Tablets "Ambrobene" for children: instructions for use. Ambrobene tablets - instructions for use Dosage form Ambrobene

One tablet contains

active substance: ambroxol hydrochloride 60.0 mg,

excipients: lactose monohydrate, corn starch, magnesium stearate, colloidal anhydrous silica.

Description

Tablets are white, round, with a biconvex surface, with a cruciform risk on one side.

Pharmacotherapeutic group

Expectorants. Mucolytics. Ambroxol.

ATX code R05CB 06

Pharmacological properties"type="checkbox">

Pharmacological properties

Pharmacokinetics

Suction. Absorption is high and almost complete, linearly dependent on the therapeutic dose. The maximum plasma concentration is reached within 1 - 2.5 hours. Absolute bioavailability - 79%.

Distribution. Distribution is rapid and extensive, with highest concentrations in lung tissue. The volume of distribution is approximately 552 liters. Communication with blood plasma proteins is approximately 90%.

Metabolism and excretion. Approximately 30% of an oral dose undergoes a "first pass" effect through the liver.

CYP3A4 is the main enzyme responsible for the metabolism of ambroxol, under the action of which, mainly in the liver, conjugates are formed.

The half-life is 10 hours. Total clearance: within 660 ml / min, renal clearance is 83% of the total clearance. Excreted by the kidneys: 26% in the form of conjugates, 6% in free form.

Excretion decreases with impaired liver function, which leads to an increase in plasma levels by 1.3-2 times, but does not require dose adjustment.

Gender and age do not have a clinically significant effect on the pharmacokinetics of ambroxol and do not require dose adjustment.

Eating does not affect the bioavailability of ambroxol hydrochloride.

Pharmacodynamics

Ambrobene® has a secretolytic and expectorant effect; stimulates the serous cells of the glands of the bronchial mucosa, increases the content of the mucous secretion and the release of a surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolyzing enzymes and increasing the release of lysosomes from Clara cells, it reduces the viscosity of sputum. Increases the motor activity of the cilia of the ciliated epithelium, increases the mucociliary transport of sputum. Increased secretion and mucociliary clearance improves sputum separation and relieves cough.

It has been proven that the local anesthetic effect of ambroxol is due to a dose-dependent blockade of sodium channels of neurons. Under the influence of ambroxol, the release of cytokines from the blood, as well as from tissue mononuclear cells and polymorphonuclear cells, is significantly reduced.

Clinical studies on patients with sore throat have shown a significant reduction in pain and redness in the throat.

Indications for use

Secretolytic therapy of acute and chronic bronchopulmonary diseases characterized by impaired secretion and difficult sputum discharge

Dosage and administration

Ambrobene® tablets are taken orally after a meal with a sufficient amount of water. Swallow whole without chewing.

Adults and children over 12 years old: In the first 2-3 days, ½ tablet of Ambrobene® 60 mg 3 times a day (equivalent to 30 mg of ambroxol hydrochloride 3 times a day). Then Ambrobene® 60 mg is taken ½ tablet 2 times a day (equivalent to 30 mg Ambroxol hydrochloride 2 times a day).

The duration of treatment depends on the characteristics of the course of the disease. It is not recommended to use Ambrobene® without medical prescription for more than 4-5 days.

Side effects"type="checkbox">

Side effects

Gastrointestinal Disorders

Often (≥ 1/100 -< 1/10):

Nausea, taste changes, decreased sensation in the mouth and throat (oral and pharyngeal hypoesthesia)

Uncommon (≥ 1/1000 -< 1/100):

Vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth

Rare (≥ 1/10000 -< 1/1000):

Dry throat

Immune system disorders

Unknown:

Anaphylactic reactions, including anaphylactic shock

Skin and subcutaneous tissue disorders

Rare (≥ 1/10000 -< 1/1000):

Rash, hives

Unknown:

Itching and other hypersensitivity reactions, angioedema angioedema.

Contraindications

Hypersensitivity to ambroxol and / or other components of the drug

severe kidney failure

severe liver failure

I trimester of pregnancy

Rare hereditary galactose intolerance, Lapp lactase deficiency, glucose malabsorption syndrome, galactose

Children's age up to 12 years

drug interaction"type="checkbox">

drug interaction

No clinically significant adverse drug interactions have been reported.

