Fluimucil: instructions for using the medicine, structure, Contraindications
Active material: Acetylcysteine
When ATH: R05CB01
CCF: Mucolytic drug with antioxidant properties
ICD-10 codes (testimony): E84, J01, J04, J15, J20, J21, J32, J37, J42, J45, J47
When CSF: 12.02.01
Manufacturer: ZAMBON SWITZERLAND Ltd. (Switzerland)
Fluimucil: dosage form, composition and packaging
◊ Granules for oral solution with orange fragrance.
| 1 again. | |
| acetylcysteine | 200 mg |
Excipients: Aspartame, betakaroten, orange flavor, sorbitol.
Packages multilayered laminated (20) – packs cardboard.
Packages multilayered laminated (60) – packs cardboard.
◊ Effervescent tablets for solution for oral administration white, round, with lemon, slightly sulphurous odor; ready solution slightly opalescent, with characteristic odor and taste of lemon flavoring.
| 1 tab. | |
| acetylcysteine | 600 mg |
Excipients: lemon acid, sodium bicarbonate, Aspartame, lemon flavor.
2 PC. – packings Valium planimetric (5) – packs cardboard.
2 PC. – packings Valium planimetric (10) – packs cardboard.
10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – packings Valium planimetric (2) – packs cardboard.
| Solution for injection and inhalation | 1 ml | 1 amp. |
| acetylcysteine | 100 mg | 300 mg |
Excipients: disodium эdetat, Sodium hydroxide, water d / and.
3 ml – vials of dark glass (5) – Plastic holders (1) – packs cardboard.
Fluimucil: pharmachologic effect
Mucolytic drugs. It liquefies phlegm and facilitates its isolation. Action acetylcysteine related to the ability of its sulfhydryl groups to break disulfide bonds of acid mucopolysaccharides sputum, which leads to depolarization and mukoproteidov decrease mucus viscosity. Saves activity in the presence of purulent sputum. Fluimucil® It has anti-adhesive properties, It has an antioxidant effect, due to the presence of a nucleophilic thiol group SH-, which easily gives hydrogen, neutralizing oxidative radicals.
Acetylcysteine is easily penetrates the cell, deacetylated to L-cysteine, from which it is synthesized intracellular glutathione, is an antioxidant and cytoprotectant, neutralizing endogenous and exogenous toxins and free radicals. Thus, acetylcysteine prevents exhaustion and promotes the synthesis of intracellular glutathione, contributing to detoxification of hazardous substances. This explains the effect of acetylcysteine as antidote for poisoning by paracetamol.
In applying the drug marked decrease in the frequency and severity of exacerbations in patients with chronic bronchitis and cystic fibrosis.
The study BRONCUS (Bronchitis Randomised On NAC Cost Utility Study) It examined the effect of long-term therapy Fluimutsilom® in chronic obstructive pulmonary disease (COPD) moderate and severe stages.
Fluimucil® It is able to reduce the frequency of exacerbations of COPD and pulmonary hyperinflation. Its positive effects are particularly pronounced in the severe stages of COPD.
Fluimucil: pharmacokinetics
Absorption
If ingestion is well absorbed from the gastrointestinal tract. Once inside 600 acetylcysteine mg in healthy volunteers Cmax plasma achieved through 1 h and is 15 mmol / l. The on / in the introduction 600 mg of acetylcysteine Cmax Plasma is 300 mmol / l.
Bioavailability is 10% because of the pronounced effect “first pass” through the liver.
Distribution
It penetrates into the intercellular space, mainly distributed in liver, kidney, light, bronchial secretions.
Vd at steady state is 0.34 l / kg.
Metabolism
Rapidly deacetylated to cysteine in the liver. The dynamic equilibrium plasma is free and bound to plasma proteins of acetylcysteine and its metabolites (cysteine, cystine, diacetilcistina).
Deduction
T1/2 ingestion of 1 no. Acetylcysteine and its metabolites are excreted mainly in urine. The total clearance of 0.21 L / h / kg.
Fluimucil: testimony
Respiratory diseases, accompanied by the formation of highly viscous mucus, including:
- acute and chronic bronchitis;
- tracheitis;
- bronhiolit;
- atelectasis due to obstruction of the bronchus with mucus;
- pneumonia;
- bronchiectasis;
- mukovystsydoz;
- bronchial asthma;
- to remove viscous secretions from the respiratory tract in post-traumatic and postoperative conditions;
- to facilitate the discharge of mucus in sinusitis.
