Epiflur
Generic name:sodium fluoride
Dosage form: tablet
Drug class:Minerals and electrolytes
Medically reviewed by Drugs.com. Last updated on Jul 22, 2021.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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DESCRIPTION:
Each Epiflur™ (sodium fluoride) Tablet is sugar free, saccharine free and erythrosine (FD&C Red Dye #3) free. Each Epiflur™ Tablet 1 mg F* (full-strength) contains 1 mg fluoride ion (F*) from 2.2 mg sodium fluoride (NaF). Each Epiflur™ Tablet 0.5 mg (half-strength) contains 0.5 mg F* from 1.1 mg sodium fluoride (NaF). Each Epiflur™ Tablet 0.25 mg (quarter-strength) contains 0.25 mg F* from 0.55 mg sodium fluoride (NaF).
Each tablet for oral administration contains sodium fluoride equivalent to fluoride 0.25 mg, 0.5 mg or 1 mg and the following inactive ingredients: microcrystalline cellulose, maltodextrin, sorbitol, colloidal silicon dioxide, natural and artificial vanilla flavored powder and magnesium stearate. In addition, the 0.5 mg tablet contains purple lake blend and the 1 mg tablet contains pink lake blend.
CLINICAL PHARMACOLOGY:
Sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization, and by inhibiting the cariogenic microbial process.
INDICATIONS AND USAGE:
For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F*) during the period of tooth development results in a significant decrease in the incidence of dental caries.1 Epiflur ™ (sodium fluoride) Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to age 3 years and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*.
