Sodium fluoride oromucosal toothpaste
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Toothpaste formulation of sodium fluoride.
Drugs List
Therapeutic Indications
Uses
Prophylaxis of dental caries
Sodium fluoride is indicated for the prevention of dental caries (coronal and root).
Sodium fluoride 2800ppm is also indicated for the treatment of dental caries (coronal and root).
Dosage
Adults
2800ppm strength
Apply 1cm of paste to the toothbrush and brush the teeth thoroughly for 1 minute morning and evening. Spit out after use.
For best results, do not drink or rinse for 30 minutes after use.
5000ppm strength
Apply 2cm of paste to the toothbrush (this provides 3mg to 5mg of fluoride) and brush the teeth thoroughly for 3 minutes three times daily (after each meal).
Teeth should be brushed vertically from the gum to the tip of the tooth.
Children
Contraindicated for use in children under 10 years of age.
Children over 16 years
Apply 2cm of the 5000ppm paste to the toothbrush (this provides 3mg to 5mg of fluoride) and brush the teeth thoroughly for 3 minutes three times daily (after each meal).
Teeth should be brushed vertically from the gum to the tip of the tooth.
Children over 10 years
Apply 1cm of the 2800ppm paste to the toothbrush and brush the teeth thoroughly for 1 minute morning and evening. Spit out after use.
For best results, do not drink or rinse for 30 minutes after use.
Contraindications
Children under 10 years
Precautions and Warnings
Children aged 10 to 16 years
Breastfeeding
Pregnancy
Not all available brands are licensed for all age groups
May contain sodium benzoate: mild mucous membrane irritant
Do not swallow
If using fluoride supplements, consult your dentist
Advise patient to avoid drinking or rinsing mouth for 30 minutes after use
This additional source of fluoride may lead to fluorosis. To prevent the accumulation of fluoride, the total intake must be assessed before this product is used. Fluoride tablets, drops, chewing gum, gels or varnishes, and fluoridated water or salt should be avoided during the use of this product.
The recommended daily fluoride intake is 0.05mg/kg and should not exceed 1mg per day. An allowance must be made for the possible ingestion of this toothpaste.
Pregnancy and Lactation
Pregnancy
Use sodium fluoride with caution during pregnancy.
The manufacturer recommends that sodium fluoride should not be used during pregnancy unless the potential benefits outweigh the possible risks.
There is no adequate data from the use of sodium fluoride toothpaste 5000ppm in human pregnancy. Animal studies have shown reproductive toxicity when sodium fluoride was administered at very high levels.
Lactation
Use sodium fluoride with caution during breastfeeding.
The manufacturer recommends that sodium fluoride should not be used during breastfeeding unless the potential benefits outweigh the possible risks. There is no adequate data from the use of sodium fluoride 5000ppm during breastfeeding and it is unknown if fluoride is excreted in breast milk.
Side Effects
Burning sensation of the mouth
Hypersensitivity reactions
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2013
Reference Sources
Summary of Product Characteristics: Colgate Duraphat 2800ppm Fluoride Toothpaste. Colgate-Palmolive (UK) Ltd. July 2006.
Summary of Product Characteristics: Colgate Duraphat 5000ppm Fluoride Toothpaste. Colgate-Palmolive (UK) Ltd. September 2003.
Summary of Product Characteristics: Fluoritop LF 2800ppm Fluoride Toothpaste. Rx Farma. November 2021.
Summary of Product Characteristics: Fluoritop HF 5000ppm Fluoride Toothpaste. Rx Farma. March 2019.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 17 June 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.