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

Sinusitis, Lung inflammation (pneumonia), Sore throat, Tracheitis, Otitis, Bronchitis, Chronic obstructive pulmonary disease, Guillotine, Cough

Respiratory diseases, accompanied by viscous sputum difficult to separate:

• acute and chronic bronchitis, obstructive bronchitis;
• tracheitis, laryngotracheitis;
• pneumonia;
• mucoviscidosis;

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

Active ingredient

Acetylcysteine

How to take, the dosage

Pellets should be dissolved in water, juice or cold tea and taken after meals. Additional fluid intake increases the mucolytic effect of the drug. In short-term colds the course is 5-7 days. For long-term illnesses, the course of therapy is determined by the attending physician.

In chronic bronchitis and cystic fibrosis the drug should be taken for a longer time to achieve a preventive effect in infections. In the absence of other prescriptions, it is recommended to adhere to the following dosages:

Mucolytic therapy:
adults and adolescents over 14 years: 2 sachets of AtsC® 100 mg or 1 sachet of AtsC® 200 mg 2-3 times a day (400-600 mg per day);
children from 6 to 14 years: 1 sachet 3 times a day or 2 sachets 2 times a day of AtsC® 100 mg (300-400 mg per day).

Acc® 200 mg should be taken 3 times a day in 1/2 sachet or 2 sachets 2 times a day in 1 sachet (300-400 mg per day);

Children from 2 to 6 years: 1 sachet of ACC® 100 mg or 1/2 sachet of ACC® 200 mg 2-3 times a day(200-300 mg per day).

Mucoviscidosis

Children over 6 years of age: 2 sachets of ACC® 100 mg or 1 sachet of ACC® 200 mg 3 times a day (600 mg per day); children from 2 to 6 years of age: 1 sachet of ACC® 100 mg or 1/2 sachet of ACC® 200 mg 4 times a day (400 mg per day); patients with a body weight ≥ 30 kg: if necessary, the dose may be increased to 800 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 antibiotics for oral administration (penicillins, tetracyclines, cephalosporins, etc.) their interaction with thiol group of acetylcysteine is possible, which may lead to reduction of their antibacterial activity.

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

Concomitant administration with vasodilators and nitroglycerin may lead to increased vasodilatory effects.

Special Instructions

NOTE FOR diabetic patients

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

DERIFICATIONS

When handling the drug it is necessary to use glassware, avoid contact with metals, rubber, oxygen, and easily oxidizing substances.

In the use of acetylcysteine very rarely cases of severe allergic reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome) have been reported. In case of changes of the skin and mucous membranes it is necessary to consult a physician immediately, the drug should be discontinued.

Do not take the drug immediately before going to bed (it is recommended to take the drug before 6 p.m.).

Impact on the ability to operate vehicles and other activities requiring concentration and quick psychomotor reactions

There are no data about negative effect of the drug AtsZ® in recommended doses on the ability to drive vehicles and perform other activities requiring concentration and quick psychomotor reactions.

Contraindications

• High sensitivity to acetylcysteine or other drug components;
• Gastric and duodenal ulcer, acute stage;
• bleeding, pulmonary hemorrhage;
sugar/isomaltase deficiency, fructose intolerance, glucose-galactose deficiency;
• pregnancy;
• period of breastfeeding;
• children under 6 years (for this dosage form).

With caution:
gastric and duodenal ulcer in anamnesis, arterial hypertension, 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 occurrence of intolerance symptoms, such as headache, vasomotor rhinitis, itching), esophageal varices, adrenal diseases.

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).

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

Sensory organs:
infrequent: tinnitus.

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

.

Overdose

Acetylcysteine at doses of 500 mg/kg/day does not cause signs and symptoms of overdose.

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

Treatment: symptomatic.

Pregnancy use

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

Similarities

ACS 200, ACS-long, Acetylcysteine, Fluimucil, Acetylcysteine Canon, Espa-Naz, Eifa AC