Libexin - instructions for use, dose, side effects, contraindications

Active substancePrenoxdiazinePrenoxdiazine

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Libexin®

pills inwards

HINOIN Pharmaceutical and Chemical Products Plant, ZAO Hungary

Dosage form: & nbsppills

Composition:

1 tablet contains:

active substance: prenoxdiazine hydrochloride 100 mg;

Excipients: glycerol (glycerin), magnesium stearate, talcum, povidone, corn starch, lactose monohydrate.

Description:

Round flat tablets white or almost white with a bevel on both sides. On one side of the engraving "LIBEXIN", on the other side of the risk, dividing the pill into four parts.

Pharmacotherapeutic group:Antitussive remedy of peripheral action

ATX: & nbsp

R.05.D.B.18 Prenoxdiazine

Pharmacodynamics:

Prenoxdiazine is an antitussive remedy for peripheral action.

The drug blocks the peripheral links of the cough reflex due to the following effects:

- local anesthetic action, which reduces the irritability of peripheral sensory (cough) respiratory tract receptors;

- bronchodilator action, which suppresses the stretch receptors that participate in the cough reflex;

- a slight decrease in the activity of the respiratory center (without respiratory depression).

The antitussive effect of the drug is approximately equal to that of codeine.

Prenoxidiazine does not cause addiction and drug dependence.

In chronic bronchitis, the anti-inflammatory effect of prenoxdiazin was noted.

Prenoxidiazine does not affect the function of the central nervous system, except for possible indirect anxiolytic effects.

Pharmacokinetics:

Prenoxdiazine is rapidly and largely absorbed from the gastrointestinal tract.

The maximum plasma concentration of prenoxdiazine is reached 30 minutes after taking the drug, its therapeutic concentration is maintained for 6-8 hours.

The connection with plasma proteins is 55-59%.

The elimination half-life is 2.6 hours.

Most of the accepted dose is metabolized in the liver, only about 1/3 of the accepted dose of the drug is excreted unchanged, and the rest - in the form of metabolites (4 metabolites of prenoxdiazine are allocated).

During the first 12 hours of metabolism of prenoxediazin, the most important role is played by biliary excretion of its and its metabolites. After 24 hours after taking 93% of the drug is allocated. For 72 hours after ingestion, 50-74% of the accepted dose is excreted with feces and 26-50% with urine.

Indications:

Unproductive cough of any origin (with catarrh of the upper respiratory tract, influenza, acute and chronic bronchitis, pneumonia, emphysema, night cough in patients with heart failure, preparing patients for bronchoscopy or bronchography).

Contraindications:

Hypersensitivity to the drug.

Diseases associated with abundant bronchial secretion.

Condition after inhalation anesthesia.

Intolerance to galactose, insufficiency of lactase or malabsorption of glucose-galactose.

Carefully:

Childhood.

Pregnancy and lactation:

During pregnancy and lactation, the use of Libexin® is only possible if the potential benefit to the mother exceeds the possible risk to the fetus or child.

Dosing and Administration:

Average dose for adults is 100 mg three or four times a day (1 tablet 3-4 times a day). In more complicated 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).

Average dose for children, depending on the age and body weight of 25-50 mg three or four times a day (1/4 - 1/2 tablets 3-4 times a day).

The maximum single dose for children is 50 mg (1/2 tablet), for adults 300 mg (3 tablets).The maximum daily dose for children is 200 mg (2 tablets), for adults - 900 mg (9 tablets).

When preparing for bronchoscopy, a dose of 0.9-3.8 mg / kg of body weight is combined with 0.5-1 mg of atropine for 1 hour before the procedure.

Tablets are swallowed without chewing (to avoid anesthesia of the oral mucosa).

Side effects:

Side effects are divided into system-organ classes in accordance with the classification of the Medical Dictionary of Regulatory Activities (MedDRA) with the frequency of their occurrence according to WHO classification: often (≥ 1% and <10%); rarely (≥ 0.01% and <0.1%), an unknown frequency (according to available data, it is not possible to determine the frequency of occurrence of a side effect).

Allergic reactions

Rarely: skin rash; angioedema.

Unknown frequency: bronchospasm.

From the gastrointestinal tract

Rarely: dry mouth or throat; anesthesia (temporary numbness and loss of sensitivity) of the oral mucosa;

Often: pain in the stomach; constipation; nausea.

From the nervous system (when using the drug in high doses)

Unknown frequency: mild sedation; fatigue.

It should be emphasized that both sedation and fatigue are manifested when the drug is administered in doses above therapeutic, and all symptoms spontaneously cease within a few hours after discontinuation of the drug.

Overdose:

Data on overdose for a person is not available. In case of taking a dose that exceeds the therapeutic dose, it is possible to develop a sedative effect and weakness.

Interaction:

It is not recommended to combine the drug with mucolytic and expectorant, it can make it difficult to isolate sputum liquefied by the latter.

There are no preclinical or clinical data on the interaction with other drugs.

Special instructions:

The drug can cause complaints from the gastrointestinal tract in patients with lactose intolerance, tk. tablets contain lactose (0.38 mg of lactose in each tablet).

Effect on the ability to drive transp. cf. and fur:

Taking the drug in high doses can slow down the reaction rate, so when taking the drug in high doses, the question of the possibility of driving a car or taking jobs associated with an increased risk must be addressed individually.

Form release / dosage:

Tablets, 100 mg.

Packaging:

For 20 tablets in a blister of polyvinylchloride film and aluminum foil.

1 blister with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not take it beyond the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N015126 / 01

Date of registration:29.10.2008

Expiration Date:Unlimited

The owner of the registration certificate:HINOIN Pharmaceutical and Chemical Products Plant, ZAO HINOIN Pharmaceutical and Chemical Products Plant, ZAO Hungary

Manufacturer: & nbsp

CHINOIN Pharmaceutical and Chemical Works, Co. Ltd. Hungary

Representation: & nbspSanofi Aventis GroupSanofi Aventis Group

Information update date: & nbsp04.03.2018

Illustrated instructions

Instructions

Libexin® (Libexin®)