The instruction for medical use
of Ambrobene Torgovoye medicine
Ambrobene
Mezhdunarodnoye's name the unlicensed
name Ambroxol Dosage Form
of the Tablet, 30 mg
Structure
One tablet contains
active agent: Ambroxol hydrochloride of 30.0 mg,
excipients: lactoses monohydrate, starch corn, magnesium stearate, silicon dioxide colloidal anhydrous.
The description
of the Tablet, white color, round, with a biconvex surface, with risky on the one hand
Pharmacotherapeutic group
Drugs for elimination of symptoms of cold and cough. Expectorant drugs. Mucolytics. Ambroxol.
ATX R05CB06 code
Pharmacological action
Pharmacokinetics
Absorption. Absorption high and almost full, a lineynozavisima from a therapeutic dose. The maximum plasma concentration is reached within 1 - 2.5 hours. Absolute bioavailability of 79%.
Distribution. Distribution fast and extensive, with the highest concentration in tissue of lungs. The volume of distribution is about 552 l. Communication with proteins of blood plasma makes about 90%.
Metabolism and removal. About 30% of the dose accepted inside are exposed to effect of the first passing through a liver.
CYP3A4 the main enzyme responsible for metabolism of Ambroxol under the influence of which, mainly in a liver, conjugates are formed.
Elimination half-life makes 10 hours. General clearance: within 660 ml/min., the renal clearance is 83% of the general clearance. It is removed by kidneys: 26% in the form of conjugates, 6% - in a free look.
Removal decreases in abnormal liver functions that leads to increase in level in blood plasma by 1.3-2 times, but does not demand dose adjustment.
Gender and age have no clinically significant impact on pharmacokinetics of Ambroxol and do not demand dose adjustment.
Meal does not influence bioavailability of Ambroxol of a hydrochloride.
Ambrobene's pharmacodynamics possesses sekretolitichesky and expectorant action, stimulates serous cells of glands of a mucous membrane of bronchial tubes, increases the content of mucous secretion and discharge of surfactant in alveoluses and bronchial tubes, normalizes the broken ratio of serous and mucous components of a phlegm. Activating the hydrolyzing enzymes and strengthening release of lysosomes from cells Klara, reduces viscosity of a phlegm. Increases physical activity of cilia of a ciliary epithelium, increases mukotsiliarny transport of a phlegm. Increase in secretion and mukotsiliarny clearance improves department of a phlegm and facilitates cough.
It is proved that mestnoanesteziruyushchy effect of Ambroxol is caused by dose-dependent blockade of natrium channels of neurons. Under the influence of Ambroxol the release of cytokines from blood and also from fabric mononuklear and polimorfonuklearny cells considerably decreases.
Clinical trials on patients with a sore throat showed considerable reduction of pain and reddening in a throat.
Indications
- sekretolitichesky therapy of the acute and chronic bronchopulmonary diseases which are characterized by disturbance of secretion and the complicated phlegm otkhozhdeniye
the Route of administration and doses
Adults and children are more senior than 12 years: 1 tablet (30 mg) 3 times a day,
If necessary for strengthening of therapeutic effect it is possible to appoint on 2 tablets (60 mg) 2 times a day.
The course makes 14 days for treatment of acute respiratory diseases and for initial treatment of chronicities.
General information. In case at the carried-out therapy of acute respiratory diseases the state did not improve, it is necessary to ask for medical care.
Side effects
Gastrointestinal disorders
Often (& ge, 1/100 - & lt, 1/10):
- nausea, change of taste, decrease in sensitivity in an oral cavity and a throat (oral and pharyngeal giposteziya)
Infrequently (& ge, 1/1000 - & lt, 1/100):
- vomiting, diarrhea, dyspepsia, an abdominal pain, dryness in a mouth
it is rare (& ge, 1/10000 - & lt, 1/1000):
- dryness in a throat
of Disturbance of the immune system
It is unknown:
- anaphylactic reactions, including an acute anaphylaxis
of Disturbance of skin and hypodermic cellulose
Seldom (& ge, 1/10000 - & lt, 1/1000):
- rash, urticaria
It is unknown:
- itching and other reactions of hypersensitivity, Quincke's disease.
Contraindications
hypersensitivity to Ambroxol and/or other components of drug
a heavy renal failure
a heavy liver failure
the I trimester of pregnancy
rare hereditary intolerance of a galactose, deficiency of Lappa lactase, a sprue of glucose, a galactose
children's age up to 12 years
Medicinal interaction
was not reported about clinically significant adverse interactions with other drugs.
Combined use with antibechic drugs leads to difficulty of an otkhozhdeniye of a phlegm against the background of suppression of cough.
