Ambroxol, tablets 30 mg 20 pcs

Pharmacotherapeutic group

A expectorant, mucolytic agent

ATC code

R05CB06

Pharmacodynamics:

Ambroxol is the active N-demethylated metabolite of bromhexine.

It has secretomotor secretolytic and expectorant action. It stimulates the work of the bronchial glands increases the motor activity of the atomizing epithelium by acting on type 2 pneumocytes in the alveoli and Clara cells in the bronchioles, increases the formation of endogenous surfactant – a surfactant providing gliding of bronchial secretion in the airway lumen. Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure and contributing to reduction of viscosity and thinning of sputum; as a result mucociliary transport is improved and expulsion of sputum from the bronchial tree becomes easier. Pharmacokinetics:

Absorption. After oral administration, ambroxol is quickly and almost completely absorbed from the gastrointestinal tract. Maximum concentration (Cmax) in blood plasma is reached after 1-3 hours. Volume of distribution is 552 l. Absolute bioavailability of ambroxol in oral administration as a result of “primary passage” through the liver is reduced by approximately 1/3.

Distribution. Binding with blood plasma proteins is 80-90%. Ambroxol penetrates through placental and blood-brain barrier and is excreted with breast milk.

Metabolism. Ambroxol is metabolized in the liver by conjugation to form pharmacologically inactive metabolites.

Extraction. The terminal blood plasma elimination half-life (T1/2) is 7-12 hours. Total elimination half-life of ambroxol and its metabolites is about 22 hours. Total clearance is within 660 ml/min. Excreted by the kidneys: 90% as metabolites (such as dibromoanthranilic acid glucuronides) about 10% – unchanged. In severe renal impairment (creatinine clearance less than 30 ml/min) accumulation of ambroxol metabolites is possible; in severe hepatic failure ambroxol clearance is reduced by 20-40 %.

Due to the high degree of binding to plasma proteins and significant volume of distribution and slow reverse distribution from tissues into blood, effective elimination of ambroxol by dialysis or forced diuresis is unlikely.

Indications

Active ingredient

Composition

Active ingredient:

Ambroxol hydrochloride – 30.0 mg

Excipients:

Lactose monohydrate – 171.0mg

Corn starch – 36.0 mg

Colloidal silica (aerosil) – 1.8 mg

Magnesium stearate – 1.2 mg.

How to take, the dosage

Overly with plenty of fluids after meals.

Adults and children over 12 years of age: 30 mg (1 tablet) 3 times a day for the first 2-3 days, then the dose should be reduced to 1 tablet 2 times a day.

Children from 6 to 12 years of age: 15 mg (1/2 tablet) 2 to 3 times a day.

If symptoms persist for 4 to 5 days after starting treatment, it is recommended that you see a doctor.

Interaction

In concomitant use of ambroxol with anti-cough drugs, sputum may be difficult to excrete as a result of suppression of the cough reflex.

In concomitant use with amoxicillin cefuroxime erythromycin doxycycline ambroxol increases their concentration in the bronchial secretion.

Contraindications

Hypersensitivity to the components of the drug hereditary galactose intolerance lactase deficiency or glucose and galactose malabsorption syndrome first trimester of pregnancy and breastfeeding period children under 6 years of age.

Bronchial motility disorder and increased mucus secretion (e.g. in rare primary ciliary dyskinesia syndrome); renal failure and/or severe liver failure); gastric and duodenal ulcer including history; II-III trimesters of pregnancy.

Side effects

Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO):

Very common > 1/10; common > 1/100 to < 1/10; infrequent > 1/1000 to < 1/100; rare > 1/10000 to < 1/1000; very rare < 1/10000 including individual reports; frequency unknown – the incidence cannot be determined from available data.

Allergic reactions:

frequency unknown – hypersensitivity reactions anaphylactic reactions (including anaphylactic shock) angioedema.

Disorders of the digestive system:

often – nausea decreased sensitivity in the mouth or pharynx; infrequent – dyspepsia vomiting diarrhea abdominal pain; rarely – heartburn dryness of the mucous membrane of the mouth and pharynx constipation.

Respiratory system disorders:

rarely – dryness of the mucous membrane of the respiratory tract rhinorrhea (mucus discharge from the nose).

Skin disorders:

seldom – skin rash urticaria; frequency unknown – skin itching Stevens-Johnson syndrome (erythema multiforme exudative) Lyell syndrome (toxic epidermal necrolysis) acute generalized exanthematous pustulosis.

Sensory system disorders:

frequent – dysgeusia (taste disturbances).

Other:

rarely – weakness headache dysuria (urinary disorders) hyperthermia fever.

Overdose

Symptoms: nausea vomiting diarrhea upper abdominal pain heartburn dyspepsia (digestive distress). There are reports of the occurrence of transient anxiety. In severe overdose a significant decrease in blood pressure is possible.

Pregnancy use

Similarities