Flavamed tablets 30mg №10×2

Name:
Flavamed.
Description:
Tablets are white or almost white with a yellowish tinge, round, plane-parallel, with beveled edges and one-sided risk. The main active ingredient Ambroxol Release form Tablets are white or almost white with a yellowish tint, round, plane-parallel, with beveled edges and one-sided risk. 1 tab. Active substance: ambroxol hydrochloride 30 mg; Excipients: lactose monohydrate – 40 mg, corn starch – 30 mg, microcrystalline cellulose – 30 mg, croscarmellose sodium – 5.3 mg, povidone (K-30) – 4 mg, magnesium stearate – 0.7 mg. 10 pieces. – blisters (1) – packs of cardboard. 10 pieces. – blisters (2) – packs of cardboard. 10 pieces. – blisters (5) – packs of cardboard. Special instructions In severe renal failure, it is necessary to take into account the possibility of cumulation of ambroxolol metabolites formed in the liver. To maintain the secretolytic action of ambroxol during the period of taking the drug, it is necessary to ensure that the body receives a sufficient amount of fluid. When prescribing the drug to patients with diabetes, it should be borne in mind that 5 ml of solution (1 measuring spoon) contains 1.75 g of sorbitol, which corresponds to 0.15 XE. Influence on the ability to drive vehicles and control mechanisms Not established. Pharmacological action Expectorant mucolytic agent. Ambroxol is the active N-demethylated metabolite of bromhexine. It has a secretomotor, secretolytic and expectorant effect. Stimulates the serous cells of the glands of the bronchial mucosa, increasing the content of the mucous secretion and, thus, changes the disturbed ratio of the serous and mucous components of sputum. Ambroxol increases the content of mucous secretion and the release of a surfactant (surfactant) in the alveoli and bronchi. Increases the motor activity of the ciliated epithelium, increases the mucociliary transport of sputum. On average, when taken orally, the effect occurs after 30 minutes, the duration of action is 6-12 hours, depending on the size of a single dose. Pharmacokinetics Absorption After oral administration, Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract. Cmax is reached after approximately 1-3 hours. The absolute bioavailability of ambroxol when taken orally as a result of metabolism associated with the effect of the first passage through the liver, is reduced by approximately 1/3. The resulting metabolites (such as dibromanthranilic acid, hycuronides) are excreted by the kidneys. Distribution Plasma protein binding – about 85% (80-90%). Ambroxol crosses the BBB and placental barriers, and is also excreted in breast milk. Metabolism Ambroxol is metabolized in the liver by conjugation to form pharmacologically inactive metabolites. Elimination T1 / 2 is 7-12 hours. T1 / 2 of ambroxol and its metabolites (in total) is about 22 hours. It is excreted mainly by the kidneys – 90% in the form of metabolites formed in the liver. Less than 10% of the amount excreted through the kidneys is accounted for by ambroxol in unchanged form. Pharmacokinetics in special clinical situations In severe renal impairment, T1 / 2 of ambroxol metabolites increases, but does not change in severe liver disease. Due to the high degree of binding to plasma proteins and the large volume of distribution, as well as the slow reverse distribution from tissues to the blood, significant elimination of ambroxol by dialysis or forced diuresis should not be expected. Indications for use Acute and chronic diseases of the respiratory tract, accompanied by impaired secretion and transport of sputum: acute and chronic bronchitis; pneumonia; chronic obstructive pulmonary disease; bronchial asthma with difficulty in sputum discharge; bronchiectasis. Dosage and administration Adults and children over 12 years of age during the first 2-3 days are prescribed 3 times / day for 30 mg (1 tab. or 2 measuring spoons (10 ml) of solution, which corresponds to 90 mg of ambroxol hydrochloride / day, then – 2 times / day, 30 mg (1 tab. or 2 scoops), (which corresponds to 60 mg of ambroxol hydrochloride / day. If necessary, to enhance the therapeutic effect, you can prescribe 60 mg (2 tab. or 4 scoops. Spoons (20 ml) solution) 2 times / day (corresponding to 120 mg ambroxol hydrochloride / day). Children aged 6 to 12 years: 2-3 times / day, 15 mg (1/2 tab. or 1 scoop of solution) , which corresponds to 30-45 mg of ambroxol hydrochloride / day. Children aged 2 to 6 years, the drug is prescribed only as a solution 3 times / day, 1/2 scoop (2.5 ml), which corresponds to 22.5 mg of ambroxol hydrochloride / day Children under 2 years of age: 2 times / day, 1/2 measuring spoon (2.5 ml) of solution, which corresponds to 15 mg of ambroxol hydrochloride / day. liver damage, increase the interval between doses or reduce the dose. The drug is taken after meals: tablets – without chewing and drinking a sufficient amount of liquid, solution – using a measuring spoon. The duration of use is set individually, depending on the indications and the course of the disease. Without a doctor’s prescription, Flavamed® should not be taken for more than 4-5 days. Use during pregnancy and lactation The use of the drug in the first trimester of pregnancy is contraindicated. In the II and III trimesters of pregnancy, the drug should be taken with caution. The use of the drug during lactation is possible only if the expected benefit of treatment for the mother outweighs the possible risk to the baby. Precautions: With caution, the drug should be prescribed for impaired bronchial motility and the formation of a secret in significant quantities (for example, with a rare syndrome of immobile cilia), with renal or hepatic insufficiency, with peptic ulcer of the stomach and duodenum, as well as children under 2 years of age (solution ). Interaction with other drugs With the combined use of ambroxol and antitussive drugs that suppress the cough reflex, due to the weakening of the cough reflex, there may be a risk of congestion in the bronchi. Increases penetration into the bronchial secretion of amoxicillin, cefuroxime, erythromycin and doxycycline. Contraindications Congenital fructose intolerance (for solution); children’s age up to 6 years (for tablets); hypersensitivity to ambroxol or other components of the drug. With caution, the drug should be prescribed for violation of bronchial motility and the formation of a secret in significant quantities (for example, with a rare syndrome of immobile cilia), with renal or hepatic insufficiency, with peptic ulcer of the stomach and duodenum, as well as children under the age of 2 years (solution) . Composition Active substance: ambroxol hydrochloride 30 mg; Excipients: lactose monohydrate – 40 mg, corn starch – 30 mg, microcrystalline cellulose – 30 mg, croscarmellose sodium – 5.3 mg, povidone (K-30) – 4 mg, magnesium stearate – 0.7 mg. Overdose Symptoms: short-term anxiety, diarrhea, nausea, vomiting. With a significant excess of the dose of the drug (more than 25 mg / kg / day), a decrease in blood pressure, salivation is possible. Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, taking fat-containing foods, symptomatic therapy. Side effects Possible side effects are listed below in descending frequency of occurrence: sometimes (> 0.1%; <1%), very rarely (<0.01%), including individual messages. Allergic reactions: sometimes - skin rash, urticaria, angioedema (tablets), swelling of the face (solution), hyperthermia, shortness of breath; very rarely - anaphylactic shock. From the digestive system: sometimes - diarrhea, dry mouth, constipation (tablets); with prolonged use - abdominal pain, nausea, vomiting (tablets and solution). Dermatological reactions: very rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome (tablets). Others: very rarely - weakness, headache, dysuria, exanthema (tablets). Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Buy Flavamed tablets 30mg №10x2 Price for Flavamed tablets 30mg №10x2Instruction for use for Flavamed tablets 30mg №10x2