Increases penetration and concentration in a bronchial secret of amoxicillin, a tsefuroksim and erythromycin.
Special instructions
Are registered very exceptional cases of severe damages of skin such as Stephens-Johnson's syndrome and toxic epidermal necrolysis, at hydrochloride Ambroxol use. Mainly they are caused by weight of a basic disease and the accompanying treatment. Besides at an early stage of a syndrome of Stephens-Johnson and a toxic epidermal necrolysis at patients signs of the beginning of a nonspecific disease, with the following symptoms can be shown: fervescence, all body pain, rhinitis, cough and sore throat. Emergence of these signs can lead to unnecessary symptomatic treatment by anti-cold drugs. In case of skin defeats the patient immediately looks round the doctor, intake of Ambroxol of a hydrochloride stops.
1 tablet contains 169.46 mg of lactose that makes 677 84 mg of lactose in most recommended daily dose of 120 mg.
Pregnancy and the period of a lactation
of Ambroxol a hydrochloride gets through a placental barrier. Preclinical trials did not show direct or indirect negative impact on pregnancy, fetation, childbirth and post-natal development.
It is not recommended to apply Ambrobene in the period of the I trimester of pregnancy. In spite of the fact that there are no reliable data of negative influence on a fruit and babies, use of drug in II and III trimesters of pregnancy and in the period of a lactation perhaps after the careful analysis of a ratio advantage/risk the attending physician so far.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Overdose
Symptoms does not influence: excitement, nausea, the raised sialosis, vomiting, diarrhea, dyspepsia, hypotension
Treatment: symptomatic therapy.
A form of release and packing
On 10 tablets in blister strip packaging from a film of polyvinylchloride and printing aluminum foil. On 1 or 2 planimetric packs together with the instruction for medical use in the state and Russian languages put in a box of cardboard.
To Store storage conditions at a temperature not above 25C.
To store out of children's reach!
Not to apply a period of storage of 5 years after expiry date!
Prescription status
Without prescription
of Proizvoditel Merkle GmbH, Germany
the Owner of the registration certificate
ratiopharm GmbH, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
Limited liability partnership ratiopharm Kazakhstan, 050040, Almaty, Al-Farabi Ave., 19,
BC Nurly-Tau, 1B, office 603, phone number: (727) 311 09 15, fax: (727) 311 07 34
of Ambrobene Torgovoye medicine
Ambrobene
Mezhdunarodnoye's name the unlicensed
name Ambroxol Dosage Form
of the Tablet, 30 mg
Structure
One tablet contains
active agent: Ambroxol hydrochloride of 30.0 mg,
excipients: lactoses monohydrate, starch corn, magnesium stearate, silicon dioxide colloidal anhydrous.
The description
of the Tablet, white color, round, with a biconvex surface, with risky on the one hand
Pharmacotherapeutic group
Drugs for elimination of symptoms of cold and cough. Expectorant drugs. Mucolytics. Ambroxol.
ATX R05CB06 code
Pharmacological action
Pharmacokinetics
Absorption. Absorption high and almost full, a lineynozavisima from a therapeutic dose. The maximum plasma concentration is reached within 1 - 2.5 hours. Absolute bioavailability of 79%.
Distribution. Distribution fast and extensive, with the highest concentration in tissue of lungs. The volume of distribution is about 552 l. Communication with proteins of blood plasma makes about 90%.
Metabolism and removal. About 30% of the dose accepted inside are exposed to effect of the first passing through a liver.
CYP3A4 the main enzyme responsible for metabolism of Ambroxol under the influence of which, mainly in a liver, conjugates are formed.
Elimination half-life makes 10 hours. General clearance: within 660 ml/min., the renal clearance is 83% of the general clearance. It is removed by kidneys: 26% in the form of conjugates, 6% - in a free look.
Removal decreases in abnormal liver functions that leads to increase in level in blood plasma by 1.3-2 times, but does not demand dose adjustment.
Gender and age have no clinically significant impact on pharmacokinetics of Ambroxol and do not demand dose adjustment.
Meal does not influence bioavailability of Ambroxol of a hydrochloride.
Ambrobene's pharmacodynamics possesses sekretolitichesky and expectorant action, stimulates serous cells of glands of a mucous membrane of bronchial tubes, increases the content of mucous secretion and discharge of surfactant in alveoluses and bronchial tubes, normalizes the broken ratio of serous and mucous components of a phlegm. Activating the hydrolyzing enzymes and strengthening release of lysosomes from cells Klara, reduces viscosity of a phlegm. Increases physical activity of cilia of a ciliary epithelium, increases mukotsiliarny transport of a phlegm. Increase in secretion and mukotsiliarny clearance improves department of a phlegm and facilitates cough.
