Flavamed Max tabs 60mg #10

Flavamed Max instruction

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Composition

Composition per 1 tablet: Active ingredient: Ambroxol hydrochloride - 60.00 mg;
Excipients: anhydrous citric acid - 846.90 mg, sodium bicarbonate - 298.00 mg, anhydrous sodium carbonate - 71.00 mg, sodium saccharinate - 9.00 mg, sodium cyclamate - 45.00 mg, sodium chloride - 20, 00 mg, sodium citrate - 0.70 mg, anhydrous lactose - 110.00 mg, mannitol - 180.00 mg, sorbitol - 29.00 mg, cherry flavor - 30.00 mg, simethicone - 0.40 mg.

Pharmachologic effect

Ambroxol is an active N-demethylated metabolite of bromhexine.
It has a secretomotor, skretoliticheskim and expectorant effect.
It stimulates the work of the bronchial glands, increases the motor activity of the ciliated epithelium by acting on type 2 pneumocytes in the alveoli and Clara cells in the bronchioles, enhances the formation of endogenous surfactant - a surface-active substance that provides glide of bronchial secretion in the lumen of the respiratory tract.
Ambroxol increases the share of the serous component in bronchial secretions, improving its structure, contributing to a decrease in viscosity and liquefaction of sputum; as a result, mucociliary transport is improved and sputum excretion from the bronchial tree is facilitated.
On average, the effect of Flavamed Max when administered orally appears after 30 minutes, the duration of action is 6-12 hours, depending on the dose taken.

Pharmacokinetics

Suction. After oral administration, Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract. The time to reach maximum plasma concentration (TCax) is 1-3 hours. The absolute bioavailability of ambroxol when taken orally as a result of the “primary passage” through the liver decreases by about 1/3.
Distribution. Communication with plasma proteins - 80-90%. Ambroxol crosses the placental and blood-brain barriers, excreted in breast milk
Metabolism. Ambroxol is metabolized in the liver by conjugation with the formation of pharmacologically inactive metabolites. Breeding. The terminal half-life from plasma (T1 / 2) is 7-12 hours. The total half-life of ambroxol and its metabolites is about 22 hours.
It is excreted by the kidneys: 90% in the form of metabolites (such as dibromoanthranilic acid, glucuronides), about 10% - unchanged. In severe renal impairment (creatinine clearance less than 30 ml / min), the accumulation of ambroxol metabolites is possible; in severe liver failure, ambroxol clearance is reduced by 20-40%. Due to the high degree of binding to blood plasma proteins and a significant volume of distribution, as well as the slow redistribution from tissues to blood, effective elimination of ambroxol by dialysis or forced diuresis is unlikely.

Side effects of Flavamed Max

Possible side effects are listed below in descending incidence: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1 / 10000, <1/1000), very rarely (<1/10000), including individual messages, the frequency is unknown (according to the available data, the frequency cannot be set).
Disorders of the gastrointestinal tract Often: nausea; Infrequently: vomiting, dry oral mucosa, diarrhea, dyspepsia, abdominal pain.
Disorders of the immune system Infrequently: hyperthermia; Rarely: skin rash, urticaria; In isolated cases: anaphylactic reactions up to the development of shock, angioedema, pruritus, and other hypersensitivity reactions.
Disorders of the skin and subcutaneous tissue Very rarely: toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome (see section "Special instructions") Frequency unknown: acute generalized exanthematous pustulosis.
Violations of the nervous system Often dysgeusia (violation of taste sensations).
Disorders from the respiratory system, chest and mediastinal organs Often: decreased sensitivity in the mouth and pharynx; Rarely: dryness of the mucous membrane of the respiratory tract, rhinorrhea; In isolated cases: dryness of the mucous membrane of the pharynx.

Special conditions

There is evidence of the occurrence in very rare cases of skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis) with Ambroxol. If allergic reactions occur, discontinue use of Flavamed Max immediately and consult a doctor.
In severe renal failure (creatinine clearance less than 30 ml / min), it is necessary to take into account the risk of cumulation of ambroxol metabolites formed in the liver.
Mucolytics can damage the mucous barrier of the gastrointestinal tract, therefore, Ambroxol should be used with caution in patients with peptic ulcer of the stomach and duodenum, including a history.
To maintain the secretolytic effect of the drug Flavamed max during the period of use of the drug, it is necessary to ensure the intake of a sufficient amount of fluid.
In patients with bronchial asthma, ambroxol may increase coughing.
One effervescent tablet of Flavamed "max contains 126.5 g of sodium, which must be taken into account for patients on a diet low in sodium.
Flavamed Max contains sorbitol (sorbitol) and lactose, therefore its use in patients with hereditary fructose intolerance, hereditary galactose intolerance, lactase deficiency or glucose and galactose malabsorption syndrome is contraindicated.
Information for patents with diabetes mellitus: 1 tablet contains 29 mg of sorbitol, which corresponds to 0.0024 bread units (XE).
Influence on the ability to drive vehicles and control mechanisms. Flavamed Max ns affects the implementation of potentially dangerous activities that require increased attention and speed of psychomotor reactions.

Indications

Violation of secretion and transport of sputum in acute and chronic respiratory diseases: acute and chronic bronchitis; pneumonia; chronic obstructive pulmonary disease; bronchial asthma; bronchiectatic disease.

Contraindications

hypersensitivity to the components of Flavamed Max (see section "Composition");
hereditary fructose intolerance;
hereditary galactose intolerance, lactase deficiency or glucose and galactose malabsorption syndrome;
I trimester of pregnancy and the period of breastfeeding;
children under 12 years old. With caution, impaired motility of the bronchi and increased secretion of mucus (for example, with a rare syndrome of primary ciliary dyskinesia);
renal failure and / or severe liver failure;
peptic ulcer of the stomach and duodenum, including a history of;
11 and III trimesters of pregnancy.

Use during pregnancy and during breastfeeding

The use of the drug Flavamed max in the first trimester of pregnancy and the period of breastfeeding is contraindicated. The use of the drug in the II and III trimesters of pregnancy is possible only after a careful assessment of the ratio of the benefits of treatment and possible risks.

Drug interaction

With the simultaneous use of ambroxol and antitussive drugs, such as codeine, due to the suppression of the cough reflex, there may be a risk of sputum accumulation in the lumen of the respiratory tract with difficulty in eliminating it, therefore, the simultaneous use of ambroxol and antitussive drugs should be carried out with extreme caution.
Increases penetration into the bronchial lumen of amoxipillin, cefurosime, erythromycin and doxycycline.

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You can buy Flavamed Max without a prescription.