Name:
Ambrohexal syrup 3mg/ml in vial 100ml in pack. No. 1
Description:
Transparent or almost transparent colorless or slightly yellowish liquid (similar to syrup), without foreign particles. The main active substance Ambroxol Release form Syrup Dosage 3 mg/ml Pharmacological action Pharmacodynamics surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolyzing enzymes and increasing the release of lysosomes from Clara cells, it reduces the viscosity of sputum. Increases the motor activity of the cilia of the ciliated epithelium, increases the mucociliary transport of sputum. After oral administration, the action occurs after 30 minutes and lasts for 6-12 hours. Pharmacokinetics Absorption is high, the time to reach the maximum concentration after oral administration is 1-3 hours, the duration of action is 6-12 hours. Absolute bioavailability is 79%. Plasma protein binding is approximately 90%. About 30% of the administered oral dose is excreted as a result of first pass metabolism in the liver (“first pass effect”). Ambroxol hydrochloride is metabolized mainly in the liver by glucuronidation, the formation of dibromanthranilic acid (about 10% of the dose), as well as other minor metabolites. Studies on human liver microsomes have shown that CYP3A4 is involved in the metabolism of ambroxol hydrochloride to dibromanthranilic acid. After three days of oral administration, about 6% of the dose is excreted in free form, about 26% of the dose is found in the urine in the form of conjugates. The total clearance is in the range of 660 ml / min, renal clearance is approximately 8% of the total clearance. Due to the high protein binding and large volume of distribution, as well as the slow redistribution from tissues to the blood, significant excretion of ambroxol by dialysis or forced diuresis is not expected. Ambroxol clearance is reduced by 20-40% in severe liver damage. In severe renal impairment, the half-life of ambroxol metabolites increases. Ambroxol crosses the blood-brain and placental barriers and is excreted in breast milk. Pharmacokinetics of special groups of patients In patients with impaired liver function, the excretion of ambroxol decreases, resulting in an increase in plasma levels by 1.3-2 times. Due to the wide therapeutic range of ambroxol hydrochloride, dose adjustment is not required. Age and gender of patients Age and gender do not have a clinically significant effect on the pharmacokinetics of ambroxol hydrochloride, and therefore dose adjustment is not required. Indications for use Acute and chronic diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, chronic obstructive pulmonary disease, pneumonia, bronchial asthma with difficulty in sputum discharge, bronchiectasis. Dosage and administration Take orally, regardless of food intake. Adults and adolescents over 12 years of age: 2-3 days 3 times a day, 30 mg of ambroxol hydrochloride (10 ml or 2 scoops of syrup), and then 2 times a day, 30 mg of ambroxol hydrochloride (10 ml or 2 scoops of syrup). ). In severe cases of the disease, the dose is not reduced during the entire course of taking the drug. The maximum dose is 2 times a day, 60 mg of ambroxol hydrochloride (20 ml or 4 measuring spoons of syrup). For adolescents aged 12 years and older and adults taking high doses, ambroxol cough syrup 6 mg/ml or ambroxol 30 mg tablets are recommended. Children aged 6 to 12 years: appoint 2-3 times a day for 15 mg of ambroxol hydrochloride (5 ml or 1 measuring spoon). Children aged 2 to 5 years: appoint 3 times a day for 7.5 mg of ambroxol hydrochloride (2.5 ml or ½ measuring spoon). If the condition improves, after 2-3 days the dosing regimen can be changed to 2 times a day (every 12 hours). Elderly patients with normal renal function are advised to take the usual doses. Patients with hepatic or renal insufficiency: caution should be exercised. In case of skipping the next dose, the next dose should not exceed a single dose of the drug. To enhance the secretolytic effect of the drug, drink plenty of fluids (juices, tea, water). The duration of use depends on the severity of the disease. Do not take the drug for longer than 4-5 days without consulting a doctor. If the condition does not improve or worsens after 5 days of taking the drug, consult a doctor. Use during pregnancy and lactation The drug is not recommended for use during the first trimester of pregnancy. If it is necessary to use ambroxol in the II-III trimesters of pregnancy, the potential benefit to the mother and the possible risk to the fetus should be assessed. Ambroxol hydrochloride passes into breast milk, and therefore its use is not recommended during breastfeeding. Precautions Severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis have been reported in association with ambroxol