Ambroxol Wedl Syrurt Instructions for use. Ambroxol-Wal. Application during pregnancy and in breastfeeding period

19.07.2020 Glucometers

Mulitatic remedy with an expectorant action. Stimulates serous cells of the glance of the bronchi mucous membrane, increasing the content of the mucous membrane, and, thus, changes the disturbance ratio of the serous and mucous components of sputum. In this case, hydrolyzing enzymes are activated, and the release of lysosomes from Clara cells is enhanced, which leads to a decrease in sputum viscosity. Ambroxol increases the content of surfactant in the lungs, which is associated with the enhancement of its synthesis and secretion in alveolar pneumocytes, as well as with impaired decay. Increases mukicillary spruds. Slightly suppresses cough.

Pharmacokinetics

After taking inside, the ambroxol is almost completely absorbed from the gastrointestinal tract. C Max in the blood plasma is achieved by approximately 0.5-3 hours. Does not cumulate. Binding of plasma proteins is about 90%.

After taking inside and parenteral administration, the ambroxol is quickly distributed in the body tissues, the most high concentration Determined in the lungs.

Penetrates the BC and the placental barrier, stand out with breast milk.

Metabolized in the liver by conjugation with the formation of pharmacologically inactive metabolites.

T 1/2 is 7-12 hours. It is removed mainly by the kidneys in the form of metabolites - 90%, unchanged - 5%.

T 1/2 increases with chronic renal failure of severe.

Form release

100 ml - polyethylene bottles (1) bundled with a measuring cap - packs cardboard.

Dosage

Inside adults and children over 12 years old - 30 mg 2-3 times / day.

Dosing mode for children under the age of 12 is presented in the following table.

Inhalations with adults and children over 5 years old - 15-22.5 mg 1-2 times / day.

Adult parenterally (in / m, in / c) - 15 mg, in severe cases - 30 mg 2-3 times / day.

Children in / m - 1.2-1.6 mg / kg 3 times / day; V / B - 1.2-1.6 mg / kg / day.

Children under 2 years old in / in - 15 mg / day, multiplicity of administration - 2 times / day.

Children from 2 to 5 years old in / in - 22.5 mg / day, the multiplicity of administration is 3 times / day.

Children over 5 years - 30-45 mg / day, multiplicity of administration - 2-3 times / day.

For the treatment of respiratory distress syndrome in premature and newborn children, ambroxol is introduced in / in or in / m in a dose of 10 mg / kg / day, the multiplicity of administration is 3-4 times / day, if necessary, a dose can be gradually increased to 30 mg / kg / day.

Interaction

With simultaneous use with antitussive agents, sputum is hampered against the background of the cough reduction; With amoxicillin, doxycycline, cefuroxime, erythromycin - the strengthening of their penetration into the bronchial secret.

Ambroxol is compatible with drugs that are braking tribal activities.

Side effects

From side digestive system: Rarely - nausea, vomiting, diarrhea, abdominal pain.

Allergic reactions: Skin rash, urticaria, angioedema swelling.

Others: rarely - weakness, headache.

Indications

Sharp i. chronic diseases respiratory tractaccompanied by excretion of viscous sputum (chronic bronchitis with broncho-prestructive syndrome, bronchial asthma, bronchiectatic disease). Respiratory distress syndrome in newborns and premature babies.

Contraindications

Ulcer of the stomach and duodenal gut, convulsive syndrome various etiology, I trimester of pregnancy, increased sensitivity to ambroxol.

Features of application

Application in pregnancy and breastfeeding

Ambroxol is contraindicated in the first trimester of pregnancy. If necessary, use in the II and III trimesters should evaluate the potential benefit of therapy for the mother and possible risk For fetal.

If necessary, the use of ambroxol during the lactation period should be resolved breastfeeding.

Application in children

Application in elderly patients

Application is possible according to the dosing mode.

special instructions

In patients suffering bronchial asthmaIn order to avoid nonspecific irritation of the respiratory tract and their spasm before the inhalation of ambroxol, bronchophiles can be used. Yangzhou number 3 Pharmal Ko.LTD.

