Tablets - 1 tab .: Active substance: ambroxol hydrochloride 30 mg ....
Tablets - 1 tab .:
- Active ingredient: Ambroxol hydrochloride 30 mg.
- Excipients: lactose monohydrate - 102 mg, calcium hydrogen phosphate dihydrate - 50 mg, corn starch - 10 mg, sodium carboxymethyl starch - 4 mg, magnesium stearate - 2 mg, colloidal silicon dioxide - 2 mg.
10 pieces. - contour cell packages (2) - cardboard packs.
Description of the dosage form
The tablets are white, round, flat, with beveled edges, with a notch on one side.
pharmachologic effect
Mucolytic drug with an expectorant effect. It has a secretory, secretolytic and expectorant effect. Stimulates serous cells of the bronchial mucosa, 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 hydrolyzing enzymes and enhancing the release of lysosomes from Clara cells, ambroxol reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport, facilitates the removal of sputum from the respiratory tract.
When ambroxol is taken orally, the effect, on average, occurs after 30 minutes and lasts 6-12 hours, depending on the size of the single dose.
Pharmacokinetics
Suction
After oral administration, Ambroxol is rapidly and almost completely absorbed. Tmax is 1-3 hours.
Distribution
Plasma protein binding is approximately 85%. Ambroxol crosses the placental barrier and is excreted in breast milk.
Metabolism
It is metabolized in the liver with the formation of metabolites (dibromantranilic acid, glucuronic conjugates), which are excreted by the kidneys.
Withdrawal
It is excreted mainly by the kidneys - 90% in the form of metabolites, less than 10% unchanged. T1 / 2 from plasma is 7-12 hours. T1 / 2 of ambroxol and its metabolites is approximately 22 hours.
Pharmacokinetics in special clinical situations
Due to the high binding to proteins and high Vd, as well as the slow reverse penetration from tissues into the blood, during dialysis or forced diuresis, no significant excretion of Ambroxol occurs.
Ambroxol clearance in patients with severe hepatic impairment is reduced by 20-40%.
In severe renal failure, T1 / 2 of ambroxol metabolites increases.
Clinical pharmacology
Mucolytic and expectorant drug.
Indications for the use of Ambrohexal
Acute and chronic diseases of the respiratory tract with the release of viscous sputum:
- acute and chronic bronchitis;
- pneumonia;
- COPD;
- bronchial asthma with difficulty in sputum discharge;
- bronchiectasis;
- treatment and prevention of respiratory distress syndrome (for 3 mg / ml syrup and solution for oral administration and inhalation).
Contraindications to the use of Ambrohexal
- I trimester of pregnancy;
- lactation period (breastfeeding);
- children under 6 years of age (for tablets);
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption (for tablets);
- hereditary fructose intolerance (for syrup);
- hypersensitivity to ambroxol and other components of the dosage forms of the drug.
The drug should be used with caution in case of gastric ulcer and duodenal ulcer (due to possible exacerbation), renal failure, liver failure, in the II and III trimesters of pregnancy.
Ambrohexal Use during pregnancy and children
The drug is contraindicated for use in the first trimester of pregnancy.
The use of the drug in the II and III trimesters of pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.
Ambroxol crosses the placental barrier. In experimental studies on animals, it has been shown that the drug has no effect on embryopetal development, childbirth and postnatal development.
Ambroxol is excreted in small quantities in breast milk, therefore, when using the Ambrohexal® drug, it is necessary to resolve the issue of stopping breastfeeding.
Application in children
Contraindicated in children under 6 years of age (for tablets).
Ambrohexal Side effects
Classification of undesirable effects according to the frequency of their development (WHO): very often (≥1 / 10), often (from ≥1 / 100 to<1/10), нечасто (от ≥1/1000 до <1/100), редко (от ≥1/10 000 до <1/1000), очень редко (<1/10 000), частота неизвестна - по имеющимся данным установить частоту возникновения не представлялось возможным.
Allergic reactions: rarely - skin rash, urticaria; frequency unknown - anaphylactic reactions, including anaphylactic shock, angioedema, pruritus and other hypersensitivity reactions. For syrup 6 mg / ml additionally: rarely - exanthema, facial edema, shortness of breath, itching, fever; very rarely - angioedema; frequency unknown - allergic contact dermatitis.
From the digestive system: often - nausea; infrequently - vomiting, diarrhea, dyspepsia, abdominal pain. For syrup 3 mg / ml additionally: infrequently - heartburn. For syrup 6 mg / ml: often - oral and pharyngeal hypesthesia; infrequently - with prolonged use in high doses - gastralgia, nausea, vomiting; rarely diarrhea.
From the nervous system: often - a change in taste.
On the part of the skin: for syrup 6 mg / ml: very rarely - severe skin reactions (epidermal necrolysis, Stevens-Johnson syndrome).
Others: often - decreased sensitivity in the mouth or pharynx; infrequently - dry mouth; frequency unknown - dryness of the mucous membranes of the respiratory tract. For syrup 6 mg / ml: rarely - dry mouth and respiratory tract, rhinorrhea, dysuria, weakness, headache.
Drug interactions
With the simultaneous use of the drug Abrohexal ® with antitussives (including codeine), there is a difficulty in sputum discharge against the background of a decrease in cough.
Abrohexal ® increases the penetration of amoxicillin, cefuroxime, doxycycline, erythromycin into the bronchial secretions.
