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Fluimucil 200 mg 20 pcs. granules for the preparation of solution for oral administration

pharmachologic effect

Expectorant mucolytic agent.

Composition and release form Fluimucil 200 mg 20 pcs. granules for the preparation of solution for oral administration

Granules - 1 pack:

active substance: acetylcysteine - 200 mg;
excipients: aspartame; beta-carotene; orange flavor; sorbitol

In sachets of 1 g; There are 20 sachets in a cardboard pack.

Description of the dosage form

The granules are white-yellow in color with orange inclusions with a characteristic orange, slightly sulfurous odor.

Directions for use and doses

Inside. The granules are dissolved in 1/3 cup of water.

Pharmacodynamics

A mucolytic agent that thins sputum, increases its volume, and facilitates the separation of sputum.

The action is associated with the ability of free sulfhydryl groups of acetylcysteine to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolymerization of mucoproteins and a decrease in sputum viscosity.

In addition, it reduces induced hyperplasia of mucoid cells, enhances the production of surfactants by stimulating type II pneumocytes, and stimulates mucociliary activity, which leads to improved mucociliary clearance.

Remains active against purulent sputum, mucopurulent and mucous 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 the bronchi, the secretion of which is lysed by fibrin. It has a similar effect on the secretions formed during inflammatory diseases of the ENT organs.

It has an antioxidant effect due to the presence of an SH group that can neutralize electrophilic oxidative toxins.

Acetylcysteine easily penetrates into the cell and is deacetylated to L-cysteine, from which intracellular glutathione is synthesized.

Glutathione is a highly reactive tripeptide, a powerful antioxidant, cytoprotector that traps endogenous and exogenous free radicals and toxins.

Acetylcysteine prevents exhaustion and helps increase the synthesis of intracellular glutathione, which is involved in the redox processes of cells, thus promoting the detoxification of harmful substances. This explains the effect of acetylcysteine as an antidote for paracetamol poisoning.

Paracetamol exerts its cytotoxic effect through the progressive depletion of glutathione. The main role of acetylcysteine is to maintain proper levels of glutathione concentration, thereby providing protection to cells.

Protects alpha 1-antitrypsin (elastase inhibitor) from the inactivating effects of HOC1, an oxidizing agent produced by myeloperoxidase of active phagocytes.

It also has an anti-inflammatory effect (by suppressing the formation of free radicals and reactive oxygen-containing substances responsible for the development of inflammation in the lung tissue).

Pharmacokinetics

Absorption

Fluimucil® is well absorbed when taken orally. It is immediately deacetylated to cysteine in the liver. In the blood, a mobile equilibrium of free acetylcysteine and its metabolites (cysteine, cystine, diacetylcysteine) is observed, free and bound to plasma proteins. Due to the strong first-pass effect through the liver, the bioavailability of acetylcysteine is about 10%.

Distribution

Acetylcysteine is distributed both unchanged (20%) and in the form of metabolites (active) (80%) penetrates into the intercellular space, mainly distributed in the liver, kidneys, lungs, and bronchial secretions.

The volume of distribution of acetylcysteine varies from 0.33 to 0.47 l/kg, the maximum concentration in plasma is reached 1-3 hours after oral administration and is 15 mmol/l, binding to plasma proteins is 50% 4 hours after administration and decreases up to 20% after 12 hours. Penetrates through the placental barrier.

Metabolism

After ingestion, acetylcysteine is quickly and extensively metabolized in the intestinal walls to form a pharmacologically active metabolite - cysteine, as well as diacetylcystine, cystine.

Removal

It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part is excreted unchanged through the intestines. The half-life (T1/2) of acetylcysteine from plasma is about 1 hour; if liver function is impaired, the value increases to 8 hours.

Indications for use Fluimucil 200 mg 20 pcs. granules for the preparation of solution for oral administration

Impaired sputum discharge: bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, emphysema, laryngotracheitis, interstitial lung diseases, pulmonary atelectasis (due to blockage of the bronchi by mucus plug). Catarrhal and purulent otitis media, sinusitis, sinusitis (facilitation of secretion discharge).

Removal of viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.

Contraindications

Hypersensitivity to acetylcysteine, peptic ulcer of the stomach and duodenum in the acute stage, children under 2 years of age, lactation period.

Use in children under 2 years of age is possible only if there are vital indications and under strict medical supervision.

Carefully:

Peptic ulcer of the stomach and duodenum, varicose veins of the esophagus, hemoptysis, pulmonary hemorrhage, phenylketonuria, bronchial asthma, adrenal diseases, liver and/or kidney failure, arterial hypertension.

Application Fluimucil 200 mg 20 pcs. granules for the preparation of a solution for oral administration during pregnancy and lactation

Data on the use of acetylcysteine during pregnancy and breastfeeding are limited, therefore the use of the drug during pregnancy is contraindicated.

If it is necessary to use the drug, breastfeeding should be stopped.

special instructions

For patients with bronchial asthma and obstructive bronchitis, acetylcysteine should be prescribed with caution under systematic monitoring of bronchial patency.

The drug contains aspartame, so its use in patients with phenylketonuria is not recommended.

The presence of a slight sulfuric odor is the characteristic odor of the active substance.

When dissolving acetylcysteine, you must use glass containers and avoid contact with metal and rubber surfaces.

