Fluimucil® (Tablets, Granules, Solution) Instructions for Use
ATC Code
R05CB01 (Acetylcysteine)
Active Substance
Acetylcysteine (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Mucolytic drug with antioxidant properties
Pharmacotherapeutic Group
Mucolytic expectorant
Pharmacological Action
A mucolytic agent, it is a derivative of the amino acid cysteine. It has a mucolytic effect, increases the volume of sputum, and facilitates its expectoration due to a direct effect on the rheological properties of sputum. The action of acetylcysteine is associated with the ability of its sulfhydryl groups to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides in sputum, which leads to the depolarization of mucoproteins and a decrease in sputum viscosity.
It reduces induced hyperplasia of mucoid cells, enhances the production of surfactant compounds by stimulating type II pneumocytes, and stimulates mucociliary activity, leading to improved mucociliary clearance.
It remains active in the presence of purulent, mucopurulent, and mucous sputum.
It increases the secretion of less viscous sialomucins by goblet cells and reduces bacterial adhesion to epithelial cells of the bronchial mucosa. It stimulates bronchial mucosal cells, the secretion of which lyses fibrin. It has a similar effect on the secretion formed in inflammatory diseases of the ENT organs.
It has an antioxidant effect, due to the ability of its reactive sulfhydryl groups (SH-groups) to bind with oxidative radicals and thus neutralize them.
Acetylcysteine easily penetrates into the cell, is deacetylated to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant and cytoprotector, neutralizing endogenous and exogenous free radicals and toxins. Acetylcysteine prevents depletion and promotes an increase in the synthesis of intracellular glutathione, which is involved in the redox processes of cells, promoting the detoxification of harmful substances. This explains the action of acetylcysteine as an antidote in paracetamol poisoning.
It protects alpha1-antitrypsin (elastase inhibitor) from the inactivating effect of HOCl, an oxidant produced by myeloperoxidase of active phagocytes. It also has an anti-inflammatory effect (due to the suppression of the formation of free radicals and reactive oxygen species responsible for the development of inflammation in the lung tissue).
Pharmacokinetics
When taken orally, it is well absorbed from the gastrointestinal tract. It is largely subject to the first-pass effect through the liver, which leads to reduced bioavailability. Plasma protein binding is up to 50% (4 hours after oral administration). It is metabolized in the liver and possibly in the intestinal wall. It is detected in the plasma unchanged, as well as in the form of metabolites – N-acetylcysteine, N,N-diacetylcysteine, and cysteine ester.
Renal clearance is 30% of total clearance.
Indications
As a mucolytic agent for the treatment of acute and chronic respiratory diseases associated with excessive bronchial secretion: bronchitis; tracheitis; bronchiolitis; pneumonia; bronchiectasis; cystic fibrosis; lung abscess; pulmonary emphysema; laryngotracheitis; interstitial lung diseases; lung atelectasis (due to bronchial obstruction by a mucous plug); for catarrhal and purulent otitis, sinusitis (to facilitate secretion discharge); for the removal of viscous secretion from the respiratory tract in post-traumatic and postoperative conditions.
Preparation for bronchoscopy, bronchography, aspiration drainage.
For washing abscesses, nasal passages, maxillary sinuses, middle ear, treating fistulas, and the surgical field during operations on the nasal cavity and mastoid process.
As an antidote in adults and children for the treatment of paracetamol overdose.
ICD codes
| ICD-10 code | Indication |
| E84 | Cystic fibrosis |
| J01 | Acute sinusitis |
| J04.1 | Acute tracheitis |
| J05 | Acute obstructive laryngitis [croup] and epiglottitis |
| J15 | Bacterial pneumonia, not elsewhere classified |
| J20 | Acute bronchitis |
| J32 | Chronic sinusitis |
| J37.1 | Chronic laryngotracheitis |
| J42 | Unspecified chronic bronchitis |
| J45 | Asthma |
| J47 | Bronchiectasis |
| J98.1 | Pulmonary collapse (including atelectasis) |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| CA01 | Acute rhinosinusitis |
| CA05.1 | Acute tracheitis |
| CA06.Z | Acute obstructive laryngitis or epiglottitis, unspecified |
| CA0A.Z | Chronic rhinosinusitis, unspecified |
| CA0G | Chronic laryngitis or laryngotracheitis |
| CA20.1Z | Chronic bronchitis, unspecified |
| CA23 | Asthma |
| CA24 | Bronchiectasis |
| CA25.Z | Cystic fibrosis, unspecified |
| CA40.0Z | Bacterial pneumonia, unspecified |
| CA42.Z | Acute bronchitis, unspecified |
| CB40.2 | Lung collapse |
| QB9A | Preparatory procedures for subsequent treatment |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Tablets, Granules
Adults are prescribed 600 mg/day. Children over 6 years – 200 mg 2-3 times/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/day.
