Либексин®

General characteristics. Structure:

Active ingredient: Prenoxdiazinum a hydrochloride – 100 mg.
Excipients: глицерол (glycerin), magnesium stearate, talc, povidone, starch corn, lactoses monohydrate.

Description: round flat tablets of white or almost white color with a facet from two parties. On one party an engraving of "LIBEXIN", on other party – risk, dividing a tablet into four parts.

Pharmacological properties:

Pharmacodynamics. Prenoxdiazinum is an antibechic of peripheral action. Drug blocks peripheral links of a tussive reflex due to the following effects:
• local anesthetic effect which reduces irritability of peripheral sensitive (tussive) receptors of respiratory tracts;
• bronchodilatory action thanks to which there is a suppression of the stretch receptors which are taking part in a tussive reflex;
• insignificant decrease of the activity of a respiratory center (without respiratory depression)
Antibechic the effect of drug is approximately equal to that at codeine. Prenoxdiazinum does not cause accustoming and medicinal dependence. At chronic bronchitis protivospalitelny action of Prenoxdiazinum is noted.
Prenoxdiazinum does not influence function of the central nervous system, except for possible indirect anxiolytic action.

Pharmacokinetics. Prenoxdiazinum is quickly and substantially absorbed from digestive tract. The maximum plasma concentration of Prenoxdiazinum is reached in 30 minutes after administration of drug, its therapeutic concentration is maintained within 6-8 hours. Communication with proteins of plasma makes 55-59%. The elimination half-life makes 2,6 hours. The most part of the accepted dose is metabolized in a liver, only about 1/3 accepted doses of drug are removed in not changed look, and other part – in the form of metabolites (4 metabolites of Prenoxdiazinum are allocated). Within the first 12 hours of metabolism of Prenoxdiazinum the most important role is played by biliary excretion of its and its metabolites. In 24 hours after reception 93% of drug are allocated. In 72 hours after intake of 50-74% of the accepted dose also 26-50% – with urine are removed with a stake.

Indications to use:

Unproductive cough of any origin (at Qatar of upper respiratory tracts, flu, acute and chronic bronchitis, pneumonia, emphysema; night cough at patients with heart failure; to training of patients for a bronchoscopic or bronkhografichesky research).

Route of administration and doses:

The average dose for adults makes 100 mg three or four times a day (on 1 tablet 3-4 times a day). In more difficult cases the dose can be increased to 200 mg three – four times or to 300 mg three times a day (on 2 tablets 3-4 times a day or on 3 tablets 3 times a day).
Average dose for children, depending on age and body weight, 25-50 mg three or four times a day (on 1/4 – 1/2 tablets 3-4 times a day). The maximum single dose for children – 50 mg (1/2 tablets), for adults – 300 mg (3 tablets). The maximum daily dose for children – 200 mg (2 tablets), for adults – 900 mg (9 tablets). By preparation for a bronkhoskopiya the dose in 0,9 – 3,8 mg/kg of body weight is combined from 0,5 – 1 mg of atropine in 1 hour prior to the procedure.
Tablets are swallowed, without chewing (in order to avoid anesthesia of a mucous membrane of an oral cavity).

Features of use:

Drug can cause complaints from digestive tract in patients with a lactose intolerance since tablets contain lactose (0,38 mg of lactose in each tablet).

Influence on ability to manage motor transport and to perform the works connected with the increased danger

Administration of drug in high doses can slow down the speed of reactions therefore at administration of drug in high doses the question of a possibility of driving or occupation the works connected with the increased danger has to be solved individually.

Side effects:

Allergic reactions
Seldom: skin rash, Quincke's disease.
From digestive tract
Seldom: dryness in a mouth or in a throat, anesthesia (temporary numbness and an anesthesia) of a mucous membrane of an oral cavity.
Less than in 10% of cases: stomach aches, tendency to locks, nausea.
From a nervous system (when using drug in high doses): easy sedation, fatigue.
It is necessary to emphasize that, both sedation, and fatigue, are shown at doses above therapeutic, and all symptoms spontaneously stop within several hours after the termination of administration of drug.

Interaction with other medicines:

It is not recommended to combine drug with mucolytic and expectorants since it can complicate expectoration, liquefied by the last.
There are neither preclinical, nor clinical data on interaction with other drugs.

Contraindications:

Hypersensitivity to drug.
The diseases connected with plentiful bronchial secretion.
State after an inhalation anesthesia.
Intolerance of a galactose, insufficiency of lactase or malabsorption of glucose galactose.
With care: children's age.

Pregnancy and lactation

During the periods of pregnancy and a lactation use of Libexinum is possible only if the potential advantage for mother exceeds possible risk for a fruit or the child.

Overdose:

Data on overdose for the person are not available. In case of reception of the dose exceeding therapeutic development of sedation and weakness is possible.

Storage conditions:

To store at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity of 5 years.
Not to accept after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

Tablets of 100 mg.
On 20 tablets in the blister from a film of polyvinyl chloride and aluminum foil.
On 1 blister together with the application instruction in a cardboard pack.