ACC 100 effervescent tablets 100 mg, 20 pcs. (Acetylcysteine)

Latin name

ACC 100



packaging 20 pcs

Pharmacological action

Pharmacodynamics

Acetylcysteine ​​is a derivative of the amino acid cysteine. It has a mucolytic effect, facilitates sputum discharge due to 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 the 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 oxidizing 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 “first pass” effect through the liver). The time to reach maximum concentration (Cmax) in blood plasma is 1 to 3 hours. Communication with plasma proteins is 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 associated with the formation of viscous, difficult to separate sputum: acute and chronic

bronchitis, obstructive bronchitis

tracheitis, laryngotracheitis

pneumonia

lung abscess

bronchiectatic disease, bronchial asthma, chronic obstructive pulmonary disease (COPD), bronchiolitis

cystic fibrosis, and moderate otitis media (acute inflammation).

Contraindications

Hypersensitivity to acetylcysteine ​​or other components of the drug

peptic ulcer of the stomach and duodenum in the acute stage

pregnancy

breastfeeding

hemoptysis, pulmonary hemorrhage

lactase deficiency, lactose intolerance, glucose-galactose malabsorption

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

WITH CAUTION

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

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 effervescent tablet contains: active substance:

acetylcysteine ​​- 100, 00 mg

excipients:

citric acid anhydrous - 679.85 mg

sodium bicarbonate - 194.00 mg

sodium carbonate anhydrous - 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

blackberry flavor “B” - 20.00 mg.

Dosage and Administration

Inside, after meals.

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. An additional liquid intake enhances the mucolytic effect of the drug. For short-term colds, the duration of administration is 5 to 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 to 3 times a day (400 to 600 mg each)

children 6 to 14 years old: 1 effervescent tablet 3 times a day, or 2 effervescent tablets 2 times a day (300 - 400 mg)

children from 2 to 6 years: 1 effervescent tablet 2 to 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 old: 2 effervescent tablets 3 times a day (600 mg).

Side effects of

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)

Respiratory

system rarely: shortness of breath, bronchospasm (mainly in patients with bronchial asthma hyperresponsiveness)

From the sensory organs

infrequently: tinnitus

From the gastrointestinal tract

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

Other

infrequently: 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 antitussives are used concurrently, sputum stagnation may occur. When co-administered with antibiotics for oral administration (penicillins, tetracyclines, cephalosporins, etc.), their interaction with the thiol group of acetylcysteine ​​is possible, which can 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 loracarbene). Co-administration with vasodilating agents and nitroglycerin can lead to increased vasodilator action.

overdose

Symptoms: when mistaken or intentional overdose occurs, such as diarrhea, vomiting, stomach pain, heartburn and nausea.

Treatment: symptomatic.

Storage conditions

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

Expiration

3 years.

Deystvuyuschee

acetylcysteine ​​



pharmacy dispensing terms without a prescription

dosage form

dosage form

tablets soluble



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