ACC powder for solution preparation 200 mg orange sachets 20 pcs. (Acetylcytes stein)

Latin name

ACC

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). The time to reach maximum plasma concentration is 1-3 hours.

Communication with plasma proteins - 50%. It is excreted 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 viscous, difficult to separate sputum:

• acute and chronic bronchitis, obstructive bronchitis

• tracheitis, laryngotracheitis

• pneumonia, bronchitis, bronchitis, bronchitis 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

• sucrose deficiency, glucose malignancy, pregnancy failure breastfeeding

• Children under 6 years of age (for this dosage form).

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

Special instructions

INDICATIONS FOR PATIENTS WITH DIABETES

When treating patients with diabetes, it must be taken into account that the preparation contains sucrose.

Indication for patients with diabetes mellitus: 1 sachet of ACCВ® 100 mg corresponds to 0.24 XE.

1 sachet of ACCВ® 200 mg corresponds to 0.23 XE.

SPECIAL INSTRUCTIONS

When working with the drug, use glassware, avoid contact with metals, rubber, oxygen, and easily oxidized substances.

Cases of severe allergic reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome) have been very rarely reported with acetylcysteine. If changes in the skin and mucous membranes occur, you should immediately consult a doctor, taking the drug must be stopped.

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

INFLUENCE ON THE ABILITY TO DRIVE VEHICLES, MECHANISMS

There is no evidence of the negative effect of the ACCВ® drug in recommended doses on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions.



composition 1 sachet contains

active substance:

acetylcysteine ??- 100.0 / 200.0 mg

excipients: sucrose - 2829.5 / 2717.0 mg

ascorbic acid - 12.5 / 25.0 mg

s Harin - 8.0 / 8.0 mg orange flavoring

- 50.0 / 50.0 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. With 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: 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: 1 sachet of ATSTS® 100 mg or 1/2 sachet of ATSTs® 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 Istemi: rare: dyspnoea, bronchoconstriction (mainly in patients with bronchial hyperreactivity in bronchial asthma)

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

From the sensory organs: infrequently: tinnitus.

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

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

When used simultaneously 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 cefixime and loracarbef).

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

Overdose

Acetylcysteine, when taken at doses of 500 mg / kg / day, does not cause any signs or 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

The product should be stored in a dry, out of reach of children at a temperature not exceeding 25 ° C.

Shelf life

3 years.

ka from drugstore

Without a prescription

dosage form

powder for oral

Prescription

Prescription

For adults, Children over 6 years old

sandwich, switzerland Switzerland



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