ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Fluoride: Drug information

Fluoride: Drug information
(For additional information see "Fluoride: Patient drug information" and see "Fluoride: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cavarest [DSC];
  • Clinpro 5000;
  • Denta 5000 Plus;
  • DentaGel;
  • Easygel;
  • Easygel [OTC];
  • Fluorabon [DSC];
  • Fluoridex;
  • Fluoridex Daily Renewal;
  • Fluoridex Enhanced Whitening;
  • Fluoridex Sensitivity Relief;
  • FluoriMax 5000;
  • FluoriMax 5000 Sensitive;
  • Fluoritab [DSC];
  • Flura-Drops [DSC];
  • Gel-Kam [OTC];
  • Just for Kids [OTC];
  • Just Right 5000;
  • NaFrinse Daily Acidulated [DSC];
  • NaFrinse Daily/Neutral [DSC];
  • NaFrinse Drops [DSC];
  • NaFrinse Weekly [DSC];
  • NaFrinse [DSC];
  • Omni Gel [OTC];
  • Parodontax [OTC];
  • PerioMed [OTC];
  • PreviDent;
  • PreviDent 5000 Booster Plus;
  • PreviDent 5000 Dry Mouth;
  • PreviDent 5000 Ortho Defense;
  • PreviDent 5000 Plus;
  • Sensodyne Complete Protection [OTC];
  • Sensodyne Rapid Relief [OTC];
  • Sensodyne Repair & Protect [OTC];
  • SF;
  • SF 5000 Plus;
  • Sodium Fluoride 5000 Plus;
  • Sodium Fluoride 5000 PPM
Brand Names: Canada
  • Butler Prophy Paste
Pharmacologic Category
  • Nutritional Supplement
Dosing: Adult

Also refer to specific product labeling.

Dental caries, prevention

Dental caries, prevention:

Cream or paste:

Clinpro 5000 paste, Control Rx 1.1%, Denta 5000 Plus: Once daily, in place of conventional toothpaste, brush teeth with a thin ribbon or pea-sized amount of paste for at least 2 minutes; do not swallow. Brush teeth with cream or paste once daily regardless of fluoride content of drinking water.

PreviDent 5000 Booster Plus, SF 5000 Plus: Once daily, in place of conventional toothpaste, brush teeth with a thin ribbon of paste or cream for at least 2 minutes; do not swallow. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after treatment.

PreviDent 5000 Sensitive: Twice daily, brush teeth with a 1-inch strip of toothpaste for at least 1 minute. After brushing, expectorate and rinse mouth thoroughly. Brush teeth twice daily regardless of fluoride content of drinking water.

Dental rinse or gel:

ACT Restoring 0.02% rinse, ACT Total Care 0.02% rinse: Twice daily after brushing, rinse 10 mL around and between teeth for 1 minute, then spit. Do not eat, drink, or rinse mouth for at least 30 minutes after treatment; do not swallow.

ACT 0.05% rinse, ACT Anticavity 0.05% rinse, Phos-Flur Rinse, TheraBreath: Once daily after brushing, rinse 10 mL around and between teeth for 1 minute, then spit. Do not eat, drink, or rinse mouth for at least 30 minutes after treatment; do not swallow.

Cavirinse, PreviDent rinse: Once weekly, rinse 10 mL vigorously around and between teeth for 1 minute, then spit; this should be done preferably at bedtime, after thoroughly brushing teeth; do not swallow. For maximum benefit with PreviDent rinse, do not eat, drink, or rinse mouth for at least 30 minutes after treatment.

Gel-Kam rinse: After diluting solution as directed, rinse with 15 mL for 1 minute at least daily, then spit. Repeat with remaining solution.

PreviDent gel: Once daily after brushing, apply a thin ribbon of gel for at least 1 minute; do not swallow. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after treatment.

Lozenge: Lozi-Flur: One lozenge daily regardless of fluoride content of drinking water.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Fluoride: Pediatric drug information")

Note: Dosages below may be presented as fluoride ion, sodium fluoride, or stannous fluoride; use caution to ensure the correct product is ordered or administered.

