Libexin tablets 100mg №20×1 (prenoxdiazine)

Name:
Libexin tab 100mg in a blister pack No. 20×1
Description:
Almost white, flat tablets with bevelled edges. On one side there is the marking “LIBEXIN”, on the other side there are two dividing marks dividing the tablet into four parts. The main active ingredient Prenoxdiazine, Carbocysteine Release form Tablets Dosage 100 mg Special instructions The drug may cause complaints from the gastrointestinal tract in patients with lactose intolerance, because The tablets contain lactose (0.38 mg lactose per tablet). Influence on the ability to drive vehicles and perform work associated with increased danger Taking the drug in high doses can slow down the rate of reactions, therefore, when taking the drug in high doses, the question of the possibility of driving a car or doing work associated with increased danger should be decided individually. Pharmacodynamics The active substance of the drug, prenoxdiazine hydrochloride, exhibits an antitussive effect due to the following mechanisms: Local anesthetic effect: reduces the excitability of peripheral sensory (cough) receptors. Bronchodilator action (relaxation of the smooth muscles of the bronchi): by reducing the excitability of the stretch receptors of the lungs and inhibition of the cough reflex, Central action: to a small extent reduces the activity of the respiratory center, without respiratory depression. Facilitates breathing and sputum discharge. Antitussive action lasts 3-4 hours. Pharmacokinetics The active substance is rapidly and well absorbed from the stomach. The maximum blood level is reached 30 minutes after ingestion, while the therapeutic plasma level is observed within 6-8 hours. On average, in the first hour it is 55-59% bound to plasma proteins. The half-life is 2.6 hours. Most of the dose taken is metabolized in the liver, about 1/3 of it is excreted unchanged. In addition to the unchanged product, the drug is excreted in the form of 4 metabolites. The data obtained show that biliary secretion plays an important role in the metabolic processes of the product during the first 12 hours after application. Within 24 hours, 93% of the administered dose is excreted from the body, 50%-74% is excreted in the feces and 26-50% in the urine within 72 hours after ingestion. Indications for use Acute or chronic cough – mostly non-productive – of any (tracheobronchial, pulmonary, pleural and cardiac) origin. The drug can be used to relieve cough in diseases accompanied by impaired breathing and gas exchange, since the drug does not depress the respiratory center. Preparation of patients for bronchoscopic or bronchographic examination Dosage and administration The average dose for adults is 100 mg three or four times a day (1 tablet 3-4 times a day), in more difficult cases the dose can be increased to 200 mg three to four times or up to 300 mg three times a day (2 tablets 3-4 times a day or 3 tablets 3 times a day). Children (aged 3-14 years) According to the age and body weight of the patient, the usual dose is proportionally lower than 1/4 – 1/2 tablet 3-4 times a day (25-50 mg 3-4 times a day). For children aged 3 to 6 years or weighing 10-20 kg: 1/2 tablet 3 times a day (50 mg 3 times a day). For children aged 6 to 14 years or weighing more than 20 kg: 1/2 tablet 3-4 times a day (50 mg 3-4 times a day). In preparation for bronchoscopy, a dose of 0.9-3.8 mg / kg of body weight is combined with 0.5-1 mg of atropine 1 hour before the procedure. The maximum single dose for children is 1/2 tablet, for adults – 3 tablets. The maximum daily dose for children is 2 tablets, for adults – 9. Use during pregnancy and lactation The limited data available do not indicate the presence of prenoxdiazine fetal (neonatal) toxicity and the ability to cause malformations. To date, there are no other relevant epidemiological data. The drug should be used with the usual precautions. There are no clinical data on whether the drug is excreted into breast milk, so during lactation it can be used after carefully weighing the benefit-to-risk ratio, on the advice of a physician. Precautions In cases of difficult separation of thick sputum, it may be necessary to take expectorants or mucolytics. Tablets must be swallowed whole, without chewing, otherwise, the drug may cause temporary numbness, insensitivity of the oral mucosa. The drug contains 38.0 mg of lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Interactions with other drugs Be sure to inform your doctor about all the medicines you are taking, even if this happens occasionally. There are no data. Contraindications Hypersensitivity to the components of the drug. Diseases accompanied by excessive bronchial secretion. Postoperative conditions (after inhalation anesthesia). Children under the age of 3 years are not recommended to use the drug in this dosage form. Composition 1 tablet contains: active substance: prenoxdiazine hydrochloride – 100 mg; excipients: glycerin (E422), magnesium stearate (E470), talc (E553), polyvidone (E1201), corn starch, lactose monohydrate. Overdose In case of drug overdose, contact your doctor or emergency room immediately! When using higher than therapeutic doses, sedation and fatigue occur, which spontaneously disappear within a few hours after application. Side effects In case of symptoms similar to those described below, please contact your doctor immediately! Undesirable effects are listed according to their frequency based on the following convention: very common (? 1/10), common (? 1/100 to < 1/10), infrequent (? 1/1,000 to < 1/100), rare (? 1 /10.000 to < 1/1.000), very rare (< 1/10.000), frequency unknown (cannot be calculated from available data). Gastrointestinal disorders: Rare: dry mouth and throat. The frequency is not known; gastrointestinal adverse reactions (in < 10% of cases), manifested by stomach pain, constipation, which usually disappear after eating. Immune system disorders: Rare: allergic reactions. Respiratory, thoracic and mediastinal disorders: Not known: Bronchospasm. Storage conditionsStore at a temperature not exceeding 25 °C. Keep out of the reach of children. 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