Active Ingredients: 1mL suspension contains 50mg sodium fluoride, equivalent to 22,600 ppm F, in an alcoholic solution of resin
1Marinho V et al (2002) Cochrane Database Syst. Rev. No. 3
2Clark RE, et al (1992) J Clin Res; 71 (Spec Issue): 628
Colgate Duraphat Varnish is a 22,600ppm Sodium Fluoride varnish for clinical use for caries prevention through deep penetration with fluoride as well as desensitsation of sensitive teeth.
Colgate Duraphat Varnish is to be applied by the dental professional, and is not for self-medication by the patient. Before applying Colgate Duraphat, accumulations of plaque and excess saliva should be removed. Colgate Duraphat is applied as a thin layer to the most affected areas of dentition using a brush, probe or applicator.
Dosage:
For primary teeth up to 0.25mL (5.65mg fluoride)
For mixed dentition up to 0.40mL (9.04mg fluoride).
For permanent dentition up to 0.75mL (16.95mg fluoride).
For caries prevention, the application is usually repeated every 6 months but more frequent applications (every 3 months) may be made.
For hypersensitivity 2 or 3 applications should be made within a few days. The patient should not brush the teeth or chew hard food for 4 hours after treatment. During this time fluids and soft foods may be consumed.
Instructions:
1. If necessary, clean the teeth especially at the sites most susceptible to caries. When groups of patients (eg. in children's dentistry) are to be treated, they should clean the teeth themselves using a toothbrush.
2. Clear one or two quadrants of excessive saliva. Dispense the correct amount of Colgate Duraphat from the tube onto an application/dosage pad. Apply to the teeth using a cotton applicator, probe or brush, painting and dabbing repeatedly to form a thin layer. Then treat the next quadrants in the same manner.
3. It is advisable to begin by applying the varnish to teeth in the lower jaw before too much saliva collects. It may not be necessary to paint the lingual surfaces, as these are generally more caries resistant. Colgate Duraphat should preferaby be applied to those spots most susceptible to caries attack.
4. The yellowish colour of Colgate Duraphat greatly facilitates its application and control. Colgate Duraphat sets in the presence of saliva. The effect of Colgate Duraphat is dependant on the prolonged activity of fluoride. The varnish film should not be removed prematurely. Patients should be advised not to brush their teeth or chew hard food for at least 4 hours after treatment. During this time fluids and soft foods may be consumed.
5. Instruments, clothing etc which comes into contact with Colgate Duraphat can be cleaned with alcohol.
Contraindications: Hypersensitivity to colophony (natural resin), ulcerative gingivitis, stomatitis, and bronchial asthma.
Precautions: Not for systemic treatment. DO NOT SWALLOW. As this product contains 33.8% volume of ethanol, it is recommended to avoid its use in pregnant or lactating women. Each dose contains up to 0.2g of alcohol.
Interaction with other drugs: On the day when Colgate Duraphat has been applied, no high dose fluoride preparations such as fluoride gels should be used. The administration of fluoride supplements should be suspended for several days after applying Colgate Duraphat. The presence of alcohol in the Duraphat formula should be considered.
Adverse Reactions: In subjects with a tendency to allergic reactions, oedematous swelling of the oral mucosa has been observed in exceptional cases, especially after extensive application. Ulcerative gingivitis and stomatitis have been reported by sensitive individuals. In rare cases, asthma attacks may occur in patients who have bronchial asthma. In patients with gastric sensitivity retching or vomiting may occur after a high dosage and extensive application. If necessary the varnish layer can easily be removed from the mouth by brushing and rinsing.
Overdosage: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting and diarrhoea may soon occur after ingestion (within 30 minutes) and are accompanied by salivation, haematernesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight have been ingested give calcium (eg milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight has been ingested give milk orally if possible and seek immediate medical assistance. For accidental ingestion of more than 15mg fluoride/kg body weight, admit immediately to a hospital facility. For further information, contact the Poisons Information Centre on 13 1126 (Australia), 0800 764 766 (New Zealand).
Excipient Ingredients: Ethanol, white beeswax, shellac, colophony BP, mastic, sodium saccharin, flavour.
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