Ambrohexal tablets 30mg №20×1

Name:
Ambrohexal tab 30mg in a blister. in pack. No. 20×1 Main active ingredient Ambroxol Release form Tablets Composition One tablet contains: Active substance: Ambroxol hydrochloride 30 mg. Excipients: lactose monohydrate, calcium hydrophosphate dihydrate, corn starch, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide.
Description:
White, round, flat tablets with bevelled edges and a notch on one side. Dosage 30 mg Pharmacological properties Pharmacodynamics Has a secretomotor and secretolytic effect (i.e. improves sputum excretion and reduces its viscosity), facilitates expectoration, stimulates serous cells of the glands of the bronchial mucosa, increases the content of mucous secretion 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 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 effect 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 connection with blood plasma proteins is 80-90%. The drug is metabolized in the liver to inactive metabolites (dibromanthranilic acid and glucuronic conjugates). The absolute bioavailability of ambroxol when administered orally is approximately 70%. About 30% of the administered dose is excreted during the first pass as a result of first pass metabolism. The plasma half-life (T1 / 2) is from 7 to 12 hours. The total plasma half-life of ambroxol and its metabolites is approximately 22 hours. 90% of ambroxol is excreted by the kidneys in the form of metabolites, 10% – unchanged. Due to the high protein binding and large volume of distribution, as well as the slow redistribution from tissues into the blood, significant excretion of ambroxol by dialysis or forced diuresis is not expected. Ambroxol clearance is reduced by 20-40% in severe liver disease. 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. No clinically significant effect of age on the pharmacokinetics of ambroxol was found. Contraindications Hypersensitivity to ambroxol hydrochloride or excipients of the drug. 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 with a possible risk to the fetus should be assessed. Ambroxol hydrochloride is excreted in breast milk. Taking the drug during breastfeeding is not recommended. Dosage and administration Take orally after a meal with a sufficient amount of liquid. Adults and adolescents over 12 years: 1 tablet (30 mg ambroxol hydrochloride) 3 times a day for the first 2-3 days, then the dose should be reduced to 1 tablet 2 times a day. To increase efficiency, if necessary, take 2 tablets 2 times a day. Children aged 6 to 12 years: by ? tablets (15 mg ambroxol hydrochloride) 2-3 times a day. Children under 6 years of age are recommended to take AmbroGEXAL® syrup or oral solution. 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. 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. To enhance the secretolytic effect of the drug, drink plenty of fluids (juices, tea, water). 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 often: more than 1 in 10 patients; often: in 1-10 patients out of 100; infrequently: in 1-10 patients out of 1,000; rarely: in 1-10 patients out of 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. Uncommon: dry mouth. Very rare: rhinorrhea, dry airways. Frequency unknown: dry throat. 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. 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 a significant overdose in the first 1-2 hours. If necessary, symptomatic therapy is recommended. 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. 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), you should immediately stop taking the drug AmbroGEXAL® and consult a doctor. 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. Instruction for patients with diabetes mellitus 1 tablet contains less than 0.01 bread units. The drug contains lactose, so it should not be taken by patients with rare congenital galactose intolerance, lactase deficiency or malabsorption of glucose-galactose. Storage conditionsKeep out of the reach of children! Store in a place protected from light at a temperature not exceeding 25 ° C. Buy Ambrohexal tablets 30mg No. 20×1 Price for Ambrohexal tablets 30mg No. 20×1