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MEXIDOL® (Emoxipine) 125 mg, 50 coated tablets
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Description
The instruction for medical use
of Ambro® medicine
the Trade name
of Ambro®
the International unlicensed
name Ambroxol Dosage Form
of the Tablet of 30 mg
Structure
One tablet contains
active agent – Ambroxol a hydrochloride of 30.0 mg,
excipients: lactoses monohydrate, potato starch, silicon dioxide colloidal anhydrous (aerosil), calcium stearate.
Description
of the Tablet of color, white or white with yellowish shade, ploskotsilindrichesky form. On one party of a tablet there is a facet, on another – a facet and a signature logo in the form of a cross.
Pharmacotherapeutic group
Drugs for elimination of symptoms of cold and cough.
Expectorant drugs. Mucolytics. Ambroxol
the ATX R05CB06 Code
the Pharmacological
Pharmacokinetics Absorption properties high and almost full, it is linearly dependent on a therapeutic dose. The maximum plasma concentration is reached within 1-2.5 hours. After intake the action comes in 30 min. and continues within 6-12 hours.
Distribution fast with the highest concentration in tissue of lungs. Communication with proteins of blood plasma makes about 90%.
About 30% of the dose accepted inside eliminirutsya through the first passing of metabolism. Ambroxol is metabolized mainly in a liver with formation of conjugates.
Final elimination half-life makes 10 hours.
It is removed by kidneys of 90% in the form of water-soluble metabolites, in not changed look – 5%.
Elimination half-life increases in heavy chronic kidney disease, but does not change in an abnormal liver function.
The gender and age has no clinically significant impact on pharmacokinetics of Ambroxol and do not demand dose adjustment.
A pharmacodynamics
Ambroxol – mucolytic drug. Possesses sekretomotorny, 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 a ciliary epithelium, prevents its adhesion, increases mukotsiliarny transport. Ambroxol has anti-inflammatory effect and also antioxidant properties, stimulates local immunity, increases concentration of antibiotics in a phlegm and a bronchial secret.
Indications
– acute and chronic bronchitis
– pneumonia
– the chronic obstructive pulmonary disease (COPD)
– bronchial asthma with the complicated phlegm otkhozhdeniye
– a bronchoectatic disease
Inside, after meal, washing down the Route of administration and doses with enough liquid, not chewing.
Adults and children are more senior than 12 years: on 1 tablet (30 mg) 3 times a day within the first 2-3 days, then on 1 tablet 2 times a day.
Children from 6 to 12 years: on ½ tablet (15 mg) 2-3 times a day.
Duration of treatment depends on features of a course of the disease.
Without medical appointment the drug has to be taken no more than 4-5 days.
Side effects
Seldom
– weakness, a headache
– gastralgias, nausea, vomiting, diarrhea
– dryness in a mouth and airways, a rhinorrhea
– allergic reactions (skin rash, an itching, a small tortoiseshell,
a Quincke’s disease, anaphylactoid reactions)
It is very rare
– disturbance of breath
of the Contraindication
– hypersensitivity to Ambroxol and/or other components
of drug
– a peptic ulcer of a stomach and duodenum
– the I trimester of pregnancy
Medicinal interactions
is not recommended simultaneous use of Ambro® with the medicines having antibechic activity (for example, containing codeine). Simultaneous use of Ambro® with antibiotics (amoxicillin, tsefuroksy, erythromycin, doxycycline and others) improves receipt of antibiotics in pulmonary ways that can reduce treatment terms.
Special instructions
With care are appointed in an abnormal liver function or kidneys, motor dysfunction of bronchial tubes or at discharge of a large amount of secretion (because of threat of an accumulation of slime). In a heavy liver and renal failure it is necessary to reduce a dosage or to increase intervals between administrations of drug.
Use in pediatrics
This dosage form is not recommended for reception to children 6 years are younger.
Excipients
the Drug is not recommended to be taken to patients with rare hereditary intolerance of a galactose, deficiency of lactase (Lappa type) or a sprue of glucose galactose.
Pregnancy and the period of a lactation
is not recommended in the I trimester of pregnancy. In II and III trimester of pregnancy and in the period of a lactation the use of drug is possible if the expected effect of therapy exceeds potential risk for the fruit/child.
Амбро® gets into breast milk, however, appointed in therapeutic doses, it does not make negative impact on the child.
The feature of influence of medicine on ability to run motor transport and potentially dangerous mechanisms
does not influence.
Overdose
Symptoms: nausea, vomiting, diarrhea, dyspepsia.
Treatment: to wash out a stomach in the first 1-2 hours after administration of drug, symptomatic therapy.
A release form
On 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On the 2nd blister strip packagings together with the approved instruction for medical use in the state and Russian languages place in a pack from cardboard for a retail container.
To Store storage conditions in the dry, protected from light place, at a temperature not higher than 30 wasps.
To store out of children’s reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
Without prescription
the Producer:
JSC Khimpharm,
Kazakhstan, Shymkent, Rashidov St.,/N, ph.: 560882
The owner of the registration certificate
of JSC Khimpharm, Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Khimpharm, Shymkent, KAZAKHSTAN, Rashidov St.,/N, ph.: 560882 Phone number 7252 (561342) Fax number 7252 (561342) E-mail address of standart@santo.kz
Additional information
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