ACC 100 effervescent pills 100mg, 20pcs

Composition

1 effervescent tablet contains: Active ingredient: acetylcysteine-100,00 mg; excipients: citric acid anhydrous – 679,85 mg;sodium bicarbonate – of 194.00 mg;sodium carbonate anhydrous – of 97.00 mg;mannitol – 65,00 mg;lactose anhydrous – 75,00 mg;ascorbic acid – 12,50 mg;sodium saccharin – 6,00 mg;sodium citrate – 0,65 mg;flavoring Black Berry “In” – 20,00 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. It is rapidly metabolized in the liver to form 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 (Cmax) in the blood plasma is 1-3 hours. The 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 extension of T 1/2 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;

• lung abscess;

• 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 breastfeeding, you should decide whether to stop it.

Contraindications

• Hypersensitivity to acetylcysteine or other components of the drug; 
• acute peptic ulcer of the stomach and duodenum
• ; pregnancy
• ; breast-feeding;
• hemoptysis, pulmonary bleeding;
• lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• children under 2 years of age (for this dosage form).

CAUTION

gastric ulcer and duodenal ulcer in the anamnesis, bronchial asthma, obstructive bronchitis, liver and/or renal failure, hypersensitivity to histamine (avoid prolonged use of the drug because acetylcysteine affects the metabolism of histamine can cause symptoms of intolerance such as headaches, vasomotor rhinitis, itching), varicose veins of the esophagus, diseases of the adrenal hypertension.

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 reactionsincastly: 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).

From the respiratory system

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

From the side of the senses

infrequently: tinnitus.

From the gastrointestinal tract

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

Other

infrequently: 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 loracarben). Concomitant use with vasodilating agents and nitroglycerin may lead to increased vasodilator action.

How to take, course of use and dosage

Inside, after eating.

Effervescent tablets should be dissolved in one glass of water. Tablets should be taken immediately after dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours. Additional fluid intake increases 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 preventive effect.

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:  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 from 2 to 6 years:  take 1 effervescent tablet 2-3 times a day (200-300 mg).

Cystic fibrosis: children from 2 to 6 years old:  1 effervescent tablet 4 times a day (400 mg); children over 6 years of age:  2 effervescent tablets 3 times a day (600 mg).

Overdose

Symptoms: if an overdose is taken incorrectly or intentionally, it may cause diarrhea, vomiting, stomach pain, heartburn, and nausea.

Treatment: symptomatic.

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 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. In patients with asthma and obstructive bronchitis, acetylcysteine should be administered with caution under systemic monitoring of bronchial patency. 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® 100 in the recommended doses on the ability to drive vehicles and mechanisms.

Product form

round flat-cylindrical tablets of white color with the smell of blackberries. There may be a faint sulfur smell.

Storage conditions

In a dry place, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Acetylcysteine

Dosage form

soluble tablets

Purpose

Children over 2 years old, For adults

Indications

Tracheitis, Cough, Chronic Obstructive Pulmonary disease, Bronchitis, Pneumonia, Otitis Media, Sinusitis, Sinusitis