Acc® 200

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT AСС® 100, AСС® 200 (AСС® 100, AСС® 200)

Composition:

Active ingredient: acetylcysteine;
1 sachet contains acetylcysteine 100 mg or 200 mg.
Excipients: sucrose, ascorbic acid, saccharin, orange flavoring.

Pharmaceutical form:

Oral powder for solution.
A powder from white to yellowish in color, with possible presence of agglomerates, with an orange odor.

Name and address of the manufacturer:

Salutas Pharma GmbH, Germany (testing, packaging, batch release)
Otto-von-Guericke-Allee, 1, 39179 Barleben, Germany

Lindopharm GmbH, Germany (bulk production, testing, packaging)
Neustrasse, 82, 40721 Hilden, Germany

or

Zambon Switzerland Ltd, Switzerland (bulk production, testing, packaging)
Via Industria 13, 6814 Cadempino, Switzerland

Pharmacotherapeutic group:

Mucolytic agents.
ATC code: R05CB01.

Acetylcysteine (ACC) is a mucolytic and expectorant agent used to liquefy sputum in respiratory diseases associated with the production of thick mucus. Acetylcysteine is a derivative of the amino acid cysteine. The mucolytic effect of the drug is of chemical nature. Due to its free sulfhydryl group, acetylcysteine breaks disulfide bonds in acidic mucopolysaccharides, leading to depolymerization of mucus proteins, reduction of mucus viscosity, and facilitation of expectoration and bronchial secretion clearance. The drug retains activity in the presence of purulent sputum.

Acetylcysteine also has antioxidant and pneumoprotective properties due to binding of chemical radicals by its sulfhydryl groups, thus neutralizing them. Additionally, the drug promotes increased synthesis of glutathione – an important factor in intracellular protection not only against exogenous and endogenous oxidative toxins, but also against various cytotoxic substances. This property of acetylcysteine allows its effective use in paracetamol overdose.

After oral administration, acetylcysteine is rapidly and completely absorbed and undergoes hepatic metabolism to form cysteine, a pharmacologically active metabolite, as well as diacetylcysteine, cystine, and subsequently mixed disulfides. Bioavailability is very low – approximately 10%. Maximum plasma concentration is reached within 1–3 hours after administration. Plasma protein binding is approximately 50%. Acetylcysteine is excreted by the kidneys as inactive metabolites (inorganic sulfates, diacetylcysteine). The elimination half-life is primarily determined by rapid hepatic biotransformation and is approximately 1 hour. In case of impaired liver function, the elimination half-life is prolonged up to 8 hours.

Indications:

Treatment of acute and chronic diseases of the bronchopulmonary system requiring reduction of sputum viscosity, improved sputum clearance and expectoration.

Contraindications:

Hypersensitivity to acetylcysteine or any other component of the drug.
Acute peptic ulcer of the stomach or duodenum, hemoptysis, pulmonary hemorrhage.

Safety precautions:

The drug should be used with caution in patients with a history of gastric or duodenal ulcer, especially when concomitantly taking other drugs that irritate the gastric mucosa.
There have been isolated reports of severe skin reactions (Stevens-Johnson syndrome and Lyell's syndrome) with acetylcysteine use; therefore, if skin or mucous membrane changes occur, the drug should be discontinued immediately and medical advice should be sought regarding further treatment.
Acetylcysteine should be prescribed with caution to patients with bronchial asthma due to the possible development of bronchospasm.
When pouring the powder into a container during solution preparation, the powder may become airborne and irritate the nasal mucosa, potentially causing reflex bronchospasm.
Patients with liver or kidney disease should receive acetylcysteine with caution to avoid accumulation of nitrogen-containing substances in the body.
Acetylcysteine use leads to liquefaction of bronchial secretions. If the patient is unable to effectively cough up sputum, postural drainage and bronchoaspiration may be necessary.
Acetylcysteine affects histamine metabolism; therefore, prolonged therapy should not be prescribed to patients with histamine intolerance, as this may lead to intolerance symptoms (headache, vasomotor rhinitis, pruritus).
The drug contains sucrose and therefore should not be administered to patients with rare hereditary forms of fructose intolerance, sucrase-isomaltase deficiency, or glucose-galactose malabsorption syndrome.
One sachet of AСС® 100 contains 2.8 g of sucrose (approximately 0.24 bread units); one sachet of AСС® 200 contains 2.7 g of sucrose (approximately 0.23 bread units). This should be considered when administering the drug to patients with diabetes mellitus.

