Ambrobene 20s 75 mg capsules retard
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The instruction for medical use of Ambrobene medicine of 75 mg
the Trade name
of Ambrobene75 of mg
the International unlicensed
name Ambroxol Dosage Form
of the Capsule retard 75 mg
Structure
1 capsule contains
active agent: Ambroxol hydrochloride of 75.0 mg.
excipients: microcrystalline cellulose, karmeloza, gipromeloza, Eudragit of RS 30 D, triethyl citrate, silica gel, titan dioxide, ferrous oxide yellow (E 172), ferrous oxide black (E 172), ferrous oxide red (E 172), gelatin.
Description
Contents of capsules: granules from white till light yellow color.
Capsule: upper part brown, opaque, opaque, lower part colourless transparent.
Pharmacotherapeutic group
Expectorant drugs. Mucolytics.
The code of automatic telephone exchange R05CB06
Pharmacological action
Pharmacokinetics
After intake Ambroxol is almost completely absorbed from digestive tract. Usually action comes in 30 minutes and continues within 6-12 hours. Linking of Ambroxol with proteins of plasma makes about 85%. The bioavailability of Ambroxol after oral reception is reduced approximately on 1/3 metabolism of the first passing. At the same time the metabolites removed through kidneys (90%) are formed.
The pharmacodynamics
Ambroxol is the mucolytic drug rendering bronkhosekretolitichesky and sekretomotorny (expectorant) action.
Ambroxol normalizes the changed bronchopulmonary secretion, improves rheological indicators of a phlegm, reducing its viscosity, and facilitates removal of a phlegm from bronchial tubes. Ambroxol promotes activization of a system of surface-active substances through direct impact on pnevmotsita of type 2 in alveoluses and Klara cell, stimulates education and removal of surface-active material (surfactant) in alveolar and bronchial area of germinal and adult lungs. In addition, antioxygenic effects of Ambroxol are established. After use of Ambroxol the concentration of antibiotics in a phlegm and a bronchial secret increases.
Indications
Sekretolitichesky therapy in the acute and chronic bronkhopulmonalny diseases connected with disturbance of education and transportation of slime:
- acute and chronic bronchitis, pneumonia
- bronchial asthma with difficulty of an otkhozhdeniye of a phlegm
- a bronchoectatic disease.
The route of administration and doses
Adults and children are more senior than 12 years: on 1 capsule once a day inside after a meal with enough the warm liquid (for example, water) which is not chewed. Duration of treatment depends on features of a course of the disease. Without medical appointment has to be accepted no more than 4-5 days.
Side effects
Sometimes:
- weakness, a headache
- dryness in airways, a rhinorrhea
- dryness in a mouth, a gastralgia, nausea, vomiting, diarrhea, constipations
- a dieback, a dysuria.
Seldom:
- allergic reactions (skin manifestations, breath disturbance, temperature reaction with a fever, allergic contact dermatitis and an acute anaphylaxis).
The contraindication
- hypersensitivity to Ambroxol and/or other components of drug
- a peptic ulcer of a stomach and duodenum
- the I trimester of pregnancy
- children's age up to 12 years
Medicinal interactions
Simultaneous use of Ambrobene of 75 mg with the medicines having antibechic activity (for example, containing codeine), is not recommended because of difficulty of removal of a phlegm from bronchial tubes against the background of reduction of cough.
Simultaneous use of Ambrobene of 75 mg with antibiotics (amoxicillin, tsefuroksy, erythromycin, doxycycline) can cause improvement of receipt of antibiotics in pulmonary ways. Similar interaction with doxycycline is widely used in the therapeutic purposes.
The special
instructions Pregnancy and a lactation
there are no sufficient data on Ambroxol use by pregnant women. It concerns, especially the period up to 28 weeks of pregnancy.
There are no data on penetration of drug into breast milk therefore Ambrobene of 75 mg during feeding by a breast has to be accepted only after careful weighing of a ratio of advantage and risk.
At restriction of functional capacity of kidneys and/or in a serious illness of a liver of Ambrobene of 75 mg it is necessary to apply with extra care, reducing the applied dose and increasing time between administrations of drug.
The overdose
in case of overdose is necessary symptomatic therapy.
A form of release and packing
of the Capsule on 75 mg No. 10 in blister strip packaging (blister), on the 2 or 5 blister strip packaging (blister) together with the instruction for use in a cardboard box.
Instructions on storage
to Store at a temperature not above 25C.
To store out of children's reach.
4 years
not to apply a period of storage after expiry date!