Dental caries, prevention

Dental caries, prevention:

Systemic therapy:

Drops/tablets: Oral: The recommended oral daily dose of fluoride ion is adjusted in proportion to the fluoride content of available drinking water (ppm of fluoride in drinking water):

Birth to 6 months: No supplement required regardless of fluoride content of drinking water.

6 months to 3 years:

<0.3 ppm: 0.25 mg fluoride ion once daily.

≥0.3 ppm: No supplement required.

3 to 6 years:

<0.3 ppm: 0.5 mg fluoride ion once daily.

0.3 to 0.6 ppm: 0.25 mg fluoride ion once daily.

>0.6 ppm: No supplement required.

6 to 16 years:

<0.3 ppm: 1 mg fluoride ion once daily.

0.3 to 0.6 ppm: 0.5 mg fluoride ion once daily.

>0.6 ppm: No supplement required.

Lozenges (Lozi-Flur): Children ≥6 years and Adolescents: Oral: 1 lozenge daily; allow lozenge to dissolve slowly in the mouth and swallow with saliva. Note: For use in areas where the fluoride content of drinking water is <0.3 ppm.

Topical therapy:

Dental rinse: Note: Do not eat, drink, or rinse mouth for at least 30 minutes after treatment; do not swallow.

Sodium fluoride: Topical:

0.02% Sodium fluoride: Children ≥6 years and Adolescents: 10 mL swish and spit twice daily after brushing.

0.04% Sodium fluoride: Children ≥6 years and Adolescents: 10 mL once daily after brushing; swish between teeth for 1 minute, then spit.

0.05% Sodium fluoride: Children ≥6 years and Adolescents: 10 mL swish and spit once daily after brushing.

0.2% Neutral sodium fluoride: Children ≥6 years and Adolescents: 10 mL swish and spit once weekly, preferably at bedtime after brushing.

Stannous fluoride 0.63%: Children ≥6 years and Adolescents: Topical: After diluting solution as directed, rinse with 15 mL (1/2 of the prepared solution) for 1 minute, then spit out; repeat with remaining solution. Use once daily.

Gel:

Stannous fluoride 0.4%: Children ≥6 years and Adolescents: Topical: Once daily after brushing, apply a pea-sized amount of gel to teeth and brush thoroughly. Allow gel to remain on teeth for 1 minute prior to spitting out.

Sodium fluoride 1.1%: Children ≥6 years and Adolescents: Topical: Once daily after brushing, apply a thin ribbon of gel to teeth with a toothbrush or mouth tray. Allow gel to remain on teeth for 1 minute then expectorate; children ≥6 years and adolescents <16 years should also rinse mouth thoroughly with water.

Paste or cream:

Sodium fluoride:

1.1% Neutral sodium fluoride: Children ≥6 years and Adolescents: Topical: Once daily, preferably at bedtime, in place of conventional toothpaste; brush teeth with a thin ribbon or pea-sized amount of toothpaste for at least 2 minutes then expectorate; some products recommend children ≥6 years and adolescents <16 years should also rinse mouth thoroughly with water after use.

Sodium fluoride and potassium nitrate:

0.25% Sodium fluoride/5% Potassium nitrate: Children ≥12 years and Adolescents: Topical: Brush teeth with a 1-inch strip of toothpaste for at least 1 minute 2 to 3 times daily then expectorate.

1.1% Sodium fluoride /5% Potassium nitrate: Children ≥12 years and Adolescents: Topical: Twice daily, brush teeth with a 1-inch strip of toothpaste for at least 1 minute. After brushing, expectorate and rinse mouth thoroughly.

Stannous fluoride 0.454%: Children ≥2 years and Adolescents: Topical: Brush teeth with a pea-sized amount of toothpaste 2 to 3 times daily, preferably after meals. Expectorate after brushing.

Dental varnish: 5% Sodium fluoride (2.26% Fluoride ion): Infants (after primary tooth eruption), Children, and Adolescents: Topical: Apply a thin layer of varnish to surfaces of teeth at least every 3 to 6 months (ADA [Weyant 2013]). Note: Must be professionally applied; USPSTF recommends dental varnish may be applied by primary care practitioners to the primary teeth of all infants and children starting at the age of primary tooth eruption through 5 years of age (USPSTF 2014).

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified. Frequency not defined.