Special warnings:

Use during pregnancy or breastfeeding:
Acetylcysteine may be used during pregnancy or breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Effect on the ability to drive vehicles or operate machinery:
No effect.

Children:

The drug may be used in children from 2 years of age.

Dosage and administration:

Adults and children over 14 years: 400–600 mg of acetylcysteine per day, divided into 1–3 doses.
Children aged 6 to 14 years: 400–600 mg per day, divided into 2–3 doses.
Children aged 2 to 6 years: 200–400 mg per day, divided into 2 doses.

The drug should be taken after meals.
The contents of one sachet should be dissolved in ½ glass of water, juice, or cold tea. The prepared solution should be consumed as soon as possible. In some cases, due to the presence of ascorbic acid (a stabilizer) in the formulation, the prepared solution may be stored for approximately 2 hours before use.
Additional fluid intake enhances the mucolytic effect of the drug.

The duration of treatment for chronic conditions is determined by the physician depending on the nature and course of the disease. For acute uncomplicated conditions, acetylcysteine is administered for 5–7 days.

Overdose:

There are no reported cases of overdose with oral acetylcysteine.
Symptoms: nausea, vomiting, diarrhea. In children, there is a risk of hypersensitivity.
Treatment: symptomatic therapy.

Adverse reactions:

The following classification is used to describe the frequency of adverse reactions:
Very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000).

• Cardiovascular system: uncommon – tachycardia, arterial hypotension.
• Nervous system: uncommon – headache.
• Skin: uncommon – allergic reactions (pruritus, urticaria, exanthema, eczema, rash, angioneurotic edema).
• Auditory system: uncommon – tinnitus.
• Respiratory system: rare – dyspnea, bronchospasm (mainly in patients with bronchial hyperreactivity associated with bronchial asthma), rhinorrhea.
• Gastrointestinal tract: uncommon – heartburn, dyspepsia, stomatitis, abdominal pain, nausea, vomiting, diarrhea, unpleasant taste in the mouth.
• General disorders: uncommon – fever.

There have been reports of isolated severe skin reactions (Stevens-Johnson syndrome and Lyell's syndrome).
Very rarely, bleeding has been reported, mostly associated with hypersensitivity reactions. Cases of reduced platelet aggregation have been observed, although without clinical confirmation.
Very rarely, cases of Quincke's edema, facial swelling, anemia, hemorrhage, anaphylactic reactions, or even shock have been reported.

Interaction with other medicinal products and other types of interactions:

Concomitant use of acetylcysteine with antitussive agents may enhance sputum retention due to suppression of the cough reflex.
When used simultaneously with antibiotics such as tetracyclines (except doxycycline), ampicillin, amphotericin B, cephalosporins, and aminoglycosides, interaction with the thiol group of acetylcysteine may occur, leading to reduced activity of both drugs. Therefore, the interval between administration of these drugs should be at least 2 hours. This does not apply to cefixime and loracarbef.
Activated charcoal reduces the effectiveness of acetylcysteine.
It is not recommended to dissolve acetylcysteine together with other drugs in the same glass.
Acetylcysteine reduces the hepatotoxic effect of paracetamol.
Synergism between acetylcysteine and bronchodilators has been observed.
Acetylcysteine can act as a cysteine donor and increase glutathione levels, promoting detoxification of oxygen free radicals and certain toxic substances in the body.
Concomitant administration of nitroglycerin and acetylcysteine may enhance the vasodilatory effect of nitroglycerin.
Contact with metals or rubber leads to the formation of sulfides with a characteristic odor; therefore, glassware should be used for dissolving the drug.

Shelf life:

3 years.

Storage conditions:

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging:

3 g of powder in a sachet. 20 sachets in a cardboard box.

Prescription status:

Over-the-counter (without prescription).