Description
Latin name
ACC long
Release form
Effervescent tablets 600 mg
Primary packaging
For 6, 10 or 20 effervescent tablets in a polypropylene tube.
Secondary packaging
1 tube in a carton box along with instructions for use.
packaging 10 pcs
Pharmacological action
PHARMACODYNAMICS
Acetylcysteine is a derivative of the amino acid cysteine. It has a mucolytic effect, facilitates sputum discharge due to a direct effect on the rheological properties of sputum. The action is due to the ability to break the disulfide bonds of mucopolysaccharide chains and cause depolymerization of mucoproteins of sputum, which leads to a decrease in the viscosity of sputum. The drug remains active in the presence of purulent sputum. It has an antioxidant effect, based on the ability of its reactive sulfhydryl groups (SH-groups) to bind to oxidizing radicals and, thus, neutralize them. In addition, acetylcysteine promotes the synthesis of glutathione, an important component of the antioxidant system and chemical detoxification of the body. The antioxidant effect of acetylcysteine increases the protection of cells from the damaging effects of free radical oxidation, which is characteristic of an intense inflammatory reaction. With the prophylactic use of acetylcysteine, there is a decrease in the frequency and severity of exacerbations of bacterial etiology in patients with chronic bronchitis and cystic fibrosis.
PHARMACOKINETICS
Absorption is high. It is rapidly metabolized in the liver with the formation of a pharmacologically active metabolite – cysteine, as well as diacetylcysteine, cystine and mixed disulfides. Oral bioavailability is 10% (due to the presence of a pronounced effect of “first passage” through the liver). The time to reach maximum plasma concentration is 1-3 hours. Communication with plasma proteins is 50%. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). The half-life (T1 / 2) is about 1 hour, impaired liver function leads to an extension of T1 / 2 to 8 hours. It penetrates the placental barrier. Data on the ability of acetylcysteine to cross the blood-brain barrier and excreted in breast milk are not available.
Indications
Diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of the peripheral joints and spine: rheumatic lesions of the soft tissues
Muscle pains of rheumatic and non-rheumatic origin srmfrm10 tissue lesions srdlfdrm10 Respiratory diseases accompanied by the formation of viscous, difficult to separate sputum:
² Ñ acute and chronic Sky bronchitis obstructive bronchitis
² Ñ tracheitis, laryngotracheitis
² Ñ pneumonia
² Ñ lung abscess
² Ñ bronchiectatic disease, bronchial asthma, chronic obstructive pulmonary disease (COPD), bronchiolitis
² Ñ cystic fibrosis and sphyllitis medulla sinusitis 50 and mild chronic dysfunctional fibrosis and cardiomyopathy of chronic sphyllitis and cardiomyopathy of patients with chronic sphlitis disease
Respiratory diseases associated with the formation of viscous, difficult to separate sputum:
² Ñ acute and chronic bronchitis, obstructive bronchitis
² Ñ tracheitis, laryngotracheitis
² Ñ pneumonia
² Ñ abscess le who
² Ñ bronchiectasis, asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiolitis
² Ñ
Acute and chronic sinusitis, inflammation of the middle ear (otitis media).
Contraindications
hypersensitivity to acetylcysteine or other components of the
preparation gastric and duodenal ulcer in the acute stage
hemoptysis, pulmonary hemorrhage
pregnancy
age for lactation age for lactation 14 years old lactation period
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
With caution – a history of gastric and duodenal ulcer, bronchial asthma, obstructive bronchitis, liver and / or renal failure, histamine intolerance (long-term use of the drug should be avoided, as acetylcysteine affects the metabolism of histamine and can lead to signs of intolerance (such as headache, vasomotor rhinitis, pruritus), varicose veins of the esophagus, adrenal disease, arterial hypertension.
Use during pregnancy and lactation
Data on the use of acetylcysteine during pregnancy and breastfeeding are limited, so the use of the drug during pregnancy is contraindicated.
If you need to use the drug during lactation, you should decide on the termination of breastfeeding.
Composition
1 effervescent tablet contains:
active ingredient: acetylcysteine 600 mg
excipients: citric acid anhydrous – 625.00 mg sodium bicarbonate – 327.00 mg sodium carbonate – 104.00 mg mannitol – 72.80 mg lactose – 70.00 mg ascorbic acid – 75.00 mg sodium cyclamate – 30.75 mg sodium saccharinate dihydrate – 5.00 mg sodium citrate dihydrate – 0.45 mg blackberry flavor B – 40.00 mg.
Dosage and administration
Inside, after meals. Effervescent tablets should be dissolved in one glass of water. Tablets should be taken immediately after dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours. An additional liquid intake enhances the mucolytic effect of the drug. With short-term colds, the duration of administration is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to achieve a preventive effect.
Unless otherwise prescribed, the following dosages are recommended: Mucolytic therapy: Adults and children over 14 years of age: 1 effervescent tablet 1 time per day (600 mg).
Side effects of
According to the World Health Organization (WHO), adverse effects are classified according to their frequency of development as follows: very often ( 1/10), often ( 1/100, allergic reactions
infrequently: skin itching, rash , exanthema, urticaria, angioedema, decreased blood pressure,
tachycardia is very rare: anaphylactic reactions up to anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome).
From the respiratory system
rarely: shortness of breath, bronchospasm (mainly in patients with bronchial hyperresponsiveness with asthma).
On the sensory side,
is infrequent: tinnitus. From the gastrointestinal tract
infrequently: stomatitis, abdominal pain, nausea, vomiting, diarrhea, dyspepsia.
Other
is very rare: headache, fever, isolated reports of the development of bleeding due to the presence of a hypersensitivity reaction, decreased platelet aggregation.
Drug Interaction
When acetylcysteine and antitussive agents are used at the same time, sputum stagnation may occur due to cough reflex suppression. When used concurrently with antibiotics for oral administration (penicillins, tetracyclines, cephalosporins, etc.), their interaction with the thiol group of acetylcysteine is possible, which can lead to a decrease in their antibacterial activity. Therefore, the interval between the administration of antibiotics and acetylcysteine should be at least 2 h (except cefixime and loracarb). Concomitant use with vasodilating agents and nitroglycerin can lead to increased vasodilator action.
overdose
Symptoms: when mistaken or intentional overdose occurs, such as diarrhea, vomiting, stomach pain, heartburn and nausea. Treatment: symptomatic.
Storage conditions
In a dry, dark place at a temperature of no higher than 30 ° C.
Keep out of the reach of children.
Expiration
3 years.
Do not use after the specified expiry date.
Deystvuyuschee substances
acetylcysteine
Terms of delivery from
pharmacies Without a prescription
dosage form
dosage form
tablets soluble
sandoz, switzerland