Overdose

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

Side effects Fluimucil 200 mg 20 pcs. granules for the preparation of solution for oral administration

In rare cases, possible: nausea, heartburn, feeling of fullness in the stomach, vomiting, diarrhea, skin rash, itching, urticaria, nosebleeds, tinnitus. When taking acetylcysteine, cases of bronchospasm, collapse, stomatitis, and decreased platelet aggregation have been described.

Drug interactions

The combined use of acetylcysteine with antitussives may increase sputum stagnation due to suppression of the cough reflex.

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

The simultaneous use of acetylcysteine and nitroglycerin can lead to an increase in the vasodilating and disaggregating effects of the latter. Acetylcysteine eliminates the toxic effects of paracetamol.

Fluimucil granules for the preparation of solution for oral administration 200 mg, sachets 20 pcs.

Registration Certificate Holder

ZAMBON SWITZERLAND (Switzerland)

Dosage form

Medicine - Fluimucil® (Fluimucil)

Description

Granules for the preparation of solution for oral administration

white-yellow in color with orange inclusions, with a characteristic orange, slightly sulfurous odor.

1 pack

acetylcysteine 200 mg

Excipients

: aspartame - 25 mg, betacarotene - 12.3 mg, orange flavor - 100 mg, sorbitol - 662.7 mg.

1 g - multilayer bags (20) - cardboard packs. 1 g - multilayer bags (60) - cardboard packs.

Indications

respiratory diseases accompanied by impaired sputum discharge (including bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, pulmonary emphysema, laryngotracheitis, interstitial lung diseases, pulmonary atelectasis /due to blockage of the bronchi by mucus plug/);
catarrhal and purulent otitis, sinusitis, incl. sinusitis (to facilitate the passage of secretions);
for removing viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.

Contraindications for use

peptic ulcer of the stomach and duodenum in the acute phase;
lactation period;
children under 2 years of age (for granules for the preparation of a solution for oral administration);
children and adolescents up to 18 years of age (for effervescent tablets);
hypersensitivity to acetylcysteine.

Carefully:

for peptic ulcers of the stomach and duodenum, varicose veins of the esophagus, hemoptysis, pulmonary hemorrhage, phenylketonuria, bronchial asthma, diseases of the adrenal glands, liver and/or kidney failure, arterial hypertension.

pharmachologic effect

Liquefies mucus, increases its volume and facilitates its separation. The action of acetylcysteine is associated with the ability of its sulfhydryl groups to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolarization of mucoproteins and a decrease in sputum viscosity. Remains active in the presence of purulent sputum.

It has an antioxidant effect due to the presence of an SH group that can neutralize electrophilic oxidative toxins.

Acetylcysteine easily penetrates into the cell and is deacetylated to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant and cytoprotector that neutralizes endogenous and exogenous free radicals and toxins. Acetylcysteine prevents exhaustion and helps increase the synthesis of intracellular glutathione, which is involved in the redox processes of cells, promoting the detoxification of harmful substances. This explains the effect of acetylcysteine as an antidote for paracetamol poisoning.

Protects α1-antitrypsin (elastase inhibitor) from the inactivating effects of HOCI, an oxidizing agent produced by myeloperoxidase of active phagocytes. It also has an anti-inflammatory effect (by suppressing the formation of free radicals and reactive oxygen-containing substances responsible for the development of inflammation in the lung tissue).

Drug interactions

Concomitant use with antitussives may increase sputum stagnation due to suppression of the cough reflex.

When used simultaneously with antibiotics, such as tetracyclines (excluding doxycycline), ampicillin, amphotericin B, they may interact with the thiol group of acetylcysteine, which leads to a decrease in the activity of both drugs, so the interval between taking acetylcysteine and antibiotics should be at least 2 hours.

Simultaneous use with nitroglycerin can lead to increased vasodilatory and antiplatelet effects of the latter.

Acetylcysteine reduces the hepatotoxic effect of paracetamol.

Dosage regimen

Prescribed for adults

600 mg/day.
Children over 6 years old
- 200 mg 2-3 times a day;
children aged 2 to 6 years
- 200 mg 2 times / day or 100 mg 3 times / day;
children aged 1 to 2 years
- 100 mg 2 times a day.
In newborns,
the drug is used only for health reasons at a dose of 10 mg/kg body weight under the strict supervision of a physician.

The duration of the course of treatment is determined individually. For acute diseases, the duration of treatment is from 5 to 10 days, for chronic diseases - up to several months.

Side effect

From the digestive system:

rarely - heartburn, nausea, feeling of fullness in the stomach, vomiting, diarrhea;
Cases of the development of stomatitis have been described. Allergic reactions:
rarely - skin rash, itching, urticaria; Cases of bronchospasm have been described.

Other:

rarely - nosebleeds, tinnitus; Cases of collapse and decreased platelet aggregation have been described.

special instructions

Patients with bronchial asthma and obstructive bronchitis should be prescribed with caution under systematic monitoring of bronchial conduction.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - Contraindicated.

During pregnancy, use is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to prescribe during lactation, breastfeeding should be stopped.

Use for renal impairment

Restrictions in case of impaired renal function - With caution. Caution should be prescribed in case of renal failure.

Use for liver dysfunction

Restrictions for liver dysfunction - With caution. Caution should be prescribed in case of liver failure.

Use in children

Restrictions for children - With caution. Contraindicated in children under 2 years of age (for granules for the preparation of a solution for oral administration); in childhood and adolescence up to 18 years (for effervescent tablets).