Country of origin

China

Group of goods

Respiratory system

Mukolithic I. expectorant drug

Forms of release

  • flake 100ml

Description of the dosage form

  • Syrup is homogeneous, transparent, colorless, with the smell of raspberry.

pharmachologic effect

The musolitic agent, stimulates the prenatal development of the lungs (increases the synthesis, the secretion of the surfactant and blocks its decay). It has secretomotor, secretolithic and expectorant action; stimulates the serous cells of the glance of the bronchi mucous membrane, increases the content of the secrecy of the secret and the release of the surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of the serous and mucous components of sputum. Activating hydrolyzing enzymes and enhanced release of lysosomes from Clara cells reduces the viscosity of sputum. Increases the motor activity of the fiscal epithelium, increases mukicillion transport. After receiving inside the action occurs after 30 minutes, with rectal administration - after 10-30 minutes and continues for 6-12 hours. In parenteral administration, the action occurs quickly and continues for 6-10 hours.

Pharmacokinetics

Absorption is high (with any way of administration), TCmax - 2 hours, connection with plasma proteins - 80%. Penetrates the BC, a placental barrier, stands out with breast milk. Metabolism - in the liver, forms dibromantranyl acid and glucuronic conjugates. T1 / 2 - 7-12 h. Examped by the kidneys: 90% in the form of water-soluble metabolites, unchanged - 5%. T1 / 2 increases with severe CPN, does not change when the liver function is broken.

Structure

  • ambroxol hydrochloride 15 mg excipients: benzoic acid, glycerol 85%, sorbitol 70%, hydroxyethylcellulose 6000 MPAS (hyatelosis), crushing flavoring, purified water.

Ambroxol-Val testimony for use

  • The diseases of the respiratory tract with the formation of viscous sputum: acute and chronic bronchitis, pneumonia, COPD, bronchial asthma with difficulty wetting sputum, bronchiectatic disease. Stimulation of prenatal ripening of lungs, treatment and prevention (in the threat of premature genera and when shown artificial premature births between 28 and 34 weeks of pregnancy, if clinical picture It allows you to assume the extension of the period of pregnancy for 3 days) respiratory distress syndrome in premature children and newborns.

Ambroxol-Wial Contraindications

  • Hypersensitivity, pregnancy (I trimester), phenylketonuria (for dosage formscontaining aspartam). Carefully. Liver failure, renumber failure, ulcerative disease Stomach and 12 Pans, Pregnancy (II-III Trimester), Lactation Period

Ambroxol-Wal Dosage

  • 15 mg / 5ml

Ambroxol-Vial Side effects

  • Allergic reactions: skin rash, urticaria, angioedema swelling, in some cases - allergic contact dermatitis, anaphylactic shock. Rarely - weakness, headache, diarrhea, dryness mucous membrane and respiratory tract, Exanthem, Rinorea, constipation, dysuria. For long use In high doses - gastralgy, nausea, vomiting.

Medicinal interaction

Enhances the penetration of amoxicillin, cefuroxime, erythromycin and doxycycline into the bronchial secret. Simultaneous use with antitussive means leads to the difficulty of wetting the sputum. Compatible with drugs that brake generic activities. Enhances the penetration of amoxicillin, cefuroxime, erythromycin and doxycycline into the bronchial secret. Simultaneous use with antitussive means leads to the difficulty of wetting the sputum. Compatible with drugs that brake generic activities.

Storage conditions

  • bear from children
Information provided

The drug with mercolytic, expectorant, anti-allergic and vasoconductive effect

Release form, composition and packaging

Syrup thick, from light orange to orange, with a characteristic smell.

Excipients: Sugaraza, methylpaultydroxybenzoate, propyl apricydroxybenzoate, Dinatari Edetat, sorbitol, glycerin, menthol, citrate, sodium citrate, melon flavoring, dye, yellow, purified water.