Postmarketing:

Dermatologic: Acneiform eruption (Foti 2014), allergic contact dermatitis (Foti 2014), allergic skin rash, atopic dermatitis, cheilitis (Foti 2014), eczema, perioral dermatitis (Peters 2013), urticaria (Foti 2014)

Gastrointestinal: Aphthous stomatitis (Foti 2014), gastric distress, nausea, swelling of the mouth

Hypersensitivity: Hypersensitivity reaction

Nervous system: Asthenia, headache

Respiratory: Dyspnea

Contraindications

Clinpro 5000, PreviDent, PreviDent 5000 Booster Plus, SF 5000 Plus: Pediatric patients <6 years of age unless recommended by a health care provider.

Fluorabon: When fluoride content of drinking water exceeds 0.6 ppm.

Flura-Drops, LoziFlur: When fluoride content of drinking water is ≥0.3 ppm; pediatric patients <6 months of age.

PreviDent 5000 Sensitive: Pediatric patients <12 years of age unless recommended by a health care provider.

Sodium fluoride chewable tablets:

0.25 mg tablets: When the fluoride content of drinking water is >0.6 ppm; pediatric patients <3 years of age.

0.5 mg tablets: When the fluoride content of drinking water is >0.6 ppm; pediatric patients <6 years of age. When the fluoride content of drinking water is ≥0.3 ppm; pediatric patients <3 years of age.

1 mg tablets: When the fluoride content of drinking water is >0.3 ppm; pediatric patients <6 years of age.

Warnings/Precautions

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.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

• 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).

Warnings: Additional Pediatric Considerations

Supervise children <12 years of age using topical fluoride products, especially children <6 years old, to prevent repeated swallowing; swallowing should be minimized with topical products (eg, creams, gels, rinses).

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Concentrate, Mouth/Throat, as stannous fluoride:

Fluoridex Daily Renewal: 0.63% (248 mL)

PerioMed: 0.63% (283.5 g) [alcohol free; mint flavor]

PerioMed: 0.63% (283.5 g) [alcohol free; tropical fruit flavor]

Cream, Dental, as sodium:

Denta 5000 Plus: 1.1% (51 g) [spearmint flavor]

Denta 5000 Plus: 1.1% (51 g) [contains fd&c blue #1 (brilliant blue), saccharin sodium; spearmint flavor]

PreviDent 5000 Plus: 1.1% (51 g) [fruit flavor]

PreviDent 5000 Plus: 1.1% (51 g) [spearmint flavor]

SF 5000 Plus: 1.1% (51 g) [contains fd&c blue #1 (brilliant blue), saccharin sodium; spearmint flavor]

Sodium Fluoride 5000 Plus: 1.1% (51 g [DSC]) [contains fd&c blue #1 (brilliant blue), saccharin sodium]

Sodium Fluoride 5000 Plus: 1.1% (51 g) [contains fd&c blue #1 (brilliant blue), saccharin sodium, sodium benzoate; spearmint flavor]

Sodium Fluoride 5000 PPM: 1.1% (51 g) [contains fd&c blue #1 (brilliant blue), saccharin sodium]

Gel, Dental, as sodium (toothpaste):

Cavarest: 1.1% (56 g [DSC]) [contains saccharin sodium; natural flavor]

Cavarest: 1.1% (56 g [DSC]) [contains saccharin sodium; vanilla mint flavor]

DentaGel: 1.1% (56 g [DSC]) [mint flavor]

DentaGel: 1.1% (56 g) [contains fd&c blue #1 (brilliant blue), methylparaben, propylparaben, saccharin sodium; fresh mint flavor]

Just Right 5000: 1.1% (97 g [DSC]) [contains fd&c blue #1 (brilliant blue), saccharin sodium, sodium benzoate; bubble-mint flavor]

Just Right 5000: 1.1% (97 g [DSC]) [contains menthol, saccharin sodium, sodium benzoate; spearmint flavor]

PreviDent: 1.1% (56.6 g) [berry flavor]

PreviDent: 1.1% (56.6 g) [mint flavor]

PreviDent 5000 Dry Mouth: 1.1% (100 mL) [contains fd&c blue #1 (brilliant blue), propylene glycol, saccharin sodium, sodium benzoate; mint flavor]

