Natriumfluoride

Generic name
Natriumfluoride
Brand name
ATC Code
A01AA01
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Natriumfluoride

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

T1/2: 1,5-9 hours 
Vd:1 l/kg 
Tmax: 0,5-1 uur
Fluoride is primarily excreted throught the kidney. A small amount is excreted through faeces. 
[SmPCs]

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Prevention of dental caries
  • Oromucosal
    • Mouthwash
      • ≥ 6 years
        • Fluoride concentration in drinking water or mineral water < 0,3 mg/l 0,3-0,7 mg/l
          Dose (Fluoride) 1 mg/day 0,5 mg/day

        • Note: When brushing teeth 2 times a day with a fluoride-containing (1000 ppm) toothpaste (amount: pea size), no tablet administration is necessary.

    • 0 years up to 3 years
      • (Fluoride) 0.25 mg/day in 1 dose Only indicated if fluoride concentration in drinking water or mineral water is < 0,3 mg/l. Use in combination with vitamin D..

      • From tooth eruption: in combination with tooth brushing (without toothpaste or with fluoride-free toothpaste).
        Alternative:
        From tooth eruption to <1 year: 1 - 2 x daily tooth brushing with a fluoride-containing (1000 ppm) toothpaste (quantity: rice grain size).
        ≥1 year to <2 years: 2 x daily brushing with a fluoride-containing (1000 ppm) toothpaste (amount: rice grain size)
        ≥2 years to <3 years: 2 x daily brushing with a fluoride-containing (1000 ppm) toothpaste (amount: pea size).

    • 3 years up to 6 years
      • Fluoride concentration in drinking water or mineral water

        		 < 0,3 mg/l 0,3-0,7 mg/l >0,7 mg/L
        Dose (Fluoride) 0,5 mg/day 0,25 mg/day -

      • Note: When brushing teeth 2 times a day with a fluoride-containing (1000 ppm) toothpaste (amount: pea size), no tablet administration is necessary.

    • ≥ 6 years
      [7]
      • Fluoride concentration in drinking water or mineral water < 0,3 mg/l 0,3-0,7 mg/l
        Dose (Fluoride) 1 mg/day 0,5 mg/day

      • Note: When brushing teeth 2 times a day with a fluoride-containing (1000 ppm) toothpaste (amount: pea size), no tablet administration is necessary.

  • Dental
    • ≥ 4 years

      • Suspension: fluoride 50 mg / ml: application by a dentist or dental hygienist using a brush, probe or cotton swab; Apply a thin layer

        • Primary teeth: max. 0.25 ml
        • mixed teeth: max. 0.4 ml
        • permanent teeth max. 0.75 ml

        The coating is created by curing in the presence of saliva; do not brush the teeth or chew on food for up to 4 hours after treatment (soft food and drinks are possible) to prevent premature removal of the coating; repeat treatment every 6 months, if necessary every 3 months;

        Gel : fluoride 4 mg / ml: professional application by dentist or dental hygienist using an application spoon; if necessary, repeat treatment every 6 months;

        Toothpaste: fluoride 12.5 mg / g:  Apply once a week before going to bed and after brushing the teeth:  1-1.5 cm on a toothbrush thoroughly on all surfaces of teeth and molars; Leave on for 3-4 minutes; spit out excess gel and saliva. Professional application by dentist or dental hygienist using a brush or an application spoon; if necessary, repeat treatment every 6 months;

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Fluoride-containing products should not be ingested

Excessive use of fluoride by children during tooth formation may cause fluorosis (spotted enamel, zebra-like teeth). The vulnerable age phase is in particular between ½ and 4½ years, because the visible enamel of the incisors is formed during that period. Fluorosis can only be noticed after the age of approximately 6 years, when the permanent teeth have come through.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

STOMATOLOGICAL PREPARATIONS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Antiinfectives and antiseptics for local oral treatment
A01AB03
ANTIINFECTIVES AND ANTISEPTICS FOR LOCAL ORAL TREATMENT
A01AB03

References

  1. Gouka B.V., Dentigel, tandgel 0,4 % (RVG 14981) 27-12-2015, www.geneesmiddeleninformatiebank.nl
  2. CP GABA GmbH, Duraphat suspensie voor dentaal gebruik (RVG 10942) 13-11-2018, www.geneesmiddeleninformatiebank.nl
  3. Milstein CV , SmPC Endekay® 0,4 % Thixotrope Fluogel 0,4% met fruitsmaak (RvG 11455) 12-03-2019 , www.geneesmiddeleninformatiebank.nl
  4. Formularium der Nederlandse Apothekers, Therapeutische informatie Natriumfluoride , Juni 2013
  5. Ivoren Kruis, Advies Cariëspreventie, www.ivorenkruis.nl, 2011
  6. Nederlandse Maatschappij tot bevordering der Tandheelkunde, Richtlijn Mondzorg voor jeugdigen, 2013
  7. Sanofi-Aventis Deutschland GmbH, SmPC Fluoretten (6546182), 08-2017
  8. Formularium der Nederlandse Apothekers, Therapeutische informatie Natriumfluoride, Juni 2013
  9. Milstein CV, SmPC Endekay® 0,4 % Thixotrope Fluogel 0,4% met fruitsmaak (RvG 11455) 12-03-2019, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose