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

Excipients: citric acid anhydrous 843.03 mg / 648.99 mg, sodium hydrogen carbonate 695.64 mg / 548.72 mg, lemon flavor 100.00 mg / 100.00 mg, adipic acid 100.00 mg / 12.83 mg, adipic acid fine acid 20.00 mg / 48.99 mg, povidone 21.33 mg / 20.47 mg, aspartame 20.00 mg / 20.00 mg.

Description:

White or white with a yellowish tinge, round, flat tablets with a lemon scent. On one side of the pill is risk.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

S.01.X.A.08 Acetylcysteine

R.05.C.B.01 Acetylcysteine

Pharmacodynamics:

Acetylcysteine has a mucolytic effect on sputum (mucus) in the lumen of the bronchial ways, which is determined by its secretolitic and secretory properties. The drug dilutes sputum, increasing its volume, facilitates its separation. Its effect is preserved and in the presence of purulent sputum.

The mechanism of action of acetylcitein is based on the ability of sulfhydryl groups of the drug to break the disulfide bonds of acid mucopolysaccharides of sputum, which leads to depolarization of mucoproteins and a decrease in the viscosity of mucus.

Promotes the synthesis of glutathione, which is an antioxidantfactor of intracellular protection and ensures the maintenance of the functional activity and morphological integrity of the cells of the mucous membrane of the respiratory tract, which, in particular, explains its effectiveness as an antidote for paracetamol poisoning.

Due to the ability of sulfhydryl groups to neutralize electrophilic oxidative toxins, acetylcysteine has an antioxidant effect.

It also has moderate anti-inflammatory properties (by suppressing the formation of free radicals and active forms of oxygen responsible for the development of inflammation in the lung tissue).

Pharmacokinetics:

Ingestion acetylcysteine well absorbed from the gastrointestinal tract. It is subjected to the effect of "first passage" through the liver, is metabolized with the formation of cysteine, diacetylcysteine, cystine and disulfides, which reduces the bioavailability of the drug to 10%. The maximum concentration of acetylcysteine in the blood plasma is achieved in 1-3 hours, and in patients with impaired liver function - after 8 hours.

Therapeutic effect is observed after 30-90 minutes and lasts for 2-4 hours.

It is excreted mainly by the kidneys in the form of inactive metabolites, a small part is excreted unchanged through the intestine.

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

Indications:

Diseases of the respiratory system and condition, accompanied by the formation of viscous, hard-to-detachable mucopurulent sputum:

- Acute and chronic bronchitis;

- chronic obstructive pulmonary disease (COPD);

- tracheitis due to bacterial and / or viral infection;

- bronchiolitis;

- pneumonia;

- bronchial asthma;

- bronchoectatic disease;

- atelectasis due to congestion of the bronchi by a mucous plug;

- cystic fibrosis (as part of combination therapy);

- removal of a viscous secretion from the respiratory tract in post-traumatic and postoperative conditions;

- catarrhal and purulent otitis, sinusitis, including sinusitis (facilitation of secretion).

The drug is used in the treatment of overdose with paracetamol.

Contraindications:

- Known hypersensitivity to acetylcysteine or other ingredients of the finished dosage form;

- pregnancy, the period of breastfeeding;

- Stomach ulcer and duodenal ulcer in the phase of exacerbation;

- phenylketonuria;

- Children under the age of 14 years (for tablets 600 mg): Children under 2 years (for tablets 200 mg).

Carefully:

With extreme caution apply acetylcysteine in patients with bronchial asthma, liver, kidney disease, adrenal gland disorders, varicose veins of the esophagus, in persons prone to pulmonary hemorrhage, hemoptysis, arterial hypotension, intolerance to histamine. acetylcysteine affects the metabolism of histamine and can lead to signs of intolerance, such as: headache, vasomotor rhinitis, itching).

Pregnancy and lactation:

Data on the use of acetylcysteine during pregnancy and breastfeeding are limited, so the use of the drug in pregnancy is contraindicated.

If it is necessary to use the drug during lactation, the question of stopping breastfeeding should be resolved.

Dosing and Administration:

Inside, after eating, pre-dissolving tablets effervescent in a glass of water. The effervescent tablets should be taken immediately after dissolution.

Usually the following dosages are recommended:

Effervescent tablets 600 mg

- Adults and adolescents over 14 years of age: 1/2 tablets effervescent 2 times a day or 1 tablet effervescent once a day (600 mg of acetylcysteine per day).

