Eifa AC Granules for preparation of oral solution 200mg Renewal sachet bags, 20pcs

Composition

Active ingredient: Acetylcysteine-200 mgsupport substances: sucrose – 2717.0 mg, orange flavor-50.0 mg, ascorbic acid-25.0 mg, sodium saccharinate-8.0 mg

Pharmacological action

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, acetylcysteine reduces the induced hyperplasia of mucoid cells, increases the production of surfactants by stimulating type II pneumocytes, and stimulates mucociliary activity, which leads to an improvement in mucociliary clearance.

It remains active in purulent, mucopurulent and mucosal sputum.

Acetylcysteine increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. It stimulates mucosal cells of the bronchi, the secret of which lyses fibrin. It has a similar effect on the secret formed in inflammatory diseases of ENT organs. It has an antioxidant effect due to the presence of the SH group, which can neutralize electrophilic oxidative toxins.

Acetylcysteine easily penetrates into the cell, deacetylates to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant, and a cytoprotector that traps exogenous and endogenous free radicals and toxins. Acetylcysteine prevents depletion and increases the synthesis of intracellular glutathione, which is involved in the redox processes of cells, thus contributing to the detoxification of harmful substances. This explains the effect of acetylcysteine as an antidote for paracetamol poisoning. The main role of acetylcysteine is to maintain the proper level of glutathione concentration, thus providing cell protection.

Acetylcysteine protects alpha-1-antitrypsin (elastase inhibitor) from the inactivating effect of HOCL, an oxidant produced by the myeloperoxidase of 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).

Indications

Acute and chronic respiratory diseases associated with the formation of viscous difficult-to-separate bronchial secretions (as an expectorant): bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, emphysema, laryngotracheitis, interstitial lung diseases, lung atelectasis (due to blockage of the bronchi with a mucous plug).

Catarrhal and purulent otitis, sinusitis, sinusitis (relief of discharge of secretions).

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

Use during pregnancy and lactation

Data on the use of acetyl cysteine during pregnancy and lactation are limited, so the use of the drug during pregnancy is contraindicated. If it is necessary to use the drug during breastfeeding, you should decide whether to stop it.

Contraindications

Hypersensitivity to acetylcysteine or other components of the drug; children under 14 years of age (for a dosage of 600 mg), children under 6 years of age (for a dosage of 200 mg), children under 2 years of age (for a dosage of 100 mg); stomach and duodenal ulcer in the acute stage; hemoptysis, pulmonary bleeding; sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption; pregnancy and lactation feeding sessions.

Side effects

According to the World Health Organization (WHO), adverse events are classified according to their frequency as follows: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (

Immune system disorders

• infrequently: hypersensitivity reaction, angioedema;
• very rarely: anaphylactic reactions up to anaphylactic shock, bleeding (isolated reports due to the presence of a hypersensitivity reaction).

Nervous system disorders

• rare: headache.

Hearing disorders and labyrinth disorders

• infrequently: tinnitus.

Cardiac and vascular

• disorders infrequently: tachycardia, decreased blood pressure; cases of collapse have been described when taking acetylcysteine.

Disorders of the blood and lymphatic system

• are very rare: reduced platelet aggregation.

Respiratory, thoracic and mediastinal

• disorders are rare: dyspnea, bronchospasm (mainly in patients with hyperreactivity of the bronchi in bronchial asthma).

Gastrointestinal disorders

• infrequently: inflammation of the oral mucosa (stomatitis); abdominal pain; diarrhea, nausea, vomiting;
• rarely: heartburn, dyspepsia

Skin and subcutaneous tissue disorders

• infrequently: pruritus, skin rash, exanthema, urticaria;<
• very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome).

General disorders and disorders at the injection

• site very rare: fever;
• frequency unknown: facial edema.

With caution:

A history of gastric and duodenal ulcers, esophageal varicose veins, bronchial asthma, hepatic and/or renal failure, adrenal diseases, arterial hypertension, histamine intolerance (long-term use of the drug should be avoided, since acetylcysteine affects the metabolism of histamine and may lead to signs of intolerance, such as headache, vasomotor rhinitis, pruritus).

Interaction

The combined use of acetylcysteine with antitussive agents may increase sputum congestion due to suppression of the cough reflex.

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

Concomitant use of acetylcysteine and nitroglycerin may cause a marked decrease in blood pressure and headache.

Concomitant use of acetylcysteine and carbamazepine may result in subtherapeutic levels of carbamazepine.

Activated carbon can reduce the effect of acetylcysteine.

Acetylcysteine eliminates the toxic effects of paracetamol.

Acetylcysteine may affect the results of colorimetric determination of salicylates.

Acetylcysteine may affect the analysis of ketones in the urine.

How to take, course of use and dosage

In the absence of other prescriptions, it is recommended to adhere to the following dosages: :

Mucolytic therapy:

• adults and adolescents over 14 years of age: it is recommended to take 1 sachet 2-3 times a day (400-600 mg per day);
• children aged 6 to 14 years: it is recommended to take 1/2 sachet 3 times a day or 1 sachet 2 times a day (300-400 mg per day).

Cystic fibrosis:

• children over the age of 6 years: it is recommended to take 1 sachet 3 times a day (600 mg per day);
• patients with a body weight of ≥ 30 kg: if necessary, it is possible to increase the dose to 800 mg of the drug.

Warning:

Due to the high content of the Active ingredient (200 mg of acetylcysteine in a sachet), children under 6 years of age should not take the drug. In this case, it is recommended to use the drug Eifa AC in other dosages with a lower content of acetylcysteine.

Overdose

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

Symptoms:  nausea, vomiting and diarrhea may occur.

Treatment:  a specific antidote is missing and treatment is symptomatic.

Special instructions

Patients with bronchial asthma and obstructive bronchitis should be prescribed acetylcysteine with caution under systematic monitoring of bronchial patency. When treating patients with diabetes mellitus, it should be taken into account that the drug contains sucrose (1 sachet of the drug Eifa AC 600 mg corresponds to 018 XE 200 mg corresponds to 023 XE 100 mg-024 XE).

Acetylcysteine may affect histamine metabolism to a small extent, so caution should be exercised when using the drug for the long-term treatment of patients suffering from histamine intolerance with symptoms of intolerance (headache, vasomotor rhinitis, pruritus).

When taking the drug it is necessary to use glassware avoid contact of the finished product with metals rubber oxygen and easily oxidizing substances.

The drug should be avoided in patients with renal and / or hepatic insufficiency in order to avoid additional formation of nitrogenous compounds. If the patient is unable to clear his throat effectively, drainage or aspiration of secretions should be performed.

Do not take the drug immediately before bedtime (it is recommended to take the drug 4 hours before bedtime).

Influence on the ability to drive vehicles and mechanisms:

There are no data confirming the effect of acetylcysteine on the ability to drive vehicles with mechanisms.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 4 years.

Do not use after the expiration date.

Active ingredient

Acetylcysteine

Dosage form

granules