Acetylcysteine - instructions for use, dose, side effects, contraindications

Excipients: ascorbic acid 25 mg, sodium carbonate anhydrous 93 mg, sodium hydrogen carbonate 894 mg, citric acid anhydrous 998 mg sorbitol 695 mg macrogol 6000 70 mg sodium citrate 500 mg sodium saccharate 5 mg, flavoring lemon - 20 mg.

Description:

Round flat cylindrical tablets of white or almost white color with a facet, a rough surface and a weak characteristic smell.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

S.01.X.A.08 Acetylcysteine

R.05.C.B.01 Acetylcysteine

Pharmacodynamics:

The presence of sulfhydryl groups in the structure of acetylcysteine promotes the rupture of disulfide bonds of acid mucopolysaccharides of sputum, which leads to a reduction in the viscosity of mucus. It has a mucolytic effect, facilitates the escape of sputum due to a direct effect on the rheological properties of sputum. The drug remains active in the presence of purulent sputum.

With the preventive use of acetylcysteine, there is a decrease in the frequency of severity of exacerbations in patients with chronic bronchitis and cystic fibrosis.

Pharmacokinetics:

Acetylcysteine is rapidly absorbed when taken orally, but because of the high "first pass" effect through the liver (deacetylation with the formation of cysteine), its bioavailability is about 10%.

After oral administration, its maximum concentration in the blood plasma is achieved in 1-3 hours, with blood plasma proteins bind 50% of its amount. The drug penetrates the placental barrier, accumulates in the amniotic fluid. The half-life period is 1 hour, with cirrhosis of the liver it increases to 8 hours. Displayed acetylcysteine mainly kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part of it is excreted unchanged by the intestine.

Indications:

- Diseases of the respiratory system, accompanied by the formation of viscous hard-to-detachable sputum: acute and chronic bronchitis, obstructive bronchitis, laryngotracheitis, pneumonia, bronchiectasis, bronchial asthma, bronchiolitis, cystic fibrosis;

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

- chronic obstructive pulmonary disease (COPD).

Contraindications:

- Hypersensitivity to acetylcysteine or other components of the drug;

- children's age till 14 years;

- pregnancy and the period of breastfeeding;

- intolerance to fructose, tk. the preparation contains sorbitol.

Carefully:

- Stomach ulcer and duodenal ulcer in anamnesis;

- hemoptysis;

- pulmonary hemorrhage;

varicose veins of the esophagus;

- adrenal gland diseases;

- Hepatic and / or renal insufficiency;

- intolerance to histamine (acetylcysteine affects the metabolism of histamine and can lead to signs of intolerance, such as headache, vasomotor rhinitis, itching);

- bronchial asthma.

Pregnancy and lactation:

For safety reasons, due to the lack of data during pregnancy and lactation, the use of the drug is contraindicated.

Dosing and Administration:

Inside.

Effervescent tablets should be dissolved in a single glass of water and taken after meals. Tablets should be taken immediately after dissolution, in exceptional cases, you can leave ready-to-use solution for 2 hours.

In the absence of other prescriptions, it is recommended to adhere to the following dosages: 2-3 times a day for 1 effervescent tablet (400-600 mg of acetylcysteine per day). With short-term catarrhal diseases, the duration of admission is 5-7 days. For long-term illnesses, the duration of therapy is determined by the attending physician.

In chronic bronchitis, the drug should be taken for a longer time to achieve a preventive effect in infections.

Side effects:

The incidence of adverse events is classified according to the recommendations

World Health Organization:

very often: ≥ 1/10 (> 10%);

often: from ≥ 1/100 to <1/10 (> 1% and <10%);

infrequently: from ≥ 1/1000 to <1/100 (> 0.1% and <1%);

rarely: from ≥ 1/10000 to <1/1000 (> 0.01% and <0.1%);

very rarely: <1/10000 (0.01%);

frequency is unknown: the frequency can not be estimated from the available data.

From the nervous system:

rarely - a headache.

From the digestive system:

rarely - inflammation of the oral mucosa (stomatitis);

very rarely - diarrhea, vomiting, heartburn, nausea;

frequency is unknown - dyspepsia.

From the cardiovascular system.

very rarely - a drop in blood pressure, an increase in heart rate (tachycardia).

Allergic reactions:

very rarely - bronchospasm (mainly in patients with bronchial hyperreactivity), skin rash, skin itching, urticaria, exanthema, angioedema, anaphylactic reactions up to shock, bleeding due to the presence of hypersensitivity reactions;

frequency unknown - Stevens-Johnson syndrome and Lyell syndrome, toxic epidermal necrolysis.

Other:

rarely - noise in the ears, shortness of breath;

frequency unknown - decreased platelet aggregation.

With the development of side effects, you should cancel the drug and consult a doctor.

Overdose:

In case of erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pain, heartburn and nausea are observed. To date, no serious and life-threatening side effects have been observed. Treatment is symptomatic.

Interaction:

With concomitant use of acetylcysteine and antitussive agents, mucus congestion may occur due to suppression of the cough reflex. Therefore, such combinations should be selected with caution.

Simultaneous intake of acetylcysteine and nitroglycerin may lead to an increase in the vasodilator effect of the latter.

Pharmaceutically incompatible with antibiotics (penicillins, cephalosporins, erythromycin, tetracycline and amphotericin B) and proteolytic enzymes. Upon contact with metals, rubber, sulphides with a characteristic odor are formed.Reduces the absorption of penicillins, cephalosporins, tetracycline (they should be taken no earlier than 2 hours after ingestion of acetylcysteine).

Special instructions:

Additional fluid intake enhances the mucolytic effect of the drug.

Patients with bronchial asthma and obstructive bronchitis acetylcysteine should be administered with caution under the systematic control of bronchial patency. When working with the drug should use glassware, avoid contact with metals, rubber, oxygen, easily oxidizable substances.

For patients with diabetes mellitus:

1 effervescent tablet corresponds to 0.058 bread. units

Effect on the ability to drive transp. cf. and fur:

Data on the negative effect of the drug at recommended doses on the ability to drive vehicles and perform other activities that require concentration of attention and speed of psychomotor reactions are not.

Form release / dosage:The effervescent tablets are 200 mg.

Packaging:

24 tablets in a polypropylene case, sealed with a polyethylene plug with silica gel.

4 tablets in a planar cell box made of lacquered aluminum foil and laminated aluminum foil.

2 tablets in contour non-jammed packaging from laminated paper.

A pencil, 6 of cellular contour packs or packages contour bezgyachakova 12 together with instructions for medical use in a stack of cardboard.

Storage conditions:

Store in a dry place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:3 of the year.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002771

Date of registration:17.12.2014 / 05.05.2016

Expiration Date:17.12.2019

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VITALE-XD, Ltd. Estonia

Information update date: & nbsp02.10.2017

Illustrated instructions

Instructions

Acetylcysteine (Acetylcysteine)