hydrochloride. If symptoms or signs of a progressive skin rash appear (sometimes accompanied by the formation of blisters or changes in the mucous membranes), AmbroGEXAL® should be stopped immediately and a doctor should be consulted. In most cases, such reactions were associated with the severity of the underlying disease of the patient and (or) the use of concomitant drugs. In addition, in the early stages of Stevens-Johnson syndrome or toxic epidermal necrolysis, patients may initially present with flu-like symptoms such as fever, body aches, runny nose, cough, and sore throat. It is possible that because of the confusion about these non-specific flu-like symptoms, symptomatic treatment was started with cold and cough medicines. In case of impaired renal function or severe liver disease, AmbroGEXAL® should be taken only after consulting a doctor. As with any drug with hepatic metabolism followed by excretion via the kidneys, accumulation of ambroxol metabolites should be expected in severe renal insufficiency. Patients with impaired bronchial motility and abundant bronchial secretions (as, for example, with a rare syndrome of primary ciliary dyskinesia), AmbroGEKSAL® should be used with caution due to the risk of difficult discharge of large amounts of sputum and blockage of the bronchi. Patients with rare hereditary fructose intolerance should not take this drug. The drug contains sorbitol, which may have a mild laxative effect. The drug contains metabisulphite, which in rare cases can cause severe hypersensitivity reactions and bronchospasm. Direction for patients with diabetes mellitus 1 scoop (5 ml of syrup) contains 1.75 g of sorbitol (less than 0.15 bread units). Interaction with other drugs The use of ambroxol hydrochloride with antitussive drugs leads to a complication of sputum discharge against the background of a decrease in cough, so this combination should not be used. The use of ambroxol hydrochloride with antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline) increases the concentration of antibiotics in sputum and bronchial secretions. Contraindications Hypersensitivity to ambroxol hydrochloride or excipients of the drug; children’s age up to 2 years. Composition 1 ml of syrup contains: Active substance: ambroxol hydrochloride 3 mg. Excipients: benzoic acid (E 210), sodium metabisulphite (E 223), citric acid monohydrate, sodium hydroxide, polyvidone, sorbitol solution 70% (E 420), glycerin 85% (E 422), sodium cyclamate, raspberry flavor, water purified. Overdose Overdose caused by ambroxol is not accompanied by serious toxic manifestations. Symptoms: possible transient anxiety, diarrhea. With a significant overdose, hypersalivation, vomiting, arterial hypotension are possible. Treatment: urgent measures such as induction of vomiting and gastric lavage are not indicated, they are used only in case of significant overdose in the first 1-2 hours. If necessary, symptomatic therapy is recommended. Side effects Like all medicines, AmbroGEXAL® can cause side effects, although not everyone gets them. The evaluation of side effects is based on the frequency of their occurrence: very common: more than 1 in 10 patients common: 1-10 patients in 100 uncommon: 1-10 patients in 1,000 rare: 1-10 patients in 10,000 very rare : less than 1 in 10,000 patients frequency unknown: cannot be determined from the available data Immune system disorders Rare: hypersensitivity reactions. Frequency unknown: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Gastrointestinal disorders Common: Nausea, oral hypoesthesia. Uncommon: Vomiting, diarrhea, dyspepsia and abdominal pain, dry mouth. Very rare: constipation, salivation. Frequency unknown: dry throat. Skin and subcutaneous tissue disorders Rare: rash, urticaria. Frequency unknown: severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis). Nervous system disorders Common: dysgeusia (change in taste). Respiratory, thoracic and mediastinal disorders Common: pharyngeal hypoesthesia. Very rare: rhinorrhea. Renal and urinary disorders Very rare: dysuria. Other Rare: drug fever. If you notice any side effects, including those not mentioned in this leaflet, please tell your doctor. Storage conditions Keep out of the reach of children! Store in a place protected from light at a temperature not exceeding 25 ° C. Buy Ambrohexal syrup 3mg/ml 100ml №1 Price for Ambrohexal syrup 3mg/ml 100ml №1Instruction for use for Ambrohexal syrup 3mg/ml 100ml №1
INN | AMBROXOL |
---|---|
The code | 6 459 |
Barcode | 4 030 855 000 197 |
Dosage | 3mg/1ml 100ml |
Active substance | Ambroxol hydrochloride |
Manufacturer | Lichtenheldt GmbH Pharmacoutische Factory, Germany/Salutas Pharma GmbH, Germany |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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