Sodium fluoride


Generic Medicine Info
Indications and Dosage
Dental
Prophylaxis of dental caries
Adult: As 0.619% (2,800 ppm fluoride) toothpaste: Apply a 1 cm line on the head of a toothbrush and brush teeth for at least 1 minute bid, preferably in the morning and the evening. As 1.1% (5,000 ppm fluoride) toothpaste: Apply a 2 cm ribbon on the head of a toothbrush and brush teeth for approx 3 minutes tid, after each meal. Alternatively, apply a thin ribbon or pea-sized amount on the head of the toothbrush and brush teeth for approx 2 minutes once daily. Use sodium fluoride toothpaste daily in place of conventional toothpaste; spit out and rinse mouth thoroughly after use. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: As 0.619% (2,800 ppm fluoride) toothpaste: >10 years Same as adult dose. As 1.1% (5,000 ppm fluoride) toothpaste: ≥16 years Same as adult dose. Use sodium fluoride toothpaste daily in place of conventional toothpaste; spit out and rinse mouth thoroughly after use. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).

Mouth/Throat
Prophylaxis of dental caries
Adult: As 0.05% mouthwash solution: Rinse or swish between the teeth once daily using approx 10 mL solution or as prescribed, for 1 minute and then spit out. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: As 0.05% mouthwash solution: >6 years Same as adult dose. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).

Oral
Prophylaxis of dental caries
Child: 1.1 mg and 2.2 mg sodium fluoride are equivalent to 0.5 mg and 1 mg fluoride, respectively. Recommended daily dosage of fluoride ions is based on the fluoride content of drinking water. As tab: Water content <0.3 ppm fluoride: 3-6 years 1.1 mg (0.5 mg fluoride ion) daily; >6 years 2.2 mg (1 mg fluoride ion) daily. Water content 0.3-0.7 ppm fluoride: 3-6 years 0.55 mg (0.25 mg fluoride ion) daily; >6 years 1.1 mg (0.5 mg fluoride ion) daily. Tablets may be allowed to dissolve slowly in the mouth, chewed or sucked before swallowing. Doses are preferably taken at a different time of day to tooth brushing. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).
Contraindications
Hypersensitivity. Drinking water containing >0.7 ppm fluoride or artificially fluoridated (tab). Not for use in children <3 years (1.1 mg tab); <6 years (2.2 mg tab); <10 years (0.619% toothpaste); <16 years (1.1% toothpaste).
Special Precautions
Children with developing dentition. Pregnancy and lactation.
Adverse Reactions
Significant: Dental fluorosis and osseous changes (prolonged ingestion with excessive doses).
Gastrointestinal disorders: Burning oral sensation.
Immune system disorders: Hypersensitivity reaction.
Skin and subcutaneous tissue disorders: Rash.
Patient Counseling Information
Do not swallow the dental preparations (e.g. toothpaste, gel) and mouthwash. As 0.619% or 1.1% toothpaste: Do not drink or rinse the mouth for approx 30 minutes after use. As 0.05% mouthwash: Avoid eating or drinking for at least 15-30 minutes after rinse.
Monitoring Parameters
Asses overall fluoride intake (e.g. drinking water, fluoridated salt, other fluoride-containing drugs) prior to initiation.
Overdosage
Symptoms: Nausea, vomiting, diarrhoea, acute burning in the mouth and sore tongue; electrolyte imbalance (e.g. hypocalcaemia), rhythm disturbance, and circulatory collapse; tetany and convulsions may also occur. Management: Symptomatic and supportive treatment. Give Ca (e.g. milk) or antacids containing Al hydroxide, Ca or Mg to reduce absorption. Monitor serum Ca and may administer IV Ca gluconate for hypocalcaemia and in potentially severe cases. Observe the patient for several hours after ingestion even if vomiting has occurred.
Drug Interactions
Absorption of fluoride may be decreased by Al, Ca, or Mg salts.
Food Interaction
Dairy products may cause a delay in absorption.
Action
Description: Sodium fluoride lowers the tooth enamel solubility in an acidic environment which increases tooth resistance to acid and prevents demineralisation. It also promotes remineralisation of decalcified enamel and inhibits the cariogenic microbial process in dental plaque.
Pharmacokinetics:
Absorption: Readily absorbed from the gastrointestinal tract (approx 50%). May delay absorption with dairy products. Time to peak plasma concentration: Approx 30-60 minutes.
Distribution: Crosses the placenta and enters breast milk. Mainly distributed in the bones and teeth; present in saliva, hair and nails. Volume of distribution: 1 L/kg.
Metabolism: Metabolised into hydrofluoric acid.
Excretion: Mainly via urine; faeces and sweat (small amounts). Terminal elimination half-life: 2-9 hours.
Chemical Structure

Chemical Structure Image
Sodium fluoride

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5235, Sodium fluoride. https://pubchem.ncbi.nlm.nih.gov/compound/Sodium-fluoride. Accessed Feb. 22, 2021.

Storage
Store between 20-25°C.
MIMS Class
Preparations for Oral Ulceration & Inflammation
ATC Classification
A01AA01 - sodium fluoride ; Belongs to the class of caries prophylactic agents. Used for the prevention of dental cavities.
References
Act Anticavity Fluoride Cinnamon Rinse (Chattem, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 27/11/2020.

Anon. Fluoride. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 27/11/2020.

Buckingham R (ed). Sodium Fluoride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 27/11/2020.

Clinpro 5000 Paste, Dentifrice (3M ESPE Dental Products). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 27/11/2020.

Denta 5000 Plus Gel, Dentifrice (Rising Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 27/11/2020.

Dentagel (Rising Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 27/11/2020.

Duraphat 2800 ppm Fluoride Toothpaste (Colgate-Palmolive [UK] Ltd). MHRA. https://products.mhra.gov.uk. Accessed 27/11/2020.

Endekay Daily Fluoride Mouthrinse (Manx Healthcare Ltd). MHRA. https://products.mhra.gov.uk. Accessed 27/11/2020.

Endekay Fluotabs 3-6 Years 1.1 mg Tablets (Manx Healthcare Ltd). MHRA. https://products.mhra.gov.uk. Accessed 27/11/2020.

Endekay Fluotabs 6+ Years 2.2.mg Tablets (Manx Healthcare Ltd). MHRA. https://products.mhra.gov.uk. Accessed 27/11/2020.

Fluorbon Drops (Kirkman Group, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 27/11/2020.

Fluoritab Chewable Cherry (Fluoritab Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 27/11/2020.

Joint Formulary Committee. Sodium Fluoride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 27/11/2020.

Prevident 5000 Dry Mouth Gel Dentifrice (Colgate Oral Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 27/11/2020.

Sodium Fluoride 5000 ppm Toothpaste (Olinka [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 27/11/2020.

Disclaimer: This information is independently developed by MIMS based on Sodium fluoride from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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