Pill Identifier App

Epiflur

Generic Name: sodium fluoride
Dosage Form: tablet

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.

Epiflur
(Sodium Fluoride) Tablets
0.25 mg, 0.5 mg and 1 mg F*
Rx only

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).

Slideshow: Viagra: 11 Interesting Facts That You Can't Help But Be Amazed By

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*.

CONTRAINDICATIONS:

Epiflur™ Tablets, 1 mg F* 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 age 6 years.

Epiflur™ Tablets, 0.5 mg F* are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F* and should not be administered to pediatric patients under age 6 when the fluoride content of drinking water is 0.3 ppm F* or to pediatric patients under age 3 years.

Epiflur™ Tablets, 0. 25 mg F* are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F* and should not be administered to pediatric patients under age 3 years when the fluoride content of drinking water is 0.3 ppm F* or more.

Do not administer Epiflur™ Tablets (any strength) to pediatric patients under age 6 months. Epiflur™ Tablets (any strength) are not indicated for use in adults.

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. Read directions carefully before using. Keep out of the reach of infants and children.

PRECAUTIONS:

General

Please refer to the CONTRAINDICATIONS:,  WARNINGS: and OVERDOSAGE sections for overdosage concerns. Use in pediatric patients below the age of 6 months is not recommended by current American Dental Association and American Academy of Pediatrics guidelines.

Drug interactions:

Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported for male rats treated with 2.5 mg and 4.1 mg of body weight. In a second study, no carcinogenesis was observed in rats, males or females treated with fluoride up to 11.3 mg/kg of body weight. This dose is at least 400 times greater than the recommended daily dose of Epiflur™ Tablets. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those in which humans are exposed. In vivo data is conflicting. Some studies report chromosome damage in rodents while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower doses of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. This dose is approximately 200 times greater than the recommended daily dose of Epiflur™ Tablets.

Pregnancy

Teratogenic Effects

Pregnancy Category B

It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Nursing Mothers

It is not known if fluoride is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when Fluoride Tablets are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98 – 137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. This dose is at least 200 times greater than the recommended daily dose of Epiflur™ Tablets.

Pediatric Use

The use of Epiflur™ Tablets as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well controlled studies on fluoride supplementation from birth through adolescence. 1-5

Geriatric Use

Epiflur™ Tablets (any strength) are not indicated for use in geriatric patients.

ADVERSE REACTIONS:

Allergic rash and other idiosyncrasies have been rarely reported.

OVERDOSAGE:

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e. less than 2.3 mg fluoride/lb body weight) has been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e. more than 2.3 mg fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g. milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e. more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose of Epiflur™ Tablets contains 0.25, 0.5 or 1 mg fluoride. The treatment of choice depends upon the age of the child and the water fluoride content. A bottle of 120 0.25 mg tablets contains 30 mg fluoride. A bottle of 120 0.5 mg tablets contains 60 mg fluoride. A bottle of 120 1 mg tablets contains 120 mg fluoride. [The total amount of sodium fluoride in a bottle of 120 Epiflur™ Tablets (all strengths) conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time for safety purposes.]

Epiflur Dosage and Administration

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth. See schedule below to determine dosage.

Water F* Content
Total Amount of Fluoride Allowed Per Day
Ages

0 ppm F* to

<0.3 ppm F

0.3 ppm F* to

0.6 ppm F*

<0.6 ppm F*
6 mo. to <3 yrs. 0.25 mg* 0 0
3 to 6 yrs. 0.5 mg* 0.25 mg* 0
>6 to 16 yrs. 1 mg* 0.5 mg* 0
* per day

How is Epiflur Supplied

Epiflur™ (sodium fluoride) Tablets, 0. 25 mg F* (equivalent to 0.25 mg of fluoride) are white, round, biconvex tablets debossed “Є 37” available in bottles of 120’s and 1000’s.

Epiflur™ (sodium fluoride) Tablets, 0. 5 mg F* (equivalent to 0.5 mg of fluoride) are purple, round, biconvex tablets debossed “Є 60” available in bottles of 120’s and 1000’s.

Epiflur™ (sodium fluoride) Tablets, 1 mg F* (equivalent to 1mg of fluoride) are pink, round, biconvex tablets debossed “Є 73” available in bottles of 120’s and 1000’s.

STORAGE

Store at Controlled Room Temperature, 20-25°C (68-77°F). [See USP Controlled Room Temperature].

F* from sodium fluoride.

REFERENCES

  1. Accepted Dental Therapeutics, Ed. 40, American Dental Association, Chicago, 399-402 (1984).
  2. J. Jakush, New Fluoride Schedule Adopted, ADA News, 12, 14 (May 16, 1994
  3. Aasenden, R., and Peebles, T.C. “Effects of Fluoride Supplementation From Birth on Dental Caries and Fluorosis in Teenaged Children", Arch. Oral Biol. 23, 111-115 (1974).
  4. Hamberg, L. “Controlled Trial of Fluoride Vitamin Drops for Prevention of Caries in Children”, Lancet, 1, 441-442 (1971).
  5. Hennon, D.K. Stookey, G.K. and Beiswanger, B.B. “Fluoride-Vitamin Supplements:

Effects on Dental Caries and Fluorosis When Used in Areas with Suboptimum Fluoride in

the Water Supply”, JADA, 95, 965-971 (1977).

Manufactured by:

Epic Pharma, LLC

Laurelton, NY 11413


Issued 6/09

MF037ISS0609

OE1014

MG #27933 (01)

PRINCIPLE DISPLAY PANEL

PRINCIPLE DISPLAY PANEL

PRINCIPLE DISPLAY PANEL

Epiflur 
sodium fluoride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42806-037
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.55 mg
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor VANILLA Imprint Code E37
Contains         
Packaging
# Item Code Package Description
1 NDC:42806-037-12 120 TABLET in 1 BOTTLE
2 NDC:42806-037-10 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/19/2009 04/30/2013
Epiflur 
sodium fluoride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42806-060
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.1 mg
Product Characteristics
Color PURPLE Score 2 pieces
Shape ROUND Size 8mm
Flavor VANILLA Imprint Code E60
Contains         
Packaging
# Item Code Package Description
1 NDC:42806-060-12 120 TABLET in 1 BOTTLE
2 NDC:42806-060-10 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/19/2009 08/31/2013
Epiflur 
sodium fluoride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42806-073
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2.2 mg
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 8mm
Flavor VANILLA Imprint Code E73
Contains         
Packaging
# Item Code Package Description
1 NDC:42806-073-12 120 TABLET in 1 BOTTLE
2 NDC:42806-073-10 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/19/2009 04/30/2013
Labeler - Epic Pharma, LLC (827915443)
Revised: 08/2012
 
Epic Pharma, LLC



Hide
(web2)