100 ml - Dark Glass Vials (1) - Cardboard packs.

pharmachologic effect

Combined drug used for colds. Givephenesin and ambroxol reduce the viscosity of the bronchial secret and facilitate expectoration. Chloropenamine Maleat has an anti-allergic effect: eliminates tearing, itching in the eyes and nose. Phenylephrina hydrochloride has a vasoconstrictor effect, reduces the swelling and hyperemia of the mucous membranes of the upper spacing of the respiratory tract and the apparent sinuses.

Pharmacokinetics

Data on the pharmacokinetics of the drug Ricnicold Broncho is not provided.

Dosage

Reception of the drug should be evenly distributed throughout the day. Before use, syrup must be blamed.

Overdose

Symptoms: Strengthening expression side Effects.

Treatment: Washing the stomach, receiving activated carbon, laxatives (Vaseline oil, salt laxatives); Symptomatic therapy. In pronounced disorders, contact the doctor.

Medicinal interaction

The drug enhances the effect of sedatives, ethanol.

Sharing With antidepressants, phenothiazine derivatives (chlorpromazine, trifluorosine, levomepromazine), anti-parkinsonic and antipsychotic means increases the risk of urine delay, dryness in the mouth, constipation.

With simultaneous use with GKS (prednisolone, dexamethasone, triamcinolone), the risk of developing glaucoma increases. Chloropenamine when used simultaneously with Mao inhibitors (Niiamid), furazolidone can lead to hypertensive crisis, excitation, hyperpirection.

Application in conjunction with tricyclic antidepressants is intensified sympathomimetic effect, with halotan - risk of risk of ventricular arrhythmia, with guanethidine - its hypotensive effect is reduced. Guanethidine, in turn, enhances the alpha-adrenostimulating activity of phenylephrine, which is part of the drug.

The simultaneous use of ambroxol and giving gumption with antitussive means leads to the difficulty of wetting the sputum.

Pregnancy and lactation

The drug is contraindicated to use during pregnancy and during lactation.

Side effects

From the side of the cardiovascular system:possible rise hell, tachycardia.

From the CNS: Headache, drowsiness, dizziness, elevated excitabilitydisappearing. Children have an excitement, anxiety, irritability. In elderly patients, confusion is also possible, irritability.

From the digestive system: Nausea, vomiting, constipation, diarrhea, pain in the epigastric area.

From the body of the vision:midship, accommodation paralysis, increase intraocular pressure.

Allergic reactions: Skin rash, itching, swelling quinque.

Others: Dry mucous membranes, difficulty urination.

Terms and Storage Terms

The drug should be stored in an inaccessible place for children at a temperature not higher than 25 ° C; Do not freeze. Shelf life - 3 years.

Indications

- symptomatic treatment cold illness, Influenza and ORVI, accompanied by a cough with a difficult viscous mocroid.

Contraindications

- convulsions of various etiologies;

- pronounced atherosclerosis coronary arteries;

arterial hypertension;

diabetes;

- thyrotoxicosis;

- pheochromocytoma;

- Clothing glaucoma;

- ulcerative disease of the stomach and duodenum;

- Adenoma prostatic gland;

- Glucose-6-phosphate dehydrogenase enzyme deficiency;

- pregnancy;

- lactation period (breastfeeding);

childhood (up to 6 years);

- simultaneous reception of tricyclic antidepressants, Mao inhibitors, beta-adrenoblastors;

- the simultaneous reception of other drugs containing the active substances that are part of Rynikold Broncho;

- Increased sensitivity to the components of the drug.

Carefullyfollow prescribe a drug with renal and / or liver failure.

special instructions

When applying the drug, urine color can be painted in pink color.

With violations of the kidney function

Carefullya drug should be prescribed in renal failure.

When violations of the liver function

Carefullythe drug should be prescribed during liver failure.

Childcare

Contraindication: children's age (up to 6 years).

Conditions of vacation from pharmacies

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

Syrup - 100 ml:

  • Active substance: Ambroxol hydrochloride 0.3 g.
  • Auxiliary substances: Propylene glycol 5 g, ethanol 95% 2.28 g, sorbitol 42 g, methyl aprichedroxybenzoate 0.12 g, propyl aprichedroxybenzoate 0.04 g, Banana flavor 0.1 g, purified water to 100 ml.