Dosage of Ambrohexal
During treatment with Ambrohexal ® it is necessary to consume a lot of fluids (juices, tea, water) to enhance the mucolytic effect of the drug.
The duration of treatment with Ambrohexal® is determined by the doctor individually and depends on the severity of the disease. If it is necessary to use the drug for more than 4-5 days, a doctor's consultation is required.
Pills
The drug should be taken orally after meals with a sufficient amount of liquid.
Adults and children over the age of 12 are prescribed 1 tab. (30 mg) 3 times / day for the first 2-3 days. Then the dose of the drug should be reduced to 1 tab. 2 times / day
Children aged 6 to 12 years are prescribed 1/2 tab. (15 mg) 2-3 times / day.
Syrup 3 mg / 1 ml
The drug should be taken orally after meals. 1 scoop of Ambrohexal® syrup (5 ml) contains 15 mg of Ambroxol hydrochloride.
Adults and children over the age of 12 are prescribed 2 scoops 2-3 times / day (60-90 mg / day) in the first 2-3 days, then 2 scoops 2 times / day (60 mg / day). In severe cases of the disease, the dose is not reduced during the entire course of treatment. The maximum dose is 4 scoops (60 mg) 2 times / day (120 mg / day).
Children aged 5 to 12 years are prescribed 1 measuring spoon 2-3 times / day (30-45 mg / day).
Children aged 2 to 5 years are prescribed 1/2 measuring spoon 3 times / day (22.5 mg / day).
Children under 2 years of age are prescribed 1/2 measuring spoon after 2 times / day (15 mg / day). The drug is prescribed only under medical supervision.
Syrup 6 mg / 1 ml
The drug should be taken orally.
Adults and children over the age of 12 are prescribed 1 measuring spoon (5 ml) 3 times / day for the first 2-3 days, then 1 measuring spoon (5 ml) 2 times / day.
Children aged 6 to 12 years are prescribed 1/2 measuring spoon (2.5 ml) 2-3 times / day.
Children aged 2 to 6 years are prescribed 1/4 measuring spoon (1.25 ml) 3 times / day.
Children under 2 years of age: 1/4 measuring spoon (1.25 ml) 2 times / day. The drug is prescribed only under medical supervision.
Solution for oral administration and inhalation
Ingestion
The drug should be taken orally after meals, diluted with tea, fruit juices, milk or water.
1 ml of solution (20 drops) contains 7.5 mg of ambroxol hydrochloride.
Adults and children over the age of 12 are prescribed 4 ml (80 drops) 3 times / day (90 mg / day) in the first 2-3 days, then 4 ml (80 drops) 2 times / day (60 mg / day ).
Children aged 5 to 12 years are prescribed 2 ml (40 drops) 2-3 times / day (30-45 mg / day).
Children aged 2 to 5 years are prescribed 1 ml (20 drops) 3 times / day (22.5 mg / day).
Children under 2 years of age are prescribed 1 ml (20 drops) 2 times / day (15 mg / day). The drug is prescribed only under medical supervision.
Inhalation use
Adults and children over the age of 5 years are recommended to carry out inhalations 1-2 times / day, 2-3 ml (40-60 drops, which corresponds to 15-45 mg of ambroxol).
The solution for inhalation can be applied using any modern inhalation equipment (except for steam inhalers). The drug is mixed with a saline solution, in order to achieve the optimal level of air humidification in the respirator, the drug can be diluted in a 1: 1 ratio. Since during inhalation therapy, a deep breath can provoke cough tremors, inhalations should be carried out in a normal breathing mode. It is usually recommended to warm the inhalation solution to body temperature before inhaling. Patients with bronchial asthma can be advised to carry out inhalation after taking bronchodilators.
Overdose
Symptoms: nausea, vomiting, diarrhea, gastralgia, dyspepsia, increased salivation (syrup 6 mg / ml).
Treatment: cancel the drug, induce artificial vomiting, wash the stomach during the first 1-2 hours after taking the drug; taking fat-containing foods; symptomatic therapy.
Precautions
Ambroxol should not be taken concurrently with antitussive drugs that can inhibit the cough reflex, such as codeine. this can make it difficult to remove the liquefied phlegm from the bronchi.
Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.
You should not take Ambroxol just before bed.
In patients with bronchial asthma, ambroxol may aggravate the cough.
Patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - may experience a flu-like condition in the early phase: fever, body pains, rhinitis, cough, pharyngitis. With symptomatic therapy, mucolytic agents such as ambroxol hydrochloride may be mistakenly prescribed.
There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis that coincided with the appointment of the drug. However, there is no causal relationship with the drug intake.
With the development of the above syndromes, it is recommended to stop taking the drug; the patient should see a doctor immediately.
The solution for oral administration and inhalation contains sodium metabisulfite (preservative), which can cause the development of hypersensitivity reactions (especially in patients with bronchial asthma), which manifests itself in the form of vomiting, diarrhea, bronchospasm attacks, impaired consciousness or anaphylactic shock. These reactions can be very individual and can lead to life-threatening consequences.
For syrup 6 mg / ml additionally: in case of bronchial motility disorders and an increase in the amount of secretion (for example, immobile cilia syndrome) due to the danger of mucus accumulation, the drug can be taken only after consultation with the attending physician and under medical supervision. In case of severe impairment of renal and liver function, it is necessary to use lower concentrations, or to increase the interval between doses of the drug.
