Ambroxol vramed instructions for use. Ambroxol vramed instructions for use, contraindications, side effects, reviews

Date: 04.07.2020

Instructions for use

Clinical and pharmacological group

Mucolytic and expectorant drug

Release form, composition and packaging

◊ Syrup transparent, viscous, with a raspberry smell, from colorless to light yellow.

Excipients: sorbitol, citric acid, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol, propylene glycol, sodium saccharin, raspberry essence, purified water.

100 ml - plastic bottles (1) - cardboard packs.
100 ml - dark glass bottles (1) - cardboard packs.

pharmachologic effect

Mucolytic drug. It has a secretomotor, secretolytic and expectorant effect; stimulates serous cells of the glands of the bronchial mucosa, increases the content of mucous secretions and the release of a surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolyzing enzymes and enhancing the release of lysosomes from Clara cells, it reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport.

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

Pharmacokinetics

Suction

After taking the drug inside, absorption is high. C max in blood plasma is reached after 0.5-3 hours.

Distribution

Plasma protein binding - 80%. Penetrates the BBB, placental barrier, excreted in breast milk.

Metabolism

It is metabolized in the liver to form dibromantranilic acid and glucuronic conjugates.

Withdrawal

T 1/2 is 1.3 hours.

Excreted by the kidneys: 90% - in the form of water-soluble metabolites, 5% - unchanged.

Pharmacokinetics in special clinical situations

T 1/2 increases with severe chronic renal failure, does not change with impaired liver function.

Dosage

The drug is administered orally, during meals, with a small amount of liquid.

Adults and children over 12 years old the drug is prescribed for the first 2-3 days, 10 ml (2 teaspoons), and then 5 ml (1 teaspoon) 3 times / day.

Children aged 5-12 appoint 5 ml (1 teaspoon) 2-3 times / day.

Children aged 2-5 years- 2.5 ml (1/2 teaspoon) 3 times / day.

With a long course of treatment, the dose can be reduced by 2 times.

Overdose

Symptoms: nausea, vomiting, diarrhea, dyspepsia.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; eating food containing fats.

Drug interactions

WITH caution

special instructions

The drug can affect the clinical picture of gastric ulcer and duodenal ulcer.

With impaired renal function

WITH caution the drug should be prescribed for renal failure.

Childhood use

The drug is prescribed for children over 2 years old (see Dosage regimen).

Conditions of dispensing from pharmacies

The drug is approved for use as a means of OTC.

Respiratory tract diseases with secretion of viscous sputum:

acute and chronic bronchitis;
pneumonia;
chronic obstructive pulmonary disease;
bronchial asthma with difficulty in sputum discharge;
bronchiectasis.

Contraindications

I trimester of pregnancy;
hypersensitivity to the components of the drug;
hypersensitivity to bromhexine.

WITH caution the drug should be prescribed for renal failure.

Composition

◊ Syrup transparent, viscous, from colorless to light yellow, with a raspberry smell.

Sorbitol, citric acid monohydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol, propylene glycol, sodium saccharinate, raspberry flavor, purified water.

100 ml - dark glass bottles (1) complete with a measuring spoon or glass - cardboard packs.
100 ml - bottles of dark polyethylene terephthalate (1) complete with a measuring spoon or glass - cardboard packs.

◊ Syrup transparent, viscous, with a raspberry smell, from colorless to light yellow.

Excipients: sorbitol, citric acid, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol, propylene glycol, sodium saccharin, raspberry essence, purified water.

100 ml - plastic bottles (1) - cardboard packs.
100 ml - dark glass bottles (1) - cardboard packs.

Overdose

Symptoms: nausea, vomiting, diarrhea, dyspepsia.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; eating food containing fats.

Additional Information

Pharmacological action

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

Pharmacokinetics

Suction

After taking the drug inside, absorption is high. C max in blood plasma is reached after 0.5-3 hours.

Distribution

Plasma protein binding - 80%. Penetrates the BBB, placental barrier, excreted in breast milk.

Metabolism

It is metabolized in the liver to form dibromantranilic acid and glucuronic conjugates.

Withdrawal

T 1/2 is 1.3 hours.

Excreted by the kidneys: 90% - in the form of water-soluble metabolites, 5% - unchanged.