100 ml - orange glass vials (1) complete with a measuring cup or a dimensional spoon - cardboard packs.

Description of the dosage form

Syrup colorless or slightly yellowish, transparent.

pharmachologic effect

Mulitatic remedy with an expectorant action. Stimulates serous cells of the glance of the bronchi mucous membrane, increasing the content of the mucous membrane, and, thus, changes the disturbance ratio of the serous and mucous components of sputum. In this case, hydrolyzing enzymes are activated, and the release of lysosomes from Clara cells is enhanced, which leads to a decrease in sputum viscosity. Ambroxol increases the content of surfactant in the lungs, which is associated with the enhancement of its synthesis and secretion in alveolar pneumocytes, as well as with impaired decay. Increases mukicillary spruds. Slightly suppresses cough.

Pharmacokinetics

After taking inside, ambroxol is quickly and almost completely absorbed. Tmax stores 1-3 h. Binding of plasma proteins is approximately 85%. Penetrates the placental barrier, stands out with breast milk. Metabolized in the liver with the formation of metabolites (dibromantranyl acid, glucuronic conjugates), which are removed by the kidneys. It is removed mainly by the kidneys - 90% in the form of metabolites, less than 10% unchanged. The plasma T1 / 2 is 7-12 hours. T1 / 2 ambroxole and its metabolites is approximately 22 hours.

Due to high binding to proteins and large VD, as well as slow inverse penetration from tissues into blood, during dialysis or forced diurea, the substantial removal of ambroxol does not occur. Ambroxol clearance in patients with severe liver failure decreases by 20-40%. With severe renal failure T1 / 2, the metabolites of ambroxol increases.

Clinical pharmacology

Mulgarian and expectorant drug.

Indications for the use of Ambroxol-Wal

Acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum (chronic bronchitis with broncho-prestructive syndrome, bronchial asthma, bronchiectatic disease). Respiratory distress syndrome in newborns and premature babies.

Contraindications to Ambroxol-Wal

Ulcery disease of the stomach and duodenalist, convulsive syndrome of various etiology, I trimester of pregnancy, increased sensitivity to ambroxol.

Ambroxol-Vial Application during pregnancy and children

Ambroxol is contraindicated in the first trimester of pregnancy. If necessary, use in II and III trimesters should evaluate the potential benefit of therapy for the mother and the possible risk to the fetus.

If necessary, the use of ambroxol during the lactation period should be resolved about the cessation of breastfeeding.

Application in children

Application is possible in accordance with the dosing regimen.

Ambroxol-Vial Side effects

From the digestive system: rarely - nausea, vomiting, diarrhea, abdominal pain.

Allergic reactions: skin rash, urticaria, angioedema swelling.

Others: rarely - weakness, headache.

Medicinal interaction

With simultaneous use with antitussive agents, sputum is hampered against the background of the cough reduction; With amoxicillin, doxycycline, cefuroxime, erythromycin - the strengthening of their penetration into the bronchial secret.

Dosage Ambroxol-Wal

The duration of treatment is determined by the doctor individually and depends on the severity of the disease. If you need to use the drug more than 4-5 days, a doctor's advice is required.

For receiving inside

Take inside after meals with sufficient liquid.

Dosage forms of the usual duration of action (tablets, syrup, solution for receiving inside, pasteili)

Adults and children over the age of 12 years: 30 mg 2-3 times / day for the first 2-3 days, then 30 mg 2 times / day.

Children aged 5 to 12 years: 30-45 mg / day in 2-3 reception.

Children aged 2 to 5 years: 22.5 mg / day in 3 reception.

Children under 2 years of age: 15 mg / day in 2 reception. The drug is prescribed only under the control of the doctor.

Capsules of prolonged action

Adults and children over 12 years old: 75 mg 1 time / day.

For in / in administration

Enter in / in slowly inkjet or drip.

