Flavamed max tab spike. 60 mg 10 pcs

Description

Composition
Active substance:
1 tablet contains: ambroxol hydrochloride – 60.00 mg ;.
Excipients:
Citric Acid Anhydrous – 846.90 mg Sodium hydrogencarbonate – 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 lactose anhydrous – 110,00 mg mannitol – 180.00 mg, sorbitol – 29.00 mg cherry flavoring – 30.00 mg simethicone – 0.40 mg.
Description:
White round tablets with a smooth surface, with a notch for dividing on one side with a cherry flavor.
Solution Appearance: colorless, transparent solution containing no visible mechanical inclusions.
Product form:
Effervescent tablets 60 mg.
10 tablets in a polypropylene tube, sealed with a polyethylene cap containing a desiccant.
1 or 2 the tube together with instructions for use placed in a cardboard box.
Contraindications
Increased sensitivity to the drug (see “Composition”.); hereditary fructose intolerance; hereditary galactose intolerance, lactase deficiency syndrome or malabsorption of glucose and galactose; I trimester of pregnancy and lactation; Children up to age 12 years.
Precautions dysmotility and increased bronchial mucus secretion (e.g., a rare syndrome, primary ciliary dyskinesia); renal insufficiency and / or severe hepatic impairment; gastric ulcer and duodenal ulcer, including a history; II and III trimesters of pregnancy.
Dosage
60 mg
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; bronchiectasis.
Interaction with other drugs
With simultaneous application of ambroxol and antitussives, for example codeine, by suppressing the cough reflex can occur sputum concentrations of danger in the lumen of airways obstruction its elimination, therefore simultaneous use of ambroxol and cold preparations should be carried out with extreme caution.
Increases penetration into the bronchial lumen of amoxicillin, cefuroxime, erythromycin and doxycycline.
Overdose
Symptoms: The symptoms of specific ambroxol overdose in humans has not been described. The observed symptoms of overdose consistent with the known side effects of Ambroxol, used at the recommended doses (nausea, vomiting, abdominal pain, diarrhea, dyspepsia).
Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after ingestion; reception of fat-containing products; symptomatic therapy. Due to the high degree of ambroxol binding to plasma proteins 80-90%, diuresis and hemodialysis ineffective.
pharmachologic effect
Pharmacological group:
Expectorant mucolytic agent.
Pharmacodynamics:
Ambroxol is the active N-desmethyl metabolite of bromhexine.
It has secretomotoric, sekretoliticheskim and expectorant effects.
Stimulates the bronchial glands, increases motor activity of ciliated epithelium by exposure to pneumocytes type 2 alveolar cells and Clara bronchioles, enhances the formation of endogenous surfactant – surfactant providing sliding bronchial secretions in the lumen of the airways. Ambroxol increases the proportion of the component in serous bronchial secretion, improving its structure, contributing to a decrease in viscosity and dilution of sputum; thereby improving mucociliary transport and facilitates the excretion of phlegm from the bronchial tree.
On average, the effect of the drug when administered evident after 30 minutes, duration – 6-12 hours depending on the dose.
Pharmacokinetics:
Suction. After oral administration Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract. The time to reach maximum plasma concentration (TC max) is 1.3 hours. The absolute bioavailability after oral administration of ambroxol a result of “first pass” through the liver is reduced by approximately 1/3.
Distribution. Relationship to plasma proteins – 80-90%. Ambroxol crosses the placental and blood-brain barrier, excreted in breast milk.
Metabolism. Ambroxol is metabolized in the liver by konyugantsii to produce pharmacologically active metabolites.
Withdrawal. Terminal elimination half-life from the blood plasma (T 1/2) is 7-12 h half-life of total ambroxol and its metabolites is about 22 hours excreted by the kidneys:.. 90% as metabolites (such as dibromoantranilovaya acid, glucuronides), about 10% – unchanged. In severe renal impairment (creatinine clearance less than 30 mL / min) may be the accumulation of metabolites of ambroxol; with severe hepatic impairment ambroxol clearance is reduced by 20 to 40%.
Due to the high degree of binding to plasma proteins and large distribution volume, and slow redistribution from tissues into the blood, the effective elimination of ambroxol through dialysis or forced diuresis unlikely.
Pregnancy and breast-feeding
Use of the drug in I max Flavamed® trimester of pregnancy and breastfeeding is contraindicated. Use of the drug in the II and III trimester of pregnancy only after careful assessment of treatment benefit ratios and potential risks.
Conditions of supply of pharmacies
Without recipe.
side effects
Possible side effects are listed below in descending frequency of occurrence of cases: very often (> 1/10), often (> 1/100
special instructions
There is evidence of the occurrence in very rare cases of skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis) when applying ambroxol. If you have allergic reactions, should immediately stop using the product and seek medical advice.
In severe renal failure (creatinine clearance less than 30 mL / min) to be considered a risk of cumulation ambroxol metabolites produced in the liver.
Mucolytics can damage the mucosal barrier of the gastrointestinal tract, so ambroxol should be used with caution in patients with gastric ulcer and duodenal ulcer, including history.
To maintain secretolytic drug action Flavamed® max during treatment is necessary to ensure the intake of a sufficient amount of liquid.
Patients with asthma may enhance ambroxol cough.
One effervescent tablet formulation Flavamed® max contained 126.5 g of sodium, which should be considered for patients to follow a diet with reduced sodium content.
Max Flavamed® preparation comprises sorbitol (sorbitol) and lactose, therefore its application in patients with hereditary fructose intolerance, hereditary galactose intolerance, lactase deficiency or malabsorption of glucose and galactose is contraindicated.
Information for diabetic patients: 1 tablet contains 29 mg of sorbitol, which corresponds to 0.0024 bread units (BU).
Effects on ability to drive vehicles and management mechanisms:
The drug does not affect the performance of potentially hazardous activities that require increased attention and psychomotor speed reactions.
Storage conditions
At temperatures above 25 C in a tightly closed package.
Drug store out of reach of children !.
Dosing and Administration
Inside. It is recommended to be taken after meals. A tablet dissolved in a glass of water at room temperature, the resulting solution was immediately drink.
If your doctor prescribed otherwise, the following doses are recommended:
Adults and children over 12 years old: 1/2 tablet formulation Flavamed® max 3 times per day (corresponding to 90 mg of ambroxol hydrochloride / day) during the first 2-3 days, then – by 1/2 tablet formulation Flavamed® max 2 twice daily (equivalent to 60 mg of ambroxol hydrochloride / day).
If necessary, an adult may be administered 1 tablet Flavamed® max two times per day (corresponding to 120 mg of ambroxol hydrochloride / day).
In patients with renal impairment and / or severe hepatic insufficiency the drug should be taken with longer intervals between doses or in small doses.
Duration of treatment is determined individually depending on the indication and the disease. Usually the drug Flavamed® max take no more than 4-5 days, more long-term use needs to see a doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist