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

Interactions
PK
Renal impairment
References

Natriumfluoride

Generic name
Natriumfluoride
Brand name
ATC Code
A01AA01

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]

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

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Available formulations

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Dosages

Prevention of dental caries
  • Oromucosal
    • Mouthwash
      • ≥ 6 years
        [4] [5] [6]

        • (Fluorid)

          • Mouthwash 0.5 mg/ml (0.225 mg Fluoride per ml):  Rince mounth once DAILY using 10 ml during 1 minute
          • Mouthwash 2 mg/ml (0.9 mg Fluoride per ml): Rince mounth once WEEKLY using 10 ml during 1 minute

          Spit out afterwards. Do not swallow. To be used preferably before going to bed and after brushing of the teeth

           

    • 0 years up to 3 years
      [7]
      • (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
      [7]
      • 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
      [1] [2] [3] [5] [6]

      • 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;

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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.

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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.

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Interactions

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

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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

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Changes

Changes