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

Excipients: sodium saccharinate (saccharin sodium) 0.5 mg, sorbitol 1373.5 mg, macrogol 6000 30 mg, talc 60 mg, peppermint flavoring powder 9/008677 16 mg.

Description:

White round tablets are smooth on both sides with bevelled edges with a matte or slightly shiny surface and the smell of peppermint.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Local anesthetic effect of ambroxol (the active component of the drug) is explained by the property of the drug to block sodium channels. In the study in vitro shown, that ambroxol blocks cloned neuronal sodium channels; binding is reversible and depends on the concentration of ambroxol.

These pharmacological properties correspond to additional observations obtained in clinical studies evaluating the efficacy of ambroxol: with inhalation. When ambroxol is used as a mucolytic agent, there was a decrease in pain and associated discomfort in the ear, throat and nose.

In clinical studies it was confirmed that LAZONGIN has an analgesic effect in patients with acute pharyngitis of viral etiology. Has a quick onset of action with a duration of at least 3 hours. LAZONGIN significantly reduces hyperemia of the mucous membrane of the throat in patients with sore throat.

Ambroxol has an anti-inflammatory effect. Determined that in vitro Ambroxol significantly reduces the release of cytokines from mononuclear and polynucleated blood cells andtissues.

Ambroxol increases the production and secretion of surfactant in the lungs and stimulates the activity of ciliated cells. Strengthening mucociliary clearance improves sputum discharge and facilitates coughing.

Pharmacokinetics:

LAZONGIN acts locally on the mucous membrane of the mouth and throat. For all immediate-release ambroxol dosage forms, rapid and almost complete absorption with a linear dose-response in the therapeutic range of concentrations is characteristic. The maximum concentration (Cmah) ambroxol in the plasma with oral intake is achieved after 1 - 2.5 hours. The transfer of ambroxol from the blood to the tissue with oral administration occurs rapidly. The highest concentrations of the active component of the drug are observed in the lungs.

The volume of distribution is 552 liters. In the therapeutic range of concentrations the binding to plasma proteins is approximately 90%.

Approximately 30% of the oral dose taken is exposed to the effect of a primary pass through the liver. Ambroxol hydrochloride originally metabolized in the liver, mainly by glucuronidation and by partial cleavage up to dibromantranilic acid (approximately 10% of the administered dose), as well as a small number of additional metabolites.

Studies on microsomes of the human liver have shown that CYP3A4 is the predominant isoenzyme, responsible for the metabolism of ambroxol to dibromantranilic acid. The terminal half-life of ambroxol is 10 hours. The total clearance is within 660 ml / min, the renal clearance accounts for approximately 83% of the total clearance.

In patients with impaired hepatic function, the isolation of ambroxol hydrochloride is slowed, so the content of ambroxol hydrochloride in the plasma is increased (about 1,3-2 times). Dose adjustments in these patients are not required, since ambroxol hydrochloride has a wide therapeutic range.

No clinically significant influence of age and sex on pharmacokinetics of ambroxol, so there is no the basis for choosing the dosage for these featured. Food does not affect the bioavailability of ambroxol hydrochloride.

Indications:

It is used as a symptomatic tool to relieve pain in the throat.

Contraindications:

Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester).children under 12 years of age (no efficacy data), lactase deficiency, lactose intolerance, fructose intolerance, glucose-galactose malabsorption.

Carefully:

Pregnancy period (II - III trimester) and lactation period, renal and / or hepatic insufficiency.

Pregnancy and lactation:

Ambroxol penetrates the placental barrier. Preclinical studies showed no direct or indirect adverse effects on pregnancy, fetal / fetal, postnatal development, and on generic activities.

The extensive clinical experience of the use of ambroxol after the 28th week of pregnancy found no evidence of a negative effect of the drug on the fetus. However, it is necessary to observe the usual precautions when using the medication during pregnancy. It is especially not recommended to take LAZONGIN in the first trimester of pregnancy.

Ambroxol is excreted in breast milk. Despite the fact that undesirable effects in children receiving breastfeeding were not observed, it is not recommended to use LAZONGIN during lactation.

Preclinical studies of ambroxol showed no adverse effects on fertility.

Dosing and Administration:

Adults and adolescents over 12 years old: rassasyvat 1 tablet from 1 to 6 times a day. The drug can be used before or after a meal.

In the event that the high temperature and symptoms persist for 3 days, the advisability of further taking the drug is determined by the attending physician.

Side effects:

Disorders from the gastrointestinal tract

Often (1,0 - 10,0%) - nausea, decreased sensitivity in the oral cavity or pharynx;

Infrequent (0,1 - 1,0%) - dyspepsia, abdominal pain, dry mouth;

Rarely (0.01 - 0.1%) - diarrhea, dryness in the throat; vomiting *.

Immune system disorders, skin and subcutaneous tissue damage

Rash *, urticaria *, anaphylactic reactions (including anaphylactic shock) *, angioedema, * itching *, hypersensitivity *.

Disorders from the nervous system

Often (1,0 - 10,0%) - dysgeusia (a violation of taste sensations).

* - these adverse reactions were observed with a wide application of the drug; with 95% probability, the incidence of these adverse reactions is infrequent (0.1% -1.0%), but possibly less frequently; the exact frequency is difficult to assess, since they were not noted during clinical trials.

Overdose:

Specific symptoms of an overdose in humans are not described.

Possible: nausea, vomiting, diarrhea, indigestion.

Treatment: symptomatic therapy.

Interaction:Not installed.

Special instructions:

LAZONGIN at application in the maximum recommended daily dose contains 8.2 g of sorbitol (one tablet for resorption contains 1.37 g of sorbitol). Patients with a rare hereditary intolerance to fructose should not take this drug.

In patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - temperature, body pain, rhinitis, cough and sore throat may appear in the early phase. With symptomatic treatment, it is possible to erroneously administer mucolytic agents, such as ambroxol hydrochloride. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the appointment of the drug; but there is no causal relationship with taking the drug.

With the development of the above syndromes (sudden appearance of rashes and spots on the face and trunk, which later can spread to other parts of the body), it is recommended to stop treatment and immediatelyseek medical attention.

LAZONGIN contains less than 1 mg of lactose in the dry flavor of peppermint 9/008677. Patients with lactase deficiency, lactose intolerance, glucose galactose malabsorption should not take this drug.

If the kidney function is disrupted LAZONGIN should be used only on the advice of a doctor.

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

There were no cases of drug effects on the ability to drive vehicles and mechanisms. Studies on the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions were not carried out.

Form release / dosage:

Tablets for resorption of 20 mg.

Packaging:

3 or 10 tablets for resorption in a strip made of A1 foil or in a blister of polypropylene / A1 foil;

1 or 2 blisters (or strip) in a cardboard box with instructions for use.

Storage conditions:

In a dry place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:PL-000523

Date of registration:01.03.2011 / 01.08.2017

Expiration Date:Unlimited

The owner of the registration certificate:SANOFI RUSSIA, CJSCSANOFI RUSSIA, CJSC

Manufacturer: & nbsp

DELPHARM REIMS France

Representation: & nbspSanofi Russia, JSCSanofi Russia, JSCRussia

Information update date: & nbsp09.02.2018

Illustrated instructions

Instructions

Lazognin® (Lazongin®)