Ambroxol

General characteristics. Structure:

Active ingredient: 30 mg of Ambroxol of a hydrochloride in 1 tablet.

Excipients: lactoses monohydrate, potato starch, calcium stearate, silicon dioxide colloid anhydrous.

Pharmacological properties:

Pharmacodynamics. Mucolytic means, increases synthesis, secretion of surfactant and blocks its disintegration. Possesses sekretomotorny, sekretolitichesky and expectorant action; stimulates serous cells of glands of a mucous membrane of bronchial tubes, increases the maintenance of a mucous secret and release of surface-active substance (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 Clark's cells, reduces viscosity of a phlegm. Increases physical activity of a ciliary epithelium, increases mukotsiliarny transport.

After intake action comes in 30 min. and continues during 6 - 12 h.

Pharmacokinetics. Absorption − high (at any ways of introduction), time Cmax dostizheniiya - 2 h, communication with proteins of plasma – 80%. Gets through a blood-brain barrier, a placental barrier, it is allocated with breast milk.

Metabolism − in a liver, forms dibromantranilovy acid and glucuronic conjugates. T1/2 − 7-12 h. It is removed by kidneys: 90% in the form of water-soluble metabolites, in not changed look – 5%.

T1/2 increases at a heavy chronic renal failure.

At patients with abnormal liver functions removal of Ambroxol of a hydrochloride decreases that leads to increase in its level in a blood plasma by 1,3-2 times. Due to the broad terapevticheky range of Ambroxol of a hydrochloride of change of a dose it is not required.

The pharmacokinetics of Ambroxol does not depend on age and a floor and by that does not demand change of a dosage. Food does not influence bioavailability of Ambroxol of a hydrochloride.

Indications to use:

Respiratory diseases with allocation of a viscous phlegm: acute and chronic bronchitis, pneumonia, a chronic obstructive pulmonary disease, bronchial asthma with difficulty of an otkhozhdeniye of a phlegm, a bronchoectatic disease.

Route of administration and doses:

Inside, during meal, with a small amount of liquid.

To adults and children 12 years are more senior: on 1 tablet (30 mg) 3 times a day in the first 2 - 3 days, then on 1 tablet 2 times or 1/2 tablets (15 mg) 3 times a day.

To children aged from 6 up to 12 years: 1/2 tablets (15 mg) 2 - 3 times a day.

Duration of treatment is defined by the doctor individually and depends on disease severity. At non-compliance with the mode of dosing reduction of efficiency of treatment is possible.

Features of use:

It is not necessary to combine with the antibechics complicating removal of a phlegm.

It was reported about several cases of heavy injury of skin, including Stephens-Jones's syndrome and a toxic epidermal necrolysis associated with reception of such expectorants as Ambroxol. These cases can be explained, as a rule, with severity of associated diseases or a concomitant use of other drugs. Besides, at an early stage of a syndrome of Stephens-Jones and a toxic epidermal necrolysis patients can have signs of the beginning of the nonspecific disease reminding flu: fervescence, all body pain, rhinitis, cough and pharyngalgia. Emergence of these signs can lead to an unnecessary symptomatic treatment anti-cold drugs. Therefore, at emergence of injuries of skin or mucous it is necessary to see immediately a doctor, and treatment by Ambroxol should be stopped as a precautionary measure.

At renal failures Ambroxol can be accepted only after consultation with the doctor.

Medicine contains lactose therefore drug should not be accepted to the patients having rare inborn intolerance of a galactose, deficit of lactase of Lapp or with bad digestion of glucose galactose.

Pregnancy and lactation. Adequate and strictly controlled clinical trials on safety of use of Ambroxol at pregnancy and in the period of a lactation it was not carried out.

Ambroxol gets through a placental barrier. Researches on animals did not show direct or indirect negative impact on pregnancy, development of an embryo/fruit, childbirth or post-natal development of an embryo/fruit. Broad clinical experience showed lack of any signs of an adverse effect on a fruit after the 28th week of pregnancy. Nevertheless, it is necessary to observe usual precautionary measures concerning use of medicines during pregnancy. Ambroxol is not recommended to be applied especially during the first trimester of pregnancy.

Ambroxol gets into breast milk. Though an adverse effect of drug on the child, Ambroxol is not supposed it is not recommended for mothers during breastfeeding.

Influence on ability of driving of motor transport and control of mechanisms. It is not known of cases of influence of drug on ability to drive the car and mechanisms. The corresponding researches were not conducted.

Side effects:

From digestive tract: seldom - diarrhea, dryness in a mouth, a lock; at prolonged use in high doses - heartburn, a gastralgia, nausea, vomiting.

Allergic reactions: seldom - skin rash, a small tortoiseshell, a Quincke's disease, an itch; in some cases - allergic contact dermatitis; in isolated cases – reactions of anaphylactic type.

Others: seldom - weakness, a headache

Interaction with other medicines:

Combined use with antibechic medicines leads to difficulty of an otkhozhdeniye of a phlegm against the background of reduction of cough.

Increases penetration into a bronchial secret of amoxicillin, a tsefuroksim, erythromycin and doxycycline.

Contraindications:

Hypersensitivity to any of medicine komponenent, pregnancy (the I trimester), a renal and/or liver failure.

The rare hereditary diseases connected with intolerance of any of the excipients which are a part of drug (see the section "Precautionary measures").

With care to apply during pregnancy (II– III a trimester) and lactations, and also to the patients suffering from a peptic ulcer of a stomach or duodenum.

Overdose:

Symptoms: nausea, vomiting, diarrhea, dyspepsia is possible.

Treatment: artificial vomiting, a gastric lavage in the first 1-2 h after medicine reception; reception of fat-containing products; symptomatic therapy.

Storage conditions:

List B. In the place protected from light and moisture, at a temperature not over 25 ºС. To store in the place, unavailable to children. A period of validity - 3 years. Not to apply after expiry date.

Issue conditions:

Without recipe

Packaging:

On 10 tablets in a blister strip packaging; on the 2nd blister strip packagings in a pack from a cardboard.