Composition, form of production and packaging
? Powder for solution for ingestion white, crystalline, with the smell of pomegranate and lemon.
1 sachet
acetylcysteine ​​100 mg
Excipients: isomalt (FE and C), lemon-garnet flavors, sodium saccharin, lemon oil.
2 g - sachets (20) - packs of cardboard.
2 g - sachets (50) - packs of cardboard.
? Powder for solution for ingestion white, crystalline, with the smell of pomegranate and lemon.
1 sachet
acetylcysteine ​​200 mg
Excipients: isomalt (FE and C), lemon-garnet flavors, sodium saccharin, lemon oil.
2 g - sachets (20) - packs of cardboard.
2 g - sachets (50) - packs of cardboard.
? Powder for solution for ingestion white, crystalline, with the smell of raspberry.
1 sachet
acetylcysteine ​​600 mg
Excipients: xylitol, aspartame, raspberry flavor, lemon oil.
3 g - sachets (20) - packs of cardboard.
3 g - sachets (50) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the print edition of 2007.
PHARMACHOLOGIC EFFECT
[I] - Instruction on medical use approved by the Pharmacological Committee of the Ministry of Health of the Russian Federation
Acetylcysteine ​​manifests a secretion and secretory effect in the bronchial tract. It liquefies phlegm, increasing its volume, facilitates its separation. It retains its activity even in the presence of purulent sputum. The mechanism of action is based on the ability of sulfhydryl groups of acetylcysteine ​​to disrupt the disulfide bonds of acid mucopolysaccharides of sputum, which leads to depolarization of mucoproteins and a reduction in mucus viscosity.
It promotes the synthesis of glutathione, which is an important antioxidant factor of intracellular protection and ensures the maintenance of the functional activity and morphological integrity of the cell, which, in particular, explains its effectiveness as an antidote for paracetamol poisoning.
The therapeutic effect is observed after 30-90 min and persists for 2-4 hours.
INDICATIONS
Diseases of the respiratory system and condition, accompanied by the formation of viscous, hard-to-detachable mucopurulent sputum:
- Acute and chronic bronchitis;
- tracheitis due to bacterial and / or viral infection;
- bronchiolitis;
- pneumonia;
- bronchial asthma;
- bronchoectatic disease;
- atelectasis due to congestion of the bronchi by a mucous plug;
- cystic fibrosis (as part of combination therapy);
- removal of a viscous secretion from the respiratory tract in post-traumatic and postoperative conditions;
- facilitating secretion and secretion of mucus with sinusitis.
DOSING MODE
Inside, after eating, pre-dissolving the powder in a glass of water. Usually the following dosages are recommended: for adults and adolescents older than 14 years : 400-600 mg / day, divided by 2-3 doses; Children over 6 years of age : 400 mg / day, divided into 2-3 doses; children aged 2 to 6 years : 200 mg of acetylcysteine ​​per day, divided by 2-3 admission.
In newborn infants are used only for vital indications in a dose of 10 mg / kg of body weight under the strict supervision of a doctor. Children of the first year of life are allowed to drink the resulting solution from a spoon or a bottle for feeding. Children from 1 year to 2 years (only under strict medical supervision) are prescribed 100-200 mg / day, divided by 2-3 admission.
Treatment of cystic fibrosis . Children over 6 years are prescribed 600 mg / day, divided into 3 doses; children from 2 to 6 years : 400 mg / day, divided into 4 doses,infants from the 10th day of life and children under 2 years : 100-150 mg / day, divided into 2-3 admission under strict medical supervision.
The duration (continuity) of application depends on the characteristics of the disease. In the treatment of chronic bronchitis and cystic fibrosis treatment can be long (up to several months).
SIDE EFFECT
From the digestive system: rarely - heartburn, nausea, vomiting, diarrhea, sensation of stomach overflow.
Allergic reactions: rarely - skin rash, itching, urticaria, bronchospasm.
Other: rarely - nosebleeds, tinnitus, drowsiness, fever.
If undesirable side effects occur, you should consult a doctor.
CONTRAINDICATIONS
- known hypersensitivity to acetylcysteine ​​or other ingredients of the finished dosage form;
- Stomach ulcer and duodenal ulcer in the phase of exacerbation;
With caution: bronchial asthma; liver disease; kidney disease; adrenal gland diseases; varicose veins of the esophagus; arterial hypertension; propensity to pulmonary hemorrhage, hemoptysis; children under 2 years.
Infants and children under 2 years of age can be prescribed only for vital signs, under hospital conditions and under direct medical supervision at a dose of 10 mg / kg of body weight.
PREGNANCY AND LACTATION
The use of the drug during pregnancy and lactation is possible only if the intended benefit to the mother exceeds the potential risk to the fetus or baby.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use with caution in kidney disease.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Use with caution in liver diseases.
APPLICATION FOR CHILDREN
Infants and children under 2 years of age can be prescribed only for vital signs, under hospital conditions and under direct medical supervision at a dose of 10 mg / kg of body weight.
SPECIAL INSTRUCTIONS
When using the drug in patients with bronchial asthma, it is necessary to provide sputum drainage, to combine with bronchodilators.
During the period of application of the drug, the patient is recommended to drink plenty of liquid, which supports the secretion effect of the drug. When using the drug, it is necessary to use glassware, avoid contact with metals, rubber, oxygen, easily oxidizing substances.
Patients with diabetes should remember that one packet (sachet) of 100 mg contains 1.85 g of carbohydrates, and one sachet (200 mg) contains 1.75 g of carbohydrates, which corresponds to about 0.15 XE.
OVERDOSE
To date, cases of overdose of acetylcysteine ​​with oral use have not been described.
Symptoms: with the occasional use of very large doses, nausea, vomiting, and diarrhea are possible.
Treatment: symptomatic.
DRUG INTERACTION
With the simultaneous use of acetylcysteine ​​and antitussive drugs, sputum stagnation may increase due to the suppression of the cough reflex, so this combined treatment should be carried out only under direct medical supervision.
There is evidence that the thiol group of acetylcysteine ​​can neutralize the activity of certain antibiotics (amphotericin B, ampicillin, tetracyclines, excluding doxycycline, semisynthetic penicillins, cephalosporins, aminoglycosides). Therefore, it is advisable to take these antibiotics orally 2 hours after taking acetylcysteine.
It has also been established that antibiotics such as amoxicillin, doxycycline, erythromycin, triamterene, cefuroxime do not interact with acetylcysteine. Acetylcysteine ​​reduces the hepatotoxic effect of paracetamol.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not higher than 25 В° C, out of the reach of children.
Shelf life - 5 years.
Do not use after the expiration date indicated on the package.
