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FLUR-E-DAY 2.21 MG No. 1Composition:


active ingredient: sodium fluoride;


1 tablet contains 2.21 mg of sodium fluoride, which is equivalent to 1 mg of fluoride;


excipients: xylitol, sorbitol (E 420), artificial cherry flavor, magnesium stearate, raspberry flavor.


Dosage form. Chewable tablets.


Basic physical and chemical properties: tablets of white or almost white color in the form of airplanes with the smell and taste of raspberries.


Pharmacotherapeutic group. Mineral supplements. Fluoride preparations. Sodium fluoride.


ATX code A12C D01.


Pharmacological properties.


Pharmacodynamics.


Fluoride ions accumulate in the body, mainly in the tissues of teeth and bones, creating slightly soluble fluorapatites. Fluoride stimulates the mineralization of hard tooth tissues, promotes the maturation and hardening of tooth enamel, as well as its resistance to acid, reduces the production of acid by bacteria and causes a bactericidal effect against microorganisms that cause tooth decay, inhibits the formation of lactic acid from carbohydrates, stimulates osteoblasts and replenishes fluoride deficiency in the body. Fluorides can also contribute to the remineralization of decalcified tooth enamel and have a bactericidal effect against microorganisms that cause tooth decay. The most important component of food that affects the chemical composition of teeth is fluoride ions. A natural source of fluoride is drinking water. The optimal level of fluoride in water is set to 0.0001 %. If the water has a lower level of fluoride, there is an increase in cases of caries, and if it is too high, there are cases of "spotted" enamel (fluorosis).


Pharmacokinetics.


Observations of children who drank fluoridated water (0.0001 %) before the age of 10 showed no side effects on growth, general body condition and bone condition.


Fluorides in solution or in the form of instant salts are easily and almost completely absorbed from the gastrointestinal tract, accumulate in teeth and bones, and are excreted by the kidneys. The time to reach the maximum concentration in the blood is 30-60 minutes.


Clinical characteristics.


Indications.


As part of a complex of therapeutic and preventive measures in children aged 6 to 14 years to prevent caries and improve the formation of hard tissues of permanent teeth.


Contraindications.


Hypersensitivity to sodium fluoride or to any component of the drug.


The concentration of fluoride in drinking water is more than 0.7 mg/l.


Severe diseases of the liver and kidneys, exacerbation of peptic ulcer of the stomach and duodenum.


Impaired pancreatic function.


Interactions with other drugs and other types of interactions.


The drug is not recommended to be prescribed simultaneously with drugs that contain calcium, because the absorption of sodium fluoride decreases.


Application features.


Do not increase the indicated doses of the drug, since sodium fluoride can have a toxic effect on the body if overdosed. People with blood diseases need to monitor their blood composition. The drug should be used as prescribed by a dentist who takes into account the fluoride content in the water of this locality, especially in rural areas where water from a well is used. Children should take the drug under the supervision of their parents to prevent overdose.


Excessive use of fluoride causes dental fluorosis. To avoid fluorosis, it is advisable to regularly conduct a dental examination of the child's teeth at least once every 3 months.


When taking sodium fluoride with a meal or with milk, the absorption of the drug decreases.


The drug contains sorbitol, so if the child has an intolerance to certain sugars, consult your doctor before taking this medicine.


Use during pregnancy or lactation.


The study was not conducted. The drug is recommended for use in children.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


The drug is intended for use in pediatric practice.


Dosage and administration.


The drug should be administered orally.


The dose of the drug depends on the age of the child and the concentration of fluoride in water (prescribe if the fluoride content in water is less than 0.7 mg/l).


Normal doses: children aged 6 to 14 years, 1 tablet per day.


The drug should be taken after meals daily 1 time a day, preferably in the evening after brushing your teeth. The tablet should be chewed slowly and washed down with water. It is recommended to take it for at least 250 days, every year (up to 14 years).


Children. Do not use in children under 6 years of age.


For children under 2 years of age, there are special dosage forms of sodium fluoride in the form of a solution, children aged 2 to 6 years should use tablets with a lower dosage or solution.


Overdose.


In case of overdose with the drug, the following symptoms are observed: black stools, blood impurities in the vomit, diarrhea, drowsiness, dizziness, increased salivation, nausea or vomiting, shallow breathing, stomach pain or spasms, trembling, increased excitability, lacrimation, weakness.


To help the victim, wash the stomach with 1-5% calcium chloride solution or 0.15% calcium hydroxide solution (for fluoride deposition), prescribe saline laxatives (sodium sulfate) and diuretics. After gastric lavage, aluminum hydroxide is used to reduce the absorption of fluorides. Enter slowly intravenously a 10-20% solution of calcium gluconate, prescribe Vitamin preparations, conduct symptomatic therapy, hemodialysis.


Chronic overdose. Excess fluoride, which is formed in the body with prolonged use of large amounts of sodium fluoride, induces fluorosis of bones and teeth. At the same time, there is an increase in bone density, calcification of ligaments and tendons. These disorders are manifested in limited mobility, deformity and soreness of the joints, darkening of the enamel of the teeth, the appearance of spots on the enamel of the teeth.


According to clinical data, a fatal outcome in adults is possible when using sodium fluoride in a single dose of 5 to 10 g. however, serious poisoning occurs already at a dose of less than 1 g. in children, this dose is 5 mg per 1 kg of body weight.


Symptoms of overdose: salty or soapy taste in the mouth, abdominal pain, fainting; in more severe cases: hypocalcemia, hypomagnesemia, hyperkalemia, hypereflexia, convulsions, arrhythmia, shock, respiratory arrest, heart failure.


Adverse reactions.


Immune system disorders: hypersensitivity reactions, including dermatitis; urticaria, allergic reactions.


From the endocrine system: possible manifestations of hypothyroidism.


From the skin and mucous membranes: stomatitis, ulceration in the mouth, dermatitis, hyperemia of the skin.


From the gastrointestinal tract: nausea, dyspeptic phenomena.


Musculoskeletal disorders: pain in the legs and joints.


General: increased fatigue, headache complaints.


Others: chronic toxicity in the form of dental fluorosis and increased bone density.20

Tags: Sodium Fluoride