Combined use with antitussive drugs leads to difficulty in sputum discharge against the background of cough suppression.

Increases the penetration and concentration in the bronchial secretion of amoxicillin, cefuroxime and erythromycin.

special instructions

Very rare cases of severe skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with the use of ambroxol hydrochloride. They are mainly due to the severity of the underlying disease and concomitant treatment. In addition, on early stage Stevens-Johnson syndrome and toxic epidermal necrolysis, patients may show signs of the onset of a non-specific disease, with the following symptoms: fever, pain throughout the body, rhinitis, cough and sore throat. The appearance of these symptoms may lead to unnecessary symptomatic treatment anti-cold drugs. In the event of skin lesions, the patient is immediately examined by a doctor, the use of ambroxol hydrochloride is stopped.

Pregnancy and lactation

Ambroxol hydrochloride crosses the placental barrier. Preclinical studies have not shown direct or indirect negative effects on pregnancy, fetal development, childbirth and postnatal development.

It is not recommended to use Ambrobene® during the first trimester of pregnancy. Despite the fact that so far there is no reliable evidence of a negative effect on the fetus and infants, the use of the drug in the II and III trimesters of pregnancy and during lactation is possible after a thorough analysis of the benefit / risk ratio by the attending physician.

1 tablet contains Ambroxol hydrochloride 30 mg

Release form:

Tablets for oral administration - 20 pieces per pack

Pharmachologic effect:

Mucolytic and expectorant drug

Ambroxol is a benzylamine, a metabolite of bromhexine. It differs from bromhexine in the absence of a methyl group and the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring. It has a secretomotor, secretolytic and expectorant effect.

After oral administration, the effect occurs after 30 minutes and lasts for 6-12 hours (depending on the dose taken).

Preclinical studies have shown that ambroxol stimulates the serous cells of the glands of the bronchial mucosa. By activating the cells of the ciliated epithelium and reducing the viscosity of sputum, it improves mucociliary transport.

Indication for use:

Sharp and chronic diseases respiratory tract, accompanied by a violation of the formation and discharge of sputum.

Dosage and administration:

The duration of treatment is set individually depending on the course of the disease. It is not recommended to take Ambrobene without a doctor's prescription for more than 4-5 days. The mucolytic effect of the drug is manifested when taking a large amount of liquid. Therefore, during treatment, it is recommended to drink plenty of water.

Tablets should be swallowed whole, without chewing, after meals, drinking plenty of liquid.

Children aged 6 to 12 years should take 1/2 tab. 2-3 times / day (15 mg ambroxol 2-3 times / day).

Adults and children over 12 years old in the first 2-3 days of treatment should take 1 tab. 3 times / day (30 mg ambroxol 3 times / day). With the ineffectiveness of therapy, adults can increase the dose to 2 tab. 2 times / day (120 mg ambroxol / day). In the following days, you should take 1 tab. 2 times / day (30 mg ambroxol 2 times / day).

Contraindications:

• I trimester of pregnancy;
• childhood up to 6 years;
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption (for tablets);
• hypersensitivity to the components of the drug.

Special instructions:

Should not be combined with antitussives medicines making it difficult to expel mucus.

Storage conditions:

Tablets should be stored out of the reach of children at a temperature not exceeding 25 ° C.

Tradename: Ambrobene

international generic name(INN): ambroxol

Dosage form:

Composition
1 tablet contains:
Active substance:
Ambroxol hydrochloride 30.0 mg
Excipients:
Lactose monohydrate, corn starch, magnesium stearate, colloidal anhydrous silica.

Description
White, round, biconvex tablets, scored on one side and smooth on the other side.

Pharmacotherapeutic group:

ATC Code: R05CB06

pharmachologic effect

Pharmacodynamics:
Ambroxol is a benzylamine, a metabolite of bromhexine. It differs from bromhexine in the absence of a methyl group and the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring. It has a secretomotor, secretolytic and expectorant effect.

After oral administration, the effect occurs after 30 minutes and lasts for 6-12 hours (depending on the dose taken).

Preclinical studies have shown that ambroxol stimulates the serous cells of the glands of the bronchial mucosa. By activating the cells of the ciliated epithelium and reducing the viscosity of sputum, it improves mucociliary transport.

