Espa-Nac powder for oral solution preparation 200mg sachets, 20pcs

Composition

1 sachet contains:

Active ingredient:  

• acetylcysteine-200.0 mg;

excipients:  

• sucrose – 2744.10 mg,

• orange flavor-50.0 mg,

• colloidal silicon dioxide-3.00 mg,

• tartaric acid-2.00 mg,

• sodium chloride-0.90 mg

Pharmacological action

Mucolytic agent, dilutes sputum, increases its volume, facilitates sputum discharge. The action is associated with the ability of free sulfhydryl groups of acetylcysteine to break intra – and intermolecular disulfide bonds of mucopolysaccharide chains, which leads to depolymerization of mucoproteins and a decrease in sputum viscosity (in some cases, this leads to a significant increase in sputum volume, which requires aspiration of the contents of the bronchi).

It remains active in purulent sputum. It does not affect the immune system.

Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa.

It stimulates mucosal cells of the bronchi, the secret of which lyses fibrin.

It has a similar effect on the secret formed in inflammatory diseases of ENT organs.

It has an antioxidant effect due to the presence of the SH group, which can neutralize electrophilic oxidative toxins.

Protects alpha-1-antitrypsin (elastase inhibitor) from the inactivating effect of CARRIER 1, an oxidant produced by the myeloperoxidase of active phagocytes.

It also has a certain anti-inflammatory effect (by suppressing the formation of free radicals and active oxygen-containing substances responsible for the development of inflammation in the lung tissue).

It leads to an increased synthesis of glutathione, which explains the detoxification effect of paracetamol poisoning.

With the prophylactic use of acetylcysteine, there is a decrease in the frequency and severity of exacerbations in patients with chronic bronchitis and cystic fibrosis.

Indications

Respiratory diseases accompanied by the formation of viscous sputum that is difficult to separate:

– acute and chronic bronchitis, obstructive bronchitis;

– tracheitis, laryngotracheitis;

– pneumonia;

– bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease (COPD), bronchiolitis;

– cystic fibrosis.

Acute and chronic sinusitis, inflammation of the middle ear (otitis media).

Contraindications

– Hypersensitivity to acetylcysteine or other components of the drug;

– stomach ulcer and duodenal ulcer in the acute stage;

– hemoptysis, pulmonary hemorrhage;

– deficiency of sucrase/isomaltase, fructose intolerance, glucose-galactose malabsorption (product contains sucrose);

– pregnancy;

– lactation period;

– children’s age up to 14 years (for a dosage of 600 mg), children’s age up to 2 years (for dosage 200 mg).

With caution: A history of gastric and duodenal ulcers, esophageal varicose veins, bronchial asthma, obstructive bronchitis, adrenal diseases, liver and/or kidney failure, arterial hypertension, histamine intolerance (long-term use of the drug should be avoided, since acetylcysteine affects the metabolism of histamine and may lead to signs of intolerance, such as headache, vasomotor rhinitis, itching).

Side effects

According to the World Health Organization (WHO), adverse events are classified according to their frequency as follows: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000), and very rare (

From the cardiovascular system:

rarely-a decrease in blood pressure, an increase in heart rate (tachycardia).

Respiratory system disorders:

very rarely – the development of pulmonary bleeding, as a manifestation of a hypersensitivity reaction.

Allergic reactions:

rarely-bronchospasm (mainly in patients with hyperreactive bronchial system with bronchial asthma), skin rash, pruritus and urticaria, exanthema, angioedema;

very rarely-anaphylactic reactions up to the development of anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the gastrointestinal tract:

rarely-stomatitis, abdominal pain, nausea, vomiting and diarrhea, heartburn, dyspepsia.

From the side of the senses:

infrequently-tinnitus.

Other services:

rarely-headache, fever, isolated reports of bleeding due to hypersensitivity reactions, decreased platelet aggregation.

Interaction

With the simultaneous use of acetylcysteine and antitussive agents, mucus congestion may occur due to suppression of the cough reflex.