Effervescent tablets 200 mg

- adults and adolescents over 14 years of age: 1 tablet effervescent 2-3 times a day (400-600 mg of acetylcysteine per day);

- children aged 6 to 14 years: 1 tablet effervescent 2 times a day (400 mg of acetylcysteine per day);

- children aged 2 to 6 years: 1/2 pills effervescent 2-3 times a day (200-300 mg of acetylcysteine per day).

Treatment of cystic fibrosisa:

- children over 6 years of age: 1 tablet effervescent 3 times a day (600 mg of acetylcysteine per day):

- children aged 2 to 6 years: 1/2 tablets effervescent 4 times a day (400 mg of acetylcysteine per day).

The duration (continuity) of application depends on the characteristics of the disease. In the treatment of chronic bronchitis and cystic fibrosis treatment can be long (up to several months).

Side effects:

Undesirable effects are classified according to their frequency of development as follows: very often (≥ 1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥ 1/10000, <1/1000) and very rarely (<1/10000): the frequency is unknown (the frequency of occurrence of phenomena can not be determined on the basis of available data).

From the central nervous system: rarely - headache, drowsiness.

From the gastrointestinal tract: rarely - heartburn, nausea, vomiting, diarrhea, stomatitis, sensation of stomach overflow.

Allergic reactions: infrequently - skin rash, itching, urticaria, tachycardia, lowering blood pressure, angioedema; rarely bleeding, partially associated with a hypersensitivity reaction; very rarely - anaphylactic reactions up to anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

From the respiratory system: rarely - shortness of breath, bronchospasm (mainly in patients with bronchial hyperreactivity in bronchial asthma).

From the sense organs: infrequently, noise in the ears.

Other: rarely - nasal bleeding, rhinorrhea, fever, reduced platelet aggregation.

If undesirable side effects occur, you should consult a doctor.

Overdose:

To date, cases of overdose of acetylcysteine with oral use have not been described. In a dose of 500 mg / kg acetylcysteine did not cause symptoms of poisoning.Theoretically possible diarrhea, heartburn, nausea, vomiting, pain in the stomach.

Treatment: symptomatic.

Interaction:

With the simultaneous use of acetylcysteine and antitussive drugs, sputum stagnation may increase due to the suppression of the cough reflex, so this combined treatment should be carried out only under direct medical supervision.

There is evidence that the thiol group of acetylcysteine can neutralize the activity of certain antibiotics (amphotericin B, ampicillin, tetracyclines, excluding doxycycline, semi-synthetic penicillins, cephalosporins, aminoglycosides). Therefore, it is advisable to take these antibiotics orally 2 hours after taking acetylcysteine.

It is also established that such antibiotics as amoxicillin, doxycycline, erythromycin, thiamphenicol, cefuroxime do not interact with acetylcysteine.

There are reports that the simultaneous administration of acetylcysteine and nitroglycerin can lead to an increase in the vasodilator action of the latter and a decrease in platelet aggregation.

Acetylcysteine reduces the hepatotoxic effect of paracetamol.

Special instructions:

When using the drug in patients with bronchial asthma, it is necessary to provide sputum drainage, combined with the intake of bronchodilators.

During the period of application of the drug, the patient is recommended to drink plenty of liquid, which supports the secretion effect of the drug.

When using the drug should use glassware, avoid contact with the drug with metal, rubber, oxygen, easily oxidizing substances.

With the use of acetylcysteine, very rarely reported cases of severe allergic reactions, such as Stevens-Johnson syndrome and Lyell's syndrome. If skin and mucous membrane changes occur, the doctor should be consulted immediately, and the drug should be discontinued.

Each effervescent tablet contains 20 mg of aspartame (equivalent to 11.2 mg of phenylalanine), so the drug can not be used with phenylketonuria.

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

Data on the adverse effects of acetylcysteine at recommended doses on the ability to drive vehicles and mechanisms are not present.

Form release / dosage:

Tablets are effervescent, 200 mg and 600 mg.

Packaging:

For 10 or 20 tablets in a plastic cylindrical pencil, sealed with a plastic stopper with a tear-off ring to control the opening.

1 or 2 pencil cases together with instructions for use in a cardboard box.

Storage conditions:Store 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:П N013941 / 01

Date of registration:03.03.2009 / 28.10.2016

Expiration Date:Unlimited

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

MERCKLE, GmbH Germany

Representation: & nbspTeva Teva Israel

Information update date: & nbsp02.10.2017

Illustrated instructions

Instructions

Acetylcysteine-Teva (Acetylcysteine-Teva)