In newborns, the drug is used only for vital indications at a dose of 10 mg/kg of body weight under strict medical supervision.
The duration of the treatment course is set individually. For acute diseases, the duration of treatment is from 5 to 10 days; for chronic diseases, it can be up to several months.
Solution
It is taken orally, in the form of inhalations, intratracheally, and also topically. It is administered intravenously.
The dose depends on the patient’s age. The frequency and duration of the course are set individually.
Topically – instilled into the external auditory canal and nasal passages.
Intravenous therapy is intended for use in ICU patients and only when oral administration of acetylcysteine is not possible.
Adverse Reactions
Blood and lymphatic system disorders very rarely – decreased platelet aggregation.
Immune system disorders uncommon – hypersensitivity reactions, angioedema; very rarely – anaphylactic reactions up to anaphylactic shock, bleeding (single reports in connection with the presence of a hypersensitivity reaction).
Nervous system disorders rare – headache.
Ear and labyrinth disorders uncommon – tinnitus.
Cardiac disorders uncommon – tachycardia, decreased blood pressure; cases of collapse have been described with acetylcysteine use.
Respiratory, thoracic and mediastinal disorders rare – dyspnea, bronchospasm (mainly in patients with bronchial hyperreactivity in bronchial asthma).
Gastrointestinal disorders uncommon – stomatitis, abdominal pain, diarrhea, nausea, vomiting; rare – heartburn, dyspepsia.
Skin and subcutaneous tissue disorders uncommon – skin itching, skin rash, exanthema, urticaria; very rarely – Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome).
General disorders and administration site conditions very rarely – fever; frequency unknown – facial edema.
Contraindications
Hypersensitivity to acetylcysteine; peptic ulcer of the stomach and duodenum in the acute phase, breastfeeding period, children under 2 years of age (except for use as an antidote).
Contraindications for use in children under 18 years of age depend on the dosage form and are indicated in the instructions for use of the specific drug.
With caution
Hemoptysis, pulmonary hemorrhage; history of peptic ulcer of the stomach and duodenum; esophageal varices; bronchial asthma; obstructive bronchitis; hepatic and/or renal failure; adrenal gland diseases; arterial hypertension; histamine intolerance.
Use in Pregnancy and Lactation
Contraindicated during pregnancy and breastfeeding.
Use in Hepatic Impairment
Acetylcysteine should be used with caution in patients with liver diseases.
Use in Renal Impairment
Acetylcysteine should be used with caution in patients with kidney diseases.
Pediatric Use
Contraindicated in children under 2 years of age.
Contraindications for use in children under 18 years of age depend on the dosage form and are indicated in the instructions for use of the specific drug.
Special Precautions
In patients with bronchial asthma and obstructive bronchitis, Acetylcysteine should be used with caution and under systematic monitoring of bronchial patency.
Acetylcysteine may slightly affect histamine metabolism, so caution is required when using this agent for long-term treatment of patients suffering from histamine intolerance, if symptoms of intolerance appear (headache, vasomotor rhinitis, itching).
If changes in the skin and mucous membranes occur, you should immediately consult a doctor and stop taking acetylcysteine.
Use in patients with renal and/or hepatic insufficiency should be avoided to prevent additional formation of nitrogenous compounds.
If the patient is unable to cough effectively, drainage or aspiration of the secretion should be performed.
Acetylcysteine should not be taken immediately before bedtime (it is recommended to take it 4 hours before bedtime).
The correspondence between the route of administration and the dosage form used must be strictly observed.
Drug Interactions
Concomitant use of acetylcysteine with antitussive agents may increase sputum stasis due to suppression of the cough reflex.
When used concomitantly with antibiotics (including tetracycline, ampicillin, amphotericin B), their interaction with the thiol group of acetylcysteine is possible.
Concomitant administration of acetylcysteine and nitroglycerin may cause a pronounced decrease in blood pressure and headache.
Concomitant use of acetylcysteine and carbamazepine may be accompanied by a decrease in carbamazepine concentration to a subtherapeutic level.
Acetylcysteine eliminates the toxic effects of paracetamol.
Acetylcysteine may affect the results of the colorimetric determination of salicylates.
Acetylcysteine may affect the results of urine ketone tests.
Upon contact of acetylcysteine with metals and rubber, sulfides with a characteristic odor are formed.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Effervescent tablets 600 mg: 10 or 20 pcs.