Release from drugstores
Without prescription
of Proizvoditel Mefa Ltd, Switzerland for ratiopharm GmbH, Germany
the Trade name
of Ambrobene75 of mg
the International unlicensed
name Ambroxol Dosage Form
of the Capsule retard 75 mg
Structure
1 capsule contains
active agent: Ambroxol hydrochloride of 75.0 mg.
excipients: microcrystalline cellulose, karmeloza, gipromeloza, Eudragit of RS 30 D, triethyl citrate, silica gel, titan dioxide, ferrous oxide yellow (E 172), ferrous oxide black (E 172), ferrous oxide red (E 172), gelatin.
Description
Contents of capsules: granules from white till light yellow color.
Capsule: upper part brown, opaque, opaque, lower part colourless transparent.
Pharmacotherapeutic group
Expectorant drugs. Mucolytics.
The code of automatic telephone exchange R05CB06
Pharmacological action
Pharmacokinetics
After intake Ambroxol is almost completely absorbed from digestive tract. Usually action comes in 30 minutes and continues within 6-12 hours. Linking of Ambroxol with proteins of plasma makes about 85%. The bioavailability of Ambroxol after oral reception is reduced approximately on 1/3 metabolism of the first passing. At the same time the metabolites removed through kidneys (90%) are formed.
The pharmacodynamics
Ambroxol is the mucolytic drug rendering bronkhosekretolitichesky and sekretomotorny (expectorant) action.
Ambroxol normalizes the changed bronchopulmonary secretion, improves rheological indicators of a phlegm, reducing its viscosity, and facilitates removal of a phlegm from bronchial tubes. Ambroxol promotes activization of a system of surface-active substances through direct impact on pnevmotsita of type 2 in alveoluses and Klara cell, stimulates education and removal of surface-active material (surfactant) in alveolar and bronchial area of germinal and adult lungs. In addition, antioxygenic effects of Ambroxol are established. After use of Ambroxol the concentration of antibiotics in a phlegm and a bronchial secret increases.
Indications
Sekretolitichesky therapy in the acute and chronic bronkhopulmonalny diseases connected with disturbance of education and transportation of slime:
- acute and chronic bronchitis, pneumonia
- bronchial asthma with difficulty of an otkhozhdeniye of a phlegm
- a bronchoectatic disease.
The route of administration and doses
Adults and children are more senior than 12 years: on 1 capsule once a day inside after a meal with enough the warm liquid (for example, water) which is not chewed. Duration of treatment depends on features of a course of the disease. Without medical appointment has to be accepted no more than 4-5 days.
Side effects
Sometimes:
- weakness, a headache
- dryness in airways, a rhinorrhea
- dryness in a mouth, a gastralgia, nausea, vomiting, diarrhea, constipations
- a dieback, a dysuria.
Seldom:
- allergic reactions (skin manifestations, breath disturbance, temperature reaction with a fever, allergic contact dermatitis and an acute anaphylaxis).
The contraindication
- hypersensitivity to Ambroxol and/or other components of drug
- a peptic ulcer of a stomach and duodenum
- the I trimester of pregnancy
- children's age up to 12 years
Medicinal interactions
Simultaneous use of Ambrobene of 75 mg with the medicines having antibechic activity (for example, containing codeine), is not recommended because of difficulty of removal of a phlegm from bronchial tubes against the background of reduction of cough.
Simultaneous use of Ambrobene of 75 mg with antibiotics (amoxicillin, tsefuroksy, erythromycin, doxycycline) can cause improvement of receipt of antibiotics in pulmonary ways. Similar interaction with doxycycline is widely used in the therapeutic purposes.
The special
instructions Pregnancy and a lactation
there are no sufficient data on Ambroxol use by pregnant women. It concerns, especially the period up to 28 weeks of pregnancy.
There are no data on penetration of drug into breast milk therefore Ambrobene of 75 mg during feeding by a breast has to be accepted only after careful weighing of a ratio of advantage and risk.
At restriction of functional capacity of kidneys and/or in a serious illness of a liver of Ambrobene of 75 mg it is necessary to apply with extra care, reducing the applied dose and increasing time between administrations of drug.
The overdose
in case of overdose is necessary symptomatic therapy.
A form of release and packing
of the Capsule on 75 mg No. 10 in blister strip packaging (blister), on the 2 or 5 blister strip packaging (blister) together with the instruction for use in a cardboard box.
Instructions on storage
to Store at a temperature not above 25C.
To store out of children's reach.
4 years
not to apply a period of storage after expiry date!
Release from drugstores
Without prescription
of Proizvoditel Mefa Ltd, Switzerland for ratiopharm GmbH, Germany
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