ACC® Long, 600 mg 20 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 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 action of acetylcysteine increases cell protection against the damaging effects of free-radical oxidation inherent in the intense inflammatory reaction. With prophylactic use of acetylcysteine decrease of frequency and severity of exacerbations of bacterial etiology in patients with chronic bronchitis and cystic fibrosis is noted.

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 of reaching maximum concentration in blood plasma is 1-3 hours. Binding with plasma proteins is 50%. It is excreted by kidneys as inactive metabolites (inorganic sulfates, diacetylcysteine).

Half-life (T1/2) is about 1 hour, liver dysfunction leads to prolongation of T1/2 up to 8 hours. 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;

Berry flavoring “B” – 40.00 mg.

Tablets effervescent 600 mg
Primary package
6, 10 or 20 effervescent tablets in a tube of polypropylene.
Secondary package
1 tube in a carton pack, 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

NOTE FOR INVOLVED Diabetics

1 effervescent tablet corresponds to 0.001 IU.

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 very 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 prescribed with caution under systemic bronchial patency monitoring.
The drug should not be taken immediately before bedtime (we recommend taking the drug before 6 pm).

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 period;
– 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 (you should 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. Gastro-intestinal tract
infrequent: stomatitis, abdominal pain, nausea, vomiting, diarrhea, dyspepsia.
Other
very rare: headache, fever, single reports of bleeding due to hypersensitivity reaction, 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