SF: 1.1% (56 g) [contains fd&c blue #1 (brilliant blue), methylparaben, propylparaben, saccharin sodium; mint flavor]

Sodium Fluoride 5000 PPM: 1.1% (100 mL [DSC]) [contains fd&c blue #1 (brilliant blue), peg-40 hydrog castor oil(cremophor rh40), saccharin sodium, sodium benzoate; mint flavor]

Generic: 1.1% (56 g)

Gel, Dental, as stannous fluoride:

Easygel: 0.4% (129 g)

Easygel: 0.4% (129 g) [cherry flavor]

Easygel: 0.4% (129 g) [cinnamon flavor]

Easygel: 0.4% (129 g) [citrus flavor]

Easygel: 0.4% (129 g) [grape flavor]

Easygel: 0.4% (129 g) [mint flavor]

Gel-Kam: 0.4% (122 g) [fruit & berry flavor]

Gel-Kam: 0.4% (122 g) [mint flavor]

Just for Kids: 0.4% (121.9 g) [bubble-gum flavor]

Just for Kids: 0.4% (121.9 g) [grape flavor]

Just for Kids: 0.4% (121.9 g) [mint flavor]

Omni Gel: 0.4% (121.9 g) [mint flavor]

Paste, Dental, as sodium:

Fluoridex Sensitivity Relief: 1.1-5 % (112 g) [contains fd&c blue #1 (brilliant blue), quinoline yellow (d&c yellow #10), saccharin sodium]

FluoriMax 5000 Sensitive: 1.1-5 % (96 g) [contains saccharin sodium; spearmint flavor]

Paste, Dental, as sodium (toothpaste):

Clinpro 5000: 1.1% (113 g) [contains saccharin sodium; bubble-gum flavor]

Clinpro 5000: 1.1% (113 g) [contains saccharin sodium; spearmint flavor]

Clinpro 5000: 1.1% (113 g) [contains saccharin sodium; vanilla mint flavor]

Fluoridex: 1.1% (112 g) [contains fd&c blue #1 (brilliant blue), quinoline yellow (d&c yellow #10), saccharin sodium]

Fluoridex: 1.1% (112 g) [contains saccharin sodium]

Fluoridex Enhanced Whitening: 1.1% (112 g) [contains fd&c blue #1 (brilliant blue), quinoline yellow (d&c yellow #10), saccharin sodium]

FluoriMax 5000: 1.1% (96 g) [contains saccharin sodium; vanilla mint flavor]

Just Right 5000: 1.1% (97 g) [contains fd&c blue #1 (brilliant blue), saccharin sodium, sodium benzoate; bubble-mint flavor]

Just Right 5000: 1.1% (97 g) [contains fd&c red #40 (allura red ac dye), saccharin sodium, sodium benzoate; candy apple flavor]

Just Right 5000: 1.1% (97 g) [contains saccharin sodium, sodium benzoate; spearmint flavor]

PreviDent 5000 Booster Plus: 1.1% (100 mL) [contains fd&c blue #1 (brilliant blue), saccharin sodium, sodium benzoate; spearmint flavor]

PreviDent 5000 Booster Plus: 1.1% (100 mL) [contains saccharin sodium, sodium benzoate; fruitastic flavor]

PreviDent 5000 Ortho Defense: 1.1% (100 mL) [contains fd&c blue #1 (brilliant blue), saccharin sodium, sodium benzoate]

Sodium Fluoride 5000 PPM: 1.1% (100 mL) [contains fd&c blue #1 (brilliant blue), saccharin sodium, sodium benzoate; spearmint flavor]

Sodium Fluoride 5000 PPM: 1.1% (100 mL) [contains fd&c red #40 (allura red ac dye), saccharin sodium, sodium benzoate; fruit flavor]

Sodium Fluoride 5000 PPM: 1.1% (100 mL [DSC]) [contains saccharin sodium, sodium benzoate; fruit flavor]

Paste, Mouth/Throat, as stannous fluoride (toothpaste):

Parodontax: 0.45% (96.4 g) [contains saccharin sodium]

Parodontax: 0.45% (96.4 g) [contains saccharin sodium; mint flavor]

