Eifa AC sachet 200mg, No. 20

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

• Catarrhal and purulent otitis media, sinusitis, sinusitis (relief of secretion discharge).

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

Inside, after eating.

The granules should be dissolved in 1 glass of room temperature water and taken immediately after dissolution.

Granules for preparation of oral solution, 200 mg

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

Mucolytic therapy:

- adults and adolescents over 14 years old: it is recommended to take 1 sachet-sachet 2-3 times a day (400-600 mg per day);

- children aged 6 to 14 years: it is recommended to take by? 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: it is recommended to take 1 sachet-sachet 3 times a day (600 mg per day);

- patients with body weight? 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 bag), the drug should not be taken by children under the age of 6 years. In this case, it is recommended to use the drug Eifa AC in other dosages with a lower content of acetylcysteine. Additional fluid intake enhances the mucolytic effect of the drug.

In case of short-term colds, the duration of taking the drug Eifa AC is 5-7 days.

For long-term illnesses, the course of treatment is determined by the attending physician.

In chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to achieve a prophylactic effect in infections.

Granules for the preparation of a solution for oral administration, white or almost white, homogeneous, irregular, without agglomerates, with a characteristic odor.

1 pack. acetylcysteine ??200 mg

Excipients: sucrose - 2717 mg, orange flavor - 50 mg, ascorbic acid - 25 mg, sodium saccharinate - 8 mg.

• 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);

• peptic ulcer of the stomach and duodenum in the acute stage;

• hemoptysis, pulmonary bleeding;

• deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption;

• pregnancy and breastfeeding period.

  Carefully

• History of gastric ulcer and duodenal ulcer, 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 histamine metabolism and can lead the occurrence of signs of intolerance, such as headache, vasomotor rhinitis, itching).

Pharmacodynamics

Mucolytic agent, liquefies phlegm, increases its volume, facilitates the separation of phlegm. 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, enhances the production of surface-active compounds by stimulating type II pneumocytes, stimulates mucociliary activity, which leads to an improvement in mucociliary clearance.

Remains active with purulent, mucopurulent and mucous sputum. Acetylcysteine ??increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to epithelial cells of the bronchial mucosa. Stimulates the mucous cells of the bronchi, the secretion of which lyses fibrin. It has a similar effect on the secretion formed in inflammatory diseases of the upper respiratory tract. It has an antioxidant effect due to the presence of an SH-group capable of neutralizing electrophilic oxidative toxins.

Acetylcysteine ??easily penetrates into the cell, deacetylated to L-cysteine, from which intracellular glutathione is synthesized. Glutathione? highly reactive tripeptide, powerful antioxidant, cytoprotector, trapping 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 action of acetylcysteine ??as an antidote for paracetamol poisoning. The main role of acetylcysteine ??is to maintain the proper concentration of glutathione, thus protecting the cells.

Does acetylcysteine ??protect alpha-1-antitrypsin (elastase inhibitor) from the inactivating effects of HOCL? an oxidizing agent produced by 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).

Pharmokinetics

Absorption

Acetylcysteine ??is well absorbed when taken orally. It is immediately deacetylated to cysteine ??in the liver. A mobile equilibrium of free and plasma protein-bound acetylcysteine ??and its metabolites (cysteine, cystine, diacetylcysteine) is observed in the blood. 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 active metabolites (80%), penetrates into the intercellular space, mainly distributed in the liver, kidneys, lungs, bronchial secretions. The volume of distribution of acetylcysteine ??varies from 0.33 to 0.47 l / kg, the maximum plasma concentration is reached 1-3 hours after oral administration and is 15 mmol / l, the relationship with plasma proteins? 50% 4 hours after ingestion and drops to 20% after 12 hours. Penetrates the placental barrier.

Metabolism

After oral administration, acetylcysteine ??is rapidly and extensively metabolized in the intestinal walls to form a pharmacologically active metabolite? cysteine, as well as diacetylcysteine, cystine.

Withdrawal

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 blood plasma is about

1 hour, in case of impaired liver function, the value increases to 8 hours.

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: No specific antidote, treatment is symptomatic.

Side effects

Immune system disorders

infrequently: hypersensitivity reaction, angioedema;

very rare: anaphylactic reactions up to anaphylactic shock, bleeding (single messages due to the presence of a hypersensitivity reaction).

Nervous system disorders

rarely: headache.

Hearing and labyrinth disorders

infrequently: tinnitus.

Violations of the heart and blood vessels

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

Blood and lymphatic system disorders

very rare: decreased platelet aggregation.

Respiratory, Chest and Mediastinal Disorders

rarely: shortness of breath, bronchospasm (mainly in patients with bronchial hyperreactivity in bronchial asthma).

Gastrointestinal disorders

infrequently: inflammation of the oral mucosa (stomatitis); pain in the abdomen; 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: swelling of the face.

Special conditions

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 is necessary to take into account that the drug contains sucrose (1 sachet of the drug Eifa AC 600 mg corresponds to 0.18 XE, 200 mg corresponds to 0.23 XE, 100 mg - 0.24 XE).

Acetylcysteine ??may slightly affect histamine metabolism, therefore, care must be taken when using the drug for long-term treatment of patients suffering from histamine intolerance, with symptoms of intolerance (headache, vasomotor rhinitis, itching).

When taking the drug, you must use glassware, avoid contact of the finished drug with metals, rubber, oxygen and easily oxidizing substances.

The use of the drug in patients with renal and / or hepatic insufficiency should be avoided in order to avoid additional formation of nitrogenous compounds.

If the patient is unable to cough effectively, drainage or aspiration of secretions should be performed.

You should 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, mechanisms

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

Drug interactions

The combined use of acetylcysteine ??with antitussives can increase sputum congestion due to suppression of the cough reflex.

With simultaneous use with antibiotics such 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.

The simultaneous intake of acetylcysteine ??and nitroglycerin can cause a marked decrease in blood pressure and headache.

The simultaneous use of acetylcysteine ??and carbamazepine can be expressed in subtherapeutic levels of carbamazepine.

Activated carbon can reduce the effects of acetylcysteine.

Acetylcysteine ??eliminates the toxic effects of paracetamol.

Acetylcysteine ??can interfere with the colorimetric determination of salicylates.

Acetylcysteine ??may interfere with urine ketone analysis.