Espa-nat powder for solution inside 200mg 3g sachets 20 pcs

Description

Composition
Active substance:
Acetylcysteine ​​- 200.0 mg / mg 600.0 ;.
Excipients:
Sucrose – 2744.10 mg / 2344.10 mg Orange flavoring – 50.0 mg, colloidal silicon dioxide – 3.00 mg, tartaric acid – 2.00 mg, Sodium chloride – 0.90 mg.
Description:
Homogeneous powder white or nearly white color, without agglomerates and extraneous particles to fruity odor.
Product form:
powder for solution for oral administration, 200 mg, 600 mg.
For 3.0 g of powder in a bag of a three-layer material (paper-aluminum-polyethylene). 20 bags with instructions for use in a cardboard pack.
Contraindications
– increased sensitivity to acetylcysteine ​​or other components of the formulation; – gastric ulcer and duodenal ulcer in the acute stage; – hemoptysis, pulmonary hemorrhage; – lack of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption (preparation contains sucrose); – pregnancy; – lactation; – children up to 14 years (dosage 600 mg), children up to 2 years (dosage 200 mg).
Precautions gastric ulcer and duodenal ulcer history, varicose veins, the esophagus, bronchial asthma, obstructive bronchitis, adrenal disease, liver and / or kidney failure, arterial hypertension, intolerance to histamine (avoid prolonged dosing, effect as acetylcysteine histamine metabolism and can cause symptoms of intolerance, such as headache, vasomotor rhinitis, pruritus).
Dosage
200 mg
Indications
Respiratory diseases, accompanied by the formation of a viscous sputum: – acute and chronic bronchitis, obstructive bronchitis; – tracheitis laryngotracheitis; – pneumonia; – bronchiectasis, asthma, chronic obstructive pulmonary disease (COPD), bronchiolitis; – cystic fibrosis.
Acute and chronic sinusitis, inflammation of the middle ear (otitis media).
Interaction with other drugs
With simultaneous use of acetylcysteine ​​and antitussives mucus stagnation may occur due to the suppression of the cough reflex.
Simultaneous treatment with acetylcysteine ​​vazodilyatiruyuschimi means nitroglycerin and may lead to increased vasodilatory action of the latter. Pharmaceutically compatible with antibiotics (penicillins, cephalosporins, erythromycin, tetracycline and amphotericin B) and proteolytic enzymes. It reduces the absorption of penicillins, cephalosporins, tetracycline (to be taken no earlier than 2 hours after oral acetylcysteine).
Overdose
For oral acetylcysteine ​​application for three months in a daily dose of up to 11.6 g showed no life-threatening side effects. When oral acetylcysteine ​​at a dose of 500 mg / kg body weight poisoning phenomena were not observed.
Symptoms of heartburn and nausea, vomiting, diarrhea, stomach pain.
In newborns there is a danger of hypersecretion.
Treatment: symptomatic.
pharmachologic effect
Pharmacological group:
Expectorant mucolytic agent.
Pharmacodynamics:
Mucolytic agent, liquefies phlegm and increases its volume, facilitates expectoration. The action associated with the ability of free sulfhydryl groups acetylcysteine ​​break inside and intermolecular disulfide bonds mucopolysaccharide chains, resulting in depolymerization and mukoproteidov decrease sputum viscosity (in some cases this leads to a significant increase in sputum volume, which requires a bronchial aspirate contents). Retains activity when purulent sputum. It does not affect the immune system.
Increases secretion less viscous sialomutsinov goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. Stimulates mucosal cells of the bronchi, the secret of which lyses fibrin.
A similar effect on the secretion produced in inflammatory diseases of upper respiratory tract.
It has an antioxidant effect due to the presence of SH-groups that can neutralize electrophilic toxins oxidation.
Protects the alpha-1-antitrypsin (elastase inhibitor) from inactivation HOCl – oxidant active myeloperoxidase produced by phagocytes. Also has some antiinflammatory action (by inhibiting the formation of free radicals and active oxygenates GOVERNMENTAL responsible for the development of inflammation in lung tissue).
Leads to increased synthesis of glutathione, which explains the effect of detoxification in cases of poisoning with paracetamol.
When prophylactic use acetylcysteine ​​marked reduction in the frequency and severity of exacerbations in patients with chronic bronchitis and cystic fibrosis.
Pharmacokinetics:
Absorption after oral administration is high. The bioavailability is low – about 10% due to the presence of strongly pronounced effect of “first pass” through the liver to produce pharmacologically active metabolite – cysteine ​​and diacetylcystine, cystine.
The maximum level of concentration (Cmax) in plasma after oral dosing is achieved after approximately 1 -. 3 h Plasma protein binding is approximately 50%. Displayed in the kidneys in the form of inactive metabolites (inorganic sulfide veils, diacetylcystine), a small portion allocated unchanged in the Ka lovymi masses. The half-life (T1 / 2) of the plasma acetylcysteine ​​is about 1 hour. If abnormal liver function, this value increases up to 8 hours. penetrates the placental barrier, it accumulates in the amniotic fluid. Data on the penetration of the blood-brain barrier is absent.
Pregnancy and breast-feeding
Application data acetylcysteine ​​during pregnancy and breastfeeding is limited, so the use of the drug during pregnancy is contraindicated. If necessary, use during lactation should decide the issue of termination of breastfeeding.
Conditions of supply of pharmacies
Without recipe.
side effects
According to the World Health Organization (WHO), undesirable effects are classified according to their rate of development as follows: very common (> 1/10), common (> 1/100,
special instructions
Patients with bronchial asthma and obstructive bronchitis acetylcysteine ​​should be used with caution under systematic control of bronchial obstruction.
When dissolving the drug must be used glassware, avoiding contact with metals, rubber (sulfides formed in contact with the characteristic odor), oxygen readily oxidizable substances.
When treating diabetic patients must bear in mind that the preparation contains sucrose (200/600 in one sachet contains 0.23 mg / XE 0.20, respectively).
In patients with severe skin lesions – Stevens-Johnson syndrome or toxic epidermal necrolysis – in the early phase may appear fever, body pain, rhinitis, cough, and sore throat. The symptomatic treatment of possible erroneous appointment mucolytics. There are few reports (
Effect on the ability to drive mechanisms and
In therapeutic doses does not affect the ability to drive and use machines.
Storage conditions
At temperatures above 25 ° C. Keep out of the reach of children.
Dosing and Administration
In the absence of other appointments should follow these recommendations. The powder was dissolved in 1 cup of hot water, taken orally after meals.
Espa-NATS® in a dosage of 200 mg:
Adults and children over 14 years: 2-3 times daily 1 sachet (400-600 mg). Children aged 6 to 14 years: 2 times a day for 1 bag (400 mg).
Children 2 to 6 years: 2-3 times a day for half a bag (200-300 mg).
In cystic fibrosis:
Children aged 2 to 6 years: 2 times a day for 1 bag (400 mg). Children older than 6 years: 3 times daily 1 sachet (600 mg).
Espa-NATS® at a dosage of 600 mg:
Adults and children over 14 years: 1 time per day 1 sachet (600 mg).
In cystic fibrosis:
Children over 6 years: 1 time per day 1 sachet (600 mg).
Additional enhances fluid intake mucolytic effect of the drug. Colds during short duration of reception is 5-7 days. In chronic bronchitis and cystic fibrosis drug should take a longer time to prevent infections. During long-term disease duration of therapy is determined by the attending physician.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist