ACC 100,100 mg 20 pcs

Pharmacodynamics

Acetylcysteine is a derivative of the amino acid cysteine. It has mucolytic action, facilitates expectoration of sputum through a direct effect on the rheological properties of sputum.

The action is caused by its ability to break disulfide bonds of mucopolysaccharide chains and cause depolymerization of mucoproteins of sputum, which leads to decrease of sputum viscosity. The drug retains activity in the presence of purulent sputum.

It has an antioxidant effect, based on the ability of its reactive sulfhydryl groups (SH-groups) to bind to oxidizing radicals and thus neutralize them.

Acetylcysteine also promotes the synthesis of glutathione, an important component of the antioxidant system and chemical detoxification of the body. Antioxidant effect of acetylcysteine increases protection of cells against the damaging effects of free-radical oxidation inherent in the intense inflammatory reaction.

In prophylactic use of acetylcysteine decrease of frequency and severity of exacerbations of bacterial etiology in patients with chronic bronchitis and cystic fibrosis is noted.

Pharmacokinetics

Absorption is high. It is rapidly metabolized in the liver to form pharmacologically active metabolite – cysteine, as well as diacetylcysteine, cystine and mixed disulfides.

The bioavailability when taken orally is 10% (due to the pronounced effect of “first passage” through the liver). Time of reaching maximum concentration (Cmax) in blood plasma is 1 – 3 hours. Blood plasma protein binding is 50%. It is excreted by kidneys as inactive metabolites (inorganic sulfates, diacetylcysteine).

The elimination half-life (T1/2) is about 1 h, liver dysfunction leads to prolongation of T1/2 up to 8 h. It penetrates through the placental barrier. There is no data on the ability of acetylcysteine to penetrate through the blood-brain barrier and excreted with breast milk.

Indications

Respiratory diseases accompanied by viscous sputum that is difficult to detach:

acute and chronic bronchitis, obstructive bronchitis;

tracheitis, laryngotracheitis;

pneumonia;

lung abscess;

bronchiectatic disease, bronchial asthma, chronic obstructive pulmonary disease (COPD), bronchiolitis;

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cystic fibrosis;

Acute and chronic sinusitis, middle ear inflammation (otitis media).

Active ingredient

How to take, the dosage

Ingestion, after meals.

The effervescent tablets should be dissolved in one glass of water. Tablets should be taken immediately after dissolution, in exceptional cases it is possible to leave the ready to use solution for 2 hours. Additional fluid intake enhances the mucolytic effect of the drug. In short-term colds, the duration of intake is 5 – 7 days. In chronic bronchitis and cystic fibrosis the drug should be taken for a longer time to achieve a preventive effect.

In the absence of other prescriptions, it is recommended that the following dosages be followed:

Mucolytic therapy:
adults and children over 14 years: 2 effervescent tablets 2 – 3 times a day (400 – 600 mg);
children from 6 to 14 years: 1 effervescent tablet 3 times a day, or 2 effervescent tablets 2 times a day (300 – 400 mg);
children 2 to 6 years: 1 effervescent tablet 2 – 3 times a day (200 – 300 mg).

Mucoviscidosis:
children 2 to 6 years: 1 effervescent tablet 4 times a day (400 mg);
children over 6 years: 2 effervescent tablets 3 times a day (600 mg).

Interaction

In concomitant use of acetylcysteine and cough suppressants due to suppression of the cough reflex sputum congestion may occur.

In concomitant use with oral antibiotics (penicillins, tetracyclines, cephalosporins, etc.) they may interact with the thiol group of acetylcysteine, which may lead to a decrease in their antibacterial activity.

Therefore, the interval between the administration of antibiotics and acetylcysteine should be at least 2 hours (except for cefixime and loracarben). Concomitant use with vasodilators and nitroglycerin may lead to increased vasodilatory effects.

Special Instructions

When working with the drug it is necessary to use glassware, avoid contact with metals, rubber, oxygen, easily oxidizing substances.
When using acetylcysteine very rarely reported cases of severe allergic reactions such as Stevens-Johnson syndrome and Lyell syndrome. In case of changes in the skin and mucous membranes should immediately consult a doctor, the drug should be stopped.
Patients with bronchial asthma and obstructive bronchitis acetylcysteine should be prescribed with caution under systemic bronchial patency control.
The drug should not be taken immediately before going to bed (we recommend taking the drug before 18.00).

Impact on the ability to operate vehicles, machinery

There are no data about negative effect of ACC® 100 in recommended doses on the ability to operate vehicles, machinery.

Contraindications

WARNING

Gastric and duodenal ulcer history, bronchial asthma, obstructive bronchitis, hepatic and/or renal failure, histamine intolerance (long-term use of the drug should be avoided because.acetylcysteine affects histamine metabolism and may lead to the signs of intolerance, such as headache, vasomotor rhinitis, itching), esophageal varices, adrenal diseases, arterial hypertension.

Side effects

According to the World Health Organization (WHO), adverse effects are classified according to their frequency of development as follows: Very common (≥1/10), common (≥1/100, < 1/10), infrequent (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000) and very rare (< 1/10000); frequency unknown (the incidence of events cannot be determined from available data).

Allergic reactions

infrequent: skin itching, rash, exanthema, urticaria, angioedema, decreased blood pressure, tachycardia;
very rare: anaphylactic reactions up to anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome).

Respiratory system disorders

Rarely: dyspnea, bronchospasm (mainly in patients with bronchial hyperresponsiveness in bronchial asthma).

Sensory organs

infrequent: tinnitus.

Gastrointestinal tract disorders

infrequent: stomatitis, abdominal pain, nausea, vomiting, diarrhea, heartburn, dyspepsia.

Other

infrequent: headache, fever, single reports of bleeding due to hypersensitivity reactions, decreased platelet aggregation.

Overdose

Symptoms: diarrhea, vomiting, stomach pain, heartburn and nausea are observed in case of an erroneous or deliberate overdose.

Treatment: symptomatic.

Pregnancy use

Similarities