral solution 20 mg / ml: Transparent or slightly opalescent colorless solution with a characteristic smell of raspberries and a weak sulfuric odor.

Solution for ingestion 40 mg / ml: Transparent colorless or slightly yellow solution with a characteristic smell of strawberries and pomegranate and a weak sulfuric odor.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

S.01.X.A.08 Acetylcysteine

R.05.C.B.01 Acetylcysteine

Pharmacodynamics:

Mucolytic agent, dilutes sputum, increases its volume, facilitates the separation of sputum.The effect is related to the ability of free sulfhydryl groups of acetylcysteine to disrupt intra- and intermolecular disulfide bonds of acid mucopolysaccharides of sputum, which leads to depolymerization of mucoproteins and a reduction in the viscosity of sputum. Keeps active with purulent sputum.

Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. Stimulates mucous cells of bronchi, the secret of which lyses fibrin. A similar effect has on the secret formed by inflammatory diseases of the ENT organs. Has an antioxidant effect due to the presence of SH-group, capable of neutralizing electrophilic oxidative toxins. Acetylcysteine easily penetrates the cell, deacetylates to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant, a cytoprotector that captures endogenous and exogenous free radicals and toxins. Acetylcysteine prevents depletion and contributes to an increase in the synthesis of intracellular glutathione,participating in redox processes of cells, thus contributing to the detoxification of harmful substances. This explains the effect of acetylcysteine as an antidote in paracetamol poisoning.

Protects alpha1 antitrypsin (elastase inhibitor) from the inactivating effects of HOC1 - an oxidant produced by myeloperoxidase active phagocytes. It also has an anti-inflammatory effect (by suppressing the formation of free radicals and active oxygen-containing substances responsible for the development of inflammation in the lung tissue).

Pharmacokinetics:

Fluimucil® is well absorbed when taken orally. It is immediately deacetylated to cysteine in the liver. In the blood, a mobile equilibrium of the free and protein-bound plasma of acetylcysteine and its metabolites (cysteine, cystine, diacetylcysteine) is observed. Because of the high "first pass" effect through the liver, the bioavailability of acetylcysteine is about 10%. Acetylcysteine penetrates into the intercellular space, is mainly distributed in the liver, kidneys, lungs, bronchial secretions.

The maximum concentration in plasma is achieved 1-3 hours after oral administration and is 15 mmol / l, the connection with plasma proteins is 50%. T1 / 2 - about 1 hour, with cirrhosis increases to 8 hours. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part is released unchanged through the intestine. Penetrates through the placental barrier.

Indications:

Discharge of sputum: bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, interstitial lung diseases, atelectasis of the lung (due to bronchial blockage of the mucous plug).

Catarrhal and purulent otitis, sinusitis, sinusitis (relief of secretion). Removal of a viscous secretion from the respiratory tract in post-traumatic and postoperative conditions.

Contraindications:

Hypersensitivity to acetylcysteine and other components of the drug, children under 2 years; peptic ulcer of the stomach and duodenum in the stage of exacerbation, lactation period.

Carefully:Peptic ulcer of the stomach and duodenum, varicose veins of the esophagus, hemoptysis, pulmonary hemorrhage,adrenal gland diseases, hepatic and / or renal failure, arterial hypertension.

Pregnancy and lactation:

The drug in pregnancy is prescribed only if the intended benefit for the mother exceeds the potential risk to the fetus.

If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Inside.

The maximum daily dose of acetyl cysteine is 600 mg / day.

Adults: 15 ml of oral solution 40 mg / ml once a day (corresponding to 600 mg of acetylcysteine per day).

For children:

- children from 2 to 5 years: 5 ml of oral solution 20 mg / ml 2 - 3 times a day (corresponding to 200-300 mg of acetylcysteine per day)

- children from 6 to 14 years: 5 ml of oral solution 20 mg / ml 3-4 times a day or 4 ml of oral solution 40 mg / ml 2 times a day (corresponding to 300 - 400 mg of acetylcysteine per day)

- Children older than 14 years: 15 ml of oral solution 40 mg / ml once a day (corresponding to 600 mg of acetylcysteine per day).

Side effects:

In rare cases, nausea, heartburn, a feeling of stomach overflow, vomiting, diarrhea, skin rash, itching, urticaria, nosebleeds, tinnitus are possible.When taking acetylcysteine, cases of development of bronchospasm, collapse, stomatitis, and decrease in platelet aggregation are described.

Overdose:

Acetylcysteine at a dose of 500 mg / kg / day does not cause signs and symptoms of an overdose.

Interaction:

Combined use of acetylcysteine with antitussive drugs can increase sputum stagnation due to suppression of the cough reflex.

When used simultaneously with antibiotics such as tetracyclines (excluding, doxycycline), ampicillin, amphotericin B, possibly their interaction with thiol group of acetylcysteine, which leads to a decrease in the activity of both drugs. Therefore, the interval between the methods of these drugs should be at least 2 hours.

The simultaneous administration of acetylcysteine and nitroglycerin may lead to an increase in the vasodilator and disaggregant action of the latter.

Acetylcysteine eliminates the toxic effects of paracetamol.

Special instructions:Patients with bronchial asthma and obstructive bronchitis acetylcysteine should be administered with caution under the systematic control of bronchial patency.

Fluimucil® oral solution 40 mg / ml contains sorbitol, patients with hereditary intolerance to fructose should not take this medication.

Effect on the ability to drive transp. cf. and fur:

Data confirming the effect of acetylcysteine on the ability to drive vehicles, mechanisms are absent.

Form release / dosage:Solution for oral administration 20 mg / ml.

Packaging:

Solution for ingestion 20 mg / ml: 100 ml, 150 ml, 200 ml solution in a bottle of dark glass type III, sealed with a plastic screw cap with chlorobutyl elastomer coating. For 1 bottle complete with a measuring cap and instructions for use in a pack of cardboard.

Solution for ingestion 40 mg / ml: 150 ml, 200 ml solution in a bottle of dark glass type III, sealed with a plastic screw cap with chlorobutyl elastomeric coating. For 1 bottle complete with a measuring cap and instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date printed on the package.

After the first opening of the vial, the drug should be used within 15 days.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001052

Date of registration:24.10.2011

The owner of the registration certificate:Zambon SpAZambon SpA Italy

Manufacturer: & nbsp

ZAMBON, S.p.A. Italy

Representation: & nbspZAMBON SpA ZAMBON SpA Italy

Information update date: & nbsp24.10.2011

Illustrated instructions

Instructions

Fluimucil® (Fluimucil®)