Simultaneous use of acetylcysteine with vasodilating agents and nitroglycerin may lead to an increase in the vasodilating effect of the latter.

Pharmacologically incompatible with antibiotics (penicillins, cephalosporins, erythromycin, tetracycline and amphotericin B) and proteolytic enzymes.

Reduces the absorption of penicillins, cephalosporins, tetracycline (they should be taken no earlier than 2 hours after ingestion of acetylcysteine).

How to take, course of use and dosage

In the absence of other prescriptions, the following recommendations should be followed. The powder is dissolved in 1 cup of hot water, taken orally after meals.

ESPA-NAC® in a dosage of 200 mg:

Adults and children over 14 years of age:  2-3 times a day,1 sachet (400-600 mg).

Children from 6 to 14 years old:  2 times a day,1 sachet (400 mg).

Children from 2 to 6 years old:  2-3 times a day for 1/2 sachet (200-300 mg).

For cystic fibrosis:

Children from 2 to 6 years old:  2 times a day,1 sachet (400 mg).

Children over 6 years of age:  3 times a day,1 sachet (600 mg).

Additional fluid intake enhances the mucolytic effect of the drug.

For short-term colds, the duration of admission is 5-7 days. For chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to prevent infections. For long-term diseases, the duration of therapy is determined by the attending physician.

Overdose

When acetylcysteine was administered orally for three months in a daily dose of up to 11.6 g, no life-threatening side effects were detected. No poisoning events were observed when acetylcysteine was administered orally at a dose of up to 500 mg / kg of body weight.

Symptoms:  heartburn and nausea, vomiting, diarrhea, stomach pain. Newborns are at risk of developing hypersecretion.

Treatment:  symptomatic.

Description

Homogeneous powder of white or almost white color, without agglomerates and foreign particles, with a fruity smell.

Functional features

Absorption after oral use is high. Bioavailability is low – about 10% due to the presence of a pronounced “first pass” effect through the liver with the formation of a pharmacologically active metabolite – cysteine, as well as diacetylcystine, cystine.

The maximum plasma concentration (Cmax) after oral use is reached in approximately 1-3 hours. Binding to plasma proteins is about 50%. It is mainly excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcystine), a small part is excreted unchanged in the feces. The plasma half-life (T 1/2) of acetylcysteine is approximately 1 h. With impaired liver function, this value increases to 8 hours.

Penetrates the placental barrier, accumulates in the amniotic fluid.

There are no data on penetration through the blood-brain barrier.

Special instructions

Patients with bronchial asthma and obstructive bronchitis should be prescribed acetylcysteine with caution under systematic monitoring of bronchial patency.

When dissolving the drug, it is necessary to use glassware, avoid contact with metals, rubber (sulfides with a characteristic smell are formed upon contact), oxygen, and easily oxidizing substances.

When treating patients with diabetes mellitus, it should be taken into account that the drug contains sucrose (one sachet of 200/600 mg contains 0.23/0.20 XE, respectively).

Patients with severe skin lesions-Stevens-Johnson syndrome or Lyell’s syndrome-may experience fever, body aches, rhinitis, cough, and sore throat in the early phase. With symptomatic treatment, an erroneous appointment of mucolytic agents is possible. There are isolated messages ( If the above-mentioned syndromes develop (sudden appearance of rashes and spots on the face and torso, which can later spread to other parts of the body), it is recommended to stop treatment and immediately seek medical attention.

Influence on the ability to drive vehicles and fur. :

In therapeutic doses, it does not affect the ability to drive vehicles and mechanisms.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Active ingredient

Acetylcysteine

Dosage form

powder for oral use

Purpose

For children as prescribed by a doctor, For adults

Indications

Chronic obstructive pulmonary disease, Bronchitis, Cold, Bronchial asthma, Pneumonia, Laryngitis, Otitis media, Cough, Tracheitis, Sinusitis, Sinusitis