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

Composition:100 ml of syrup contain: active substance: Ambroxol hydrochloride 300 mg, Excipients: propylene glycol, glycerol, sucrose, sodium benzoate, caramel, orange flavor, distilled water.

Description:The liquid is colorless or yellowish with a specific smell and taste.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Mucolytic agent, stimulates prenatal lung development (increases synthesis, secretion of surfactant and blocks its disintegration).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 Clark cells, reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport.

After ingestion, the effect occurs after 30 minutes and persists for 6-12 hours (depending on the dose taken).

Pharmacokinetics:

Absorption of ambroxol is high, the time of maximum concentration is 2 hours, the connection with plasma proteins is 80%. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk.

Metabolized in the liver, forms dibromantranilic acid and glucuronic conjugates. The half-life period (T1 / 2) is 7-12 hours. It is excreted by the kidneys: 90% in the form of water-soluble metabolites, in unchanged form - 5%.

T1 / 2 increases with severe renal failure and does not change if the liver function is impaired.

Indications:

Diseases of the respiratory tract with the formation of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary diseases, bronchial asthma with difficulty of sputum discharge, bronchoectatic disease.

Contraindications:

Hypersensitivity, pregnancy (I trimester).

Carefully:

Hepatic insufficiency, renal failure, peptic ulcer of stomach and duodenum.

Pregnancy and lactation:

During pregnancy (II and III trimester), the prescription of the drug is only possible if the intended benefit to the mother exceeds the potential risk to the fetus. During the lactation period, the issue of stopping breastfeeding should be addressed.

Dosing and Administration:

Syrup Ambroxol-Vial is taken orally after a meal with a sufficient amount of warm liquid using the supplied dose cup (1 ml of syrup contains 3 mg of ambroxol).

Adults and children over 12 years: during the first 2-3 days, 10 ml 3 times a day (90 mg / day), in the following days 10 ml 2 times a day (60 mg / day) or 5 ml 3 times per day (45 mg / day).In severe cases, the dose is not reduced throughout the course of treatment.

Children 5-12 years - 5 ml 2-3 times a day (30-45 mg / day).

Children 2-5 years - 2.5 ml 3 times a day (22.5 mg / day).

Children under 2 years - 2.5 ml 2 times a day (15 mg / day).

Treatment of children under 2 years old is done only under the supervision of a doctor.

The duration of treatment depends on the features of the course of the disease. It is not recommended to use Ambroxol-Vial without medical prescription 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.

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

Overdose:

Symptoms: nausea, vomiting, diarrhea, indigestion.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; reception of fat-containing products. It is necessary to monitor the parameters of hemodynamics and to carry out symptomatic therapy if necessary.

Interaction:

It is not recommended to use joint use with antitussive drugs, as this leads to difficulty in withdrawing sputum while reducing cough.

With concomitant administration with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) increases their penetration into the bronchial secret.

Special instructions:

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

When treating patients with diabetes should take into account that 5 ml of syrup contains 0.18 XE.

Form release / dosage:

Syrup 15 mg / 5 ml.

Packaging:

100 ml per bottle of high-density polyethylene, sealed aluminum membrane and a screw cap.

One bottle together with a measuring cap and instructions for use in a cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 30 ° 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:LSR-010491/08

Date of registration:24.12.2008

Expiration Date:Unlimited

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

Manufacturer: & nbsp

YANGZHOU №3 PHARMACEUTICAL, Co.Ltd. China

Information update date: & nbsp02.07.2017

Illustrated instructions

Instructions

Ambroxol-Vial (Ambroxol-Vial)