Ambroxol activates the formation of surfactant, having a direct effect on type 2 alveolar pneumocytes and Clara cells of small airways.

Studies on cell cultures and in vivo studies on animals have shown that ambroxol stimulates the formation and secretion of a substance (surfactant) active on the surface of the alveoli and bronchi of the embryo and adult.

Also, in preclinical studies, the antioxidant effect of ambroxol has been proven. Ambroxol, when used together with antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline), increases their concentration in sputum and bronchial secretions.

Pharmacokinetics
When taken orally, Ambroxol is almost completely absorbed from the gastrointestinal tract. The maximum concentration is reached 1-3 hours after ingestion. Due to first pass metabolism, the absolute bioavailability of ambroxol after oral administration is reduced by approximately 1/3. The resulting metabolites (such as dibromoanthranilic acid, glucuronides) are eliminated in the kidneys. Plasma protein binding is about 85% (80-90%). The plasma half-life is 7 to 12 hours. The total half-life of ambroxol and its metabolites is approximately 22 hours.

It is excreted mainly by the kidneys in the form of metabolites - 90%, less than 10% is excreted unchanged.

Given the high binding to plasma proteins, the large volume of distribution and the slow redistribution from tissues to the blood, there is no significant elimination of ambroxol during dialysis or forced diuresis.

In patients with severe liver disease, ambroxol clearance is reduced by 20-40%. In patients with severely impaired renal function, the half-life of ambroxol metabolites is increased.

Ambroxol penetrates into the cerebrospinal fluid and through the placental barrier, and is also excreted in breast milk.

Indications for use
Acute and chronic diseases of the respiratory tract, accompanied by a violation of the formation and discharge of sputum.

Contraindications

• hypersensitivity to ambroxol or to one of the excipients;
• use in children under 6 years of age;
• pregnancy (I trimester);
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Carefully:
Violation of the motor function of the bronchi and increased sputum production (with immobile cilia syndrome), peptic ulcer stomach and duodenum during an exacerbation, pregnancy (II-III trimester), lactation.

Patients with impaired renal function or severe liver disease should take Ambrobene with extreme caution, observing large intervals between doses or taking the drug at a lower dose.

Use during pregnancy and lactation

Pregnancy:

There are insufficient data on the use of ambroxol during pregnancy. In particular, this applies to the first 28 weeks of pregnancy. Animal studies have not shown a teratogenic effect.

The use of Ambrobene during pregnancy (II-III trimester) is possible only on prescription, after a thorough assessment of the risk / benefit ratio.

Breastfeeding period:
Animal studies have shown that Ambroxol passes into breast milk. Due to the insufficient study of the use of the drug in women during lactation, the use of Ambrobene is possible only on prescription, after a thorough assessment of the risk / benefit ratio.

Dosage and administration
Tablets should be swallowed whole, without chewing, after meals, drinking plenty of liquid.

Children from 6 to 12 years old should be taken 1/2 tablet 2-3 times a day (15 mg ambroxol 2-3 times a day).

Adults and children over 12 years old in the first 2-3 days of treatment, take 1 tablet 3 times a day (30 mg of ambroxol 3 times a day). If therapy is ineffective, adults can increase the dose to 2 tablets 2 times a day (120 mg of ambroxol per day). In the following days, you should take 1 tablet 2 times a day (30 mg of ambroxol 2 times a day).

The duration of treatment is selected individually depending on the course of the disease. It is not recommended to take Ambrobene without a doctor's prescription for more than 4-5 days. The mucolytic effect of the drug is manifested when taking a large amount of liquid. Therefore, during treatment, it is recommended to drink plenty of water.

Side effect

General violations:
Rare (>0.1% to< 1 %): allergic reactions(urticaria, skin rash, angioedema of the face, shortness of breath, itching), fever, weakness, headache.
Very rarely (< 0,01 %): анафилактические реакции, в том числе анафилактический шок.

From the gastrointestinal tract:
Rare (>0.1% to< 1 %): тошнота, боли в животе, рвота, диарея, запоры.

Others:
Rare (>0.1% to< 1 %): сухость слизистой оболочки полости рта и дыхательных путей, экзантема, ринорея, дизурия.

Overdose

Symptoms:
Signs of intoxication with an overdose of ambroxol have not been identified. There are reports of nervous excitement and diarrhea.