Indication for patients with diabetes mellitus: 1 tablet contains less than 0.01 XE; 1 scoop (5 ml) of 3 mg / ml syrup contains 1.75 g of sorbitol (less than 0.15 XE); 1 scoop (5 ml) of 6 mg / ml syrup contains 2.525 g sorbitol (0.21 XE).
Influence on the ability to drive vehicles and use mechanisms
Ambrohexal® does not adversely affect the ability to drive vehicles or operate machinery.
P N012596 / 04.MNN Ambroxol
Trade name AmbroHexal
RegNumber P N012596 / 04
Date of registration 26.11.2007
Cancellation date
Producer of Salutas Pharma GmbH - Germany
Packing:
No. Packing ND EAN
1 capsule of prolonged action 75 mg 10 pcs., Contoured cell packs (1) - cardboard packs ~ 4030855023417
2 capsules of prolonged action 75 mg 10 pcs., Contoured cell packs (10) - cardboard packs ~ ~
3 capsules of prolonged action 75 mg 10 pcs., Contoured cell packs (2) - cardboard packs ~ ~
4 capsules of prolonged action 75 mg 10 pcs., Contoured cell packs (5) - cardboard packs ~ ~
AMBROHEXAL® (AMBROHEXAL)
Representation:
SANDOZ ATX code: R05CB06 Marketing authorization holder:
HEXAL, AG
manufactured by SALUTAS PHARMA, GmbH
ambroxol
Release form, composition and packaging
The tablets are white, round, flat, with beveled edges and a notch on one side. 1 tablet
ambroxol hydrochloride 30 mg
Excipients: lactose monohydrate, calcium hydrogen phosphate dihydrate, corn starch, sodium carboxymethyl starch, magnesium stearate, colloidal silicon dioxide.
10 - contoured cell packages (3) - cardboard packs.
Sustained-release hard gelatin capsules with white body and lid; the contents of the capsules are white and pale pink pellets. 1 caps.
ambroxol hydrochloride 75 mg
Excipients: microcrystalline cellulose, eudragit RL30D (polyethyl acrylate: methyl methacrylate: trimethylammonioethyl methacrylate chloride), eudragit RS30D (polyethyl acrylate: methyl methacrylate: trimethylammonioethyl methacrylate chloride), trimethylammonioethyl methacrylate chloride), triethyl diethyl citrate, iron red titanium dye
Shell composition: gelatin, titanium dioxide.
10 - contoured cell packs (1) - cardboard packs.
10 - contoured cell packages (2) - cardboard packs.
10 - contoured cell packs (5) - cardboard packs.
10 - contoured cell packs (10) - cardboard packs.
The solution for oral administration and inhalation is transparent, colorless. 1 ml (20 drops)
ambroxol hydrochloride 7.5 mg
Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium disulfite, citric acid, sodium hydroxide, water.
50 ml - dark glass dropper bottle (1) complete with a measuring cup - cardboard packs.
100 ml - dark glass dropper bottle (1) complete with a measuring cup - cardboard packs.
The syrup is colorless or slightly yellowish, transparent or almost transparent. 5 ml (1 measuring spoon)
ambroxol hydrochloride 15 mg
Excipients: benzoic acid, sodium disulfite (sodium metabisulfite), citric acid monohydrate, sodium hydroxide, povidone, sorbitol 70%, glycerol 85%, sodium cyclamate, raspberry flavor, purified water.
100 ml - dark glass bottles (1) complete with a measuring spoon - cardboard packs.
250 ml - dark glass bottles (1) complete with a measuring spoon - cardboard packs.
Clinical and pharmacological group: Mucolytic and expectorant drug
Registration Nos.:
tablets 30 mg: 20, 30, 50 or 100 - P No. 012596/01, 26.11.07
solution for oral administration and inhalation 7.5 mg / 1 ml: vial-drip. 50 ml or 100 ml per set with measured. a glass - П №012596 / 02, 14.03.08
syrup 3 mg / 1 ml: fl. 100 ml or 250 ml per set with measured. spoon - P No. 012596/03, 26.11.07
caps. prolong. actions of 75 mg: 10, 20, 50 or 100 - P No. 012596/04, 26.11.07
The product description is based on the officially approved instructions for use and approved by the manufacturer for the 2009 edition.
Pharmacological action | Pharmacokinetics | Indications | Dosing regimen | Side effect | Contraindications | Pregnancy and lactation | Special instructions | Overdose | Drug Interactions | Pharmacy supply terms | Storage conditions and shelf life
pharmachologic effect
Mucolytic drug with an expectorant effect. It has a secretomotor, secretolytic and expectorant effect.
A decrease in the viscosity of sputum occurs as a result of depolymerization of mucopolysaccharides, which, in turn, is associated with the rupture of disulfide bonds in their molecules. Ambroxol increases the motor activity of cilia of the ciliated epithelium, increases mucociliary transport, normalizes the ratio of serous and mucous components of sputum.
By activating hydrolyzing enzymes and enhancing the release of lysosomes from Clarke cells, ambroxol reduces the viscosity of sputum, facilitating its removal from the respiratory tract.
As a result of chronic diseases of the respiratory system, properties change (due to the formation of bonds between surface active phospholipids and inflammatory proteins) and the synthesis of surfactant decreases. Ambroxol stimulates prenatal lung development by increasing the synthesis and secretion of surfactant in the alveoli.
The action of Ambrohexal begins after 30 minutes and lasts 6-12 hours. The maximum therapeutic effect appears on the 3rd day of treatment.
