Fluoride : Drug Information – Side Effects and Some Precautions for Use

Type of Drug:

The amount of fluoride provided by a product varies with the fluoride salt (formulation) contained in the product. The table above lists the fluoride salts by the amount of fluoride contained in the formulation.

How the Drug Works:

Fluoride acts on teeth before (tablets, drops) and after (rinses, gels, creams) they erupt to make them more resistant to cavities by increasing tooth resistance to acid and bacteria decay.

Uses:

To help prevent cavities when water supplies are low in fluoride (0.7 parts per million [ppm] or less), to prevent decalcification under and around orthodontic brackets, and to control rampant dental decay after xerostomia (dry mouth)-producing radiotherapy of head and neck tumors.

Unlabeled Uses: Occasionally doctors may prescribe sodium fluoride for osteoporosis.

Precautions:

Do not use in the following situations: allergy to the drug or any of its ingredients drinking water with a fluoride content greater than 0.7 ppm low-sodium diet

Concurrent use with fluoridated drinking water: Fluoride tablets and drops provide systemic fluoride to the body. Fluoridated drinking water also provides systemic fluoride. Excessive fluoride ingestion can damage the teeth (dental fluorosis). Depending on the amount of fluoride in your drinking water (eg, 0.7 ppm), some of these products should not be used or the dose should be reduced. If you move from one community to another, fluoridation levels may Change and dosage adjustments will need to be made. Check with your doctor or dentist. This is not a concern with topical fluoride products.

Gum tissues: Gum tissues may be sensitive to some flavors or to the alcohol contained in some of the topical products.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits to the mother outweigh the possible risks to the fetus.

Breastfeeding: It is not known if fluoride appears in breast milk. Consult your doctor before you begin breastfeeding.

Children: Do not use drops or chewable tablets in children under 6 months of age. Consult your doctor before using a rinse in a child under 6 years of age. Use of a cream, rinse, or gel in pediatric patients should be supervised by an adult to prevent swallowing of the product. Do not use topical products in children under 6 years of age, unless advised to do so by your doctor

Tartrazine: Some of these products may contain the dye tartrazine (FD&C Yellow No.5), which can cause allergic reactions in certain individuals. Check package label when available or consult your doctor or pharmacist.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or if you are planning to take any over-the-counter or prescription medications or dietary supplements with fluoride. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. Dairy products and calcium supplements may interact with fluoride drops and tablets.

Doses:

Side Effects:

Every drug is capable of producing side effects. Many fluoride users experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy, and individual susceptibility. Possible side effects include:

Other: Rash; gum irritation (topical products only).

Guidelines for Use:

• Use exactly as directed by your doctor or dental professional.
• Do not stop using or change the dose, unless advised to do so by your doctor.
• For best results, do not eat, drink, or rinse mouth for 30 minutes after topical application.
• Do not swallow topical dose forms.
• Tablets and drops – Do not eat or drink dairy products within 1 hour of administration. Take with meals if stomach upset occurs.
• Tablets – Dissolve in the mouth, chew, swallow whole, add to drinking water or fruit juice, or add to water for use in infant formulas or other nondairy food.
• Drops – Take orally, undiluted, or mix with fluids or nondairy food.
• Cream – Use once a day in place of your regular toothpaste, unless advised otherwise by your dentist. Brush thoroughly for 2 minutes, then spit out. Pediatric patients 6 to 16 years of age should rinse out their mouth thoroughly after use.
• Gel- Once daily, following brushing and flossing, apply with a tooth­brush or mouth tray and allow to remain on teeth for 1 minute and then spit out. Pediatric patients 6 to 16 years of age should rinse out their mouth thoroughly after use.
• Gel drops – Apply once daily with applicators supplied by your dentist. Apply 4 to 8 drops as required to cover the inner surface of each applicator. Spread gel drops with tip of bottle. Place applicator over upper and lower teeth at the same time. Bite down lightly for 6 minutes. Remove applicators and rinse mouth. Clean applicators with cold water.
• Rinse – Use once daily or as directed by your dental professional. Most effective immediately after brushing and flossing just prior to bedtime. Vigorously swish between teeth for 1 minute. Spit out remaining solution. Do not swallow rinse. Do not dilute acidulated gels or rinses in a porcelain or glass container; use plastic.
• Notify your dentist if your teeth become spotted or stained.
• Fluoride helps to reduce cavity formation but does not replace good oral hygiene practices (eg, brushing, flossing). See your dental professional regularly.
• Store at controlled room temperature (59° to 86°F).