FLUORIDE- sodium fluoride tablet, chewable

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Dostupno od:

PureTek Corporation

INN (International ime):

SODIUM FLUORIDE

Sastav:

FLUORIDE ION 1 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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. Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*. Fluoride Chewable Tablets 1.0 mg are contraindicated when the fluoride content of drinking water is 0.3 ppm F* or more and should not be administered to pediatric patients under the age of 6 years. Do not administer Fluoride Chewable Tablets (any strength) to pediatric patients under age 6 months.

Proizvod sažetak:

Chewable tablets containing 1.0 mg fluoride are light peach-colored, orange flavor, un-scored, round, debossed “106”. Available in bottles of 120. NDC: 59088-106-73

Status autorizacije:

unapproved drug other

Svojstava lijeka

FLUORIDE- SODIUM FLUORIDE TABLET, CHEWABLE
PURETEK CORPORATION
_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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PRESCRIBING INFORMATION
DESCRIPTION
Each FLUORIDE CHEWABLE TABLET 1.0 MG is erythrosine (FD&C Red Dye No.
3) free. Each tablet
contains 1.0 mg F* from 2.2 mg sodium fluoride (NaF). Each tablet for
oral administration contains
sodium fluoride equivalent to fluoride 1.0 mg and the following
inactive ingredients: croscarmellose
sodium, FD&C Yellow No. 6 aluminum lake, magnesium stearate, mannitol,
microcrystalline cellulose,
orange flavor, sucrose.
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. Fluoride Chewable
Tablets were developed to provide systemic fluoride for use as a
supplement in pediatric patients from
6 months to 3 years of age and older living in areas where the
drinking water fluoride content does not
exceed 0.6 ppm F*.
CONTRAINDICATIONS
FLUORIDE CHEWABLE TABLETS 1.0 MG are contraindicated when the fluoride
content of drinking water is
0.3 ppm F* or more and should not be administered to pediatric
patients under the age of 6 years. Do not
administer Fluoride Chewable Tablets (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
exceeds 0.6 ppm