ACC effervescent tablets 200mg, No. 20

Diseases of the respiratory system, accompanied by the formation of viscous, difficult to separate sputum:

• acute and chronic bronchitis, obstructive bronchitis;

• tracheitis, laryngotracheitis;

• pneumonia;

• lung abscess;

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

• cystic fibrosis; Acute and chronic sinusitis, otitis media (otitis media).

Inside, after eating.
Effervescent tablets should be dissolved in one glass of water. The tablets should be taken immediately after
dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours. Additional
liquid intake enhances the mucolytic effect of the drug. For short-term colds, the
duration of admission is 5 - 7 days. In chronic bronchitis and cystic fibrosis, the drug should be
taken for a longer time to achieve a prophylactic effect against infections.
In the absence of other prescriptions, it is recommended to adhere to the following dosages:
Mucolytic therapy:
adults and children over 14 years of age: 1 effervescent tablet 2 - 3 times a day (400 - 600 mg);
children from 6 to 14 years old: 1 effervescent tablet 2 times a day (400 mg);
children from 2 to 6 years old: 1/2 effervescent tablet 2 - 3 times a day (200 - 300 mg).
Cystic fibrosis:
children from 2 to 6 years old: 1/2 effervescent tablet 4 times a day (400 mg);
children over 6 years old: 1 effervescent tablet 3 times a day (600 mg).

1 effervescent tablet contains:

active substance: acetylcysteine ??- 200.00 mg;

excipients: anhydrous citric acid - 558.50 mg; sodium bicarbonate - 200.00 mg; sodium carbonate anhydrous - 100.00 mg; mannitol - 60.00 mg; anhydrous lactose - 70.00 mg; ascorbic acid - 25.00 mg; sodium saccharinate - 6.00 mg; sodium citrate - 0.50 mg; blackberry flavoring 'B' - 20.00 mg.

• Hypersensitivity to acetylcysteine ??or other components of the drug;

• peptic ulcer of the stomach and duodenum in the acute stage;

• pregnancy;

• breastfeeding period;

• hemoptysis, pulmonary bleeding;

• lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

• children under 2 years of age (for this dosage form).

Mucolytic drug. 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 disulfide bonds of mucopolysaccharide chains and cause depolymerization of mucoproteins in sputum, which leads to a decrease in the viscosity of sputum. The drug remains active in the presence of purulent sputum.

It has an antioxidant effect due to 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 the protection of cells against the damaging effects of free radical oxidation inherent in an intense inflammatory response.

With the prophylactic use of acetylcysteine, there is a decrease in the frequency and severity of exacerbations in patients with chronic bronchitis and cystic fibrosis.

Pharmacokinetics

Absorption and distribution

The absorption is high. Oral bioavailability is 10%, which is due to the pronounced effect of the 'first pass' through the liver. The time to reach Cmax in blood plasma is 1-3 hours.

Plasma protein binding - 50%. Penetrates the placental barrier. There are no data on the ability of acetylcysteine ??to penetrate the BBB and be excreted in breast milk.

Metabolism and excretion

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

It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). T1 / 2 is about 1 hour.

Pharmacokinetics in special clinical situations

Liver dysfunction leads to an increase in T1 / 2 up to 8 hours.

Side effect

Allergic reactions: infrequently - itching, rash, exanthema, urticaria, angioedema; very rarely - anaphylactic reactions up to 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 side of the cardiovascular system: infrequently - lowering blood pressure, tachycardia.

From the digestive system: infrequently - stomatitis, abdominal pain, nausea, vomiting, diarrhea, heartburn, dyspepsia.

On the part of the organ of hearing: infrequently - tinnitus.

Others: rarely - headache, fever; in isolated cases - the development of bleeding as a manifestation of a hypersensitivity reaction, a decrease in platelet aggregation.

Application during pregnancy and lactation

Due to insufficient data, the use of the drug during pregnancy is contraindicated.

For syrup: the use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

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

Application for violations of liver function

The drug should be used with caution in liver failure.

Application for impaired renal function

The drug should be used with caution in renal failure.

special instructions

In bronchial asthma and obstructive bronchitis, acetylcysteine ??should be prescribed with caution under the systematic monitoring of bronchial patency.

With the use of acetylcysteine, cases of severe allergic reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported very rarely. If changes occur in the skin and mucous membranes, the patient should immediately stop taking the drug and consult a doctor.

It is not recommended to prescribe the drug to patients with renal and / or hepatic insufficiency in order to avoid additional formation of nitrogenous compounds.

When dissolving the drug, it is necessary to use glassware, avoid contact with metals, rubber, oxygen, easily oxidized substances.

You should not take the drug immediately before bedtime (the preferred time of admission is before 18.00).

When prescribing the drug to patients on a diet aimed at limiting sodium intake, it should be borne in mind that 1 ml of ACC syrup contains 41.02 mg of sodium.

There is no need for special precautions when disposing of unused ACCЃ.

Directions for patients with diabetes mellitus

When treating patients with diabetes mellitus, it should be borne in mind that ACCЃ in the form of granules for the preparation of a solution for oral administration (200 mg, 600 mg, orange 100 mg and 200 mg) contain sucrose.

ACCЃ in the form of granules for the preparation of a solution for oral administration / orange / 100 mg and 200 mg: 1 sachet of 100 mg corresponds to 0.24 XE, 1 sachet of 200 mg - 0.23 XE.

ACCЃ in the form of granules for the preparation of a solution for oral administration of 200 mg: 1 sachet corresponds to 0.21 XE.

ACCЃ in the form of granules for the preparation of a 600 mg oral solution: 1 sachet corresponds to 0.17 XE.

Influence on the ability to drive vehicles and use mechanisms

There is no information on the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Overdose

Acetylcysteine, when taken at a dose of 500 mg / kg / day, does not cause signs and symptoms of overdose.

Symptoms: in case of an erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pains, heartburn, nausea are observed.

Treatment: carrying out symptomatic therapy.

Drug interactions

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

With the simultaneous use of acetylcysteine ??and antibiotics for oral administration (penicillins, tetracyclines, cephalosporins, etc.), the latter may interact with the thiol group of acetylcysteine, which can lead to a decrease in antibacterial activity. Therefore, the interval between taking antibiotics and acetylcysteine ??should be at least 2 hours (except for cefixime and loracarbef).

Simultaneous use with vasodilators and nitroglycerin can lead to an increase in the vasodilator effect.