Ambroxol is well tolerated when taken orally at doses up to 25 mg/kg/day. In case of severe overdose, increased salivation, nausea, vomiting, and a decrease in blood pressure are possible.

Treatment:
Intensive therapy methods, such as induction of vomiting, gastric lavage, should be used only in cases of severe overdose, in the first 1-2 hours after taking the drug. Symptomatic treatment is shown.

Interaction with other drugs
With the simultaneous use of ambroxol and antitussives, due to the suppression of the cough reflex, secretion stagnation may occur. Therefore, such combinations should be chosen with caution.

With the joint use of ambroxol and antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline, the concentration of the latter in sputum and bronchial secretions increases.

special instructions
It should not be combined with antitussive drugs that make it difficult to remove sputum.

Extremely rarely, when using Ambrobene, severe skin reactions were observed, such as Stevens-Johnson syndrome and Lyell's syndrome. If the skin or mucous membranes change, you should immediately consult a doctor and stop taking the drug. The effect on the ability to drive vehicles and on the control of machines and mechanisms is not known to date.

Release form
Tablets 30 mg.
10 tablets in a PVC/AI foil blister.
2 or 5 blisters with instructions for use are placed in a cardboard box.

Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children!

Best before date
5 years. Do not use after the expiration date!

Holiday conditions
Without recipe.

Registration certificate holder:
"ratiopharm GmbH", Germany.

Manufacturer:

Claim address: 119049, Moscow, st. Shabolovka, 10, building 1.

P N014731/01

Tradename:

Ambrobene

International non-proprietary name (INN):

ambroxol

Dosage form Ambrobene:

tablets

Ambrobene tablets Composition

1 tablet contains:

Active substance:

Ambroxol hydrochloride 30.0 mg

Excipients:

Lactose monohydrate, corn starch, magnesium stearate, colloidal anhydrous silica.

Description Ambrobene tablets

White, round, biconvex tablets, scored on one side and smooth on the other side.

Pharmacotherapeutic group:

mucolytic expectorant.

The code ATX:

R05CB06

pharmachologic effect

Pharmacodynamics

Ambroxol is a benzylamine, a metabolite of bromhexine. It differs from bromhexine in the absence of a methyl group and the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring. It has a secretomotor, secretolytic and expectorant effect.

After oral administration, the effect occurs after 30 minutes and lasts for 6-12 hours (depending on the dose taken).

Preclinical studies have shown that ambroxol stimulates the serous cells of the glands of the bronchial mucosa. By activating the cells of the ciliated epithelium and reducing the viscosity of sputum, it improves mucociliary transport.

Ambroxol activates the formation of surfactant, having a direct effect on type 2 alveolar pneumocytes and Clara cells of small airways.

Cell culture research and researchin vivoon animals have shown that ambroxol stimulates the formation and secretion of a substance (surfactant) active on the surface of the alveoli and bronchi of the embryo and adult. Also, in preclinical studies, the antioxidant effect of ambroxol has been proven. Ambroxol, when used together with antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline), increases their concentration in sputum and bronchial secretions.

Pharmacokinetics

When taken orally, Ambroxol is almost completely absorbed from the gastrointestinal tract. The maximum concentration is reached 1-3 hours after ingestion. Due to first pass metabolism, the absolute bioavailability of ambroxol after oral administration is reduced by approximately 1/3. The resulting metabolites (such as dibromoanthranilic acid, glucuronides) are eliminated in the kidneys. Plasma protein binding is about 85% (80-90%). The plasma half-life is 7 to 12 hours. The total half-life of ambroxol and its metabolites is approximately 22 hours.

It is excreted mainly by the kidneys in the form of metabolites - 90%, less than 10% is excreted unchanged.

Given the high binding to plasma proteins, the large volume of distribution and the slow redistribution from tissues to the blood, there is no significant elimination of ambroxol during dialysis or forced diuresis.

In patients with severe liver disease, ambroxol clearance is reduced by 20-40%. In patients with severely impaired renal function, the half-life of ambroxol metabolites is increased.

Ambroxol penetrates into the cerebrospinal fluid and through the placental barrier, and is also excreted in breast milk.

Indications for use Ambrobene tablets

Acute and chronic diseases of the respiratory tract, accompanied by a violation of the formation and discharge of sputum.