Pharmacokinetics
Suction
After oral administration, Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract. Tmax is 0.5-3 hours. Bioavailability is about 80%.
Distribution
Plasma protein binding - 80-90%. Ambroxol crosses the BBB, the placental barrier, and is excreted in breast milk.
Metabolism
The drug is metabolized in the liver to inactive metabolites (dibromantranilic acid, glucuronic conjugates).
Withdrawal
It is excreted mainly in the urine - 90% in the form of metabolites, 10% unchanged. T1 / 2 from 7 to 12 hours. When using Ambrohexal in the form of capsules of prolonged action T1 / 2 of ambroxol and metabolites from blood plasma - about 22 hours.
Indications
Acute and chronic diseases of the respiratory tract, accompanied by the formation of viscous secretions:
- acute and chronic bronchitis;
- pneumonia;
- bronchial asthma with difficulty in sputum discharge;
- bronchiectasis;
- treatment and prevention of respiratory distress syndrome (for syrup and solution for oral administration and inhalation).
Dosage regimen
Pills
Adults and children over the age of 12 are prescribed 1 tab (30 mg) 3 for the first 2-3 days. Then the dose of the drug should be reduced to 1 tablet 2
Children aged 6 to 12 years are prescribed 1/2 tablet (15 mg) 2-3
Sustained-release capsules
Adults and children over the age of 12 are prescribed 1 capsule. (75 mg) 1 time / morning or evening after meals, without chewing, drinking plenty of fluids.
Adults and children over the age of 12 are prescribed 2 scoops (30 mg) 2-3 for the first 2-3 days. Then, 2 scoops 2 In severe cases, the dose is not reduced during the entire course of treatment. Maximum dose - 4 scoops (60 mg) 2 times /
Children aged 5 to 12 years are prescribed 1 scoop (15 mg) 2-3
Children aged 2 to 5 years are prescribed 1/2 measuring spoon (7.5 mg) 3
Children under the age of 2 years are prescribed 1/2 measuring spoon (7.5 mg) after meals 2 The drug is prescribed only under medical supervision.
Solution for oral administration and inhalation
Adults and children over the age of 12 are prescribed 4 ml (30 mg) 3 in the first 2-3 days. Then the dose of the drug should be reduced to 4 ml 2
Children aged 5 to 12 years are prescribed 2 ml (15 mg) 2-3
Children aged 2 to 5 years are prescribed 1 ml (7.5 mg) 3
Children under 2 years of age are prescribed 1 ml (7.5 mg) 2
The drug should be taken orally after meals, diluted with tea, fruit juices, milk or water.
The oral solution can also be used by inhalation.
For adults and children over the age of 5 years, it is recommended to carry out inhalations of 1-2, 2-3 ml (40-60 drops, which corresponds to 15-22.5 mg of ambroxol).
For inhalation, an appropriate device should be used in compliance with the rules of use.
Patients with impaired renal function or severely impaired liver function should use lower concentrations, or increase the interval between doses of the drug.
Ambrohexal should be taken orally after meals with plenty of fluids.
During treatment, it is necessary to consume a lot of fluids (juices, tea, water) to enhance the mucolytic effect of the drug.
The duration of treatment is determined by the doctor individually and depends on the severity of the disease. If it is necessary to use the drug for more than 4-5 days, medical supervision is required.
Side effect
From the digestive system: rarely - abdominal pain, nausea, constipation, dry mouth; rarely (<1%) - усиление слюноотделения.
From the respiratory system: rarely (<1%) - повышение секреции слизи в носовой полости, сухость дыхательных путей.
Allergic reactions: skin rashes, urticaria, angioedema, bronchospasm, fever and chills; very rarely (<0.01%) - анафилактический шок.
Others: rarely (<1%) - слабость, головная боль, затруднение мочеиспускания (дизурия).
For Ambrohexal in the form of a syrup and solution for oral administration and inhalation: due to the presence of sodium metabisulfite (preservative) in the composition of the drug, hypersensitivity reactions may develop (especially in patients with bronchial asthma), manifested in the form of vomiting, diarrhea, acute asthmatic attacks , impaired consciousness or shock. These reactions can be very individual and can lead to life-threatening consequences.
Contraindications
- I trimester of pregnancy;
- children under 6 years of age (for tablets);
- children under 12 years of age (for extended-release capsules);
- hypersensitivity to ambroxol and other components of the dosage forms of the drug.
The drug should be used with caution in case of gastric ulcer and duodenal ulcer (due to possible exacerbation), renal failure, liver failure.
Application during pregnancy and lactation
The use of the drug in the first trimester of pregnancy is contraindicated.
The use of the drug in the II and III trimesters of pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.
The drug should be used with caution during breastfeeding, since Ambroxol is excreted in breast milk.
Application for violations of liver function
The drug should be used with caution in liver failure.
In severely impaired liver function, lower concentrations should be used, or the interval between doses of the drug should be increased.
Application for impaired renal function
The drug should be used with caution in case of renal failure.
In severe renal impairment, lower concentrations should be used, or the interval between doses of the drug should be increased.
special instructions
Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.
In patients with bronchial asthma, ambroxol may aggravate the cough.
You should not take Ambroxol just before bed.
In severely impaired liver and / or kidney function, lower concentrations should be used, or the interval between doses of the drug should be increased.
Patients with impaired fructose tolerance should consult a doctor before using Ambrohexal.