Marketing Authorization Holder
Zambon Switzerland, Ltd. (Switzerland)
Dosage Form
 |
Fluimucil® | Effervescent tablets 600 mg: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
Effervescent tablets white, round, with a rough surface; with a lemon, slightly sulfurous odor; the solution prepared by dissolving the tablets in water should be slightly opalescent, with a characteristic odor and taste of lemon flavor.
| 1 tab. | |
| Acetylcysteine | 600 mg |
Excipients: citric acid – 680 mg, sodium bicarbonate – 500 mg, aspartame – 20 mg, lemon flavor – 100 mg.
2 pcs. – blisters (5) – cardboard boxes.
2 pcs. – blisters (10) – cardboard boxes.
10 pcs. – blisters (1) – cardboard boxes.
10 pcs. – blisters (2) – cardboard boxes.
Granules for oral solution 200 mg: sachets 20 or 60 pcs.
Marketing Authorization Holder
Zambon Switzerland, Ltd. (Switzerland)
Dosage Form
|
Fluimucil® | Granules for oral solution 200 mg: sachets 20 or 60 pcs. |
Dosage Form, Packaging, and Composition
Granules for oral solution white-yellow with orange inclusions, with a characteristic orange, slightly sulfurous odor.
| 1 sachet | |
| Acetylcysteine | 200 mg |
Excipients: aspartame – 25 mg, beta-carotene – 12.3 mg, orange flavor – 100 mg, sorbitol – 662.7 mg.
1 g – multilayer sachets (20) – cardboard boxes.
1 g – multilayer sachets (60) – cardboard boxes.
Solution for intravenous administration and inhalation 100 mg/1 ml: 3 ml amp. 5 pcs.
Marketing Authorization Holder
Zambon, S.p.A. (Italy)
Dosage Form
 |
Fluimucil® | Solution for intravenous administration and inhalation 100 mg/1 ml: 3 ml amp. 5 pcs. |
Dosage Form, Packaging, and Composition
Solution for intravenous administration and inhalation clear, colorless, with a slight sulfurous odor; after opening the ampoule, a slight pink-violet tint may appear upon prolonged contact with air.
| 1 ml | 1 amp. | |
| Acetylcysteine | 100 mg | 300 mg |
Excipients: sodium hydroxide – to pH 6.5 (~74 mg), disodium edetate – 3 mg, water for injection – up to 3 ml.
3 ml – dark glass ampoules (5) – plastic holders (1) – cardboard boxes.
Solution for oral administration 20 mg/1 ml: 100 ml, 150 ml or 200 ml bottle with a measuring cap
Solution for oral administration 40 mg/1 ml: 150 ml or 200 ml bottle with a measuring cap
Marketing Authorization Holder
Zambon, S.p.A. (Italy)
Dosage Forms
|
Fluimucil® | Solution for oral administration 20 mg/1 ml: 100 ml, 150 ml or 200 ml bottle with a measuring cap |
| Solution for oral administration 40 mg/1 ml: 150 ml or 200 ml bottle with a measuring cap |
Dosage Form, Packaging, and Composition
Solution for oral administration clear or slightly opalescent, colorless, with a characteristic raspberry odor; a slight sulfurous odor may be present.
| 1 ml | |
| Acetylcysteine | 20 mg |
Excipients: methylparahydroxybenzoate – 1 mg, sodium benzoate – 1.5 mg, disodium edetate – 1 mg, sodium carmellose – 4 mg, sodium saccharin – 0.4 mg, sodium cyclamate – 1.3 mg, sucralose – 1.8 mg, raspberry flavor – 2.5 mg, sodium hydroxide – to pH 6.5, purified water – up to 1 ml.
100 ml – dark glass type III bottles (1) with a measuring cap – cardboard boxes.
150 ml – dark glass type III bottles (1) with a measuring cap – cardboard boxes.
200 ml – dark glass type III bottles (1) with a measuring cap – cardboard boxes.
Solution for oral administration clear, colorless or pale yellow, with a characteristic strawberry and pomegranate odor and a slight sulfurous odor.
| 1 ml | |
| Acetylcysteine | 40 mg |
Excipients: methylparahydroxybenzoate – 1.8 mg, propylparahydroxybenzoate – 0.2 mg, disodium edetate – 1 mg, sodium carmellose – 4 mg, sorbitol 70% – 120 mg, sodium saccharin – 0.4 mg, strawberry flavor – 10 mg, pomegranate flavor – 2 mg, sodium hydroxide – to pH 6.5, purified water – up to 1 ml.
150 ml – dark glass type III bottles (1) with a measuring cap – cardboard boxes.
200 ml – dark glass type III bottles (1) with a measuring cap – cardboard boxes.
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