ACC Long, 600 mg 10 pcs

Pharmacodynamics

Acetylcysteine is a derivative of the amino acid cysteine. It has mucolytic action, facilitates expectoration of sputum through a direct effect on the rheological properties of sputum. Its action is due to its ability to break disulfide bonds of mucopolysaccharide chains and cause depolymerization of mucoproteins of sputum, which leads to lower viscosity of sputum. The drug retains activity in the presence of purulent sputum.

It has antioxidant effect based on the ability of its reactive sulfhydryl groups (SH-groups) to bind with oxidizing radicals and thus to 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 cellular protection against the damaging effects of free-radical oxidation inherent in the intense inflammatory reaction. Prophylactic use of acetylcysteine reduces 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 to form pharmacologically active metabolite – cysteine, as well as diacetylcysteine, cystine and mixed disulfides. Bioavailability when administered orally is 10% (due to the pronounced effect of “first passage” through the liver).

The time to reach maximum plasma concentration is 1-3 hours. Binding with plasma proteins is 50%. It is excreted by the kidneys as inactive metabolites (inorganic sulfates, diacetylcysteine). The elimination half-life (T1/2) is about 1 h, liver dysfunction leads to prolongation of T1/2 to 8 h. It penetrates through the placental barrier. There are no data on the ability of acetylcysteine to penetrate through the blood-brain barrier and excreted with breast milk.

Indications

Respiratory diseases, accompanied by the formation of viscous sputum difficult to separate:
– acute and chronic bronchitis, obstructive bronchitis;
– tracheitis, laryngotracheitis;
– pneumonia;
– lung abscess;
– Bronchiectatic disease, bronchial asthma, chronic obstructive pulmonary disease (COPD), bronchiolitis;
– cystic fibrosis;
Acute and chronic sinusitis, middle ear inflammation (otitis media).

Active ingredient

Composition

1 effervescent tablet contains:

the 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 flavoring “B” – 40.00 mg.

Tablets effervescent 600 mg

Primary packaging

Packed 6, 10 or 20 effervescent tablets in a polypropylene tube.

Secondary packaging

1 tube each in a carton packet along with instructions for use.

How to take, the dosage

Ingestion, after meals. Fizzy tablets should be dissolved in one glass of water.

The tablets should be taken immediately after dissolution, in exceptional cases it is possible to leave the ready to use solution for 2 hours. Additional fluid intake increases the mucolytic effect of the drug.

In 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.

In the absence of other prescriptions, it is recommended that the following dosages be followed:

Mucolytic therapy:

Adults and children over 14 years of age: 1 effervescent tablet once daily (600 mg).

Interaction

In concomitant use of acetylcysteine and cough suppressants due to suppression of the cough reflex sputum congestion may occur.

In concomitant use with antibiotics for oral administration (penicillins, tetracyclines, cephalosporins, etc.) their interaction with thiol group of acetylcysteine is possible, which may lead to reduction of their antibacterial activity.

Therefore, the interval between the administration of antibiotics and acetylcysteine should be at least 2 hours (except for cefixime and loracarbef).

Concomitant use with vasodilators and nitroglycerin may lead to increased vasodilatory effects.

Special Instructions

PERFACE FOR SICK DIABETHENS

1 effervescent tablet corresponds to 0.001 units of nutritional value.

DIRECTIONS

When handling the drug, glassware should be used, and contact with metals, rubber, oxygen, and easily oxidizing substances should be avoided. Severe allergic reactions such as Stevens-Johnson syndrome and Lyell syndrome have rarely been reported with acetylcysteine. If changes of the skin and mucous membranes occur, it is necessary to consult a physician immediately, the drug should be discontinued.

In patients with bronchial asthma and obstructive bronchitis, acetylcysteine should be administered with caution under systemic bronchial patency monitoring.

The drug should not be taken immediately before bedtime (it is recommended to take the drug before 6 p.m.).

Impact on the ability to operate vehicles, machinery

There are no data about negative effect of ACC® Long at recommended doses on the ability to operate vehicles, machinery.

Contraindications

– hypersensitivity to acetylcysteine or other components of the drug;
– gastric and duodenal ulcer in the acute stage;
– hemoptysis, pulmonary bleeding;
– pregnancy;
– lactation;
– children under 14 years (for this dosage form);
– lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
With caution – gastric and duodenal ulcer in the anamnesis, bronchial asthma, obstructive bronchitis, hepatic and/or renal failure, histamine intolerance (avoid long-term use of the drug, because.acetylcysteine affects histamine metabolism and may lead to the signs of intolerance, such as headache, vasomotor rhinitis, itching), esophageal varices, adrenal diseases, arterial hypertension.

Side effects

According to the World Health Organization (WHO), adverse effects are classified according to their frequency of development as follows: Very common (≥1/10), common (≥1/100, < 1/10), infrequent (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000) and very rare (< 1/10000); frequency unknown (the incidence of events cannot be determined from available data).

Allergic reactions
infrequent: skin itching, rash, exanthema, urticaria; angioedema, decreased blood pressure, tachycardia;
very rare: anaphylactic reactions up to anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome).

Respiratory system disorders: dyspnea, bronchospasm (especially in patients with bronchial hyperresponsiveness in bronchial asthma).

Sensory system disorders
infrequent: tinnitus. Gastrointestinal tract
infrequent: stomatitis, abdominal pain, nausea, vomiting, diarrhea, dyspepsia.

Other
very rare: headache, fever, single reports of bleeding due to hypersensitivity reactions, decreased platelet aggregation.

Overdose

Symptoms: diarrhea, vomiting, stomach pain, heartburn and nausea are observed in case of an erroneous or deliberate overdose.

Treatment: symptomatic.

Similarities