ACC, 200 mg orange 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. Its action is due to its ability to break disulfide bonds of mucopolysaccharide chains and cause depolymerization of mucoproteins of sputum, which leads to lower viscosity of sputum. The drug retains activity in the presence of purulent sputum.

It has antioxidant effect, based on the ability of its reactive sulfhydryl groups (SH-groups) to bind with oxidizing radicals and thus neutralize them. In addition, acetylcysteine promotes the synthesis of glutathione, an important component of the antioxidant system and chemical detoxification of the body.

The antioxidant action of acetylcysteine increases cell protection against the damaging effects of free-radical oxidation inherent in the intense inflammatory reaction.
When preventive use of acetylcysteine decrease the 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. Bioavailability with oral administration is 10% (due to the pronounced effect of “first passage” through the liver). Time of reaching maximum concentration in blood plasma is 1-3 hours.

The binding to plasma proteins is 50%. It is excreted by the 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 to 8 h. It penetrates through the placental barrier. There are no data on the ability of acetylcysteine to penetrate the blood-brain barrier and excreted with breast milk.

Indications

Respiratory diseases accompanied by the formation of viscous, difficult to separate sputum:

acute and chronic bronchitis, obstructive bronchitis;
tracheitis, laryngotracheitis;
pneumonia;
bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease (COPD), bronchiolitis;
cystic fibrosis;
Acute and chronic sinusitis, inflammation of the middle ear (otitis media).

Pharmacological effect

Pharmacodynamics

Acetylcysteine ​​is a derivative of the amino acid cysteine. It has a mucolytic effect, facilitates the discharge of sputum due to a direct effect on the rheological properties of sputum. The action is due to the ability to break the disulfide bonds of mucopolysaccharide chains and cause depolymerization of sputum mucoproteins, which leads to a decrease in sputum viscosity. The drug remains active 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 oxidative radicals and thus neutralize them. In addition, acetylcysteine ​​promotes the synthesis of glutathione, an important component of the antioxidant system and chemical detoxification of the body.

The antioxidant effect of acetylcysteine ​​increases cell protection from the damaging effects of free radical oxidation, which is characteristic of an intense inflammatory reaction.
With the prophylactic use of acetylcysteine, there is a decrease in the frequency and severity of exacerbations of bacterial etiology in patients with chronic bronchitis and cystic fibrosis.

Pharmacokinetics

Absorption is high. They are quickly metabolized in the liver to form a pharmacologically active metabolite – cysteine, as well as diacetylcysteine, cystine and mixed disulfides. Bioavailability after oral administration is 10% (due to the presence of a pronounced “first pass” effect through the liver). The time to reach maximum concentration in blood plasma is 1-3 hours.

Connection with blood plasma proteins – 50%. Excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). The half-life (T1/2) is about 1 hour, impaired liver function leads to an extension of T1/2 to 8 hours. Penetrates the placental barrier. There are no data on the ability of acetylcysteine ​​to penetrate the blood-brain barrier and be excreted in breast milk.

Special instructions

NOTICE FOR PATIENTS WITH DIABETES MELLITUS

When treating patients with diabetes, it is necessary to take into account that the drug contains sucrose.
Information for patients with diabetes mellitus:
1 sachet of ACC® 100 mg corresponds to 0.24 XE.
1 sachet of ACC® 200 mg corresponds to 0.23 XE.

SPECIAL INSTRUCTIONS

When working with the drug, you must use glass containers and avoid contact with metals, rubber, oxygen, and easily oxidized substances.

Cases of severe allergic reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell’s syndrome) have been very rarely reported with the use of acetylcysteine. If changes occur in the skin and mucous membranes, you should immediately consult a doctor and stop taking the drug.

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

INFLUENCE ON THE ABILITY TO DRIVE VEHICLES AND MECHANISMS

There is no data on the negative effect of ACC® in recommended doses on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions.

Active ingredient

Acetylcysteine

Composition

1 sachet contains

Pregnancy

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

Contraindications

Hypersensitivity to acetylcysteine ​​or other components of the drug;
peptic ulcer of the stomach and duodenum in the acute stage;
hemoptysis, pulmonary hemorrhage;
sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose deficiency;
pregnancy;
breastfeeding period;
children under 6 years of age (for this dosage form).
With caution:
history of gastric and duodenal ulcers, arterial hypertension, bronchial asthma, obstructive bronchitis, liver and/or renal failure, histamine intolerance (long-term use of the drug should be avoided, since acetylcysteine ​​affects the metabolism of histamine and can lead to signs of intolerance, such as headache, vasomotor rhinitis, itching), varicose veins dilatation of the veins of the esophagus, diseases of the adrenal glands.

Side Effects

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

Allergic reactions:

uncommon: 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’s syndrome).

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

From the gastrointestinal tract:
uncommon: stomatitis, abdominal pain, nausea, vomiting, diarrhea, heartburn, dyspepsia.

From the senses:
uncommon: tinnitus.

Other:
very rarely: headache, fever, isolated reports of bleeding due to a hypersensitivity reaction, decreased platelet aggregation.

Interaction

With the simultaneous use of acetylcysteine ​​and antitussives, sputum stagnation may occur due to suppression of the cough reflex.

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

Therefore, the interval between taking antibiotics and acetylcysteine ​​should be at least 2 hours (except for cefixime and loracarbef).

Simultaneous use with vasodilating agents and nitroglycerin can lead to increased vasodilatory effects.

Overdose

Acetylcysteine ​​when taken in doses of 500 mg/kg/day does not cause signs and symptoms of overdose.

In case of an erroneous or intentional overdose, phenomena such as diarrhea, vomiting, stomach pain, heartburn and nausea are observed.

Treatment: symptomatic.

Storage conditions

The drug should be stored in a dry place, out of reach of children, at a temperature not exceeding 25°C.

Shelf life

3 years.

Manufacturer

Lindopharm GmbH, Germany