Overdose
Symptoms: nausea, vomiting, epigastric pain. There are reports of short-term anxiety, diarrhea. With a pronounced overdose, a drop in blood pressure is possible.
Treatment: drug withdrawal. Induce artificial vomiting, rinse the stomach during the first 2 hours; intake of fat-containing foods is shown. Symptomatic therapy.
Drug interactions
With the simultaneous use of Abrohexal with antibiotics (including amoxicillin, cefuroxime, doxycycline, erythromycin), the concentration of the latter increases in the bronchial secretion.
With the simultaneous use of Abrohexal with antitussives (including codeine), due to the suppression of the cough reflex, it may be difficult to discharge sputum from the bronchial tree.
Terms of dispensing from pharmacies
The drug is approved for use as a means of OTC.
Storage conditions and periods
The drug in the form of tablets should be stored out of the reach of children at a temperature not exceeding 25 ° C. The shelf life is 5 years.
The drug in the form of prolonged-release capsules should be stored out of the reach of children at a temperature not exceeding 25 ° C. The shelf life is 3 years.
The drug in the form of a syrup should be stored out of the reach of children, protected from light at a temperature not exceeding 25 ° C. The shelf life is 3 years.
The drug in the form of a solution for oral administration and inhalation should be stored out of the reach of children, protected from light at a temperature not exceeding 25 ° C. Shelf life is 4 years.
Every mother faces a cough in a child, and since this symptom causes severe discomfort in children, I want to help a coughing child as soon as possible. If the phlegm in the bronchi is too thick, and it is difficult for the baby to cough it up, the pediatrician will recommend mucolytic medications. One of them is AmbroGEXAL. Is it possible to give this drug to children under one year old, how does the child's body react to its active substance, how is AmbroGEXAL correctly dosed and what drugs can be used to replace it?
Release form
AmbroGEXAL is available in the following variants:
- Syrup... It is presented as a colorless or yellowish liquid, packaged in dark glass bottles of 100 ml or 250 ml. The concentration of the active substance in such AmbroGEXAL is 3 mg or 6 mg in 1 ml. The package includes a measuring spoon.
- Solution, which is taken orally or inhaled with it. Such liquid transparent AmbroGEXAL without color is poured into glass vials in the form of a dropper with a capacity of 50 or 100 ml. Each milliliter of the drug (20 drops) contains 7.5 mg of the active compound. The package contains a measuring cup.
- Pills... They are white in color and round in shape. The content of the active substance in each tablet is 30 mg. The package can hold from 10 to 100 tablets, and one blister contains 10 or 20 pieces.
- Capsules... These are white dense capsules, each containing 75 mg of active substance and characterized by long-lasting action. One package contains 10, 20, 50 or 100 capsules, packed in blisters of 10 pieces.
Structure
- The main component in AmbroGEXAL is ambroxol hydrochloride.
- In addition to it, water, sorbitol solution, apricot or raspberry flavor, glycerol, propylene glycol and other substances are added to the syrup.
- In addition to ambroxol, tablets contain calcium hydrogen phosphate, silicon dioxide, corn starch, milk sugar, sodium carboxymethyl starch, and magnesium stearate.
- AmbroHEXAL solution contains water, Na hydroxide, propyl and methyl parahydroxybenzoate, Na metabisulfite and citric acid.
- Additional components of AmbroGEXAL capsules are gelatin, titanium dioxide, cellulose, dyes and other components.
Operating principle
The drug is referred to as mucolytic expectorant drugs,because it changes the structure of the polysaccharides that are in the phlegm. In addition, ambroxol enhances the production of glycoproteins. The result of this action will be a decrease in the viscosity of the secretion formed in the bronchi and trachea.
Reception of AmbroGEXAL also affects the ciliated epithelium of the bronchial tree, stimulating the movement of its cilia. The drug also has a positive effect on the formation of surfactant - ambroxol improves its synthesis and prevents its breakdown.
Video instructions for the drug can be viewed here:
Indications
AmbroGEXAL can be taken with:
- Respiratory distress syndrome.
- Acute course of bronchitis.
- Inflammation of the lungs.
- Chronic bronchitis.
- Bronchiectasis.
- Asthma.
- COPD.
Surely you will be interested in the video of the program of Dr. Evgeny Komarovsky, dedicated to the problem of childhood cough:
From what age is it allowed to take?
AmbroGEXAL can be prescribed to children from birth, but a child under two years of age (for example, at the age of 2 months) should be supervised by a pediatrician while taking such medication.
For babies, the drug is given in the form of a syrup with a dosage of 3 mg / ml or a solution that is taken orally. The tablet form of AmbroGEXAL is prescribed for children 6 years of age and older. The use of AmbroGEXAL capsules is allowed from the age of 12.
Contraindications
Instructions for use for children prohibit giving AmbroGEXAL in such situations:
- If the child has a hypersensitivity to Ambroxol or other components of the medicine.
- If the patient has an ulcerative lesion of the digestive tract.
- With convulsive syndrome.
- If bronchial motility is impaired or the secretion is secreted in the bronchial tree in an excessively large volume. In such cases, the risk of mucus stagnation increases.
The use of AmbroGEXAL is limited for liver or kidney pathologies. The tablet form is contraindicated in case of lactase deficiency or lactose allergy, and the syrup should not be given to children with fructose intolerance.
Side effects
Rare side effects from taking AmbroGEXAL are:
- Diarrhea.
- Headache.
- Hives.
- Constipation.