Contraindications

Hypersensitivity to ambroxol or to one of the excipients;

Use in children under 6 years of age;

Pregnancy (I trimester);

Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Carefully

Violation of the motor function of the bronchi and increased sputum production (with immovable cilia syndrome), peptic ulcer of the stomach and 12 duodenal ulcer during an exacerbation, pregnancy(II-IIItrimester, lactation period. Patients with impaired renal function or severe liver disease should take Ambrobene with extreme caution, observing large intervals between doses or taking the drug at a lower dose.

Use during pregnancy and lactation

Pregnancy

There are insufficient data on the use of ambroxol during pregnancy. In particular, this applies to the first 28 weeks of pregnancy. Animal studies have not shown a teratogenic effect.

The use of Ambrobene during pregnancy(II-IIItrimester) is possible only on prescription, after a thorough assessment of the risk/benefit ratio.

breastfeeding period

Animal studies have shown that Ambroxol passes into breast milk. Due to the insufficient study of the use of the drug in women during lactation, the use of Ambrobene is possible only on prescription, after a thorough assessment of the risk / benefit ratio.

Ambrobene tablets method of administration and dose

Tablets should be swallowed whole, without chewing, after meals, drinking plenty of liquid.

Children from 6 to 12 years oldshould be taken 1/2 tablet 2-3 times a day (15 mg ambroxol 2-3 times a day).

Adults and children over 12 years oldin the first 2-3 days of treatment, take 1 tablet 3 times a day (30 mg of ambroxol 3 times a day). If therapy is ineffective, adults can increase the dose to 2 tablets 2 times a day (120 mg ambroxol per day): In the following days, take 1 tablet 2 times a day (30 mg ambroxol 2 times a day).

The duration of treatment is selected individually depending on the course of the disease. It is not recommended to take Ambrobene without a doctor's prescription for more than 4-5 days.

The mucolytic effect of the drug is manifested when taking a large amount of liquid. Therefore, during treatment, it is recommended to drink plenty of water.

Side effect

General violations:

Rare (>= 0.1% to< 1%): аллергические реакции (крапивница, кожная сыпь, ангионевротический отек лица, одышка, зуд), лихорадка, слабость, головная боль.

Very rarely (< 0,01%): анафилактические реакции, в том числе анафилактический шок.

So sides of the gastrointestinal tract:

Rare (>= 0.1% to< 1%): тошнота, боли в животе, рвота, диарея, запоры.

Others:

Rare (>= 0.1% to< 1%): сухость слизистой оболочки полости рта и дыхательных путей, экзантема, ринорея, дизурия.

Overdose

Symptoms

Signs of intoxication with an overdose of ambroxol have not been identified. There are reports of nervous excitement and diarrhea.

Ambroxol is well tolerated when taken orally at doses up to 25 mg/kg/day.

In case of severe overdose, increased salivation, nausea, vomiting, and a decrease in blood pressure are possible.

Treatment

Intensive therapy methods, such as induction of vomiting, gastric lavage, should be used only in cases of severe overdose, in the first 1-2 hours after taking the drug. Symptomatic treatment is shown.

Interaction with other drugs

With the simultaneous use of ambroxol and antitussives, due to the suppression of the cough reflex, secretion stagnation may occur. Therefore, such combinations should be chosen with caution.

With the joint use of ambroxol and antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline, the concentration of the latter in sputum and bronchial secretions increases.

special instructions

It should not be combined with antitussive drugs that make it difficult to remove sputum. Extremely rarely, when using Ambrobene, severe skin reactions were observed, such as Stevens-Johnson syndrome and Lyell's syndrome. If the skin or mucous membranes change, you should immediately consult a doctor and stop taking the drug.

The effect on the ability to drive vehicles and on the control of machines and mechanisms is not known to date.

Ambrobene release form

Tablets 30 mg.

10 tablets in PVC/A blisterI-foils.

2 or 5 blisters with instructions for use are placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children!

Best before date

5 years.

Do not use after the expiration date!

Holiday conditions

Without recipe.

Registration certificate holder:

"ratiopharm GmbH", Germany.

Manufacturer:

Merkle GmbH,

Ludwig-Merkpe Strasse 3,D-89143,Blaubeuren, Germany.