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PreviDent 5000 Booster Plus Fruitastic

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Overview

What is PreviDent 5000 Booster Plus Fruitastic?

Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.



What does PreviDent 5000 Booster Plus Fruitastic look like?



What are the available doses of PreviDent 5000 Booster Plus Fruitastic?

Sorry No records found.

What should I talk to my health care provider before I take PreviDent 5000 Booster Plus Fruitastic?

Sorry No records found

How should I use PreviDent 5000 Booster Plus Fruitastic?

A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. PreviDent® 5000 BoosterPlus brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See for exception.)

Follow these instructions unless otherwise instructed by your dental professional:

1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 BoosterPlus to a toothbrush. Brush teeth thoroughly once daily for two minutes, preferably at bedtime, in place of your regular toothpaste.

2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.


What interacts with PreviDent 5000 Booster Plus Fruitastic?

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



What are the warnings of PreviDent 5000 Booster Plus Fruitastic?

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.


What are the precautions of PreviDent 5000 Booster Plus Fruitastic?

General

Not for systemic treatment.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results.

Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

Pregnancy

Nursing Mothers

It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

Pediatric Use

The use of PreviDent® 5000 BoosterPlus in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11 to 14 years conducted by Englander et al. Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

Geriatric Use

Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.


What are the side effects of PreviDent 5000 Booster Plus Fruitastic?

Allergic reactions and other idiosyncrasies have been rarely reported.


What should I look out for while using PreviDent 5000 Booster Plus Fruitastic?

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

Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. Read directions carefully before using. Keep out of reach of infants and children.


What might happen if I take too much PreviDent 5000 Booster Plus Fruitastic?

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 (a thin ribbon) of PreviDent® 5000 BoosterPlus contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 605 mg fluoride.


How should I store and handle PreviDent 5000 Booster Plus Fruitastic?

Dispense in a well-closed container as defined in the USP.Keep container tightly closed.  Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed.  Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed.  Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed.  Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed.  Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed.  Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed.  Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed.  Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 20153.4 FL OZ (100 mL) in plastic bottles. Fruitastic™: NDC 0126-0072-92


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

Non-Clinical Toxicology
Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. Read directions carefully before using. Keep out of reach of infants and children.

When given concurrently the following drugs may interact with thiazide diuretics.

Alcohol, Barbiturates, or Narcotics

Potentiation of orthostatic hypotension may occur.

Antidiabetic Drugs - (Oral Agents and Insulin)

Dosage adjustment of the antidiabetic drug may be required.

Other Antihypertensive Drugs

Additive effect or potentiation.

Cholestyramine and Colestipol Resins

Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively.

Corticosteroids, ACTH

Intensified electrolyte depletion, particularly hypokalemia.

Pressor Amines (e.g., Norepinephrine)

Possible decreased response to pressor amines but not sufficient to preclude their use.

Skeletal Muscle Relaxants, Nondepolarizing (e.g., Tubocurarine)

Possible increased responsiveness to the muscle relaxant.

Lithium

Generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with hydrochlorothiazide.

Non-Steroidal Anti-Inflammatory Drugs

In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when hydrochlorothiazide and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

Not for systemic treatment.

Allergic reactions and other idiosyncrasies have been rarely reported.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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