Instructions for use Acibrox effervescent tablets 600 mg strip No. 10
Composition
active ingredient: acetylcysteine;
1 effervescent tablet contains 200 mg or 600 mg of acetylcysteine;
excipients: ascorbic acid, anhydrous sodium carbonate, sodium bicarbonate, anhydrous citric acid, sorbitol (E 420), macrogol 6000, sodium citrate, sodium saccharin, lemon flavoring.
Dosage form
Effervescent tablets.
Main physicochemical properties: flat-cylindrical white tablets with a bevel, slight marbling is allowed, with a characteristic odor.
Pharmacotherapeutic group
Mucolytics. ATX code R05C B01.
Pharmacological properties
Pharmacodynamics
N-acetylcysteine has a mucolytic effect. The presence of sulfhydryl groups in the structure of acetylcysteine contributes to the rupture of disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolarization of mucoproteins and a decrease in mucus viscosity. The drug retains activity in the presence of purulent sputum.
Moreover, acetylcysteine has a direct antioxidant effect due to the presence of a free thiol (-SH) nucleophilic group, which easily interacts with electrophilic groups of oxidative radicals. In particular, of interest are recent data that acetylcysteine protects α-antitrypsin, a protein that inhibits elastase, from destruction under the influence of perchloric acid, a pronounced oxidizing agent produced by the myeloperoxidase protein of activated phagocytes.
Therefore, acetylcysteine can be used to treat acute and chronic diseases of the respiratory system accompanied by thick and viscous secretions.
Due to its molecular structure, acetylcysteine can easily penetrate cell membranes. Inside the cell, acetylcysteine is deacetylated to L-cysteine, an amino acid that is required for the synthesis of glutathione.
Glutathione is a highly reactive tripeptide that is a pronounced factor of intracellular protection not only against oxidative toxins of both exogenous and endogenous origin, but also against a number of cytotoxic substances.
Pharmacokinetics
Acetylcysteine is completely absorbed after oral administration. Due to metabolism in the intestinal wall and the "first-pass" effect, the bioavailability of acetylcysteine when taken orally is very low (approximately 10%). The maximum plasma concentration is reached 1-3 hours after administration and remains high for 24 hours.
Acetylcysteine is distributed both in unchanged form (20%) and in the form of metabolites (80%), mainly distributed in the liver, kidneys, lungs and bronchial secretions.
The volume of distribution of acetylcysteine is from 0.33 to 0.47 l/kg. Protein binding is about 50% 4 hours after administration and decreases to 20% after 12 hours.
Acetylcysteine is rapidly metabolized in the intestinal walls and liver after oral administration.
About 30% is excreted by the kidneys. T1/2 of NAC is 6.25 hours.
Indication
Mucolytic agent for the treatment of acute and chronic diseases of the bronchopulmonary system, accompanied by increased sputum production.
Contraindication
Hypersensitivity to the active substance or to any of the excipients. Gastric and duodenal ulcer in the acute stage, hemoptysis, pulmonary hemorrhage.
Interaction with other medicinal products and other types of interactions
The use of antitussives with acetylcysteine may increase sputum congestion due to suppression of the cough reflex.
When used simultaneously with antibiotics such as tetracyclines (except doxycycline), ampicillin, amphotericin B, their interaction with the thiol group of acetylcysteine is possible, which leads to a decrease in the activity of both drugs. Therefore, the interval between the use of these drugs should be at least 2 hours.
Simultaneous administration of acetylcysteine and nitroglycerin may lead to increased vasodilator and antiplatelet effects of the latter.
Activated charcoal reduces the effectiveness of acetylcysteine.
It is not recommended to dissolve acetylcysteine with other drugs in the same glass.
Acetylcysteine reduces the toxic effects of paracetamol.
Effect on laboratory tests: Acetylcysteine may interfere with the colorimetric assay of salicylates and the determination of urates and ketone bodies.
Application features
Patients with bronchial asthma should be closely monitored during treatment due to the possible development of bronchospasm. In the event of bronchospasm, treatment with acetylcysteine should be discontinued immediately.
It is recommended to use the drug with caution in patients with a history of gastric and duodenal ulcers, especially in case of concomitant use of other medications that irritate the gastric mucosa.
