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

Excipients: propylene glycol 450 mg, glycerol 450 mg, sorbitol 550 mg, saccharin 5 mg, sodium benzoate 5.75 mg or 11.50 mg, citric acid monohydrate 5 mg, sodium disulfite sodium metabisulphite) 0.15 mg or 0.3 mg, vanillin 2.5 mg, water purified to 5 ml.

Description:

A clear liquid of colorless or light yellow color with specific odor.

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 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 phlegm. Activating hydrolyzing enzymes and enhancing release of lysosomes from Clara cells, reduces the viscosity of phlegm. Increases the motor activity of cilia of ciliated epithelium, increases mucociliary transport of sputum.

After oral administration, the effect occurs 30 minutes later. and lasts for 6-12 hours.

Pharmacokinetics:

Absorption is high, the time to reach the maximum concentration (TC_m_Oh) 2 hours, the connection with blood plasma proteins - 80%, penetrates the blood-brain barrier, placental barrier, excreted in breast milk.

Metabolism - in the liver, forms dibromantranilic acid and glucuronic conjugates. Half-life (T_1/2) - 7-12 hours. It is excreted by the kidneys: 90% in the form of water-soluble metabolites, in unchanged form - 5%.

Half-life (T_1/2) increases with severe chronic renal failure, but does not change when the liver function is impaired.

Indications:

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

1. acute and chronic bronchitis;

2. pneumonia;

3. chronic obstructive pulmonary disease;

4. bronchial asthma with difficulty in sputum discharge;

5. bronchiectatic disease.

Contraindications:

1. pregnancy (I trimester);

2. lactation period;

3. hypersensitivity to the components of the drug;

4. intolerance to fructose (because the drug contains sorbitol);

5. children's age to 6 years (for syrup 30 mg / 5 ml).

Carefully:

Renal / hepatic insufficiency (one should take half of the recommended dose for adults and the duration of therapy should not exceed 4-5 days), peptic ulcer and duodenal ulcer, pregnancy (II and III trimester).

Pregnancy and lactation:

The drug is contraindicated in the first trimester of pregnancy and during lactation.

From the 4th month of pregnancy the drug is used only as prescribed by the doctor.

If it is necessary to use the drug, breastfeeding should be discontinued.

Dosing and Administration:

The drug is administered inside, at the time of food intake, with a small amount of liquid.

Syrup 15 mg / 5 ml is prescribed:

Adults and children over 12 years of age 10 ml 3 times / day; children from 6 to 12 years of 5 ml 2-3 times / day; for children from 2 to 6 years, 2.5 ml 3 times a day; children under 2 years of 2.5 ml 2 times / day.

A syrup of 30 mg / 5 ml is prescribed:

Adults and children over 12 years of age to 5 ml 3 times / day; children from 6 to 12 years, 2.5 ml 2-3 times / day.

Side effects:

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

Other - weakness, headache, diarrhea, dryness of the oral cavity and respiratory tract mucosa, dysgeusia (dysuria), dysuria, exanthema, rhinorrhea, constipation.

With prolonged use in high doses - heartburn, gastralgia, nausea, vomiting.

Overdose:

Possible: nausea, heartburn, vomiting, diarrhea, indigestion.

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

Interaction:

Increases the penetration into the bronchial secret of amoxicillin, cefuroxime, erythromycin, doxycycline.

It is not recommended simultaneous use with drugs that suppress cough.

Clinically significant interactions of ambroxol with other drugs have not been established.

Special instructions:

If after 5 days of taking the drug, the patient's condition does not change or worsens, the attending physician should review the treatment.

There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the appointment of ambroxol; however, the causal relationship with taking the drug is not established. The preparation contains sorbitol in an amount of 35 g / 100 ml (a dose of 5 ml contains 1.75 g of sorbitol), so it can cause irritation of the stomach and diarrhea in people with congenital intolerance to fructose.

Contains as auxiliary substances methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause hives. Rarely cause immediate hypersensitivity reactions with urticaria and bronchospasm.

The preparation contains glycerol, which, when used at high doses, can cause headache, stomach irritation and diarrhea.

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

There is no information about the unfavorable effect of the drug on the ability to drive vehicles and service mechanisms that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Syrup 15 mg / 5 ml, 30 mg / 5 ml.

Packaging:

For 100 ml in polymeric bottles, hermetically sealed with polymeric screw caps.

To 100 ml in bottles of dark glass, hermetically sealed with polymeric screw caps.

Each vial with the instructions for use, complete with a spoon of a polymer or a measuring cup, is placed in a pack of cardboard.

Storage conditions:

In a dry, dark place at a temperature of 15 to 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:Ambrolore

Date of registration:LP-002257

Expiration Date:30.09.2013 / 07.09.2015

Date of cancellation:2018-09-30

The owner of the registration certificate:SLAVYANSKAYA APTEKA, LLC SLAVYANSKAYA APTEKA, LLC Russia

Manufacturer: & nbsp

SLAVYANSKAYA APTEKA, LLC Russia

Information update date: & nbsp21.07.2017

Illustrated instructions

Instructions

Ambrolore (Ambrolor)