Sensodyne Complete Protection: 0.45% (96.4 g) [contains saccharin sodium]

Sensodyne Rapid Relief: 0.45% (23 g, 96.4 g) [contains saccharin sodium]

Sensodyne Repair & Protect: 0.45% (96.4 g) [contains saccharin sodium]

Solution, Mouth/Throat, as sodium:

PreviDent: 0.2% (473 mL) [alcohol free; contains benzoic acid, fd&c blue #1 (brilliant blue), propylene glycol, sodium benzoate; cool mint flavor]

Generic: 0.2% (473 mL [DSC])

Solution, Oral, as sodium:

Fluorabon: 0.55 mg per 0.6 mL [equivalent to fluoride 0.25 mg per 0.6 mL] (60 mL [DSC])

Fluoritab: 0.275 mg/drop [equivalent to fluoride 0.125 mg/drop] (30 mL [DSC])

Flura-Drops: 0.55 mg/drop [equivalent to fluoride 0.25 mg/drop] (24 mL [DSC]) [contains methylparaben, propylparaben]

NaFrinse Drops: 0.275 mg/drop [equivalent to fluoride 0.125 mg/drop] (30 mL [DSC])

Generic: 1.1 mg/mL [equivalent to fluoride 0.5 mg/mL] (50 mL)

Solution Reconstituted, Mouth/Throat, as sodium:

NaFrinse Daily Acidulated: 1 mg per 5 mL with phosphoric acid (500 mL [DSC]) [contains saccharin sodium]

NaFrinse Daily/Neutral: 0.05% (500 mL [DSC]) [contains saccharin sodium]

NaFrinse Weekly: 0.2% (250 mL [DSC]) [contains saccharin sodium]

Tablet Chewable, Oral, as sodium:

NaFrinse: 2.2 mg [equivalent to fluoride 1 mg] [DSC]

Generic: 0.55 mg [equivalent to fluoride 0.25 mg], 1.1 mg [equivalent to fluoride 0.5 mg], 2.2 mg [equivalent to fluoride 1 mg]

Generic Equivalent Available: US

May be product dependent

Pricing: US

Chewable (Sodium Fluoride Oral)

0.55 (0.25 F) mg (per each): $0.11 - $0.12

1.1 (0.5 F) mg (per each): $0.11 - $0.12

2.2 (1 F) mg (per each): $0.11 - $0.12

Concentrate (Fluoridex Daily Renewal Mouth/Throat)

0.63% (per mL): $0.03

Concentrate (PerioMed Mouth/Throat)

0.63% (per gram): $0.04

Cream (Denta 5000 Plus Dental)

1.1% (per gram): $0.15

Cream (PreviDent 5000 Plus Dental)

1.1% (per gram): $0.43

Gel (DentaGel Dental)

1.1% (per gram): $0.15

Gel (Easygel Dental)

0.4% (per gram): $0.03

Gel (Gel-Kam Dental)

0.4% (per gram): $0.17

Gel (Just for Kids Dental)

0.4% (per gram): $0.05

Gel (Omni Gel Dental)

0.4% (per gram): $0.07

Gel (PreviDent 5000 Dry Mouth Dental)

1.1% (per mL): $0.22

Gel (PreviDent Dental)

1.1% (per gram): $0.39

Gel (Sodium Fluoride Dental)

1.1% (per gram): $0.15 - $0.22

Paste (Clinpro 5000 Dental)

1.1% (per gram): $0.12

Paste (Fluoridex Dental)

1.1% (per gram): $0.09

Paste (Fluoridex Enhanced Whitening Dental)

1.1% (per gram): $0.09

Paste (Fluoridex Sensitivity Relief Dental)

1.1-5% (per gram): $0.09

Paste (FluoriMax 5000 Dental)

1.1% (per gram): $0.13

Paste (FluoriMax 5000 Sensitive Dental)

1.1-5% (per gram): $0.13

Paste (Just Right 5000 Dental)

1.1% (per gram): $0.17

Paste (Parodontax Mouth/Throat)

0.454% (per gram): $0.06

Paste (PreviDent 5000 Booster Plus Dental)

1.1% (per mL): $0.22

Paste (PreviDent 5000 Ortho Defense Dental)

