Acetylcysteine

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Available since: 2019-09-19

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Clinical Pharmacology

Acetylcysteine is a derivative of the amino acid cysteine. It has mucolytic and secretomotor effects in the respiratory tract, facilitates sputum discharge due to a direct effect on the rheological properties of sputum. The action of the drug is due to the ability of its free sulfhydryl groups to break the intra- and intermolecular disulfide bonds of acid mucopolysaccharides of sputum, which leads to the depolymerization of mucoproteins and a decrease in the viscosity of sputum.

In addition, it reduces induced hyperplasia of mucoid cells, enhances the production of surface-active compounds (surfactant) by stimulating pneumocytes of type II, stimulates ciliary activity, which leads to an improvement in mucociliary clearance.

The drug retains activity in the presence of purulent, mucopurulent and mucous sputum.

It increases the secretion of less viscous sialomucins by the goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. Stimulates the cells of the mucous membrane of the bronchi, the secret of which lyses fibrin.

It has a similar effect on the secret that is formed in inflammatory diseases of the upper respiratory tract.

It has an antioxidant effect due to the presence of sulfhydryl groups (SH-groups) that can neutralize electrophilic oxidative toxins. Acetylcysteine easily penetrates into the cell, where it is deacetylated to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant, cytoprotector that traps endogenous and exogenous free radicals and toxins. Acetylcysteine prevents depletion and contributes to increased synthesis of intracellular glutathione, which is involved in redox processes in cells, thus contributing to the detoxification of harmful substances. This explains the effect of acetylcysteine as an antidote for paracetamol poisoning. Paracetamol exerts its cytotoxic effect through progressive depletion of glutathione. The main role of acetylcysteine is to maintain the proper level of glutathione concentration, which provides protection for the cells.

Protects alpha-1-antitrypsin (an elastase inhibitor) from the inactivating effect of HOCl, an oxidizing agent produced by myeloperoxidase active phagocytes. It also has an anti-inflammatory effect (due to the suppression of the formation of free radicals and active oxygen-containing substances responsible for the development of inflammation in the lung tissue).

With prophylactic use of acetylcysteine, a decrease in the frequency and severity of exacerbations of bacterial infections in patients with chronic bronchitis and cystic fibrosis has been observed.

Suggested use

For oral use. Powder from 1 sachet should be poured directly onto the tongue. The drug stimulates salivation, so the powder is mixed with saliva and is easily swallowed. The drug does not require drinking water. Powder for oral administration should not be chewed before swallowing.

Adults: 1 sachet once a day (equivalent to 600 mg of acetylcysteine per day).

Due to the high content of acetylcysteine (600 mg) in 1 sachet, do not use the drug in children (it is recommended to use other dosage forms of the ACC® drug or another acetylcysteine drug).

The duration of treatment should be assessed individually. With short-term catarrhal diseases, the duration of the course is 5-7 days, in the treatment of chronic diseases - up to several months (as recommended by the doctor).

Indications

Acute and chronic respiratory diseases associated with the formation of a viscous, hard-to-separate bronchial secretion (as an expectorant): bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, pulmonary emphysema, laryngotracheitis, interstitial diseases, izema, laryngitis, pulmonary lesions, lung abscess, pulmonary heart disease, pulmonary abscess, pulmonary pulmonary disease bronchial obstruction by mucosal plug).

Inflammation of the middle ear (otitis media), acute and chronic sinusitis, rhinosinusitis (relief of secretion).

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

Composition

1 sachet contains:

active ingredient: acetylcysteine 600 mg; excipients: glyceryl tripalmitate, polysorbate 65, sorbitol, xylitol, citric acid, sodium citrate, magnesium citrate, carmellose sodium, aspartame, blackberry flavor “B” (natural / identical to natural fluid flavor “Berry berry”, code 5752; natural / identical to natural liquid blackberry flavor, code 5337; vanillin; maltodextrin; mannitol; gluconolactone; sorbitol; silicon dioxide, anhydrous colloidal; magnesium carbonate), magnesium stearate.

Acetylcysteine is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
ACC			powder
Fluimucil solution for injections and inhalations	Zambon	Italy	solution
Acetylcysteine-Canon (Canonpharma	Canonpharma	Russia	granules
Acetylcysteine-Teva (TEVA	TEVA	Israel	effervescent pills
Fluimucil	Zambon	Italy	solution
ACC (Sandoz	Sandoz	Switzerland	syrup
ACC	Sandoz	Switzerland	solution
ACC	Sandoz	Switzerland	tea bags
ACC-Long	Sandoz	Switzerland	effervescent pills
ACC	Sandoz	Switzerland	granules
ACC 200	Sandoz	Switzerland	effervescent pills
ACC	Sandoz	Switzerland	effervescent pills
ACC	Sandoz	Switzerland	powder
Fluimucil	Zambon	Italy	granules
Fluimucil	Zambon	Italy	effervescent pills

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Adverse reactions

infrequently: hypersensitivity reactions;

very rarely: anaphylactic shock, anaphylactic / anaphylactoid reactions.

