ATS powder for preparation of solution 200mg orange sachets, 20pcs

Composition

1 sachet contains Active ingredient: acetylcysteine-100.0 / 200.0 mg; excipients: sucrose-2829.5 / 2717.0 mg; ascorbic acid-12.5 / 25.0 mg; saccharin-8.0 / 8.0 mg; orange flavor-50.0/50.0 mg

Pharmacological action

Pharmacodynamics

Acetylcysteine is a derivative of the amino acid cysteine. It has a mucolytic effect, facilitates sputum discharge by directly affecting the rheological properties of sputum. The effect is due to the ability to break 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 body’s antioxidant system and chemical detoxification.

The antioxidant effect of acetylcysteine increases the protection of cells from the damaging effect 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 rapidly metabolized in the liver with the formation of a pharmacologically active metabolite-cysteine, as well as diacetylcysteine, cystine and mixed disulfides. Oral bioavailability is 10% (due to the presence of a pronounced “first pass” effect through the liver). The time to reach the maximum concentration in blood plasma is 1-3 hours.

Binding to plasma proteins is 50%. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). The half-life (T 1/2) is about 1 hour, impaired liver function leads to an elongation of T1 / 2 to 8 hours. It penetrates the placental barrier. There are no data on the ability of acetylcysteine to cross the blood-brain barrier and be excreted in breast milk.

Indications

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

• 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).

Use during pregnancy and lactation

Data on the use of acetylcysteine during pregnancy and lactation are limited, so the use of the drug during pregnancy is contraindicated. If it is necessary to use the drug during lactation, the question of stopping breastfeeding should be decided.

Contraindications

• Hypersensitivity to acetylcysteine or other components of the drug; 
• acute peptic ulcer of the stomach and duodenum;
• hemoptysis, pulmonary bleeding;
• sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose insufficiency;
• pregnancy;
• breast-feeding period;
• children under 6 years of age (for this dosage form).

With caution: a history of gastric and duodenal ulcers, hypertension, bronchial asthma, obstructive bronchitis, liver and/or kidney 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, pruritus), esophageal varicose veins, esophageal diseases the adrenal glands.

Side effects

According to the World Health Organization (WHO), adverse events 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 (

Allergic reactions:

infrequently: pruritus, rash, exanthema, urticaria, angioedema, decreased blood pressure, tachycardia; very rarely: anaphylactic reactions up to anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome).

Respiratory system disorders: rarely: shortness of breath, bronchospasm (mainly in patients with bronchial hyperreactivity in bronchial asthma).

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

From the side of the senses: infrequently: tinnitus.

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

Interaction

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

When used concomitantly 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 taking antibiotics and acetylcysteine should be at least 2 hours (except for cefixime and loracarbef).

Concomitant use with vasodilators and nitroglycerin may lead to an increased vasodilator effect.

How to take, course of use and dosage

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

For 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 of age: 2 sachets of ADC ® 100 mg or 1 sachet of ADC® 200 mg 2-3 times a day (400-600 mg per day); children from 6 to 14 years of age: 1 sachet 3 times a day or 2 sachets 2 times a day of ADC® 100 mg (300-400 mg per day).

ACC ® 200 mg should be taken 3 times a day for 1/2 sachet or 2 times a day for 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).

Cystic fibrosis

children over 6 years: 2 sachets of ACC® 100 mg or 1 sachet of ACC® 200 mg 3 times daily (600 mg per day); children 2 to 6 years: 1 sachet ACC® 100 mg, or 1/2 bag of ACC® 200 mg 4 times daily (400 mg daily); patients with body weight ≥ 30 kg: if necessary, may increase the dose to 800 mg.

Overdose

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

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

Treatment: symptomatic.

Special

instructions FOR PATIENTS WITH DIABETES MELLITUS

When treating patients with diabetes mellitus, it should be taken into account that the drug contains sucrose. Note for patients with diabetes mellitus: 1 sachet of ADC ® 100 mg corresponds to 0.24 XE. 1 sachet of ADC® 200 mg corresponds to 0.23 XE.

SPECIAL INSTRUCTIONS

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

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

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

EFFECT ON THE ABILITY TO DRIVE VEHICLES, MECHANISMS

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

Form of production

Granules for making syrup

Storage conditions

The drug should be stored in a dry, inaccessible place for children at a temperature not exceeding 25°C.

Shelf

life is 3 years.

Active ingredient

Acetylcysteine

Dosage form

powder for oral use

Purpose

For adults and Children over 6 years of age

Indications

Tracheitis, Otitis Media, Sinusitis, Bronchitis, Sinusitis, Cough, Chronic Obstructive pulmonary Disease, Pneumonia