Pharmacokinetics in special clinical situations

T 1/2 increases with severe chronic renal failure, does not change with impaired liver function.

It will show you the behavior of the drug in the body: the mechanism of intake, distribution in tissues, the ability to accumulate, the pathways and rate of excretion from the body, etc.

Drug interactions

Ambroxol Vramed can be combined with other drugs. There are no data on adverse drug interactions.

Combined use with antitussive drugs leads to difficulty in sputum discharge against the background of a decrease in cough.

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

This is important information on which the effectiveness of treatment depends. Remember that the simultaneous administration of several drugs can lead either to a mutual enhancement of the medicinal properties (which is fraught with the appearance of side effects or symptoms of overdose), or to a depressing effect on each other (the consequence of this is the lack of effect from the treatment).

Side effect

Allergic reactions: skin rash, urticaria, angioedema; in some cases - allergic contact dermatitis, anaphylactic shock.

From the digestive system: rarely - diarrhea, dry mouth, constipation; with prolonged use in high doses - gastralgia, nausea, vomiting.

From the respiratory system: rarely - dryness of the mucous membranes of the respiratory tract, rhinorrhea.

Few facts about the product:

Instructions for use

Online pharmacy price website: from 80

Few facts

Ambroxol Vramed refers to drugs that activate the mucociliary system of the submucosa. As a result of the normalization of the functioning of the secretory glands, the excretion of sputum from the bronchial region is enhanced. Mucociliary clearance is a protective barrier against the spread of pathogenic microorganisms. This is a kind of local protection that suppresses and cleanses the respiratory system from external influences, including infectious ones.

Ambroxol is a breakdown product of bromhexine. There is no narcotic effect after taking the drug. In 2012, the chemical product was recognized as a substance that has a decisive effect on the functionality of the human respiratory system. The principle that determines the property of the drug is borrowed from the plant Adhatoda vasica (Adatoda vascular), from which useful components are isolated: vazicin, vasicino and other quinazoline derivatives. For centuries, this plant has been used to treat tuberculosis, bronchial asthma and other respiratory diseases. On the basis of vazicin, a synthetic analogue of it, bromhexine, was obtained, the metabolite of which was ambroxol.

Pharmacological properties of Ambroxol Vramed

The chemical has a number of therapeutic characteristics that directly affect the overall state of mucociliary clearance. These include secretomotor, secretolytic and expectorant action. The secretory function stimulates the release of mucus by wet coughing. The meaning of the secretolytic property is to change the nature of secretion, which improves the transport of phlegm to the outside. Coughing up mucus is observed with an eosinophilic infiltrative process in the respiratory system. Stimulation of the production of pulmonary surface-active components and the work of the ciliary system after taking ambroxol leads to an increase in mucus transport. As a result, the chemical product promotes the excretion of phlegm and the appearance of wet coughing. The end result is an improvement in all breathing.

The absorption (absorption) of the active ingredient takes place in the digestive system. The level of maximum bioavailability occurs within half an hour to 3 hours after taking the drug. The distribution process, based on binding to plasma proteins, is fast. The maximum bioavailability coefficient is established in the pulmonary system. Metabolic reactions occur mainly in the liver. Here dibromantranilic acid compound and glucoran conjugates are formed. The overwhelming majority of the drug is excreted from the body through the renal structure, but the drug does not accumulate in the event of its dysfunction. The substance is found in breast milk.

Composition and form of release

The main active ingredient of the product is ambroxolol hydrochloride. The medication contains 15 mg. The product is produced in the form of a colorless syrup with a viscous consistency. When a raspberry flavor is added, the medication may have a light yellow tint. The liquid is stored in 100 ml amber glass or polyethylene terephthalate vials. A measuring spoon or glass is included in the package.

Indications for the use of Ambroxol Vramed

Ambroxol Vramed is prescribed to eliminate the following pathological forms of diseases: severe and long-term inflammation of the bronchi and lungs; chronic obstructive pulmonary disease; shortness of breath with the problem of sputum release; bronchiectasis pathology.

Side effects

Accidental complications are typical for: immunity with symptoms of anaphylactic reaction in the form of shock, angioedema, itching and other problems associated with hypersensitization; central nervous system with the development of one of the forms of deterioration in gustatory sensitivity; ENT organs with a decrease in sensitivity in the oral cavity and larynx, dryness of the mucous membrane, or increased mucus production in the nasal cavity; digestive tract, when nausea with vomiting, diarrhea, pain syndrome develops; urinary system in the form of dysuria; skin - rash, nettle fever, rashes of a viral nature.

