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

Excipients: hypromellose (hydroxypropylmethylcellulose), kollidone SR [polyvinyl acetate 80%, povidone 19%, sodium lauryl sulfate 0.8%, silicon dioxide 0.2%], hyeethylase (hydroxyethylcellulose), magnesium stearate;

capsules of hard gelatin (gelatin, titanium dioxide, blue patented dye, methyl parahydroxybenzoate, propyl parahydroxybenzoate).

Description:Capsules №1 with a case and a lid of blue color.The contents of the capsules are white to light yellow powder.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Mucolytic agent. Has a secreto-motor, secretolitic and expectorant action; stimulates serous cells of the glands of the mucous membrane of the bronchi, increases the content of mucous secretions and the release of surfactant (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.

After ingestion, the effect comes in 30 minutes.

Pharmacokinetics:

Absorption is high (for any route of administration), the time to reach the maximum concentration (TC_max) - 2 hours, communication with plasma proteins - 80%. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk.

Metabolised in the liver by conjugation,forms pharmacologically inactive metabolites: dibromantranilic acid and glucuronic conjugates. Half-life (T_1/2) - 7-12 hours, and the total T_1/2 in the plasma (ambroxol and its metabolites) reaches 22 hours. It is excreted by the kidneys: 90% in the form of water-soluble metabolites, unchanged - 5%.

The half-life of ambroxol and its metabolites increases with severe chronic renal failure; does not change in case of violations of the liver function.

Indications:

Diseases of the respiratory tract with the formation of viscous sputum:

- acute and chronic bronchitis;

- pneumonia;

- chronic obstructive pulmonary disease;

- bronchial asthma with difficulty in sputum discharge;

- bronchiectatic disease.

Contraindications:

- Hypersensitivity to ambroxol or any other component of the drug;

- Pregnancy (I trimester);

- Stomach ulcer and 12 duodenal ulcer in the stage of exacerbation;

- epileptic syndrome;

- violation of bronchial motility, large volumes of secreted secret (danger of stasis of secretion in the bronchi);

- age up to 12 years.

Carefully:

Hepatic insufficiency, renal failure, peptic ulcer and duodenal ulcer (in the anamnesis), pregnancy (II-III trimester), lactation period, as well as patients with weakened cough reflex or disturbed mucociliary transport due to the possibility of sputum accumulation; patients with bronchial asthma (ambroxol can enhance coughing).

Pregnancy and lactation:

The drug should not be used in the first trimester of pregnancy. The use of the drug during breastfeeding is possible only if the expected effect of therapy exceeds the potential risk for the fetus and infant (there is still no reliable data on the adverse effects of the drug on the fetus and infants).

Dosing and Administration:

Inside, during meals, with a small amount of liquid.

Adults and children over 12 years of age are prescribed 1 capsule 75 mg in the morning.

It is not recommended to use without prescribing the doctor for more than 4-5 days.

Side effects:

Allergic reactions: skin rash, hives, angioedema, in some cases - allergic contact dermatitis, anaphylactic shock. Rarely - weakness, headache, diarrhea, dry mouth and respiratory tract, exanthema, rhinorrhea, constipation, dysuria.

Overdose:

Symptoms: nausea, vomiting, diarrhea, indigestion.

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

Interaction:

Joint use with antitussive drugs (eg, containing codeine) leads to difficulty in sputum discharge on the background of a decrease in cough, increases penetration of bronchial secretions of amoxicillin, cefuroxime, erythromycin and doxycycline.

Special instructions:

Do not combine with antitussive drugs that make it difficult to withdraw phlegm.

Patients taking the drug Ambroxol retard should not be recommended to perform breathing exercises.

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

Do not take Ambroxol retard immediately before bedtime.

Form release / dosage:Capsules of prolonged action 75 mg.

Packaging:

By 10, 14, 15 or 20 capsules in a contour mesh box made of a polyvinylchloride film and aluminum foil printed lacquered.

By 1, 2, 3 contour mesh packages together with instructions for use are placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-004854/10

Date of registration:28.05.2010

Expiration Date:Unlimited

The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Manufacturer: & nbsp

OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia

Information update date: & nbsp09.08.2017

Illustrated instructions

Instructions

Ambroxol retard (Ambroxol retard)