acetylcysteine | ACC beggar for solution preparation 100 mg orange sachets 20 pcs.

Latin name

ACC

Release form oral solution for powder (orange)

3 g of powder in a bag of combined material (aluminum foil / paper / polyethylene).

20 and 50 sachets per carton box along with instructions for use.



packaging 20 pcs 100 mg each.

Pharmacological action

Pharmacodynamics

Acetylcysteine ​​is a derivative of the amino acid cysteine. It has a mucolytic effect, facilitates sputum discharge 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 mucoproteins of 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, 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 the protection of cells 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. It is 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 effect of "first passage" through the liver).

Time to reach maximum concentration (Cmax) in blood plasma is 1-3 hours. Communication with plasma proteins is 50%. It is excreted mainly 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 through the placental barrier. Data on the ability of acetylcysteine ​​to cross the blood-brain barrier and excreted in breast milk are not available.

Indications

respiratory diseases, accompanied by the formation of a viscous sputum:

acute and chronic bronchitis, obstructive bronchitis

tracheitis, laryngotracheitis

pneumonia, lung abscess

bronchiectasis

asthma

chronic obstructive pulmonary disease (COPD)

bronchiolitis, cystic fibrosis

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

Contraindications

Hypersensitivity to acetylcysteine ​​or other components of the

preparation gastric and duodenal ulcer in the acute stage

hemoptysis, pulmonary hemorrhage

intolerance 2 years (for this dosage form).

With caution - a history of gastric and duodenal ulcer, arterial hypertension, bronchial asthma, obstructive bronchitis, liver and / or renal failure, histamine intolerance (long-term use of the drug should be avoided, as acetylcysteine ​​affects histamine metabolism and can lead to signs of intolerance, such as headache, vasomotor rhinitis, pruritus), varicose veins of the esophagus, and adrenal disease.

Use during pregnancy and lactation

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

Composition

1 sachet contains:

Active ingredient: oval plantain seed shell (Plantago ovata Forssk.) 3.53 g

Excipients:

sucrose - 0.527 g,

sodium alginate - 0.276 g,

malate acetate - 0.193 g,

citric acid monohydrate - 0.137 g,

aspartame - 0.03 g,

natural orange flavor - 0.06 g excipients:

sucrose - 2829.5 / 2717,mg

Dosage and administration

Granules should be dissolved in water, juice or cold tea and taken after meals. An additional intake of fluid enhances the mucolytic effect of the drug. With short-term colds, the duration of 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 of age: 2 sachets of ACC® 100 mg or 1 sachet of ACC® 200 mg 2-3 times a day (400-600 mg per day)

Children 6 to 14 years of age: 1 sachet 3 times a day or 2 sachets 2 times a day ACC® 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 2 to 6 years old: 1 sachet of ACC® 100 mg or 1 / 2 sachets of ACC® 200 mg 2-3 times a day (200-300 mg per day).

Cystic fibrosis

children over 6 years of age: 2 sachets of ACC® 100 mg or 1 sachet of ACCS® 200 mg 3 times a day (600 mg per day) children 2 to 6 years old: 1 sachet of ACC® 100 mg or 1 / 2 sachets of ACC® 200 mg 4 times a day (400 mg per day) patients with body weight? 30 kg: if necessary, a dose increase of up to 800 mg is possible.

Side effects

According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: very often ( 1/10), often ( 1/100, Allergic reactions: infrequently: skin itching, rash , exanthema, urticaria, angioedema, lowering blood pressure,

tachycardia is very rare: anaphylactic reactions up to anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome)

From the respiratory Systemic: rare: shortness of breath, bronchospasm (mainly in patients with bronchial asthma hyperresponsiveness).

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

From the sensory organs: infrequently: noise in ears.

Other: very rare: headache, fever, isolated reports of the development of bleeding due to the presence of a hypersensitivity reaction, decreased platelet aggregation.

Drug Interaction

When acetylcysteine ​​and antitussive agents are used at the same time, sputum stasis may occur due to cough reflex suppression.

When used in conjunction with antibiotics for oral administration (penicillins, tetracyclines, cephalosporins, etc.), their interaction with the thiol group of acetylcysteine ​​may occur, which may lead to a decrease in their antibacterial activity. Therefore, the interval between the administration of antibiotics and acetylcysteine ​​should be at least 2 h (except cefixime and loracarb).

Concomitant administration with vasodilating agents and nitroglycerin can lead to increased vasodilator action.

Overdose

Acetylcysteine, when taken at doses of 500 mg / kg / day, causes no signs and symptoms of overdose. In the event of an erroneous or deliberate overdose, phenomena such as diarrhea, vomiting, stomach pain, heartburn and nausea are observed. Treatment: symptomatic.

Storage conditions

At a temperature not exceeding 25 РC.

Keep out of the reach of children.

The Expiration of

is 3 years.

Deystvuyuschee substances

acetylcysteine ​​

dosage form

dosage rma

oral solution dosage form

sandoz, switzerland