Lazolvan Max - instructions for use, dose, side effects, contraindications

composition of capsular shell: gelatin 52,307 mg, purified water 9,135 mg, titanium dioxide (E171) 1.008 mg, iron dye red oxide (E172) 0.150 mg, iron dye oxide yellow (E172) 0.398 mg; Ink composition: shellac, titanium dioxide.

Description:

Oblong, hard gelatin capsules consisting of a red opaque cap and an orange opaque body; on the cover there is a printed designation "MUC 01 "white, the symbol of the company Behringer Ingelheim is printed on the body .

Contents of the capsule: round, yellowish-white granules with a smooth, shiny surface mixed with a small amount of powder.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

In studies it is shown that ambroxol - active ingredient of Lazolvan preparation® MAX - increases secretion in the respiratory tract. It increases the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased current and transport of mucus (mucociliary clearance). Strengthening mucociliary clearance improves sputum discharge and facilitates coughing.

In patients with chronic obstructive pulmonary disease, prolonged therapy with Lazolvan® MAX (for at least 2 months) led to a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.

Pharmacokinetics:

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 in plasma (C_m_Oh) with the administration of one capsule of prolonged action is achieved on average after 6.5 hours. Absolute bioavailability of tablets of ambroxol 30 mg is 79%. In the therapeutic concentration range, binding to plasma proteins is approximately 90%. Capsules of prolonged action of ambroxol 75 mg showed a relative bioavailability is 95% compared with taking 60 mg ambroxol hydrochloride per day (30 mg twice daily) in the form of tablets (a comparison was made after the assimilation of doses). The transfer of ambroxol from the blood to the tissue with oral administration occurs rapidly. The volume of distribution is 552 liters. The highest concentrations of the active component of the drug are observed in the lungs. Approximately 30% of the oral dose taken is exposed to the effect of a primary pass through the liver. Studies on microsomes of the human liver showed that the isoenzyme CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromoanthranilic acid. The remainder of ambroxol is metabolized in the liver, mainly by glucuronidation and by partial cleavage to dibromantranilic acid (approximately 10% of the administered dose), as well as a small number of additional metabolites.The period of terminal half-life of ambroxol is about 10 hours. The total clearance is within 660 ml / min, the renal clearance accounts for about 8% of the total clearance. With the radioactive label method, it was estimated that after taking a single dose of the drug for the next 5 days, about 83% of the dose taken is excreted in the urine. There is no clinically significant effect of age and sex on the pharmacokinetics of ambroxol, so there is no reason to select a dosage for these features.

Indications:

Acute and chronic diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchoectatic disease.

Contraindications:

Hypersensitivity to ambroksolu or other components of the drug, pregnancy (I trimester), the period of breastfeeding, children under 18 years.

Carefully:

II-III trimesters of pregnancy, renal and / or hepatic insufficiency.

Pregnancy and lactation:

Ambroxol penetrates the placental barrier.Preclinical studies showed no direct or indirect adverse effects on pregnancy, embryonic / fetal, postnatal development and delivery. The extensive clinical experience of using ambroxol after the 28th week of pregnancy found no evidence of a negative effect of the drug on the fetus.

However, the usual precautionary measures should be followed when using the medication during pregnancy. Especially it is not recommended to take Lazolvan MAX in the first trimester of pregnancy. In the II and III trimesters of pregnancy, the drug can be used only if the potential benefit to the mother exceeds the potential risk to the fetus.

Ambroxol can be excreted in breast milk. Despite the fact that adverse effects were not observed in breast-fed infants, during breastfeeding it is not recommended to use Lazolvan® MAX Capsules.

Preclinical studies of ambroxol showed no adverse effects on fertility.

Dosing and Administration:

Inside.

1 capsule of prolonged action once a day.

Capsules should not be opened or chewed.

Swallow whole with plenty of fluids.

"Capsule residues", which are sometimes present in the stool, have already released the active substance during passage through the digestive tract, so they should not be given importance.

Capsules can be used regardless of food intake.

If the symptoms persist for 4-5 days after the start of treatment, it is recommended that you consult a doctor.

Side effects:

Classification of the incidence of adverse events (WHO): very often> 1/10; often from> 1/100 to <1/10; infrequently from> 1/1000 to <1/100; rarely from> 1/10000 to <1/1000; very rarely from <1/10000; frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

Disorders from the gastrointestinal tract

Often - nausea;

Infrequently - indigestion, vomiting, diarrhea, abdominal pain.

Immune system disorders, skin and subcutaneous tissue damage

Rarely, a rash, hives;

The frequency is unknown - angioedema, anaphylactic reactions (including anaphylactic shock), itching, hypersensitivity.

Overdose:

Specific symptoms of an overdose in humans are not described.

There are reports of a random overdose and / or medical error that resulted in symptoms of known side effects of Lazolvan® MAX: nausea, indigestion, vomiting, diarrhea, abdominal pain.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, symptomatic therapy.

Interaction:

Clinically significant, undesirable interactions with other drugs have not been reported.

Ambroxol increases penetration into the bronchial secret of amoxicillin, cefuroxime. erythromycin when used simultaneously with them.

Special instructions:

Do not combine with antitussive drugs that make it difficult to withdraw phlegm.

There are isolated reports of severe skin lesions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the appointment of expectorants such as Lazolvan® MAX. In most cases, they can be explained by the severity of the underlying disease and / or concomitant therapy. In patients with Stevens-Johnson syndrome or toxic epidermal necrolysis, fever, body pain, rhinitis, cough and sore throat may appear in the early phase. With symptomatic treatment, it is possible to erroneously prescribe "anti-cold" drugs.When new lesions of the skin and mucous membranes appear, it is recommended to stop ambroxol treatment and immediately seek medical help.

If the kidney function is impaired, the drug should be used only on the advice of a doctor.

For children younger than 18 years, the use of other medicinal forms of the drug Lazolvan (syrup, lozenges, solution for ingestion and inhalation) is possible.

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 that require increased concentration, attention and speed of psychomotor reactions have not been carried out.

Form release / dosage:

Capsules of prolonged action, 75 mg.

Packaging:

For 5 or 6 capsules in a blister of PVC / PVDC / A1-foil.

1 blister with instructions for use in a cardboard box.

For 10 capsules in a blister of PVC / PVDC / A1-foil.

For 1 or 2 blisters 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:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003519

Date of registration:22.03.2016 / 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

Lazolvan® Max (Lasolvan® Max)