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

Excipients: ascorbic acid - 0,025 g, sorbitol (sorbitol) - 0,7527 g or 0,6507 g, orange flavoring (flavoring food "Orange") - 0,1 g, aspartame - 0,02 g.

Description:DThe pellets are white with a yellowish tinge. When the contents of one packet are dissolved in 80 ml of warm water for 5 minutes with stirring, an opalescent solution with a slightly yellowish tinge with an orange odor is formed.

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 rupture the intra- and intermolecular disulfide bonds of acid mucopolysaccharides of sputum, which leads to depolymerization of mucoproteins and a decrease in the viscosity of sputum (in some cases this leads to a significant increase in sputum volume, which requires aspiration of the contents of the bronchi). Keeps active with purulent sputum. Does not affect immunity.

Increases the secretion of less viscous sialomucins by goblet cells,reduces the adhesion of bacteria on 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 SHgroup capable of neutralize electrophilic oxidative toxins.

Protects alpha 1 antitrypsin (inhibitor elastase) from the inactivating action of the nosel- an oxidant produced by myeloperoxidase active phagocytes.

Has also some anti-inflammatory action (by suppressing the formation of free radicals and active oxygen-containing substances responsible for the development of inflammation in the lung tissue).

Pharmacokinetics:

Absorption is high, bioavailability is 10% (because of the pronounced effect of "first passage" through the liver - deacetylation with cysteine formation), the time to reach - the maximum concentration (TCmah) in plasma - 1-3 hours after oral intake, communication with plasma proteins - 50%.

The half-life (T1 / 2) is about 1 h, 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 excreted unchanged with the feces.

It penetrates the placental barrier, accumulates in the amniotic fluid.

Indications:

Discharge of sputum: bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, pulmonary emphysema, laryngotracheitis, bronchial asthma, atelectasis of the lung (due to congestion of the bronchial mucosa plug).

Catarrhal and purulent otitis, sinusitis, sinusitis (relief of secretion). Removal of the 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; treatment of fistula, operating field in operations on the nasal cavity and mastoid process.

Contraindications:Hypersensitivity to acetylcysteine or other components of the drug, phenylketonuria, sugarase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, pregnancy, breast-feeding, children under 2 years.

Carefully:Peptic ulcer of stomach and duodenum (in the phase of exacerbation), varicose, esophageal veins, hemoptysis, pulmonary bleeding, adrenal diseases, hepatic and / or renal failure, arterial hypotension.

Pregnancy and lactation:

In security measures, due to insufficient data, the purpose of the drug in the period of pregnancy and lactation is only possible if the intended benefit to the mother exceeds the risk to the fetus or baby.

Dosing and Administration:

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

Adults and adolescents older than 14 years - 200 mg 2-3 times a day (400 - 600 mg per day).

Children from 2 to 5 years - 100 mg 2-3 times a day (200-300 mg per day). Children from 6 to 14 years - 200 mg 2 times a day or 3 times a day for 100 mg (300-400 mg per day).

For chronic diseases for several weeks:

adults and adolescents older than 14 years - 400-600 mg / day in 1-2 divided doses; children 2-14 years - 100 mg Zraza per day (300 mg per day).

In cystic fibrosis:

children from 2 to 6 years - 100 mg 4 times a day (400 mg per day); children over 6 years - 200 mg 3 times a day (600 mg per day).

The duration of therapy is determined individually (no more than 10 days). In patients older than 65 years - use the lowest effective dose.

Side effects:

Nausea, vomiting, sensation of stomach overflow, rhinorrhea, drowsiness, fever, stomatitis; allergic reactions (cutaneous rash, itching, hives, bronchospasm (mainly in patients with bronchial hyperreactivity).

Overdose:Symptoms: diarrhea, heartburn, nausea, vomiting, pain in the stomach. Treatment: symptomatic.

Interaction:

Pharmaceutically incompatible with other drug solutions.

Upon contact with metals, rubber, sulphides with a characteristic odor are formed.

With simultaneous administration with nitroglycerin - increased vasodilator action of the latter; reduces the absorption of drugs of the penicillin group, cephalosporin, tetracycline (they should be taken no earlier than 2 hours after taking acetylcysteine).

Special instructions:When working with the drug should use glassware, avoid contact with metals, rubber, oxygen, easily oxidizing substances. Patients with bronchial obstructive syndrome should be combined with bronchodilators. The preparation contains aspartame, therefore, its use in patients with phenylketonuria is not recommended.

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

When administering vehicles or potentially dangerous mechanisms, use with caution.

Form release / dosage:Powder for the preparation of the solution for oral administration of 100 mg and 200 mg.

Packaging:

For 1 g in heat-sealing bags of packaging combined material.

For 20 or 30 packs, together with instructions for use, are placed in packs of cardboard for consumer packaging.

Storage conditions:

In a dry place 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.

Terms of leave from pharmacies:Without recipe

Registration number:PL-000623

Date of registration:21.09.2011

The owner of the registration certificate:MARBIOFARM, OJSC MARBIOFARM, OJSC Russia

Manufacturer: & nbsp

MARBIOFARM, OJSC Russia

Information update date: & nbsp21.09.2011

Illustrated instructions

Instructions

Acetylcysteine (Acetylcysteine)