1.1% (per mL): $0.22

Paste (Sensodyne Complete Protection Mouth/Throat)

0.454% (per gram): $0.11

Paste (Sensodyne Rapid Relief Mouth/Throat)

0.454% (per gram): $0.06

Paste (Sensodyne Repair & Protect Mouth/Throat)

0.454% (per gram): $0.11

Solution (PreviDent Mouth/Throat)

0.2% (per mL): $0.05

Solution (Sodium Fluoride Oral)

1.1 (0.5 F) mg/mL (per mL): $0.28 - $0.32

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Paste, Mouth/Throat:

Butler Prophy Paste: 1.23% (1 ea, 340 g)

Administration: Adult

Oral: Once-daily products are generally used at bedtime. Creams and pastes are generally to be expectorated after brushing. Rinses are generally used after routine teeth brushing and should not be swallowed. Consult specific product labeling for details.

Chewable tablets: Tablets should be dissolved in mouth or chewed prior to swallowing. Dairy products should be avoided within 1 hour of administration.

Fluorabon: Drops may be administered directly into the mouth or in a nondairy 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.

Administration: Pediatric

Systemic therapy: Dairy products should be avoided within 1 hour of administration.

Drops: May be administered undiluted or mixed in a nondairy food that will be totally consumed.

Lozenge: Allow to slowly dissolve in mouth and swallow with saliva.

Tablets: Chew or allow tablet to partially dissolve in mouth before swallowing.

Topical therapy:

Cream or paste: After brushing for at least 1 to 2 minutes, expectorate. After expectorating, some products recommend rinsing mouth thoroughly with water, especially in younger patients. Consult product-specific labeling for details.

Dental rinse: Swish or rinse in mouth then expectorate; do not swallow. Once daily products are generally used at bedtime. Do not eat, drink, or rinse mouth for at least 30 minutes after treatment. Consult specific product labeling for details.

Dental varnish: Briefly mix varnish with brush prior to application as contents may separate during storage. Dry teeth with cotton gauze immediately prior to use. Apply varnish on all surfaces of teeth. It is not necessary to use entire unit dose. Avoid eating or drinking for 30 minutes; avoid hot food and beverages; do not brush teeth until the following day (AAP [Clark 2014]). Do not apply on patients with active stomatitis or other ulcerative oral diseases. Do not use on patients with a known colophony allergy.

Use: Labeled Indications

Prevention of dental caries

Medication Safety Issues
Sound-alike/look-alike issues:

Phos-Flur may be confused with PhosLo

International issues:

Fluorex [France] may be confused with Flarex brand name for fluorometholone [U.S., Canada, and multiple international markets] and Fluarix brand name for influenza virus vaccine (inactivated) [U.S., and multiple international markets]

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

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.

Breastfeeding Considerations

Low concentrations of fluoride can be found in breast milk and the amount is not significantly affected by supplementation or concentrations in drinking water (IOM, 1997). The manufacturer recommends that caution be exercised when administering fluoride to nursing women.

Dietary Considerations

Do not administer with dairy products.

Dietary adequate intake (AI) (IOM 1997):

1 to 6 months: 0.01 mg/day; additional supplementation is not recommended in infants <6 months of age.

7 to 12 months: 0.5 mg/day.

1 to 3 years: 0.7 mg/day.

4 to 8 years: 1 mg/day.

9 to 13 years: 2 mg/day.

14 to 18 years: 3 mg/day.

Mechanism of Action

Promotes remineralization of decalcified enamel; inhibits the cariogenic microbial process in dental plaque; increases tooth resistance to acid dissolution

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Oral: ~50% absorbed from GI tract (IOM, 1997; dairy products may delay absorption)

Distribution: 99% in calcified tissue (IOM, 1997)

Excretion: Urine (IOM, 1997)

