Ambrobene syrup 15mg / 5ml fl . 100ml

Release form, composition and packaging

The syrup is transparent, from colorless to slightly yellow, with a raspberry scent.

5 ml 1 fl.

ambroxol hydrochloride 15 mg 300 mg

liquid sorbitol 70% - 60 g, propylene glycol - 5 g, raspberry flavor - 0.1 g, saccharin - 0.01 g, purified water - 49.44 g.

100 ml - dark glass bottles (1) complete with a measuring cup - cardboard packs.

pharmachologic effect

Mucolytic and expectorant drug.

Ambroxol is benzylamine, a metabolite of bromhexine.

It differs from bromhexine in the absence of a methyl group and in the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring.

It has a secretory, secretolytic and expectorant effect.

After oral administration, the effect occurs after 30 minutes and lasts for 6-12 hours (depending on the dose taken).

Preclinical studies have shown that ambroxol stimulates serous cells of the glands of the bronchial mucosa.

By activating the cells of the ciliated epithelium and reducing the viscosity of sputum, it improves mucociliary transport.

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

Studies on cell cultures and in vivo studies on animals 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 adults.

Also, in preclinical studies, the antioxidant effect of Ambroxol has been proven.

Ambroxol, when used together with antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline), increases their concentration in sputum and bronchial secretions.

Pharmacokinetics

Absorption, distribution, metabolism

When taken orally, Ambroxol is almost completely absorbed from the gastrointestinal tract.

Cmax is achieved within 1-3 hours after oral administration.

Due to presystemic metabolism, the absolute bioavailability of Ambroxol after oral administration is reduced by approximately 1/3.

The metabolites formed in this connection (such as dibromoanthranilic acid, glucuronides) are eliminated by the kidneys.

Plasma protein binding is about 85% (80-90%).

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

Withdrawal

T1 / 2 from plasma is from 7 to 12 hours. The total T1 / 2 of ambroxol and its metabolites is approximately 22 hours. It is excreted mainly by the kidneys in the form of metabolites - 90%, less than 10% is excreted unchanged.

Given the high binding to plasma proteins, high Vd and slow redistribution from tissues to blood, no significant excretion of ambroxol occurs during dialysis or forced diuresis.

Pharmacokinetics in special clinical situations

In patients with severe liver disease, the clearance of ambroxol is reduced by 20-40%.

In patients with severely impaired renal function, T1 / 2 of ambroxol metabolites increases

Indications for use

- acute and chronic diseases of the respiratory tract, accompanied by a violation of the formation and discharge of sputum.

Contraindications for use

- fructose intolerance, sucrase / isomaltase deficiency, glucose-galactose malabsorption

- I trimester of pregnancy

- hypersensitivity to drug components.

The drug should be used with caution in patients with impaired motor function of the bronchi and increased sputum production (with immobile cilia syndrome), with gastric ulcer and duodenal ulcer in the acute phase, in the II and III trimesters of pregnancy, during lactation.

Patients with impaired renal function or severe liver disease should be prescribed Ambrobene with extreme caution, while patients should observe long intervals between doses or take the drug at a lower dose.

Name ENG

AMBROBENE

Clinical and pharmacological group

Mucolytic and expectorant drug

ATX code

Ambroxol

Dosage

15mg / 5ml x 100ml

Structure

5 ml of syrup contains: Active ingredient: Ambroxol hydrochloride 15 mg

Excipients: liquid sorbitol 70%, propylene glycol, raspberry flavor, saccharin, purified water.

Indications

Acute and chronic diseases of the respiratory tract, accompanied by a violation of the formation and discharge of sputum.

Contraindications

hypersensitivity to ambroxol or one of the excipients

pregnancy (I trimester)

deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 5 years

after opening - 1 year

INN / Active ingredient

Ambroxol

Specifications

Category

Cough

,

Thinning phlegm

,

Expectorants

Scope of the drug

Respiratory system

Release form

Syrup

Manufacturer country

Germany

Package quantity, pcs

one

Scope of application

Virology

Minimum age from

From birth

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Volume, ml.

100 ml

Brand name

Ambrobene

Components

measuring glass

The amount of the dosage form in the primary package

100 ml

Primary packaging type

Dark glass bottle with jet cork

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Expectorant mucolytic agent

Anatomical and therapeutic characteristics

R05CB06 Ambroxol

Dosage form

Syrup

Dosage (volume) of the substance in the preparation

ambroxol hydrochloride 15 mg

Expiration date in days

1825

The target audience

Children

Package weight, g

190

Mode of application

:

Inside, after meals, using the supplied measuring cup.

Children: up to 2 years old - 1/2 measuring cup (2.5 ml of syrup) 2 times a day (15 mg of ambroxol per day)

from 2 to 6 years old - 1/2 measuring cup (2.5 ml of syrup) 3 times a day (22.5 mg of ambroxol per day)

from 6 to 12 years old - 1 measuring cup (5 ml of syrup) 2-3 times a day (30-45 mg of ambroxol per day).

Adults and children over 12 years of age: in the first 2-3 days of treatment - 2 measuring cups (10 ml of syrup) 3 times a day (90 mg of ambroxol per day).

If therapy is ineffective, adults can increase the dose to 4 measuring cups (20 ml of syrup) 2 times a day (120 mg of ambroxol per day).

On the following days, take 2 measuring cups (10 ml of syrup) 2 times a day (60 mg of ambroxol per day).

Information on technical characteristics, delivery set, country of manufacture