It is proved that mestnoanesteziruyushchy effect of Ambroxol is caused by dose-dependent blockade of natrium channels of neurons. Under the influence of Ambroxol the release of cytokines from blood and also from fabric mononuklear and polimorfonuklearny cells considerably decreases.
Clinical trials on patients with a sore throat showed considerable reduction of pain and reddening in a throat.
Indications
- sekretolitichesky therapy of the acute and chronic bronchopulmonary diseases which are characterized by disturbance of secretion and the complicated phlegm otkhozhdeniye
the Route of administration and doses
Adults and children are more senior than 12 years: 1 tablet (30 mg) 3 times a day,
If necessary for strengthening of therapeutic effect it is possible to appoint on 2 tablets (60 mg) 2 times a day.
The course makes 14 days for treatment of acute respiratory diseases and for initial treatment of chronicities.
General information. In case at the carried-out therapy of acute respiratory diseases the state did not improve, it is necessary to ask for medical care.
Side effects
Gastrointestinal disorders
Often (& ge, 1/100 - & lt, 1/10):
- nausea, change of taste, decrease in sensitivity in an oral cavity and a throat (oral and pharyngeal giposteziya)
Infrequently (& ge, 1/1000 - & lt, 1/100):
- vomiting, diarrhea, dyspepsia, an abdominal pain, dryness in a mouth
it is rare (& ge, 1/10000 - & lt, 1/1000):
- dryness in a throat
of Disturbance of the immune system
It is unknown:
- anaphylactic reactions, including an acute anaphylaxis
of Disturbance of skin and hypodermic cellulose
Seldom (& ge, 1/10000 - & lt, 1/1000):
- rash, urticaria
It is unknown:
- itching and other reactions of hypersensitivity, Quincke's disease.
Contraindications
hypersensitivity to Ambroxol and/or other components of drug
a heavy renal failure
a heavy liver failure
the I trimester of pregnancy
rare hereditary intolerance of a galactose, deficiency of Lappa lactase, a sprue of glucose, a galactose
children's age up to 12 years
Medicinal interaction
was not reported about clinically significant adverse interactions with other drugs.
Combined use with antibechic drugs leads to difficulty of an otkhozhdeniye of a phlegm against the background of suppression of cough.
Increases penetration and concentration in a bronchial secret of amoxicillin, a tsefuroksim and erythromycin.
Special instructions
Are registered very exceptional cases of severe damages of skin such as Stephens-Johnson's syndrome and toxic epidermal necrolysis, at hydrochloride Ambroxol use. Mainly they are caused by weight of a basic disease and the accompanying treatment. Besides at an early stage of a syndrome of Stephens-Johnson and a toxic epidermal necrolysis at patients signs of the beginning of a nonspecific disease, with the following symptoms can be shown: fervescence, all body pain, rhinitis, cough and sore throat. Emergence of these signs can lead to unnecessary symptomatic treatment by anti-cold drugs. In case of skin defeats the patient immediately looks round the doctor, intake of Ambroxol of a hydrochloride stops.
1 tablet contains 169.46 mg of lactose that makes 677 84 mg of lactose in most recommended daily dose of 120 mg.
Pregnancy and the period of a lactation
of Ambroxol a hydrochloride gets through a placental barrier. Preclinical trials did not show direct or indirect negative impact on pregnancy, fetation, childbirth and post-natal development.
It is not recommended to apply Ambrobene in the period of the I trimester of pregnancy. In spite of the fact that there are no reliable data of negative influence on a fruit and babies, use of drug in II and III trimesters of pregnancy and in the period of a lactation perhaps after the careful analysis of a ratio advantage/risk the attending physician so far.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Overdose
Symptoms does not influence: excitement, nausea, the raised sialosis, vomiting, diarrhea, dyspepsia, hypotension
Treatment: symptomatic therapy.
A form of release and packing
On 10 tablets in blister strip packaging from a film of polyvinylchloride and printing aluminum foil. On 1 or 2 planimetric packs together with the instruction for medical use in the state and Russian languages put in a box of cardboard.
To Store storage conditions at a temperature not above 25C.
To store out of children's reach!
Not to apply a period of storage of 5 years after expiry date!
Prescription status
Without prescription
of Proizvoditel Merkle GmbH, Germany
the Owner of the registration certificate
ratiopharm GmbH, Germany
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
Limited liability partnership ratiopharm Kazakhstan, 050040, Almaty, Al-Farabi Ave., 19,
BC Nurly-Tau, 1B, office 603, phone number: (727) 311 09 15, fax: (727) 311 07 34
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