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

Excipients: lactose monohydrate (sugar milk) - 145.0 mg, corn starch - 9.2 mg, microcrystalline cellulose - 9.0 mg, povidone (polyvinylpyrrolidone) 3.8 mg, magnesium stearate 2.0 mg, silicon colloidal dioxide 1.0 mg.

Description:

Tablets are white or almost white, flat-cylindrical, with a facet on both sides and risk from one side.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

The drug has an expectorant, mucolytic effect. Reducing the viscosity of sputum occurs as a result of depolymerization of mucopolysaccharides that are in sputum. Depolymerization of mucopolysaccharides is primarily associated with disruption of disulfide bonds in their molecules. Ambroxol increases the motor activity of the ciliated epithelium, increases mucociliary transport, normalizes the 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. It facilitates the excretion of sputum from the respiratory tract. The action of ambroxol is manifested for 30 minutes and is held for 6-12 hours.

Pharmacokinetics:

After application, the absorption of ambroxol from the gastrointestinal tract is high. The maximum concentration (Cmah) (after a single oral intake of 60 mg ambroxol) was 71 ng / ml. Time to reach the maximum concentration (TCmah) in the blood plasma - 2.7 hours. The volume of distribution is 6.4 l / kg. Binding to plasma proteins - 80-90%.

Ambroxol is metabolized in the liver to inactive metabolites (dibromantranilic acid and glucuronic conjugates). The half-life (T1 / 2) is 3.3 hours.Penetrates through the histohematological barriers, excreted into breast milk. It is excreted by the kidneys: 90% in the form of metabolites, 10% in unchanged form.

Indications:

Infectious and inflammatory diseases of the bronchopulmonary system, accompanied by the formation of difficult to separate sputum: acute and chronic bronchitis, tracheitis, chronic obstructive pulmonary disease, pneumonia, bronchial asthma, bronchiectatic disease.

Contraindications:

- Hypersensitivity to any component of the drug.

- Pregnancy (first trimester).

- Children under 6 years.

- Rare hereditary diseases, such as lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Carefully:

The drug should be used with caution in patients with peptic ulcer disease of the stomach and duodenum, as there may be an exacerbation of peptic ulcer, as well as with renal and hepatic insufficiency.

Pregnancy and lactation:

The drug is not recommended for use during the first trimester of pregnancy. If it is necessary to use ambroxol in II-III trimesters of pregnancy should be evaluated for potential benefits to the mother with a possible risk to the fetus.During the period of breastfeeding, use the drug with caution. Because it is excreted into breast milk.

Dosing and Administration:

The drug is used inside after eating with a sufficient amount of liquid.

Adults and children over 12 years of age:

1 tablet 30 mg 3 times during the first 2-3 days. Then the dose of the drug should be reduced to 1 tablet 2 times a day.

Children aged 6 to 12 years:

1/2 (15 mg) tablets 2-3 times a day.

It is not recommended to use without medical appointment for more than 4-5 days.

Side effects:

From the digestive system: nausea, vomiting, gastralgia, diarrhea, constipation, dry mouth.

From the respiratory system: dryness of the mucous membrane of the respiratory tract.

From the nervous system: weakness, headache.

From the urinary system: dysuria.

From the sense organs: rhinorrhea, dysgeusia.

From the skin: exanthema.

Allergic reactions: skin rash, hives, angioedema, allergic contact dermatitis, anaphylactic shock.

Overdose:

Symptoms: nausea, vomiting, diarrhea, gastralgia.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, taking fat-containing foods.

Interaction:

When used with antitussive drugs, it may be difficult for sputum to escape as a result of suppressing the cough reflex. With simultaneous use with amoxicillin, cefuroxime, erythromycin, doxycycline ambroxol increases their concentration in the bronchial secretion.

Special instructions:

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 breathing exercises; In seriously ill patients, aspiration of diluted sputum should be performed.

In patients with bronchial asthma ambroxol can strengthen cough.

Do not take ambroxol just before bed.

Ambroxol should not be taken concomitantly with antitussive drugs, which can inhibit cough reflex, for example, with codeine, tk. it may complicate the removal of diluted sputum from the bronchial tree.

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

The use of the drug does not affect the speed of psychomotor reactions.

Form release / dosage:Tablets 30 mg.

Packaging:

For 10, 20 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 10, 20, 30, 40, 50, 60 or 100 tablets into a polymer container for medicines. One container or 1, 2, 3, 4, 5, 6, 8 or 10 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

Store in a dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LS-000996

Date of registration:09.07.2010 / 13.09.2011

Expiration Date:Unlimited

The owner of the registration certificate:OZONE, LLC OZONE, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp01.08.2017

Illustrated instructions

Instructions

Ambroxol (Ambroxol)