Flur-e-day

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FLUOR-A-DAY (FLUOR-A-DAY)

Composition:

Active substance: sodium fluoride;

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

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

Dosage form. Chewable tablets.

Main physico-chemical properties: white or almost white tablets in the shape of a propeller, with a raspberry odor and taste.

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

ATC code A12C D01.

Pharmacological Properties

Pharmacodynamics

Fluoride ions accumulate in the body, predominantly in the tissues of teeth and bones, forming slightly soluble fluorapatites. Fluoride stimulates the mineralization of dental hard tissues, promotes the maturation and hardening of tooth enamel, as well as increases its resistance to acid attack. It reduces acid production by bacteria, exerts a bactericidal effect against microorganisms causing dental caries, inhibits lactic acid formation from carbohydrates, stimulates osteoblasts, and replenishes fluoride deficiency in the body. Fluorides may also promote remineralization of decalcified tooth enamel and exert a bactericidal effect against caries-causing microorganisms. The most important dietary component influencing the chemical composition of teeth is fluoride ions. The natural source of fluoride is drinking water. The optimal fluoride concentration in water has been established at 0.0001%. If water contains lower levels of fluoride, an increased incidence of dental caries is observed, while higher levels lead to the development of mottled enamel (fluorosis).

Pharmacokinetics

Observations in children who drank fluoridated water (0.0001%) until the age of 10 years showed no adverse effects on growth, general health, or bone tissue condition.

Fluorides in solution or as rapidly soluble 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 maximum plasma concentration is 30–60 minutes.

Clinical characteristics.

Indications.

As part of a comprehensive preventive and treatment regimen in children aged 6 to 14 years for caries prevention and for improved formation of hard tissues of permanent teeth.

Contraindications.

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

Fluoride concentration in drinking water exceeding 0.7 mg/L.

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

Pancreatic function disorders.

Interaction with other medicinal products and other forms of interaction.

The drug is not recommended to be administered simultaneously with products containing calcium, as it reduces the absorption of sodium fluoride.

Special precautions for use.

Do not exceed the recommended doses of the drug, since in case of overdose, sodium fluoride may have a toxic effect on the body. Blood composition monitoring is required in patients with blood disorders. The drug should be used only as prescribed by a dentist, who takes into account the fluoride content in the drinking water of the specific locality, especially in rural areas where well water is used. Children should take the drug under parental supervision to prevent overdose.

Excessive use of fluoride may lead to dental fluorosis. To avoid fluorosis, regular dental examinations of the child are recommended at least once every 3 months.

The absorption of the drug is reduced when sodium fluoride is taken simultaneously with food or milk.

The product contains sorbitol; therefore, if the child has been diagnosed with intolerance to certain sugars, consult a physician before using this medicinal product.

Use during pregnancy or breastfeeding.

Studies have not been conducted. The drug is recommended for use in children.

Ability to influence reaction rate when driving or operating machinery.

The drug is intended for use in pediatric practice.

Administration and Dosage.

The medication should be administered orally.

The dosage depends on the child's age and the fluoride concentration in the drinking water (should be prescribed when fluoride content in water is less than 0.7 mg/L).

Standard dosage: children aged 6 to 14 years – 1 tablet daily.

The medication should be taken once daily after eating, preferably in the evening after tooth brushing. The tablet should be chewed slowly and followed with water. It is recommended to take the medication for at least 250 days each year (until the age of 14).

Children. Do not administer this medication to children under 6 years of age.

For children under 2 years of age, special dosage forms of sodium fluoride in solution are available. For children aged 2 to 6 years, tablets with lower dosage or a solution should be used.

Overdose.

Symptoms of overdose include: black stools, blood in vomit, diarrhea, drowsiness, dizziness, excessive salivation, nausea or vomiting, shallow breathing, stomach pain or spasms, tremors, increased excitability, lacrimation, and weakness.

To assist the affected individual, perform gastric lavage using a 1–5% solution of calcium chloride or a 0.15% solution of calcium hydroxide (to precipitate fluorides). Administer saline laxatives (sodium sulfate) and diuretics. After gastric lavage, administer aluminum hydroxide to reduce fluoride absorption. Slowly administer 10–20% calcium gluconate intravenously. Prescribe vitamin preparations, provide symptomatic therapy, and perform hemodialysis.

Chronic overdose. Excess fluoride accumulation due to prolonged use of large amounts of sodium fluoride may induce skeletal and dental fluorosis. This results in increased bone density and calcification of ligaments and tendons. These disorders manifest as restricted mobility, joint deformities and pain, darkening of tooth enamel, and appearance of spots on tooth enamel.

According to clinical data, a lethal outcome in adults is possible after a single dose of sodium fluoride ranging from 5 to 10 g. However, serious poisoning may occur even at doses below 1 g. In children, the lethal 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, hyperreflexia, seizures, arrhythmia, shock, respiratory arrest, and cardiac failure.

Adverse reactions.

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

Endocrine system: possible manifestations of hypothyroidism.

Skin and mucous membranes: stomatitis, oral ulceration, dermatitis, skin hyperemia.

Gastrointestinal tract: nausea, dyspeptic symptoms.

Musculoskeletal system: leg and joint pain.

General disorders: increased fatigue, headache.

Other: chronic toxicity manifested as dental fluorosis and increased bone density.

Shelf life. 4 years.

Storage conditions.

Store in a tightly closed container, out of reach of children, at a temperature not exceeding 30 °C.

Packaging. 120 tablets in bottles.

Availability. Over-the-counter.

Manufacturer. Pharmascience Inc.

Manufacturer's address.

6111 Royalmount Avenue, Suite 100, Montreal, Quebec H4P 2T4, Canada.