  1. 3M Just For Kids (stannous fluoride) [prescribing information]. St. Paul, MN: 3M Oral Care; November 2019.
  2. 3M Vanish (sodium fluoride) [prescribing information]. St. Paul, MN: 3M Oral Care; received March 2020.
  3. AAP Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  4. ACT Anticavity Fluoride Cinnamon (sodium fluoride) [prescribing information]. Chattanooga, TN: Chattem Inc; September 2013.
  5. ACT Anticavity Fluoride Kids Bubblegum (sodium fluoride) [prescribing information]. Chattanooga, TN: Chattem Inc; September 2013.
  6. ACT Anticavity Fluoride Mouthwash (sodium fluoride) [prescribing information]. Chattanooga, TN: Chattem Inc; received February 2020.
  7. ACT Restoring Anticavity Fluoride Cool Mint (sodium fluoride) [prescribing information]. Chattanooga, TN: Chattem Inc; September 2013.
  8. ACT Total Care Anticavity Fluoride Icy Clean Mint (sodium fluoride) [prescribing information]. Chattanooga, TN: Chattem Inc; September 2013.
  9. ACT Total Care Dry Mouth Anticavity Mouth (sodium fluoride) [prescribing information]. Chattanooga, TN: Chattem Inc; received 2011.
  10. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  11. Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  12. Cavirinse (sodium fluoride) [prescribing information]. St. Paul, MN: 3M ESPE Dental Products; August 2009.
  13. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm [PubMed 6810084]
  14. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm [PubMed 6423951]
  15. Centers for Disease Control and Prevention, "Recommendations for Using Fluoride to Prevent and Control Dental Caries in the United States," MMWR Recomm Rep, 2001, 50(RR-14):1-42. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5014a1.htm.
  16. Clark MB, Slayton R, Section on Oral Health. Fluoride use in caries prevention in the primary care setting. Pediatrics. 2014;134(3):626-633. [PubMed 25157014]
  17. Clinpro 5000 (sodium fluoride) [prescribing information]. St. Paul, MN: 3M ESPE Dental Products; January 2012.
  18. Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing (sodium fluoride) [prescribing information]. New York, NY: Colgate-Palmolive; received December 2019.
  19. Colgate PreviDent Rinse (sodium fluoride). New York, NY: Colgate-Palmolive; January 2016.
  20. Colgate PreviDent Varnish (sodium fluoride) [prescribing information]. New York, NY: Colgate-Palmolive; no date.
  21. ControlRx (sodium fluoride) [prescribing information]. St. Paul, MN: 3M ESPE Dental Products; May 2010.
  22. Denta 5000 Plus (sodium fluoride) [prescribing information]. Allendale, NJ: Rising Pharmaceuticals Inc; May 2012.
  23. Driscoll WS, Swango PA, Horowitz AM, Kingman A. Caries-preventive effects of daily and weekly fluoride mouthrinsing in a fluoridated community: final results after 30 months. J Am Dent Assoc. 1982;105(6):1010-1013. [PubMed 6961143]
  24. DuraShield CV (fluoride) [prescribing information]. York, PA: Sultan Healthcare; received March 2020.
  25. Fluorabon Drops (sodium fluoride) [prescribing information]. Lake Oswego, OR: Kirkman Laboratories Inc; September 2005.
  26. Fluorabon Drops (sodium fluoride) [prescribing information]. Lake Oswego, OR: Kirkman Laboratories Inc; received 2014.
  27. Fluoridex (stannous fluoride) [prescribing information]. Lompoc, CA: Den-Mat Holdings LLC; received September 2018.
  28. Flura-Drops (sodium fluoride) [prescribing information]. Lake Oswego, OR: Kirkman Laboratories Inc; received September 2019.
  29. Foti C, Romita P, Ficco D, Bonamonte D, Angelini G. Allergic contact cheilitis to amine fluoride in a toothpaste. Dermatitis. 2014;25(4):209. doi:10.1097/DER.0000000000000053 [PubMed 25000240]
  30. Gel-Kam (sodium fluoride) [prescribing information]. New York, NY: Colgate Professional; 2007.
  31. IOM (Institute of Medicine), Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride, National Academy of Sciences, Washington, DC, 1997.
  32. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  33. Listerine Nightly Reset (sodium fluoride) [prescribing information]. Skillman, NJ: Johnson & Johnson Consumer Inc; received July 2018.