Fluimucil: dosing regimen
A preparation in the form of effervescent tablets appointed adult by 600 mg (1 tab.) 1 time / day. Before use, the effervescent tablet is dissolved in 1/3 cup water.
Granules for oral solution appointed adults and children over 6 years – by 200 mg 2-3 times / day; children aged 2 to 6 years – by 200 mg 2 times / day, or 100 mg 3 times / day; children aged 1 Year to 2 years – by 100 mg 2 times / day.
In newborns and infants the drug is used at a dose of 10 mg / kg of body weight under strict medical supervision.
Before applying the required amount of granules dissolved in 1/3 cup water. Babies first year of life give drink the resulting solution with a spoon or bottle feeding.
The duration of treatment is determined individually. In acute diseases, the duration of treatment ranged from 5 to 10 days, chronic – up to several months.
Solution for injection It may be administered parenterally, inhalation, Endobronhialno.
Parenteral adult introduced 300 mg (3 ml) deep / m or / 1-2 times / day. Children aged 6 to 14 years introduced 1/2 adult dose. The daily dose for children aged 6 years is 10 mg / kg body weight. The duration of treatment is determined individually.
The inhaled drug prescribed adult by 300 mg (3 ml) 1-2 times / day for 5-10 days or longer. Babies inhaled drug administered in the same dose.
Endobronhialno drug is administered using suitable equipment at a dose 300-600 mg (3-6 ml) or more / day, depending on the clinical indications.
Fluimucil: side effects
From the digestive system: rarely – heartburn, nausea, vomiting, diarrhea, stomatitis.
Allergic reactions: rarely – skin rash, itch, hives, bronchospasm.
Other: rarely – nosebleeds, noise in ears, collapse, decrease platelet aggregation.
Local reactions: for parenteral use may be a slight burning sensation at the injection site; inhalation application – reflex cough, local irritation of the respiratory tract, stomatitis, rhinitis; rarely – bronchospasm (In this case, the appointment of bronchodilators).
Fluimucil: Contraindications
- gastric ulcer and duodenal ulcer in the acute phase;
- hypersensitivity to acetylcysteine.
The drug is in the form of effervescent tablets are not indicated for children and adolescents under the age of 18 years.
Fluimucil: Pregnancy and lactation
During pregnancy and lactation the use Fluimucil® It is possible only if, if the expected benefit to the mother outweighs the potential risk to the fetus or infant.
Fluimucil: Special instructions
Precautions should be prescribed to patients with a predisposition to pulmonary hemorrhage and hemoptysis, liver diseases, kidney, adrenal.
Patients with asthma and obstructive bronchitis Fluimucil® It can be administered only by providing adequate drainage of sputum.
Dosage forms for oral administration contain aspartame, therefore should not be administered to their patients with phenylketonuria.
The dissolution of the drug must be used glassware, Avoid contact with metal and rubber surfaces. When opening the package with the smell of sulfur granules is possible, odor that the active substance is, rather than evidence of a poor quality product.
Fluimucil: overdose
Fluimucil® upon receiving a dose 500 mg / kg / day does not cause signs and symptoms of overdose.
Fluimucil: drug interaction
Concomitant use Fluimucil® with antitussives may enhance phlegm stagnation due to the suppression of the cough reflex.
While the use of antibiotics, such as tetracyclines (isklюchaя doxycycline), ampicillin, Amphotericin B, their possible interaction with a thiol group SH-acetylcysteine, which leads to reduced activity of both drugs, therefore the interval between reception acetylcysteine and antibiotics should be at least 2 no.
Simultaneous treatment with Fluimucil® nitroglycerin and may lead to increased vasodilator and antiplatelet actions of the latter.
Acetylcysteine decreases gepatotoksičeskoe action of paracetamol.
Fluimucil: terms of dispensing from pharmacies
Effervescent tablets and granules are approved for use as a means of non-prescription. The solution for injection by prescription.
Fluimucil: terms and conditions of storage
The drug should be stored in a dry, away from children at room temperature not exceeding 25 ° C. Shelf life of effervescent tablets and granules – 3 year, Injection Solution – 5 years.
Upon opening the ampoule solution for injection may be stored in a refrigerator for 24 no. Use of the drug from a previously opened vials prohibited.