Adults: 30-45 mg / day, 2-3 times / day in divided doses. In severe cases, the dose can be increased 60-90 mg / day, 2-3 times / day in divided doses.

For kids daily dose This is usually 1.2-1.6 mg / kg body weight.

Children over the age of 6: 30-45 mg / day, 2-3 times / day in divided doses.

Children aged 2 to 6 years: 22.5 mg / day, 3 times / day in divided doses.

Children under the age of 2 years: 15 mg / day, 2 times / day in divided doses.

With respiratory distress syndrome in newborn and premature babies, the daily dose is 30 mg and, as a rule, is distributed on 4 separate administrations.

Treatment of children under the age of 2 years should be carried out only under the control of the doctor.

Parenteral use stop after disappearance acute manifestations Diseases and switch to the reception of Abmroxol inside in the appropriate dosage forms.

Patients S. renal failure and severe renal insufficiency ambroxol should be used with longer intervals or in reduced doses.

Precautions

In patients suffering from bronchial asthma, in order to avoid nonspecific irritation of the respiratory tract and their spasm before inhalation of ambroxol, bronchops can be used.

Composition and form of release of the drug

100 ml - polyethylene bottles (1) bundled with a measuring cap - packs cardboard.

pharmachologic effect

Mukolithic and expectorant, is an active N-demethylated metabolite. It has secretomotor, secretolithic and expectorant action. Stimulates the serous cells of the bronchi mucosa, increases the motor activity of the flicker epithelium by influencing the type 2 pneumocytes in alveoli and the Clara cells in bronchioles, enhances the formation of an endogenous surfactant - surfactant that provides a gliding bronchial secretion in the lobes of respiratory tract.

Ambroxol increases the share of the serous component in the bronchial secret, improving its structure and contributing to a decrease in viscosity and wet wet; As a result, mukiciliary transport improves and relieves the removal of sputum from the bronchial tree.

When receiving an ambroxol inside the effect, on average, it occurs after 30 minutes and lasts 6-12 hours, depending on the one-time dose.

Pharmacokinetics

After taking inside, ambroxol is quickly and almost completely absorbed. T Max is 1-3 hours. Binding of proteins is approximately 85%. Penetrates the placental barrier, stands out with breast milk. Metabolized in the liver with the formation of metabolites (dibromantranyl acid, glucuronic conjugates), which are removed by the kidneys. It is removed mainly by the kidneys - 90% in the form of metabolites, less than 10% unchanged. T 1/2 of the plasma is 7-12 h. T 1/2 of ambroxol and its metabolites is approximately 22 hours.

Due to high binding to proteins and large V D, as well as slow inverse penetration from tissues to blood, during dialysis or forced diurea, the substantial removal of ambroxol does not occur. Clearance of ambroxol in patients with severe decreases by 20-40%. With severe renal failure T 1/2, ambroxol metabolites increase.

Indications

For receiving inside

The diseases of the respiratory tract, accompanied by the release of viscous sputum and the difficulty of dishelling sputum: sharp and chronic bronchitis; pneumonia; ; bronchiectatic disease; COPL.

For in / in administration

Respiratory diseases with viscous sputum excretion and with difficulty wetting wet when it is necessary to get a quick therapeutic effect Or impossible to take the drug inside: sharp and chronic bronchitis; pneumonia; bronchial asthma; bronchiectatic disease; Stimulation of the synthesis of surfactant in respiratory distress syndrome in premature babies and newborns (as part of complex therapy).

Contraindications

Increased sensitivity to ambroxol or auxiliary components of drugs; I trimester of pregnancy; lactation period (breastfeeding); congenital fructose intolerance (for dosage forms containing fructose); Children's age up to 6 years (for tablets); Children's age up to 12 years (for capsules of prolonged action).

Carefully:bronchial motility violation and increasing mucus secretion (for example, with rare fixed cilia syndrome); renal failure and / or severe liver failure; ulcerative ulcer of the stomach and duodenum (including a history); II and III trimesters of pregnancy; Children's age up to 2 years (solution for intake; only by appointment of a doctor).

