国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)
HTO Nevada Inc.
Sodium Fluoride
Fluoride Ion 0.5 mg
ORAL
PRESCRIPTION DRUG
For once daily, self-administered, 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. Kirkman's 1.1 mg Sodium Fluoride Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients form 6 months to 16 years of age living in areas where the drinking water fluoride content does not exceed 0.6 ppm (F). Krikman's 1.1 mg Sodium Fluoride Tablets, are contraindicated when the fluoride content of drinking water is 0.6 ppm (F) or more and should not be administered to pediatric patients under the age of 6 months. Do not administer fluoride (any strength) to pediatric patients under age 6 months. The use of Kirkman's 1.1 mg Sodium Fluoride Tablets as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well-controlled studies
unapproved drug other
SODIUM FLUORIDE CHERRY- SODIUM FLUORIDE TABLET, CHEWABLE HTO NEVADA INC. _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._ ---------- SODIUM FLUORIDE CHEWABLE TABLETS DESCRIPTION: Kirkman's 1.1 mg (0.5 mg fluoride ion) Sodium Fluoride Tablets are dye free. Each 1.1 mg (half strength) tablet contains 0.5 mg of the fluoride ion (F) from 1.1 mg sodium fluoride (NaF). Each tablet for oral administration contain sodium fluoride equivalent to 0.5 mg of the fluoride ion and the following inactive ingredients: Lactose, Cherry Flavor, Saccharin Sodium and Magnesium Stearate. 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-administered, 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. Kirkman's 1.1 mg Sodium Fluoride Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients form 6 months to 16 years of age living in areas where the drinking water fluoride content does not exceed 0.6 ppm (F). CONTRAINDICATIONS: Krikman's 1.1 mg Sodium Fluoride Tablets, are contraindicated when the fluoride content of drinking water is 0.6 ppm (F) or more and should not be administered to pediatric patients under the age of 6 months. Do not administer fluoride (any strength) to pediatric patients under age 6 months. WARNINGS: Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation e 阅读完整的文件