Prescription Drugs

CLINICAL PHARMACOLOGY It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:¹ Ca10(PO4)6(OH)2+2F ¯ > Ca10(PO4)6F2+2OH ¯ (Hydroxyapatite) (Fluorapatite) Three stages of fluoride deposition in tooth enamel can be distinguished:¹ 1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed. 2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted. 3. After eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride, and smaller amounts from saliva.

INDICATIONS Supplementation of the diet with eight essential vitamins and iron. Supplementation of the diet with fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.² POLY- VI- FLOR 0.25 mg with Iron drops provide fluoride in drop form for infants and young children from 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3-6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.² Each 1.0 mL supplies sodium fluoride (0. 25 mg fluoride) plus eight essential vitamins and iron. POLY-VI-FLOR (multivitamin, iron and fluoride) ® 0.25 mg with Iron drops supply significant amounts of vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, and Iron to supplement the diet, and to help assure that deficiencies of these nutrients will not develop. Thus, in a single easy-to-use preparation, infants and children obtain eight essential vitamins and iron, plus fluoride. DOSAGE AND ADMINISTRATION 1.0 mL daily or as prescribed. May be dropped directly into mouth with 'Safti- Dropper,' or mixed with cereal, fruit juice, or other food. HOW SUPPLIED POLY-VI-FLOR 0. 25 mg with Iron (Multivitamin, iron and fluoride supplement) drops are available on prescription only in bottles of 50 mL. REFERENCES 1. Brudevold F, McCann HG. Fluoride and caries control - Mechanism of action. In: Nizel AE, ed. The Science of Nutrition and Its Application In Clinical Dentistry. Philadelphia: WB Saunders Co.; 1966: 331- 347. 2. American Academy of Pediatrics, Committee on Nutrition. Fluoride Supplementation for Children: Interim Policy Recommendations. Pediatrics. 1995; 95: 777.

PATIENT INFORMATION See WARNINGS and PRECAUTIONS.

OVERDOSE No information provided. CONTRAINDICATIONS No information provided.

SIDE EFFECTS Allergic rash and other idiosyncrasies have been rarely reported. DRUG INTERACTIONS No information provided.

WARNINGS Close tightly and keep out of reach of children. Contains Iron, which can be harmful or fatal to children in large doses. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. PRECAUTIONS The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing VI-FLOR™ products: 1. Determine the fluoride content of the drinking water from all major sources. 2. Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste. 3. Periodically check to make sure that the child does not develop significant dental fluorosis. POLY-VI-FLOR (multivitamin, iron and fluoride) 0.25 mg with Iron drops should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50 mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)