Fluoride

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have any of the following side effects:

• discolored teeth;

• weakened tooth enamel; or

• any changes in the appearance of your teeth.

Less serious side effects may include:

• stomach upset;

• headache; or

• weakness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

(FLOR ide)

• Acidulated Phosphate Fluoride
• Sodium Fluoride
• Stannous Fluoride

Fluor-A-Day: When fluoride content of drinking water exceeds 0.6 ppm; patients with arthralgia, GI ulceration, chronic renal insufficiency and failure, or osteomalacia

Fluorabon: When fluoride content of drinking water exceeds 0.6 ppm

Fluoritab: Patients with dental fluorosis

Flura-Drops, Loziflur: When fluoride content of drinking water is ≥0.3 ppm

Once daily products are generally used at bedtime. Rinses are generally used after routine teeth brushing and should not be swallowed. Consult specific product labeling for details.

Clinpro 5000 paste, Control Rx 1.1%, Denta 5000 Plus: After brushing adults should expectorate and children 6-16 years should expectorate and rinse mouth thoroughly with water.

Fluor-A-Day: Tablets should be dissolved in mouth or chewed prior to swallowing. Drops may be administered in juice or water. Dairy products should be avoided within 1 hour of administration.

Fluorabon: Drops may be administered directly into the mouth or in a non-dairy food that will be totally consumed

Flura-Drops: Drops may be administered undiluted or in fruit juice or water. Dairy products should be avoided within 1 hour of administration.

Lozi-Flur: Lozenge should be dissolved in mouth and swallowed with saliva

Prevident 5000 Sensitive: After brushing for at least 1 minute, expectorate and rinse mouth thoroughly with water.

Concerns related to adverse effects:

• Dental fluorosis/osseous: Prolonged ingestion with excessive doses may result in dental fluorosis and osseous changes, especially if the water fluoridation exceeds 0.6 ppm; do not exceed recommended dosage.

Special populations:

• OTC products: Swallowing should be minimized with topical products (eg, creams, gels, rinses). OTC products are generally not recommended for use in children <6 years of age unless as directed by a health care provider.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Latex: Packaging of some products may contain natural latex/natural rubber.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer’s labeling.

• Tartrazine: Some products contain tartrazine.

Other warnings/precautions:

• Appropriate use: Dietary fluoride supplements are recommended for children at high risk of developing dental caries. They are not recommended for use in children <6 months of age, or any child at low risk. All sources of fluoride should be considered prior to preventive intervention (Rozier, 2010).

Fluoride crosses the placenta and can be found in the fetal circulation (IOM, 1997). Adverse events have not been observed in animal reproduction studies; epidemiological studies in areas with high levels of fluorinated water have not shown an increase in adverse effects. Heavy exposure in utero may be linked to skeletal fluorosis seen later in childhood.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very upset stomach or throwing up.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of fluoride may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.