SODIUM FLUORIDE- sodium fluoride solution/ drops

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Mayne Pharma Inc

INN (International Name):

SODIUM FLUORIDE

Sammensetning:

FLUORIDE ION 0.5 mg in 1 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in significant decrease in the incidence of dental caries. Sodium Fluoride Drops 0.5 mg were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water fluoride level does not exceed 0.6 ppm F. Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.

Produkt oppsummering:

Sodium Fluoride Drops 0.5 mg is supplied in 50 mL bottles with calibrated dropper, NDC 51862-165-50. TAMPER EVIDENT: Do not accept if printed bottle seal around cap is broken or missing. Accepted Dental Therapeutics, Ed. 40. American Dental Association, Chicago, 1984, p.339-402. Jakush, J, New Fluoride schedule adopted. ADA News, May 16, 1994, p.12,14. Store at controlled room temperature 15˚ to 30˚ C (59˚ to 86˚ F). Manufactured for: Libertas Pharma, Inc. Lawrenceville, GA 30043 Iss. 03/11 165-50         743631

Autorisasjon status:

unapproved drug other

Preparatomtale

SODIUM FLUORIDE- SODIUM FLUORIDE SOLUTION/ DROPS
MAYNE PHARMA 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._
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SODIUM FLUORIDE DROPS 0.5 MG DROPS PEACH FLAVORED
* Conforms to new ADA and AAP guidelines for supplementation.
DOSAGE SCHEDULE * WATER F CONTENT
AGE
0- 0.3 PPM
0.3-0.6 PPM
> 0.6 PPM
6 months to 3 years
0.25 mg F = 1/2 mL = Half dropperful
0
0
3-6 years
0.5 mg F= 1 mL = One dropperful
0.25 mg F= 1/2 mL = Half dropperful
0
6-16 years
1 mg F= 2 mL = Two dropperfuls
0.5 mg F= 1 mL = One dropperful
0
DESCRIPTION
Each mL of Sodium Fluoride Drops 0.5 mg contains 0.5 mg fluoride ion
(F-) from 1.1 mg sodium
fluoride (NaF). For use as a dental caries preventive in pediatric
patients. Sugar-free and saccharin-
free.
ACTIVE INGREDIENTS: Sodium Fluoride 0.11% (w/v).
OTHER INGREDIENTS: Citric acid, methyl paraben, peach flavor, purified
water, red #33, sodium benzoate,
sucralose, yellow #6.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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
It has been established that ingestion of fluoridated drinking water
(1 ppm F) during the period of tooth
development results in significant decrease in the incidence of dental
caries. Sodium Fluoride Drops
0.5 mg were developed to provide systemic fluoride for use as a
supplement in pediatric patients from
6 months to age 3 and older, living in areas where the drinking water
fluoride level does not exceed 0.6
ppm F.
CONTRAINDICATIONS
Do not use in areas where drinking water exceeds 0.6 ppm F. Do not
administer to pediatric patients less
than 6 months old.
WARNINGS
(See "CONTRAINDICATIONS" above.
PRECAUTIONS
See ""OVERDOSAGE"" section. Incompatibility of fluorid