- Weakness.
- Dryness of the mucous membranes of the mouth and nasopharynx.
- Rash on the skin.
- Discharge from the nose.
- Problems with urination.
- Angioedema.
Instructions for use and doses
The dosage and frequency of AmbroGEXAL application will depend on the patient's age and the severity of clinical manifestations. In order for the mucolytic effect of AmbroHEXAL to be more pronounced, the child should be given a lot of fluids, such as water, tea or juice. The duration of therapy will be affected by the severity of the disease, but you should not take the drug for more than 4-5 days without consulting a doctor.
Syrup
A measuring spoon of syrup with an ambroxol concentration of 3 mg / ml contains 15 mg of the active substance. This form of medication is given orally in such a single dosage:
A scoop of syrup with an ambroxol concentration of 6 mg / ml contains 30 mg of the active ingredient. A single dose of this AmbroGEXAL:
The maximum daily dosage for children aged 12 and over will be 120 mg of ambroxol, which corresponds to four scoops of 6 mg / ml syrup.
The frequency of use in babies up to two years of age is twice a day. A child 2-5 years old is given the drug 3 times a day, and at 6-12 years of age - from two to 3 times a day. Children 12 years and older in the first two or three days of treatment are given the medicine three times a day, and then they switch to a two-time dose.
Solution
This form of AmbroGEXAL is dosed in drops. For internal use, they are guided by the following doses:
The required number of drops must be diluted with tea, water, juice or milk.
If the child is given inhalation with AmbroGEXAL and saline, the procedure is performed once a day, but it can be performed twice. For babies under five years old, 40 drops of the drug (2 ml) are taken for one inhalation, and for a child over 5 years old, the dosage of AmbroGEXAL for one inhalation will be from 40 to 60 drops (2-3 ml).
The procedure is done using modern inhalers, adding the same amount of saline to the required volume of AmbroGEXAL. For example, the proportion for a 4-year-old child will be 2 ml of AmbroGEXAL + 2 ml of saline. The mixture is heated to body temperature.
Pills
Such AmbroGEXAL is given after meals. The tablet should be swallowed and then washed down with plenty of water. At the age of 6-12 years, a single dosage of this form of the drug will be half a tablet. It is given to the child 2 or 3 times a day.
If the child is already 12 years old, the dosage is increased to a whole tablet. At this age, AmbroGEXAL begins to be given three times a day, and after 2-3 days from the beginning of the reception, they switch to double use.
Capsules
A child over 12 years old is given this form of AmbroGEXAL in the morning and in the evening, one capsule each. The medicine is offered after meals. You should not chew the capsule - after swallowing it, drink it with a large amount of liquid.
Overdose
Too high a dose of AmbroGEXAL causes vomiting, abdominal pain, severe saliva, severe nausea, low blood pressure. In such a situation, it is recommended to rinse the stomach and give fat-containing foods. If the condition is severe, you need to see a doctor for another treatment.
Interaction with other drugs
- You should not prescribe AmbroGEXAL and antitussive drugs to the child, since such a combination of drugs, although it will help eliminate cough, will worsen sputum production.
- If you use AmbroGEXAL together with antibiotics such as Doxycycline, Erythromycin, Cefuroxime or Amoxicillin, then their penetration into the bronchial secretions will be enhanced.
Terms of sale
You can buy AmbroGEXAL in a pharmacy without a prescription from a doctor.The price of 20 tablets is about 100 rubles. Approximately the same cost is noted for the 3mg / ml syrup in the solution.
Shelf life and storage conditions
So that AmbroGEXAL does not lose its medicinal properties, it should be kept in a dry, dark place, far from children, where the temperature will not rise above + 25 ° C. The shelf life of the syrup is 2 years, the capsules are 3 years, and the solution is 4 years. The tablets can be stored for up to 5 years.
Ambrohexal is a drug with mucolytic, secretolytic and expectorant effects, and the active ingredient of the drug is ambroxol. The mechanism of action of this drug is associated with a decrease in the viscosity of sputum as a result of depolymerization of mucopolysaccharides in sputum, which consists in breaking disulfide bonds in molecules, enhancing the release of active hydrolyzing enzymes from Clarke cells. Also, Ambrohexal increases the activity of the cilia of the bronchial epithelium, and normalizes the ratio of all sputum components and, therefore, stimulates its mucociliary transport. This makes it easier to cough up phlegm from the airways, and also stimulates the secretion and blockage of surfactant breakdown.
Ambrohexal is rapidly absorbed from the gastrointestinal tract, having a high absorption capacity, and its optimal concentration in plasma is achieved within two hours after taking the drug: tablets, syrup, capsules with prolonged action and a solution for inhalation. The action of the drug occurs when taken in the form of a syrup or tablets - after 30 minutes and depends on the rate of absorption of the drug in the stomach and intestines. This drug is metabolized in the liver, where it is converted to dobramantranilic acid and glucuronic conjugates, and excreted by the kidneys.
Ambrohexal application
Indications for the use of Ambrohexal are: acute, obstructive bronchitis, pneumoconiosis, bronchial asthma, tuberculosis and pulmonary cystic fibrosis, bronchiectasis, acute pneumonia, pleurisy, pulmonary emphysema, acute, protracted and chronic sinusitis, chronic rhinitis. And also it is prescribed for congenital pathology of the respiratory tract and a complicated course of infectious diseases (whooping cough, scarlet fever, mumps, chickenpox, measles and rubella).
