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

Excipients: cellulose microcrystalline - 25,00 mg; eudragid RL30D (polyethyl acrylate: methyl methacrylate: trimethylammonioethyl methacrylate chloride -1:2: 0.2) - 0.57 mg; eudragid Rs30D (polyethyl acrylate: methyl methacrylate: trimethylammonioethyl methacrylate chloride - 1: 2: 0.1) - 2.77; triethyl citrate - 0.68 mg; magnesium stearate - 0.34 mg; titanium dioxide - 0.68 mg; iron dye oxide red - 0.003 mg;

hard gelatin capsule: gelatin - 60.70 mg; titanium dioxide 1.30 mg.

Description:Hard gelatin capsules, body and lid of white color, contents of capsules - pellets of white and pale pink color.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Has a secreto-motor, 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 the 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 to 12 hours, depending on the size 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.

Metabolized in the liver with the formation of metabolites, which are excreted through the kidneys (dibromantranilic acid, glucuronides)

Binding to plasma proteins is approximately 85%. The half-life of plasma blood is 7 to 12 hours. The half-life of ambroxol and its metabolites is about 22 hours. 90% of ambroxol is excreted through the kidneys in the form of metabolites. In unchanged form, less than 10% ambroxol.

Due to high binding to proteins and a large volume distribution, as well as slow reverse penetration from tissues into the blood, during dialysis or forced diuresis, significant elimination Ambroxol does not occur. Clear ambroxol in patients with severe hepatic impairment decreases by 20 - 40%. In severe renal failure, the half-life of metabolites Ambroxol increases.

Ambroxol penetrates through placental barrier and into breast milk.

Indications:

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

- acute and chronic bronchitis;

- pneumonia;

- chronic obstructive pulmonary disease;

- bronchial asthma with difficulty in sputum discharge;

- bronchiectatic disease.

Contraindications:

- increased sensitivity to ambroxol or to any of the components of the drug;

- pregnancy (I trimester);

- children under 12 years.

Carefully:

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

Pregnancy and lactation:

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

The use of AmbroGEXAL® during pregnancy (II-III trimester) and during lactation 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 breast milk in small amounts, so when taking AmbroGEXAL®, it is necessary to resolve the issue of stopping breastfeeding.

Dosing and Administration:

Adults and children over 12 years of age: 1 capsule of AmbroGEXAL® (75 mg ambroxol) per day in the morning or evening after eating, without chewing and drinking with a sufficient amount of liquid (water, tea or juice).

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: a change in taste.

Other:

often: decreased sensitivity in the oral cavity or pharynx;

infrequently: dry mouth;

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

Overdose:

Symptoms: nausea, vomiting, diarrhea, gastralgia, indigestion, lowering of blood pressure.

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

Interaction:

Joint 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 the bronchi.

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.

In patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - temperature, body pain, rhinitis, cough and sore throat may appear 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.

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

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

Form release / dosage:

Capsules of prolonged action 75 mg.

Packaging:

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

For 1, 2, 5 or 10 contour mesh packages in a cardboard box together with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N012596 / 04

Date of registration:26.11.2007

The owner of the registration certificate:HEXAL AG HEXAL AG Germany

Manufacturer: & nbsp

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp26.09.2015

Illustrated instructions

Instructions

AmbroHEXAL® (AmbroHEXAL®)