Nervous system disorders

infrequently: headache.

Violations of the heart and blood vessels

infrequently: tachycardia, arterial hypotension;

very rarely: bleeding *;

frequency unknown: when taking acetylcysteine, cases of collapse are described.

Respiratory disorders

seldom: shortness of breath, bronchospasm (mainly in patients with bronchial hyperreactivity against the background of bronchial asthma).

Disorders of the gastrointestinal tract

infrequently: abdominal pain, nausea, vomiting, diarrhea, stomatitis;

rarely: dyspepsia;

frequency unknown: heartburn.

Violations of the skin and subcutaneous tissue

infrequently: urticaria, rash, rash, angioedema, pruritus;

very rarely: Stevens-Johnson syndrome, Lyell's syndrome (see section "Special Instructions").

Disturbances from an organ of hearing and labyrinth disturbances

infrequently: ringing in the ears.

Common disorders

infrequently: fever;

frequency unknown: swelling of the face.

* Single reports of bleeding development with acetylcysteine, sometimes with hypersensitivity reactions. Decrease in platelet aggregation during the use of acetylcysteine was confirmed in some studies, the clinical significance of this phenomenon has not yet been clarified.

Contraindications

A history of gastric ulcer or duodenal ulcer, bronchial asthma, obstructive bronchitis, liver and / or kidney failure, histamine intolerance (long-term use should be avoided, as acetylcysteine affects the histamine metabolism, which can lead to symptoms of its intolerance, such as headache, vasomotor rhinitis, pruritus), esophageal varicose veins, adrenal gland diseases, arterial hypertension.

Drug interactions

With simultaneous use of acetylcysteine with antitussive drugs due to the suppression of the cough reflex, sputum in the bronchi may be stagnant. Before prescribing such a combination therapy, a thorough assessment of the patient’s condition is necessary.

Current reports that acetylcysteine inactivates antibacterial drugs such as tetracyclines (with the exception of doxycycline), aminoglycosides, cephalosporins, penicillins (ampicillin), and antifungal drugs (amphotericin B) are exclusively related to in vitro studies (pharmaceutical incompatibility). However, antimicrobials for oral administration and drug ACC® Active should be used at intervals of at least 2 hours (not applicable to cefixime and loracarbef).

Simultaneous use with acetylcysteine can lead to increased vasodilator and antiplatelet effects of nitroglycerin. If the combined use of nitroglycerin and acetylcysteine is required, the patient’s condition should be monitored for potential development of arterial hypotension (sometimes severe, headache can manifest).

The simultaneous use of acetylcysteine and carbamazepine can be expressed in reducing the concentration of carbamazepine to the subtherapeutic level.

The simultaneous use of Activated charcoal can reduce the effect of acetylcysteine.

Acetylcysteine eliminates the toxic effects of paracetamol.

Special instructions

Patients with bronchial asthma and obstructive bronchitis, acetylcysteine should be administered with caution under systemic control of bronchial patency. If the patient is not able to effectively cough, it is necessary to drain or aspirate the secret.

When using acetylcysteine, very rarely there have been reported cases of severe allergic reactions, such as Stevens-Johnson syndrome and Lyell's syndrome.In the event of changes in the skin and mucous membranes should immediately consult a doctor, the drug should be stopped.

Do not take the drug immediately before bedtime (it is recommended to take the drug before 18.00).

Impact on laboratory data. Acetylcysteine can influence the results of colorimetric determination of plasma salicylate concentrations. In urine analysis, acetylcysteine can influence the results of the determination of ketone bodies.

Influence on ability to steer vehicles, mechanisms

Acetylcysteine does not affect the ability to drive and operate machinery.

Overdosage

Cases of toxic overdose while taking acetylcysteine inside are not described. Acetylcysteine, when taken in doses up to 500 mg / kg / day, did not cause overdose symptoms. Healthy volunteers received acetylcysteine at a dose of 11.6 g per day for 3 months without developing any serious adverse reactions.

Symptoms: Gastrointestinal symptoms such as nausea, vomiting and diarrhea may occur.

Treatment: symptomatic therapy if necessary.