ACC (Granules)

Active material: acetylcysteine
When ATH: R05CB01
CCF: Mucolytic drugs
ICD-10 codes (testimony): E84, H66, J01, J04, J15, J20, J21, J32, J37, J42, J44, J45, J47
When CSF: 12.02.01
Manufacturer: Hexal AG (Germany)

Pharmaceutical form, composition and packaging

◊ Granules for oral solution (orange) white, Homogeneous, without agglomerates, with the smell of orange.

Excipients: vitamin C, saxarin, sucrose (sucrose), orange flavor.

3 g – sandwich bags (20) – packs cardboard.

◊ Granules for oral solution white, Homogeneous, not larger than 1.5 mm, without agglomerates and mechanical impurity, with the scent of lemon and honey.

Excipients: vitamin C, saxarin, sucrose (sucrose), lemon and honey flavors.

3 g – bags (6) – packs cardboard.
3 g – bags (10) – packs cardboard.
3 g – bags (20) – packs cardboard.

◊ Granules for syrup white to yellowish, Homogeneous, without agglomerated particles, with the smell of orange.

Excipients: metilparagidroksiʙenzoat, propilparagidroksibenzoat, sorbitol, sodium citrate, orange flavor.

30 g (for the preparation of 75 ml syrup) – vials of dark glass (1) complete with measuring spoon – packs cardboard.
60 g (for the preparation of 150 ml syrup) – vials of dark glass (1) complete with measuring spoon – packs cardboard.

Pharmacological action

Mucolytic drugs. The presence in the structure of the molecule acetylcysteine ​​sulfhydryl groups helps break the disulfide bonds of acid mucopolysaccharides sputum, which reduces the viscosity of mucus. The drug remains active in the presence of purulent sputum.

When prophylactic use of acetylcysteine ​​marked decrease in the frequency and severity of exacerbations in patients with chronic bronchitis and cystic fibrosis.

Pharmacokinetics

Data on drug farmkokinetike ACC^® not provided.

Testimony

- Respiratory diseases, accompanied by increased production of viscous mucus trudnootdelyaemoy (acute and chronic bronchitis, obstructive bronchitis, pneumonia, bronchiectasis, bronchial asthma, Bronchiolitis, mukovystsydoz, laringit);

- Acute and chronic sinusitis;

- Otitis media.

Dosage regimen

Adults and adolescents over 14 years It recommended to prescribe the drug for 200 mg 2-3 times / day (ACC^® in the form of granules for oral solution / orange / 100 mg 200 mg), or 200 mg 3 times / day (ACC^® in the form of granules for oral solution 200 mg) or 600 mg 1 time / day (ACC^® in the form of granules for oral solution 600 mg), or 2 measuring spoons syrup (10 ml) 2-3 times / day (ACC^® in the form of granules for syrup).

Children aged 6 to 14 years It is recommended to take 100 mg 3 times / day, or 200 mg 2 times / day (ACC^® in the form of granules for oral solution / orange / 100 mg 200 mg), or 200 mg 2 times / day (ACC^® in the form of granules for oral solution 200 mg), or 1 measuring spoon syrup (5 ml) 3-4 times / day (ACC^® in the form of granules for syrup).

Children aged 2 to 5 years the drug is recommended to take 100 mg 2-3 times / day (ACC^® in the form of granules for oral solution / orange / 100 mg 200 mg), or 1 measuring spoon syrup (5 ml) 2-3 times / day (ACC^® in the form of granules for syrup).

Children aged less than 2 years the drug is recommended to take 1/2 measuring spoon syrup (2.5 ml) 2-3 times / day (ACC^® in the form of granules for syrup).

There is no sufficient data on the dosage of the drug in Newborn.

At mukovystsydoze children over the age of 6 years the drug is recommended to take 200 mg 3 times / day (ACC^® in the form of granules for oral solution / orange / 100 mg 200 mg or ACC^® in the form of granules for oral solution 200 mg) or 2 measuring spoons syrup (10 ml) 3 times / day (ACC^® in the form of granules for syrup). Children aged 2 to 5 years – by 100 mg 4 times / day (ACC^® in the form of granules for oral solution / orange / 100 mg 200 mg) or 1 measuring spoon syrup (5 ml) 4 times / day (ACC^® in the form of granules for syrup). Patients with weighing more than 30 kg cystic fibrosis, if necessary dose can be increased to 800 mg / day.

