Ambrobene, tablets 30 mg 20 pcs

Pharmacotherapeutic group: prescribing mucolytic agent.

ATX code: R05CB06

Pharmacological action

Pharmacodynamics:

Ambroxol is a benzylamine, a metabolite of bromhexine. It differs from bromhexin 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 secretomotor, secretolytic and expectorant action.

After oral administration the action comes within 30 minutes and lasts for 6-12 hours (depending on the dose taken).

Doclinical studies have shown that ambroxol stimulates serous cells of the bronchial mucous membrane glands. By activating ciliated epithelial cells and reducing sputum viscosity, it improves mucociliary transport.

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

Studies on cell cultures and in vivo animal studies 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.

An antioxidant effect of ambroxol was also proven in preclinical studies. Ambroxol when used together with antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline) increases their concentration in sputum and bronchial secretion.

Pharmacokinetics

Ambroxol is almost completely absorbed from the gastrointestinal tract when taken orally. Maximum concentration is reached 1 to 3 hours after oral administration. Due to presystemic metabolism absolute bioavailability of ambroxol after oral administration is reduced by approximately ⅓. The resulting metabolites (such as dibromoanthranilic acid, glucuronides) are eliminated in the kidneys. Binding to plasma proteins is about 85% (80-90%). The plasma elimination half-life is 7 to 12 hours. The total half-life of ambroxol and its metabolites is approximately 22 hours.

Extracted mainly by the kidneys as metabolites – 90%, less than 10% is excreted unchanged.

Bearing in mind the high plasma protein binding, large volume of distribution and slow redistribution from tissues into blood, there is no significant excretion of ambroxol with dialysis or forced diuresis.

In patients with severe liver disease ambroxol clearance is reduced by 20-40 %. In patients with severe renal impairment the half-life of ambroxol metabolites is prolonged.

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

Ambroxol does not occur in patients with severe liver disease.

Indications

Bronchial asthma, Colds, Bronchitis, Cough, Flu, Chronic obstructive pulmonary disease, Lung inflammation (pneumonia) Acute and chronic respiratory diseases, accompanied by impaired sputum formation and discharge.

Active ingredient

Ambroxol

Composition

1 tablet contains: the active substance ambroxol hydrochloride 30.00 mg; excipients: lactose monohydrate 169.46 mg, corn starch 36.33 mg, magnesium stearate 2.41 mg, colloidal anhydrous silica 1.80 mg.

How to take, the dosage

The tablets should be swallowed whole, without chewing, after eating, drinking plenty of fluids.

Children from 6 to 12 years should take ½ tablet 2-3 times a day (15 mg ambroxol 2-3 times a day).

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

The duration of treatment is chosen individually, depending on the course of the disease. It is not recommended to take Ambrobene without prescription for more than 4-5 days.

The mucolytic effect of the drug is manifested by taking plenty of fluids. Therefore, during the treatment it is recommended to drink plenty of fluids.

Interaction

Concomitant use of ambroxol and cough suppressants may cause cough reflex stasis. Therefore, such combinations should be chosen with caution. When concomitant use of ambroxol and antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline, concentration of the latter in sputum and bronchial secretion increases.

Special Instructions

Do not combine with anti-cough drugs that make it difficult to expectorate sputum. Severe skin reactions, such as Stevens-Johnson syndrome and Lyell syndrome, have been observed very rarely during use of Ambrobene. In case of changes in the skin or mucous membranes, it is necessary to consult a doctor urgently and stop taking the drug. The effect on the ability to drive and operate machinery is not known to date.

Synopsis

Round biconvex white tablets with a separating ridge on one side.

Contraindications

– hypersensitivity to ambroxol or to one of the excipients;

– use in children under 6 years of age;

Pregnancy (first trimester);

Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

With caution:

Disorders of bronchial motor function and increased sputum production (in the fixed cilia syndrome), gastric and 12 duodenal ulcer during exacerbation, pregnancy (II-III trimester), lactation.

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

Side effects

General disorders:

Rarely (≥0.1% to < 1%): allergic reactions (urticaria, skin rash, angioedema, shortness of breath, itching), fever, weakness, headache.

Very rare (< 0.01%): anaphylactic reactions, including anaphylactic shock.

Gastrointestinal tract:

Rarely (≥ 0.1% to < 1%): nausea, abdominal pain, vomiting, diarrhea, constipation.

Others:

Rarely (≥ 0.1% to < 1%): dry mucous membrane of the mouth and respiratory tract, exanthema, rhinorrhea, dysuria.

Overdose

Symptoms:

There are no signs of intoxication in ambroxol overdose. There have been reports of nervous agitation and diarrhea.

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

In severe overdose, increased salivation, nausea, vomiting, and decreased blood pressure may occur.

Treatment:

Intensive therapy methods such as inducing 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 indicated.

Pregnancy use

Pregnancy:

There are insufficient data regarding the use of ambroxol during pregnancy. In particular, this applies to the first 28 weeks of pregnancy. Animal studies have shown no teratogenic effects.

The use of Ambrobene in pregnancy (II-III trimester) is possible only by prescription, after careful assessment of the risk/benefit ratio.

Breastfeeding period:

Animal studies have shown that ambroxol penetrates into breast milk. Due to the insufficient study of the use of the drug in women during breast-feeding the use of Ambrobene is possible only by prescription, after careful assessment of the risk/benefit ratio.

Similarities

Ambrohexal, Lazolvan, Halixol, Ambroxol, Ambrobene, Orvis Broncho, ORVIS, Lazolvan Max, Zvezdochka, Zvezdochka for colds