Prevident Drug Information

A dental caries preventive, for weekly self-applied topical use. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in adults and pediatric patients. PreviDent ® Rinse provides a ready-to-use preparation for convenient administration and favorable compliance.

May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

For caries — Adults and pediatric patients over age 6 years, 2 teaspoons (10 mL). Once a week, preferably at bedtime after thoroughly brushing the teeth, rinse vigorously around and between the teeth for one minute, then expectorate. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes afterwards.

In patients with mucositis, gingival tissues may be hypersensitive to flavor present in formulation. Allergic reactions and other idiosyncrasies are rarely reported.

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 litter size or fetal weight and did not increase frequency of skeletal or visceral malformations.

There are no adequate and well-controlled studies in pregnant women. However, 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.

Pediatric Use The use of PreviDent ® Rinse as a weekly caries preventive in pediatric patients aged 6 to 16 years is supported by adequate and well-controlled clinical studies in students aged 6 to 12 years. 1-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

Do not use in patients with dysphagia. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

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 (10 mL or two teaspoonfuls) of PreviDent ® Rinse contains approximately 9 mg fluoride. One 16 fl. oz. bottle contains approximately 429 mg fluoride.