SODIUMFLUORIDE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Fluoritab
• Fluorodex
• Flura
• Flura-Drops
• Flura-Loz
• Karidium
• Luride
• Luride Lozi-Tabs
• Luride-SF Lozi-Tabs
• Pediaflor
• Pharmaflur
• Pharmaflur 1.1
• Pharmaflur df
• Phos-Flur

In Canada?

• Flozenges
• Fluor-A-Day
• Fluoritabs
• Fluorosol
• Karidium
• PDF
• Pedi-Dent
• Solu-Flur

Generic name product may be available in the U.S. and Canada.

Category

• Dental caries prophylactic
• Nutritional supplement, mineral

Description

Fluoride (FLURE-ide)has been found to be helpful in reducing the numberof cavities in the teeth. It is usually present naturally in drinking water.However, some areas of the country do not have a high enough level in thewater to prevent cavities. To make up for this, extra fluorides may be addedto the diet. Some children may require both dietary fluorides and topicalfluoride treatments by the dentist. Use of a fluoride toothpaste or rinsemay be helpful as well.

Taking fluorides does not replace good dental habits. These include eatinga good diet, brushing and flossing teeth often, and having regular dentalcheckups.

Fluoride may also be used for other conditions as determined by your healthcare professional.

This medicine is available only with a prescription, in the following dosageforms:

Oral
• Lozenges (U.S. and Canada)
• Oral solution (U.S. and Canada)
• Tablets (U.S. and Canada)
• Chewable tablets (U.S. and Canada)

Importance of Diet

People get needed fluoride from fish, including the bones, tea, and drinkingwater that has fluoride added to it. Food that is cooked in water containingfluoride or in Teflon-coated pans also provides fluoride. However, foods cookedin aluminum pans provide less fluoride.

The daily amount of fluoride needed is defined in several different ways.

For U.S.?
• Recommended Dietary Allowances (RDAs) are the amount of vitaminsand minerals needed to provide for adequate nutrition in most healthy persons.RDAs for a given nutrient may vary depending on a person's age, sex, and physicalcondition (e.g., pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labelsto indicate the percent of the recommended daily amount of each nutrient thata serving provides. DV replaces the previous designation of United StatesRecommended Daily Allowances (USRDAs).

For Canada?
• Recommended Nutrient Intakes (RNIs) are used to determine the amountsof vitamins, minerals, and protein needed to provide adequate nutrition andlessen the risk of chronic disease.

There is no RDA or RNI for fluoride. Daily recommended intakes for fluorideare generally defined as follows:

• Infants and children?
  • Birth to 3 years of age: 0.1 to 1.5 milligrams (mg).
  • 4 to 6 years of age: 1 to 2.5 mg.
  • 7 to 10 years of age: 1.5 to 2.5 mg.
• Adolescents and adults?1.5 to 4 mg.

Remember:

• The total amount of fluoride you get every day includes what youget from the foods and beverages that you eat and what you may take as a supplement.
• This total amount should not be greaterthan the above recommendations, unless ordered by your health care professional.Taking too much fluoride can cause serious problems to the teeth and bones.

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your health care professional will make. Forsodium fluoride, the following should be considered:

Allergies?Tell your health care professional if you are allergicto any other substances, such as foods, preservatives, or dyes.

Pregnancy?It is especially important that you are receivingenough vitamins and minerals when you become pregnant and that you continueto receive the right amount of vitamins and minerals throughout your pregnancy.The healthy growth and development of the fetus depend on a steady supplyof nutrients from the mother. However, taking large amounts of a dietary supplementin pregnancy may be harmful to the mother and/or fetus and should be avoided.Sodium fluoride occurs naturally in water and has not been shown to causeproblems in infants of mothers who drank fluoridated water or took appropriatedoses of supplements.

Breast-feeding?It is especially important that you receive theright amounts of vitamins and minerals so that your baby will also get thevitamins and minerals needed to grow properly. However, taking large amountsof a dietary supplement while breast-feeding may be harmful to the motherand/or baby and should be avoided. Small amounts of sodium fluoride pass intobreast milk.

Children?Problems in children have not been reported withintake of normal daily recommended amounts. Doses of sodium fluoride thatare too large or are taken for a long time may cause bone problems and teethdiscoloration in children.