Contraindications and side effects
Contraindications to the use of Ambrohexal are hypersensitivity to the active active ingredient (ambroxol hydrochloride) or excipients that are part of the dosage form of the drug and pregnancy, especially in the early stages.
Side effects of Ambrohexal are local allergic skin reactions in the form of angioedema, urticaria and contact dermatitis, and with prolonged uncontrolled use of the drug, nausea, gastralgia, vomiting or heartburn may occur.
Mode of application
This medicinal product has the following forms of release: syrup for children and adults (3 mg in one milliliter and 6 milligrams in one milliliter), 100 and 250 milliliters in a vial, 30 milligram tablets, and retard capsules (prolonged action) - 0.75 grams ambroxol hydrochloride. And also a solution for inhalation and ingestion, which has 7.5 milligrams of ambroxol hydrochloride in one milliliter and is produced by Salyutas Pharma.
Contraindications
Contraindications to the use of Ambrohexal are hypersensitivity to Ambroxol or the components that make up this drug and during pregnancy.
Ambrohexal during pregnancy
Taking Ambrohexal during pregnancy is contraindicated during pregnancy, because there is always a risk of negative effects on the developing fetus. However, due to the fact that ambroxol is a stimulant for lung development in the perinatal period, by increasing the synthesis of surfactant and blocking its decay, it is prescribed to pregnant women if they suspect the development of fetal malnutrition to stimulate lung maturation, as well as if there is a threat of premature birth.
Ambrohexal for inhalation
The solution for inhalation contains 7.5 milligrams of active substance per milliliter.
Inhalation solution of ambrohexal, for adults and children from the age of five is used:
The duration of treatment is determined by the attending physician, but should not exceed five days.
Ambrohexal inhalation solution can be used in any inhalation apparatus except for steam inhalers. The drug is mixed with saline (in equal proportions) and heated to 36 - 37 C. Inhalations are carried out without deep breaths, so as not to provoke a cough, in the normal breathing mode.
Ambrohexal syrup
The syrup contains an active ingredient - ambroxol hydrochloride, as well as a number of components that serve to impart a pleasant taste, aroma and consistency. The syrup has a thick consistency, a pleasant berry taste and a slightly yellowish solution, which is sold in glass bottles of 100 and 250 milliliters of dark amber glass. It has two concentrations - 3 milligrams of ambroxol hydrochloride in one milliliter of syrup and 6 milligrams of active substance in one milliliter of syrup.
Syrup Ambrohexal 3 mg / ml is used in children over twelve years old and adults - first, two measuring spoons are prescribed two to three times a day for the first two days, and then two spoons twice a day.
In pediatric practice, Ambrohexal is prescribed for children under two years old - ½ teaspoon twice a day, for children from two to five years old - ½ teaspoon three times a day, from five to twelve years old - one scoop two to three times a day.
Ambrohexal tablets
Ambrohexal in tablet form looks like white, round, flat tablets with a notch on one side, containing 30 milligrams of ambroxol hydrochloride. They are prescribed in adults, adolescents and children over twelve years old by mouth, after meals, one tablet three times a day, but if necessary, the dose can be increased to two tablets twice a day. In children over six years of age, Ambrohexal is used ½ tablet two to three times a day.
Ambrohexal price
Any form of Ambrohexal is freely sold in the city's pharmacy network and is an over-the-counter drug. The cost of Ambrohexal in 3 mg / ml syrup in a 100 ml bottle ranges from 160-165 rubles, Ambrohexal tablets - 85 - 87 rubles, retard capsules - 139 - 145 rubles.
Ambrohexal reviews
Ambrohexal is a drug that is a unique development of the Salyutas Pharma pharmaceutical company, and is currently considered a very effective drug used in the practice of pediatricians and therapists, as a drug for the treatment of cough in children and adults, as well as in otolaryngology as one of the components of the complex therapy of sinusitis and chronic rhinitis to thin the viscous secretion in the sinuses.
Ambrohexal belongs to secretolytic, secretomotor and expectorant antitussive drugs, has excellent effectiveness and dilutes the viscous mucous secretion that accumulates in the lumen of the bronchi, trachea and alveoli, as well as thick mucus of the nasopharynx and paranasal sinuses. This therapeutic effect is due to a change in the structure of mucous or mucopurulent secretions. The main feature of Ambrohexal is its ability to dilute phlegm without increasing its amount and the complete absence of negative reactions, unlike many other expectorant drugs.
It is widely used to treat coughs caused by inflammatory diseases of the respiratory tract - bronchitis, pneumonia and laryngotracheitis of infectious and inflammatory genesis, accompanied by a pronounced wet cough.
Similar instructions:
P N012596 / 02
Trade name of the drug:
AmbroGEXAL®
International Non-Proprietary Name (INN):
Ambroxol
Dosage form AmbroGEXAL®:
solution for oral administration and inhalation.
Structure AmbroGEXAL ® :
1 ml of solution (about 20 drops) contains:
active substance - Ambroxol hydrochloride 7.5 mg;
excipients - methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium disulfite, citric acid, sodium hydroxide, water.
Description AmbroGEXAL® solution:
Transparent colorless solution.
Pharmacotherapeutic group:
expectorant, mucolytic agent.
The code ATX:
pharmachologic effect
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 impaired ratio of serous and mucous components of sputum. By activating hydrolyzing enzymes and increasing the release of lysosomes from Clarke cells, it reduces the viscosity of sputum. Increases the motor activity of the cilia of the ciliated epithelium, increases mucociliary transport of sputum.
