2010/12/12

ACC

Release form, composition and packing ACC 

Granules for solution for oral administration (orange), white, without agglomerates and impurities, with the smell of orange.

A pack. Acetylcysteine 100 mg - - 200 mg.

Other ingredients: ascorbic acid, saccharin, sucrose, orange flavor.

Granules for solution for oral administration in white, homogeneous, no larger than 1.5 mm, without agglomerates and impurities, with the smell of lemon and honey.

A pack. Acetylcysteine 200 mg - - 600 mg.

Other ingredients: ascorbic acid, saccharin, sukroza, honey and lemon flavors.

ATSTS ® 100

Effervescent tablets white, round, flat, with the smell of blackberries.

1 tab. NAC 100 mg.

Other ingredients: ascorbic acid, citric acid anhydride, anhydride, lactose, mannitol, sodium citrate, sodium hydrogen carbonate, saccharin, flavoring blackberry.

ATSTS ® 200

Effervescent tablets white, round, flat, with Valium, with the smell of blackberries. 1 tab. NAC 200 mg. Other ingredients: ascorbic acid, citric acid anhydride, anhydride, lactose, mannitol, sodium citrate, sodium hydrogen carbonate, saccharin, flavoring blackberry.

ATSTS ® LONG

Effervescent tablets white, round, smooth, with risk, with the smell of blackberries. 1 tab. NAC 600 mg.

Inactive ingredients: citric acid anhydrous, sodium bicarbonate, sodium carbonate anhydrous, mannitol, lactose anhydrous, ascorbic acid, sodium cyclamate, sodium saharinata dihydrate, sodium citrate dihydrate, blackberry flavor "B".

Clinico-pharmacological group: Mucolytic drug.

Pharmacological action

Mucolytic drug. That the structure of the molecule acetylcysteine sulfhydryl groups helps break the disulfide bonds of acid mucopolysaccharides of phlegm, 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 the pharmacokinetics ATSTS not given.

Statement
respiratory diseases associated with an increased formation of viscous mucus trudnootdelyaemoy (acute and chronic bronchitis, obstructive bronchitis, pneumonia, bronchiectasis, bronchial asthma, bronchiolitis, cystic fibrosis, laryngitis);
Acute and chronic sinusitis;
otitis media.

Dosing regimen

Adults and adolescents older than 14 years should appoint a drug to 200 mg 2-3 times / day (ATSTS ATSTS 100 or 200), or 200 mg 3 times / day (ATSTS in the form of granules for solution for oral administration of 200 mg) or 600 mg 1 time per day (ATSTS LONG ATSTS or in the form of granules for solution for oral administration of 600 mg).

Children aged 6 to 14 years is recommended to take 100 mg 3 times daily or 200 mg 2 times / day (ATSTS ATSTS 100 or 200) or 200 mg 2 times / day (ATSTS in the form of granules for solution for reception into 200 mg).

Children aged 2 to 5 years of preparation is recommended to take 100 mg 2-3 times / day (ATSTS ATSTS 100 or 200). In cystic fibrosis children aged> 6 years of preparation is recommended to take 200 mg 3 times / day (ATSTS 100, 200 or ATSTS ATSTS in the form of granules for solution for oral administration of 200 mg).

Children aged 2 to 6 years - 100 mg 4 times / day (ATSTS ATSTS 100 or 200).

Patients with body weight over 30 kg in cystic fibrosis and if you want to increase the dose to 800 mg / day. With a sudden short duration of colds reception is 5-7 days. In chronic bronchitis and cystic fibrosis drug should be used more long-term prevention of infections.

The drug should be taken after meals. Additional fluid intake increases the mucolytic effect of the drug. Effervescent tablets (ATSTS ATSTS 100 and 200) should be dissolved in 1 / 2 cup water, effervescent tablets (ATSTS LONG) should be dissolved in 1 cup of water.

Take immediately after the dissolution, in exceptional cases, you can leave a ready solution for 2 h. The pellets for hot beverages (1 sachet) was dissolved with stirring in 1 cup hot water and drink, if possible, hot. If necessary, you can leave the prepared solution at 3 pm

Granules for solution for oral administration (with the smell of an orange) should be dissolved in water, juice or cold tea, and taken after meals.

Side effect
CNS: Rarely - headaches, ringing in the 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.
With the respiratory system: in rare cases - the development of pulmonary hemorrhage as a manifestation of hypersensitivity reactions.

Allergic reactions: In rare cases - bronchospasm (predominantly in patients with hyperreactive bronchial system in bronchial asthma), skin rash, itching, and urticaria.

Contraindications
gastric ulcer and duodenal ulcer in acute phase;
hemoptysis;
pulmonary hemorrhage;
pregnancy;
Lactation (breastfeeding);
Children under the age of 6 years (the drug in the form of granules for solution for oral administration of 200 mg);
Children under the age of 14 years (dosage forms of the drug containing acetylcysteine 600 mg);
Hypersensitivity to acetylcysteine and other ingredients.

Caution should be used on patients with esophageal varices, with an increased risk of pulmonary hemorrhage and hemoptysis, bronchial asthma, diseases of the adrenal gland, liver and / or renal failure. ATSTS LONG should not be administered to children under the age of 14 years. This category of patients is recommended drug dosage forms for oral administration with a lower content of acetylcysteine.

Pregnancy and lactation

Due to insufficient data to use the drug during pregnancy and lactation is possible only in cases where the intended benefits to the mother outweighs the potential risk to the fetus or child.

Use in hepatic dysfunction

The drug should be used with caution in hepatic insufficiency.

Use in renal impairment

The drug should be used with caution in patients with renal insufficiency.

Cautions

Bronchial asthma and obstructive bronchitis acetylcysteine should be administered with caution under the systematic control of bronchial obstruction.

With the development of side effects should stop taking the drug. On dissolution of the drug must be used glassware, avoid contact with metal, rubber, oxygen, are easily oxidized substances.
1 tablet effervescent ATSTS ATSTS 100 and 200 corresponds to 0.006 XE.
1 tablet effervescent ATSTS LONG corresponds to 0.01 XE. ATSTS (in the form of granules for solution for oral administration of 200 mg) corresponds to 0.21 XE ATSTS (in the form of granules for the preparation of oral solution 600 mg) - 0.17 XE. ATSTS (in granules for solution for oral administration of 100 mg and 200 mg with the smell of an orange) 100 mg corresponds to 0.24 XE, 200 mg - 0.23 XE.

Use in pediatrics

Children under 6 years old are encouraged to nominate a drug in dosage forms with a lower content of acetylcysteine.

Overdose

Symptoms: may be diarrhea, vomiting, stomach pain, heartburn, nausea.

Treatment: symptomatic therapy of conduct.

Drug Interactions

With the simultaneous application of acetylcysteine and antitussives the suppression of the cough reflex may be dangerous stagnation of mucus (a combination used with caution).

With simultaneous administration of acetylcysteine and nitroglycerin may increase vasodilatory effect of nitroglycerin. Marked synergism acetylcysteine with bronchodilators.

Pharmaceutical interactions

Acetylcysteine pharmaceutically incompatible with antibiotics (penicillins, cephalosporins, erythromycin, tetracycline and amphotericin B) and proteolytic enzymes. Acetylcysteine reduces the absorption of cephalosporins, penicillins and tetracyclines, so they should ingest no earlier than 2 h after administration of acetylcysteine.