Older adults?Problems in older adults have not been reported withintake of normal daily recommended amounts. Older people are more likely tohave joint pain, kidney problems, or stomach ulcers which may be made worseby taking large doses of sodium fluoride. You should check with your healthcare professional.

Other medicines?Although certain medicines or dietary supplementsshould not be used together at all, in other cases they may be used togethereven if an interaction might occur. In these cases, your health care professionalmay want to change the dose, or other precautions may be necessary. Tell yourhealth care professional if you are taking/using any other prescription ornonprescription (over-the-counter [OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of sodium fluoride. Make sure you tell your healthcare professional if you have any other medical problems, especially:

• Brown, white, or black discoloration of teeth or
• Joint pain or
• Kidney problems (severe) or
• Stomach ulcer?Sodium fluoride may make these conditions worse

Proper Use of This Medicine

Take this medicine only as directed by your health care professional.Do not take more of it and do not take it more often than ordered. Takingtoo much fluoride over a period of time may cause unwanted effects.

For individuals taking the chewable tablet formof this medicine:

• Tablets should be chewed or crushed before they are swallowed.
• This medicine works best if it is taken at bedtime, after the teethhave been thoroughly brushed. Do not eat or drink for at least 15 minutesafter taking sodium fluoride.

For individuals taking the oral liquid formof this medicine:

• This medicine is to be taken by mouth even though it comes in a dropperbottle. The amount to be taken is to be measured with the specially markeddropper.
• Always store this medicine in the original plasticcontainer. Fluoride will affect glass and should not be stored in glasscontainers.
• This medicine may be dropped directly into the mouth or mixed withcereal, fruit juice, or other food. However, if this medicine is mixed withfoods or beverages that contain calcium, the amount of sodium fluoride thatis absorbed may be reduced.

Dosing?The dose of sodium fluoride will be differentfor different individuals. Follow your health care professional'sorders or the directions on the label. The following information includesonly the average doses of sodium fluoride. If your doseis different, do not change it unless your health care professionaltells you to do so.

The amount of solution or the number of lozenges or tablets you take dependson the strength of the medicine. Also, the number ofdoses you take each day, the time allowed between doses, and the length oftime you take the medicine depend on the medical problem for which you aretaking sodium fluoride.

• For oral dosage form (lozenges, solution,tablets, or chewable tablets):
  • To prevent cavities in the teeth (where there is not enough fluoridein the water):
    • Children?Dose is based on the amount of fluoride in drinkingwater in your area. Dose is also based on the child's age and must be determinedby your health care professional.

Missed dose?If you miss a dose of this medicine, take it assoon as you remember. However, if it is almost time for the next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses. If you have any questions about this, check with your health care professional.

Storage?To store this medicine:

• Keep out of the reach of children, since overdose is especially dangerousin children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Protect the oral liquid from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

The levelof fluoride present in the water is different in different parts of the U.S.If you move to another area, check with a health care professional in thenew area as soon as possible to see if this medicine is still needed or ifthe dose needs to be changed. Also, check with your health care professionalif you change infant feeding habits (e.g., breast-feeding to infant formula),drinking water (e.g., city water to nonfluoridated bottled water), or filtration(e.g., tap water to filtered tap water).

Do not take calcium supplements or aluminum hydroxide-containingproducts and sodium fluoride at the same time. It is best to space doses ofthese two products 2 hours apart, to get the full benefit from each medicine.

Inform your health care professional as soon as possibleif you notice white, brown, or black spots on the teeth. These aresigns of too much fluoride in children when it is given during periods oftooth development.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Check with your health care professional assoon as possible if any of the following side effects occur:

Sores in mouth and on lips (rare)

Sodium fluoridein drinking water or taken as a supplement does not usually cause any sideeffects. However, taking an overdose of fluoride maycause serious problems.

Stoptaking this medicine and check with your health care professional immediately if any of the following side effects occur, as they may be symptomsof severe overdose:

Black, tarry stools; bloody vomit; diarrhea; drowsiness; faintness; increased watering of mouth; nausea or vomiting; shallow breathing; stomach cramps or pain; tremors; unusual excitement; watery eyes; weakness

Check with your health care professional assoon as possible if the following side effects occur, as some may be earlysymptoms of possible chronic overdose:

Pain and aching of bones; stiffness; white, brown, or black discoloration of teeth?occuronly during periods of tooth development in children

Other side effects not listed above may also occur insome individuals. If you notice any other effects, check with your healthcare professional.