Ambroghexal - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate - 102.0 mg; calcium hydrophosphate dihydrate - 50.0 mg; corn starch - 10.0 mg; sodium carboxymethyl starch 4.0 mg; magnesium stearate - 2.0 mg; silicon dioxide colloidal - 2.0 mg.

Description:White, round, flat tablets with bevelled edges, with a notch on one side.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Has secretory, secretolitic and expectorant action, stimulates serous cells of the glands of the bronchial mucosa, increases the content of mucous secretion and the release of surface-active substance (surfactant) in the alveoli and bronchi, normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolysing enzymes and enhancing the release of lysosomes from Clara cells, reduces the viscosity of sputum. Increases motor activity of the ciliated epithelium, increases mucociliary transport, facilitates the excretion of phlegm from the respiratory tract. On average, the effect of taking ambroxol inside comes in 30 minutes and lasts 6-12 hours, depending on the amount of a single dose.

Pharmacokinetics:

Ambroxol after ingestion quickly and almost completely absorbed. Time to reach the maximum concentration (TC_m_Oh) after oral administration is 1-3 hours.

Metabolised in the liver with the formation of metabolites, excreted through the kidneys (dibromantranilic acid, glucuronides).

Binding to plasma proteins is approximately 85%.

The half-life (T_1/2) from the blood plasma is 7-12 hours.

T_1/2ambroxol and its metabolites is approximately 22 hours. 90% of ambroxol is excreted through the kidneys in the form of metabolites. In unchanged form, less than 10% of ambroxol is excreted through the kidneys.

Due to high binding to proteins and a large volume of distribution, as well as slow reverse penetration from tissues into the blood, during dialysis or forced diuresis, no significant removal of ambroxol occurs.

The clearance of ambroxol in patients with severe hepatic insufficiency is reduced by 20-40%.

In severe renal failure T_1/2 metabolites of ambroxol is increased. Ambroxol penetrates the placental barrier and into the mother's milk.

Indications:

Acute and chronic diseases of the respiratory tract with the release of viscous sputum:

- acute and chronic bronchitis;

- chronic obstructive pulmonary disease (COPD);

- pneumonia;

- bronchial asthma with difficulty in sputum discharge;

- bronchiectatic disease.

Contraindications:

- hypersensitivity to any component of the drug;

- pregnancy (I trimester);

- the period of breastfeeding;

- deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

- children's age till 6 years.

Carefully:

Hepatic failure, renal failure insufficiency, peptic ulcer of stomach and duodenum, pregnancy (II-III trimester).

Pregnancy and lactation:

The drug is contraindicated for use during the first trimester of pregnancy.

Use of Ambroghexal® during pregnancy (II-III trimester) is possible only if the intended benefit to the mother exceeds the potential risk to the fetus or baby.

Ambroxol penetrates the placental barrier. Animal studies have shown that the drug does not affect embryo-fetal development, childbirth and postnatal development.

Ambroxol is excreted in small amounts in breast milk, therefore, when taking Ambroghexal®, it is necessary to resolve the issue of stopping breastfeeding.

Dosing and Administration:

Ambrohexal® is used orally after a meal with a sufficient amount of liquid.

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

Children from 6 to 12 years old: on 1/2 (on 15 mg ambroksola) tablets 2-3 times a day. It is not recommended to use without medical appointment for more than 4-5 days.

During treatment it is necessary to use a lot of liquid (juices, tea, water), since it enhances the mucolytic effect of the drug.

Side effects:

According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: very often (≥1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1,000 to <1/100), rarely (from ≥1 / 10,000 to <1 / 1,000), very rarely (<1 / 10,000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

Allergic reactions

rarely: skin rash, hives;

frequency unknown: anaphylactic reactions, including anaphylactic shock, angioedema, skin itching and other hypersensitivity reactions.

From the gastrointestinal tract

often: nausea;

infrequently: vomiting, diarrhea, indigestion and pain in the abdominal cavity.

From the nervous system

often: change in taste.

Other

often: decreased sensitivity in the oral cavity or pharynx,

infrequently: dry mouth;

frequency is unknown: dryness of the mucous membranes of the respiratory tract.

Overdose:

Symptoms: nausea, vomiting, diarrhea, gastralgia, indigestion.

Treated: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; reception of fat-containing products, symptomatic therapy.

Interaction:

Simultaneous application with antitussive drugs leads to difficulty in withdrawing sputum against the background of a decrease in cough. Increases penetration into the bronchial secret amoxicillin, cefuroxime, erythromycin and doxycycline.

Special instructions:

Ambroxol should not be taken concomitantly with antitussive drugs, which can inhibit cough reflex, for example, with codeine, tk. this can make it difficult to remove diluted sputum from a bronchial tree.

Ambroxol should be used with caution in patients with a weakened cough reflex or disturbed mucociliary transport due to the possibility of sputum congestion.

Patients receiving ambroxol, do not recommend performing respiratory gymnastics; severe patients should perform aspiration of diluted sputum.

In patients with bronchial asthma ambroxol can strengthen cough.

Do not take ambroxol just before bed.

Patients with severe skin lesions (Stevens-Johnson syndrome or toxic epidermal necrolysis) may experience fever, body pain, rhinitis, cough and sore throat in the early phase. With symptomatic treatment, it is possible to erroneously administer mucolytic agents, such as ambroxol hydrochloride. There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the appointment of the drug. However, there is no causal relationship with taking the drug.

With the development of the above mentioned syndromes, it is recommended to stop treatment and immediately consult a doctor.

Indication for patients with diabetes mellitus: 1 tablet contains less than 0.01 XE.

Effect on the ability to drive transp. cf. and fur:

Ambrohexal® does not adversely affect the ability to drive or operate machinery.

Form release / dosage:Tablets 30 mg.

Packaging:

For 10 tablets in a contour mesh package of PVC / aluminum or PP / aluminum.

By 2, 3, 5 or 10 contour mesh packages in a cardboard bundle together with instructions for use.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N012596 / 01

Date of registration:26.11.2007

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp25.09.2015

Illustrated instructions

Instructions

Ambroghexal® (Ambrohexal®)