Contraindications

Ambroxol Vramed should be prescribed only by the attending physician of the appropriate profile, since the substance has a number of restrictions on the intake of: hypersensitivity to the active chemical component and other elements that make up the drug; the period of bearing a child, especially in the first trimester; stage of lactoforming; children of the first year of life. The drug should be taken with caution in case of renal and hepatic dysfunction. In this case, the dosage rate should correspond to half the usual dose for an adult, and the duration of treatment should not exceed 5 days. The same restrictions are imposed for patients suffering from ulcerative pathology of the gastrointestinal tract and pregnant women in the 2nd and 3rd trimesters.

Application during pregnancy

The fact of penetration of Ambroxol Vramed through the placental protection was noted. But according to reliable information obtained as a result of studies after the 28th week of pregnancy, violations of the intrauterine development of the child were not found. But compliance with safety measures is not canceled and the use of the drug should be carried out only under the supervision of a doctor. The use of pharmaceutical material in the first trimester of pregnancy is out of the question. At a later date, use with caution, having previously received advice from a specialized specialist. The active chemical component passes into breast milk. Since there is no data on the negative effect of the drug on the infant, the drug should be discontinued during the nursing period.

Method and features of the use of Ambroxol Vramed

The use of a chemical product is carried out orally, at the time of a meal. Any dosage, which depends on the age of the patient, is determined exclusively by medical personnel. This is especially true for children. For infants in the first year of life, the drug is not prescribed. For children from one to two years old, the dose is minimal, and the period of use is 2 times a day. Babies from 2 to 6 years old are allowed to increase the number of doses during the day while maintaining the dosage. Older children - up to 12 years old, the dose of the drug is doubled, and adolescents can take the drug at the same level as adults. Elderly people belong to a special category of patients. However, they are allowed to consume Ambroxol as usual. In the case of hepatic or renal dysfunction, the adult dosage is reduced by half. The total duration of the therapeutic course is no more than 5 days.

Alcohol compatibility

Simultaneous administration of the drug and ethanol reduces the effectiveness of the former. In addition, there is a likelihood of complications in the form of a rash on the dermis, sometimes weakness, lethargy, and drowsiness develop. At the first signs of the onset of violations, alcohol consumption should be stopped and drink as much liquid as possible during the first 4 hours. Activated carbon can be used. After a course of therapy, the use of ethyl alcohol is prohibited for 1 month. And this does not depend on the dosage form of the drug, be it a cream or a pill.

Interaction with other medications

Simultaneous use of the substance with antibacterial agents leads to a gradual accumulation of the latter in the cells of the pulmonary system. Complex treatment with Abroxol and antitussive materials is not allowed. There is no other clinically important information about the interaction of Ambroxol with other drugs.

Overdose

If the substance intake is exceeded, signs of nausea appear, turning into vomiting, diarrhea, and dyspepsia. Elimination of symptoms is carried out by flushing the gastrointestinal tract within the first two hours after an overdose and eating fatty foods.

Analogs

Substances similar to Ambroxol Vramed in terms of therapeutic effects are: Ambrobene, Flavamed, Medox, Halixol, Lazolvan, Bronchol and others. Apply strictly according to the instructions for use, taking into account the indications and contraindications.

Terms of sale

The drug can be sold without a prescription from the treating doctor, but a prescription is required for children under 2 years of age.

Storage conditions

The package with the medicine should be kept in a dark place out of the reach of children. Temperature range - no higher than 25 ° С. Storage time - 3 years, after opening the container - 1 month.

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

Pharmacokinetics

Suction

After taking the drug inside, absorption is high. C max in blood plasma is reached after 0.5-3 hours.

Distribution

Plasma protein binding - 80%. Penetrates the BBB, placental barrier, excreted in breast milk.

Metabolism

It is metabolized in the liver to form dibromantranilic acid and glucuronic conjugates.

Withdrawal

T 1/2 is 1.3 hours.

Excreted by the kidneys: 90% - in the form of water-soluble metabolites, 5% - unchanged.