After oral administration, the effect occurs after 30 minutes. and lasts for 6-12 hours.
Pharmacokinetics
Absorption is high, the time to reach the maximum concentration is 0.5 - 3 hours, the connection with blood plasma proteins is 80-90%, it penetrates the blood-brain barrier, the placental barrier, is excreted in breast milk.
The drug is metabolized in the liver to inactive metabolites (dibromantranilic acid and glucuronic conjugates). The half-life (T1 / 2) is from 7 to 12 hours. Excreted by the kidneys: 90% as metabolites, 10%! unchanged.
Indications for use AmbroGEXAL ® solution for oral administration and inhalation
Acute and chronic diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge,
bronchiectasis; treatment and prevention of respiratory distress syndrome.
Contraindications
Hypersensitivity to the components of the drug, pregnancy (I trimester).
Carefully- the drug should be used with caution in patients with gastric ulcer and duodenal ulcer, as an exacerbation of peptic ulcer disease may occur, as well as in patients with renal and hepatic insufficiency.
Application during pregnancy and lactation:The drug is not recommended for use during the first trimester of pregnancy. If necessary, the use of Ambroxol inII-IIItrimesters of pregnancy, the potential benefit to the mother with a possible risk to the fetus should be assessed.
During breastfeeding, use the drug with caution, since it is excreted in breast milk.
Method of administration and dosage AmbroGEXAL® solution:
Ingestion (1 ml \u003d 20 drops).
Children over the age of 12 and adults: the first 2-3 days - 3 times 4 ml (30 mg of ambroxol g / x) per day, then - 2 times 4 ml.
Children aged5-12 years old: 2-3 times a day, 2 ml (15 mg of ambroxol g / x).
Children aged 2 to 5: 3 times a day, 1 ml (7.5 mg of ambroxol g / x).
Children under 2 years old: 2 times a day, 1 ml (7.5 mg of ambroxol g / x).
For children under 2 years of age, Ambrohexal® is prescribed only under medical supervision.
Ambrohexal® should be taken diluted with tea, fruit juices, milk or water after meals.
During treatment, it is necessary to consume a lot of fluids (juices, tea, water) to enhance the mucolytic effect of the drug.
Application for inhalation:
Adults and children over the age of 5it is recommended to inhale 2-3 ml 1-2 times a day (40-60 drops, which corresponds to 15-22.5 mg of ambroxol g / x);
Children under the age of 5 recommended inhale 1-2 times a day, 2 ml (40 drops, which corresponds to 15 mg of ambroxol g / x).
For inhalation, you must use a suitable device in compliance with the rules of use.
The duration of therapy depends on the severity of the disease and is determined by the attending physician. Ambrohexal® should not be taken for longer than 4-5 days without a doctor's recommendation.
Side effect
From the digestive system: nausea, vomiting, gastralgia, diarrhea, constipation, dry mouth.
Allergic reactions: skin rash, urticaria, angioedema, an attack of bronchospasm, fever with chills, very rarely (< 0,01 %) - анафилактический шок.
Rarely (< 1 %): слабость, головная боль, ринорея, усиление слюноотделения, сухость в дыхательных путях, нарушение мочеиспускания (дизурия).
Due to the presence of metabisulfite (preservative) in sodium, hypersensitivity reactions may develop (especially in patients with bronchial asthma), which manifest themselves in the form of vomiting, diarrhea, acute asthmatic attacks, impaired consciousness or shock.
These reactions can be very individual and can lead to life-threatening consequences.
Overdose.
Overdose symptoms in humans have not been described. Possible: nausea, vomiting, gastralgia. There are reports of short-term anxiety and diarrhea. With a pronounced overdose, a drop in blood pressure is possible. Treatment: artificial vomiting,
gastric lavage in the first 1-2 hours after taking the drug; taking fat-containing foods, symptomatic therapy.
Interaction with other medicinal products
When used with antitussive drugs, it may be difficult to discharge sputum as a result of suppression of the cough reflex. When used simultaneously with amoxicillin, cefuroxime, erythromycin, doxycycline, ambroxol increases their concentration in bronchial secretions.
special instructions
Ambroxol should not be taken concurrently with antitussive drugs that can inhibit the cough reflex, such as codeine. this can make it difficult to remove the liquefied sputum from the bronchial tree. Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.
Patients taking ambroxol should not be advised to perform breathing exercises; in critically ill patients, aspiration of liquefied sputum should be performed.
In patients with bronchial asthma, ambroxol may aggravate the cough.
You should not take Ambroxol just before bed.
Patients with impaired fructose tolerance should consult a doctor before using Ambrohexal®.
AmbroGEXAL® frelease form
Solution for oral administration and inhalation of 7.5 mg / ml. 50 ml or 100 ml each in a dark glass dropper bottle (dropper in the form of a plastic divider), with a plastic screw cap and a first opening ring. A bottle with a measuring cup made of polypropylene in a cardboard box with instructions for use.
Storage conditions
Store the drug in a dark place at a temperature not exceeding 25 ° C!
Keep the medicinal product out of the reach of children!
Shelf life
4 years
Do not use the drug after the expiration date.
Dispensing from pharmacies
Without recipe
Manufacturer
Hexal AG,
produced by Salutas Pharma GmbH, 83607, Holzkirchen, Industristraße 25,Germany