Infants from the 10th day of life or children under the age of 2 years the drug is recommended to take 1/2 measuring spoon syrup (2.5 ml) 3 times / day (ACC^® in the form of granules for syrup). Treatment is initiated under medical supervision.

At sudden short-term colds The duration of intake of 5-7 days. At chronic bronchitis and cystic fibrosis drug should be used more long-term to prevent infections.

The drug should be taken after meals. Additional fluid intake increases mucolytic effect of the drug.

Rules of drug preparation

ACC^® in the form of granules for oral solution / orange / 100 mg 200 mg: 1/2 or 1 bag (dose dependent) dissolved in water, juice or cold tea and taken after meals.

ACC^® in the form of granules for oral solution 200 mg and ACC^® in the form of granules for oral solution 600 mg: 1 sachet dissolved with stirring 1 a glass of hot water and drink, possibly, hot. If necessary, the prepared solution can be left on the 3 no.

ACC^® in the form of granules for syrup: for the preparation of the syrup into the flask to the annular mark is necessary to add potable water at room temperature.

Side effect

CNS: rarely – headache, noise in ears.

From the digestive system: rarely – stomatitis; in some cases – diarrhea, vomiting, heartburn and nausea.

Cardio-vascular system: in some cases – drop in blood pressure, tachycardia.

The respiratory system: in a few cases – development of pulmonary hemorrhage as a manifestation of hypersensitivity reactions.

Allergic reactions: in a few cases – bronchospasm (predominantly in patients with bronchial hyperreactivity system in bronchial asthma), skin rash, itching and hives.

Contraindications

- Gastric ulcer and duodenal ulcer in the acute phase;

- Hemoptysis;

- Pulmonary hemorrhage;

- Pregnancy;

- Lactation (breast-feeding);

- Children up to age 2 years (the drug in the form of granules for oral solution / orange / 100 mg 200 mg);

- Children up to age 6 years (the drug in the form of granules for oral solution 200 mg);

- Children up to age 14 years (the drug in the form of granules for oral solution 600 mg);

- Hypersensitivity to acetylcysteine ​​and other ingredients.

FROM caution should use the drug in patients with esophageal varices, at increased risk of pulmonary hemorrhage and hemoptysis, bronchial asthma, diseases of the adrenal glands, hepatic and / or renal failure.

Pregnancy and lactation

Because of the lack of data the use of the drug during pregnancy and lactation is possible only in cases, when the intended benefits to the mother outweighs the potential risk to the fetus or child.

Cautions

In bronchial asthma and obstructive bronchitis acetylcysteine ​​should be used with caution under the systematic control of bronchial obstruction.

In developing side effects should stop taking the drug.

The dissolution of the drug must be used glassware, avoid contact with metals, Rubber, oxygen, easily oxidized substances.

ACC^® (in the form of granules for oral solution / orange / 100 mg 200 mg) 100 corresponds mg 0.24 HE, 200 mg – 0.23 HE.

ACC^® (in the form of granules for oral solution 200 mg) matches 0.21 HE, ACC (in the form of granules for oral solution 600 mg) – 0.17 HE.

ACC^® (in the form of granules for syrup) 10 ml (2 measuring spoons) contains 3.7 g sorbitol (D-glucitol), corresponding 0.31 HE.

Overdose

Symptoms: possible diarrhea, vomiting, stomachache, heartburn, nausea.

Treatment: symptomatic therapy.

Drug Interactions

With simultaneous use of acetylcysteine ​​and antitussives for suppressing the cough reflex might be dangerous stagnation of mucus (combination used with caution).

At the same time taking acetylcysteine ​​and nitroglycerin may increase the effect of vasodilator nitroglycerin.

There synergism acetylcysteine ​​with bronchodilators.

Acetylcysteine ​​pharmaceutically incompatible with antibiotics (penicillins, cephalosporins, Erythromycin, tetracycline and amphotericin B) and proteolytic enzymes.

Acetylcysteine ​​reduces the absorption of cephalosporins, penicillin and tetracycline, therefore they should be taken orally no earlier than 2 hours after receiving acetylcysteine.

Upon contact with metals acetylcysteine, rubber formed sulfide with a characteristic odor.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored in a dry, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 3 year, the shelf life of granules for oral solution (orange) – 4 year.

The prepared syrup can be stored in the refrigerator 12 days.