Pharmacokinetics in special clinical situations

T 1/2 increases with severe chronic renal failure, does not change with impaired liver function.

Release form

The syrup is transparent, viscous, from colorless to light yellow, with a raspberry smell.

Excipients: sorbitol, citric acid monohydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol, propylene glycol, sodium saccharinate, raspberry flavor, purified water.

Dosage

The drug is administered orally, during meals, with a small amount of liquid.

For adults and children over 12 years of age, the drug is prescribed for the first 2-3 days, 10 ml (2 teaspoons), and then 5 ml (1 teaspoon) 3 times / day.

Children aged 5-12 years are prescribed 5 ml (1 teaspoon) 2-3 times / day.

Children aged 2-5 years - 2.5 ml (1/2 teaspoon) 3 times / day.

With a long course of treatment, the dose can be reduced by 2 times.

Overdose

Symptoms: nausea, vomiting, diarrhea, dyspepsia.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; eating food containing fats.

Interaction

Ambroxol Vramed can be combined with other drugs. There are no data on adverse drug interactions.

Combined use with antitussive drugs leads to difficulty in sputum discharge against the background of a decrease in cough.

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

Side effects

Allergic reactions: skin rash, urticaria, angioedema; in some cases - allergic contact dermatitis, anaphylactic shock.

From the digestive system: rarely - diarrhea, dry mouth, constipation; with prolonged use in high doses - gastralgia, nausea, vomiting.

From the respiratory system: rarely - dryness of the mucous membranes of the respiratory tract, rhinorrhea.

Others: rarely - weakness, headache, dysuria, exanthema.

Indications

Respiratory tract diseases with secretion of viscous sputum:

acute and chronic bronchitis;
pneumonia;
chronic obstructive pulmonary disease;
bronchial asthma with difficulty in sputum discharge;
bronchiectasis.

Contraindications

I trimester of pregnancy;
hypersensitivity to the components of the drug;
hypersensitivity to bromhexine.

The drug should be prescribed with caution in case of renal failure.

Application features

Application during pregnancy and lactation

Based on existing data, it is believed that the drug does not have a negative effect during pregnancy and lactation. Nevertheless, the drug is not recommended for use in the first trimester of pregnancy.

Ambroxol is excreted in breast milk in an amount that does not affect the infant.

Application for impaired renal function

The drug should be used with caution in case of renal failure.

Application in children

The drug is prescribed for children over 2 years old (see Dosage regimen).

special instructions

The drug can affect the clinical picture of gastric ulcer and duodenal ulcer.

Indications for use:

Diseases of the respiratory tract with the formation of viscous sputum: acute and chronic bronchitis, pneumonia, COPD, bronchial asthma with difficulty in sputum discharge, bronchiectasis.
Stimulation of prenatal lung maturation, treatment and prevention (with the threat of preterm birth and with indicated artificial preterm birth between 28 and 34 weeks of gestation, if the clinical picture suggests an extension of the gestation period by 3 days) of respiratory distress syndrome in premature babies and newborns.

Possible substitutes:

Bronchorus (from 15.00 rubles), Bronchoxol (from 18.00 rubles), Ambroxol (from 23.00 rubles), Ambrohexal (from 53.00 rubles), Ambroxol-Hemofarm (from 71.00 rubles) Attention: the use of substitutes must be agreed with the attending physician.

Dosage form:

extended-release capsules, solution for intravenous administration, oral solution, oral solution [alcohol], solution for oral administration and inhalation, syrup, tablets, extended-release tablets, effervescent tablets

Contraindications:

Hypersensitivity, pregnancy (I trimester), phenylketonuria (for dosage forms containing aspartame). With caution. Liver failure.

