ATSTS inject - instructions for use, doses, side effects, contraindications

Stomach ulcer and duodenal ulcer in the stage of exacerbation; bronchial asthma; hepatic and / or renal insufficiency; intolerance to histamine (avoid prolonged use of the drug; acetylcysteine affects the metabolism of histamine and can lead to signs of intolerance, such as headache, vasomotor rhinitis, itching); children's age till 6 years. Children under the age of 1 year can use the drug only under the supervision of a doctor in a hospital in the presence of life indications.

Dosing and Administration:

Intravenous, intramuscular.

For intravenous administration the drug is used in the intensive care unit and only when it is impossible to use the medicinal forms of acetylcysteine for oral administration.

For intravenous administration, the first dose in a 1: 1 ratio is diluted with 0.9% sodium chloride solution or 5% dextrose (glucose) solution.

If possible, subsequent doses are given in the form of infusions.

Intravenous injection should be done slowly (for about 5 minutes).

When intramuscular injection is recommended to inject the drug deep into the muscle.

Additional fluid intake enhances the mucolytic effect of the drug.

Adults

For 300 mg (3 ml) of the drug ATSTSH inject injected intravenously or intramuscularly 1 or 2 times a day (300-600 mg of acetylcysteine per day).

Children aged 6 to 14 years

For 150 mg (1.5 ml) of the drug ATSTS® inject inject intravenously or intramuscularly 1 or 2 times a day (150-300 mg of acetylcysteine per day).

Children under 6 years of age

Preferably, the use of an acetylcysteine dosage form for oral administration. If parenteral therapy is necessary, the daily dose for children younger than 6 years is 10 mg / kg body weight. The duration of therapy is set individually and usually does not exceed 10 days. If more long-term treatment is necessary (including for chronic bronchitis and cystic fibrosis), the use of acetylcysteine dosage forms for oral administration is recommended.

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, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1/1000) and very rarely (<1/10000); frequency is unknown (the frequency of occurrence of phenomena can not be determined on the basis of available data).

From the immune system

infrequently: hypersensitivity reactions;

very rarely: anaphylactic shock, anaphylactic / anaphylactoid reactions.

From the nervous system

infrequently: headache.

From the side of the cardiovascular system

infrequently: tachycardia;

very rarely: bleeding, lowering blood pressure; frequency unknown: redness.

From the skin and subcutaneous tissues

infrequently: itchy skin, exanthema, urticaria, angioedema, skin rash.

From the respiratory system

rarely: dyspnea, bronchospasm.

From the gastrointestinal tract

infrequently: stomatitis, abdominal pain, nausea, vomiting, diarrhea; rarely: indigestion.

General disorders and disorders at the site of administration

infrequently: fever, tinnitus; frequency unknown: edema of face.

Also, when taking acetyl cysteine, very rarely reported the occurrence of Stevens-Johnson syndrome and Lyell's syndrome (toxic epidermal necrolysis). If skin and mucous membrane changes occur, the doctor should be consulted immediately, and the drug should be discontinued.

Overdose:

Symptoms of overdose may be similar to the described side effects, but are more pronounced.Symptoms: nausea, vomiting, diarrhea, in children - hypersecretion, anaphylactoid reactions with intravenous administration in a high dose.

Treatment is symptomatic.

There is no specific antidote. Hemodialysis is effective.

Interaction:

Simultaneous use with antitussive drugs can cause a violation of sputum discharge due to suppression of the cough reflex. Simultaneous reception with nitroglycerin can lead to an increase in the vasodilator effect of the latter. If simultaneous use of nitroglycerin and acetylcysteine is necessary, the patient's condition should be monitored in view of the possibility of arterial hypotension. Pharmaceutically incompatible with other drug solutions.

Data on the inactivation of antibiotics under the influence of acetylcysteine or other mucolytic drugs have so far only come from experiments in vitro, with direct mixing of the substances under study. In vitro incompatibility has been described with respect to semi-synthetic penicillins, aminoglycosides, cephalosporins, and tetracyclines. Incompatibilities with such antibiotics as amoxicillin, doxycycline, erythromycin, thiamphenicol or cefuroxime, was not noted.

Special instructions:

Intravenous injection of acetylcysteine should be carried out under the strict guidance of a physician. Adverse events occur more often if the drug is administered too quickly or in a larger amount, wh is recommended. When using the drug, it is recommended that you strictly follow the instructions in the "Instructions for Use and Dosage" section.

In patients with bronchial obstructive syndrome, the drug is administered under the control of the patient's condition, and in the case of bronchospasm, symptomatic therapy with bronchodilators is performed. The use of acetylcysteine, especially in the early stages of treatment, can lead to the dilution of sputum and an increase in its quantity. In case the patient can not expectorate sufficiently, it is necessary to take measures to eliminate sputum.

When working with the drug, it is necessary to avoid contact with metals, rubber, oxygen, easily oxidizing substances. Light staining of the acetylcysteine solution in violet does not affect the efficacy and safety of the drug.

Form release / dosage:Solution for intravenous and intramuscular injection 300 mg / 3 ml.

Packaging:

ampoules of dark glass (5) -blister packs, cardboard
ampoules of dark glass (5) -tacks of cardboard

Storage conditions:In the dark place at a temperature of no higher than 25 degrees.

Shelf life:3 years

Terms of leave from pharmacies:Without recipe

Registration number:П N013394 / 01

Date of registration:27.04.2009 / 03.06.2013

Expiration Date:Unlimited

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

EVER Pharma Jena, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp10.02.2015

Illustrated instructions

Instructions

ACTS® injection (ACC® inject)