The use of acetylcysteine, especially at the beginning of treatment, may cause liquefaction of bronchial secretions and increase their volume. If the patient is unable to cough up sputum effectively, postural drainage and bronchoaspiration are necessary.
A slight sulfuric odor is not a sign of a change in the drug, but is specific to the active substance.
This medicinal product contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Use during pregnancy or breastfeeding
During pregnancy and breastfeeding, the use of acetylcysteine is possible only if the expected benefit to the woman outweighs the potential risk to the fetus or child.
Ability to influence reaction speed when driving vehicles or other mechanisms
No data.
Method of administration and doses
Tablets of 200 mg.
Adults:
400-600 mg per day in 2-3 doses depending on clinical conditions.
For children:
2-6 years – 200-400 mg per day in 1-2 doses;
6-12 years – 400-600 mg per day in 2-3 doses, depending on clinical conditions.
From the age of 12 - doses as for adults.
The duration of the course of treatment is determined by the doctor individually, depending on the nature of the disease (acute or chronic).
Precautions for patients on a controlled sodium diet:
Each effervescent tablet contains 191 mg of sodium.
Tablets of 600 mg.
Adults and children over 14 years of age - one effervescent tablet once a day (equivalent to 600 mg of acetylcysteine per day).
Precautions for patients on a controlled sodium diet
Each effervescent tablet contains 150 mg of sodium.
In acute uncomplicated diseases, the drug is used for no more than 4-5 days without medical supervision.
The duration of treatment for chronic diseases is determined by the doctor. The drug is recommended to be taken after meals. The effervescent tablet is dissolved in ½ cup of water, juice or cold tea. When dissolving acetylcysteine, it is necessary to use glassware, avoid contact with metal and rubber surfaces. Do not add other drugs to this solution. To enhance the mucolytic effect of acetylcysteine, additional fluid intake is recommended.
Children
200 mg tablets are used in children aged 2 years and over. 600 mg tablets are used in children aged 14 years and over.
Overdose
There are no data on cases of overdose of acetylcysteine dosage forms intended for oral administration.
Acetylcysteine, when administered in doses of 500 mg/kg/day, does not cause signs and symptoms of overdose.
Symptoms.
Overdose may manifest as gastrointestinal symptoms such as nausea, vomiting, and diarrhea.
Treatment.
There is no specific antidote for acetylcysteine poisoning; therapy is symptomatic.
Adverse reactions
Immune system disorders: hypersensitivity reactions, anaphylactoid reactions, anaphylactic shock, angioedema.
From the nervous system: headache.
On the part of the organs of hearing: ringing in the ears.
Cardiovascular system: tachycardia.
Vascular disorders: hemorrhages.
From the respiratory system: bronchospasm, dyspnea.
Gastrointestinal: stomatitis, abdominal pain, nausea, vomiting, diarrhea, dyspepsia.
Skin and Appendages: urticaria, rash, angioedema, itching.
General disorders: hyperthermia, facial edema.
Research results: decreased blood pressure.
Very rarely, cases of anemia have been reported. In rare cases, severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome may occur.
Cases of decreased platelet aggregation have been reported, but the clinical significance of this has not been determined.
Expiration date
3 years.
Storage conditions
For tablets in a strip:
Store at a temperature not exceeding 25 °C in a dry, dark place out of the reach of children.
For tablets in a pencil case:
Store at a temperature not exceeding 25 °C in a dry, dark place out of the reach of children. Store in a tightly closed container.
Packaging
Effervescent tablets 200 mg:
24 tablets in a pencil case, 1 pencil case in a cardboard box; 2 tablets in a strip, 5 or 10 strips in a cardboard box.
Effervescent tablets 600 mg:
12 tablets in a pencil case, 1 pencil case in a cardboard box; 2 tablets in a strip, 5 or 10 strips in a cardboard box.
Vacation category
Without a prescription.
Producer
Vitale Pringi (Vitale-XD LLC), Estonia.
Location of the manufacturer and its business address
Vanapere tee 3, Pringi, Viimsi, 74011, Harju County, Estonia.
Applicant
ROTAPHARM LIMITED, United Kingdom.