Method of administration and dosage:

Inside, during meals, with a small amount of liquid. Adults and children over 12 years of age are prescribed - tablets: 30 mg 3 times a day for the first 2-3 days, then 30 mg 2 times or 15 mg 3 times a day, or 1 retard capsule (75 mg) in the morning; children 6-12 years old - 15 mg 2-3 times a day.
Oral solution (7.5 mg / ml) for adults during the first 2-3 days - 4 ml, and then 2 ml 3 times a day or 4 ml 2 times a day; children under 2 years old - 1 ml 2 times a day, 2-5 years old - 1 ml 3 times a day, 5-12 years old - 2 ml 2-3 times a day.
Syrup (3 mg / ml) for adults - in the first 2-3 days, 10 ml, and then 5 ml 3 times a day or 10 ml 2 times a day. In severe cases of the disease, the dose is not reduced during the entire course of treatment. Children 5-12 years old are prescribed 15 mg 2-3 times a day, 2-5 years old - 7.5 mg 3 times a day, up to 2 years old - 7.5 mg 2 times a day.
In the form of inhalation, it is prescribed for adults and children over 5 years old at 15-22.5 mg, for children under 2 years old - 7.5 mg, for children from 2-5 years old - 15 mg 1-2 times a day. In the case when it is not possible to carry out more than one inhalation per day, tablets, solution or syrup are additionally used orally.
Parenterally administered intramuscularly, intravenously (slowly, jet or drip) or s / c: adults - 15 mg, in severe cases - 30 mg 2-3 times a day; children - 1.2-1.6 mg / kg 3 times a day. Usually, children under 2 years old - 7.5 mg 2 times a day, from 2 to 5 years old - 7.5 mg 3 times a day, from 5 years old - 15 mg 2-3 times a day. For the treatment of respiratory distress syndrome in premature and newborn infants, 10 mg / kg / day is administered intravenously or intramuscularly, the frequency of administration is 3-4 times, if necessary, the dose can be increased to 30 mg / kg / day.
For intravenous drip injection, 50 ml is diluted in 500 ml of an infusion solution (0.9% NaCl solution, 5% dextrose solution, Ringer-Locke solution or other basic solution with a pH not higher than 6.3 are used as a solvent), injected over 2 hours at a speed of 84 drops / min. Repeated treatment according to the above scheme can be carried out after 14 days (while maintaining the indications).
Parenteral administration is terminated after the disappearance of acute manifestations of the disease (switch to oral administration or rectal administration).
Rectally, adults and children over 12 years old - 1 suppository (30 mg) 3 times a day for 2-3 days, then 60 mg 2 times a day, the maximum daily dose is 0.12 g; children 6-12 years old - 15 mg 2-3 times a day.
It is not recommended to use it without medical prescription for more than 4-5 days.

Pharmachologic effect:

Mucolytic agent, stimulates prenatal lung development (increases synthesis, secretion of surfactant and blocks its breakdown). It has a secretomotor, secretolytic and expectorant effect; stimulates serous cells of the glands of the bronchial mucosa, increases the content of mucous secretions and the release of a surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolyzing enzymes and enhancing the release of lysosomes from Clarke cells, it reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport.
After oral administration, the action occurs after 30 minutes, with rectal administration - after 10-30 minutes and lasts for 6-12 hours. With parenteral administration, the action occurs quickly and lasts for 6-10 hours.

Side effects:

Allergic reactions: skin rash, urticaria, 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.
With a rapid intravenous injection - a feeling of numbness, weakness, intense headaches, decreased blood pressure, shortness of breath, hyperthermia, chills. Overdose. Symptoms: nausea, vomiting, diarrhea, dyspepsia.
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; taking fat-containing foods.

Special instructions:

Should not be combined with antitussive drugs that impede the excretion of sputum.
The inhalation solution can be applied using any modern inhalation equipment (except for steam inhalers). Before inhalation, the drug is mixed with 0.9% NaCl solution (for optimal air humidification, it can be diluted in a 1: 1 ratio) and heated to body temperature. Inhalation should be carried out in normal breathing mode (so as not to provoke cough shocks).
Patients suffering from bronchial asthma, in order to avoid nonspecific irritation of the respiratory tract and their spasm, before inhalation of ambroxol, it is necessary to use bronchodilators.
Patients with diabetes mellitus can be prescribed in the form of a syrup (5 ml of syrup contains sorbitol and saccharin in an amount corresponding to 0.18 XE).
Children under 5 years of age are not recommended to use 15 mg suppositories, up to 12 years old - 30 mg (15 mg suppositories are used for them).

Interaction:

Combined use with antitussive drugs leads to difficulty in sputum discharge against the background of a decrease in cough.
Increases penetration into the bronchial secretions of amoxicillin, cefuroxime, erythromycin and doxycycline.
Solution for injection must not be used with solutions with a pH higher than 6.3.