  34. Lozi-Flur (sodium fluoride) [prescribing information]. Scottsdale, AZ: Dreir Pharmaceuticals; September 2005.
  35. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  36. Parodontax (stannous fluoride) [prescribing information]. Warren, NJ: GSK Consumer Healthcare; received June 2019.
  37. Peters P, Drummond C. Perioral dermatitis from high fluoride dentifrice: a case report and review of literature. Aust Dent J. 2013;58(3):371-372. doi:10.1111/adj.12077 [PubMed 23981221]
  38. Phos-Flur Ortho Defense (sodium fluoride) [prescribing information]. New York, NY: Colgate Oral Pharmaceuticals Inc; September 2010.
  39. Phos-Flur (sodium fluoride) [prescribing information]. New York, NY: Colgate Oral Pharmaceuticals Inc; April 2005.
  40. Phos-Flur (fluoride) [prescribing information]. New York, NY: Colgate Oral Pharmaceuticals Inc; July 2011.
  41. PreviDent 5000 Booster Plus (sodium fluoride) [prescribing information]. New York, NY: Colgate Oral Pharmaceuticals Inc; February 2015.
  42. PreviDent 5000 Ortho Defense (sodium fluoride) [prescribing information]. Canton, MA: Colgate Oral Pharmaceuticals Inc; November 2018.
  43. PreviDent 5000 Sensitive (sodium fluoride/potassium nitrate) [prescribing information]. New York, NY: Colgate Oral Pharmaceuticals; May 2019.
  44. PreviDent Alcohol Free (sodium fluoride) [prescribing information]. New York, NY: Colgate Oral Pharmaceuticals Inc; June 2016.
  45. PreviDent Gel (sodium fluoride) [prescribing information]. New York, NY: Colgate Oral Pharmaceuticals, Inc; May 2016.
  46. PreviDent Rinse (sodium fluoride) [prescribing information]. New York, NY: Colgate Oral Pharmaceuticals; January 2003.
  47. Pro-Sys (sodium fluoride) [prescribing information]. Pittston, PA: Benco Dental; received August 2017.
  48. Rozier RG, Adair S, Graham F, et al. Evidence-based clinical recommendations on the prescription of dietary fluoride supplements for caries prevention: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2010;141(12):1480-1489. [PubMed 21158195]
  49. Sensodyne Pronamel (sodium fluoride/potassium nitrate) [prescribing information]. Warren, NJ: GSK Consumer Healthcare; received June 2019.
  50. SF 1.1% gel (sodium fluoride) [prescribing information]. Morristown, NJ: Cypress Pharmaceutical Inc; June 2016.
  51. SF 5000 Plus (sodium fluoride) [prescribing information]. Nashville, TN: Westminster Pharmaceuticals LLC; December 2020.
  52. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  53. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  54. Sodium fluoride chewable tablets [prescribing information]. Fort Worth, TX: Method Pharmaceuticals LLC; July 2018.
  55. Sodium fluoride drops [prescribing information]. Montgomery, AL: H2-Pharma; received January 2017.
  56. Stannous Fluoride 0.63% Oral Rinse [prescribing information]. Madison, MS: Cypress Pharmaceuticals Inc; June 2006.
  57. TheraBreath for Kids (sodium fluoride) [prescribing information]. Los Angeles, CA: Dr. Harold Katz LLC; received August 2019.
  58. U.S. Preventive Services Task Force (USPSTF). Prevention of Dental Caries in Children From Birth Through Age 5 Years: U.S. Preventive Services Task Force Recommendation Statement. AHRQ Publication No. 12-05170-EF-2. Available at http://www.uspreventiveservicestaskforce.org/uspstf12/dentalprek/dentchfinalrs.htm USTF 2014
  59. VOCO Profluorid Varnish (sodium fluoride) [prescribing information]. Cuxhaven, Germany: VOCO GmbH; no date.
  60. Weyant RJ1, Tracy SL, Anselmo TT, et al. Topical fluoride for caries prevention: executive summary of the updated clinical recommendations and supporting systematic review. J Am Dent Assoc. 2013;144(11):1279-1291. [PubMed 24177407]
  61. Wynn RL, “Fluoride: After 50 Years, a Clearer Picture of Its Mechanism,” Gen Dent, 2002, 50(2):118-22, 124, 126. [PubMed 12004705]
  62. Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219. [PubMed 17555487]
Topic 8462 Version 347.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