Dosage

The duration of treatment is determined by the doctor individually and depends on the severity of the disease. If you need to use the drug more than 4-5 days, a doctor's advice is required.

For receiving inside

Take inside after meals with sufficient liquid.

Dosage forms of the usual duration of action (tablets, syrup, solution for receiving inside, pasteili)

Adults and children over the age of 12:30 mg 2-3 times / day for the first 2-3 days, then 30 mg 2 times / day.

Children aged 5 to 12 years: 30-45 mg / day in 2-3 reception.

Children aged 2 to 5 years:22.5 mg / day in 3 reception.

Children under 2 years old:15 mg / day in 2 reception. The drug is prescribed only under the control of the doctor.

Capsules of prolonged action

Adults and children over 12 years old: 75 mg 1 time / day.

For in / in administration

Enterv / in slowly inkjet or drip.

Adults:30-45 mg / day, 2-3 times / day in divided doses. In severe cases, the dose can be increased 60-90 mg / day, 2-3 times / day in divided doses.

For childrenthe daily dose is, as a rule, 1.2-1.6 mg / kg body weight.

Children over 6 years old:30-45 mg / day, 2-3 times / day in divided doses.

Children aged 2 to 6 years:22.5 mg / day, 3 times / day in divided doses.

Children under 2 years old:15 mg / day, 2 times / day in divided doses.

For respiratory distress syndromew. newborn and premature babies The daily dose is 30 mg and, as a rule, is distributed to 4 separate injections.

Treatment children under 2 years old It should be carried out only under the control of the doctor.

Parenteral application is stopped after the disappearance of acute manifestations of the disease and switch to the reception of the abmroxol inwards in the appropriate dosage forms.

W. patients with renal failure and heavy renal failure Ambroxol should be applied with longer intervals or reduced doses.

Side effects

Allergic reactions: rarely - skin rash, urticaria, examine, swelling of face, shortness of breath, itching, temperature rise; The frequency is unknown - anaphylactic reactions, including anaphylactic shock, angioedema edema, skin itch, Allergic contact dermatitis.

From the digestive system: often - nausea; Infrequently - vomiting, diarrhea, dyspepsia,.

From side nervous system: Often - disgusting.

From the side of the skin and subcutaneous fabrics: Very rarely - toxic epidermal necroliz (Layella syndrome), Stevens-Johnson syndrome; The frequency is unknown - a sharp generalized eczematosis empty.

From the respiratory system: Often - reduced sensitivity in the oral cavity or pharynx; Rarely - dryness of the mucous membrane of the respiratory tract, Rinorea; In isolated cases - dryness of the mucous membrane of the pharynx.

Medicinal interaction

Antitussive tools (for example, codeine) - Due to the suppression of the cough reflex, it is possible to climb the sputum in the lumen of the respiratory tract with the difficulty of its removal (simultaneous use is not recommended).

, doxycycline, cefuroxime, erythromycin - Increasing the penetration of antibiotics into the bronchial secret.

special instructions

Ambroxol should not be taken simultaneously with antitussive preparations, which can slow down the cough reflex, for example, with codeine, because This may impede the removal of a liquefied sputum from the bronchi.

With caution, an ambroxol should be used in patients with a weakened cough reflex or impaired mucocyllure transport due to the possibility of clustering sputum.

Do not take ambroxol immediately before bedtime.

In patients with bronchial asthma, Ambroxol can enhance cough.

In patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolism - in the early phase there may be flu-like condition: temperature, pain in the body, rhinitis, cough, pharyngitis. In symptomatic therapy, it is possible that the erroneous purpose of the musolithic agents, such as ambroxol hydrochloride, is possible.

Pregnancy and lactation

Ambroxol is contraindicated in the first trimester of pregnancy. If necessary, use in II and III trimesters should evaluate the potential benefit of therapy for the mother and the possible risk to the fetus.

If necessary, the use of ambroxol during the lactation period should be resolved about the cessation of breastfeeding.

Childcare

Application is possible in accordance with the dosing regimen.