1. Name of the Medicinal Product
Duraphat 50/mg/ml Dental Suspension.
2. Qualitative and Quantitative Composition
1ml of suspension contains 50mg sodium fluoride equivalent to 22.6mg of fluoride.
3. Pharmaceutical Form
4.1 Therapeutic Indications
For the prevention of caries in children and adults as part of a comprehensive control programme.
Prevention of recurring (or marginal) caries
Prevention of progression of caries
Prevention of decalcification around orthodontic appliances
Prevention of pit and fissure (occlusal) caries
For the desensitisation of hypersensitive teeth as part of a treatment regimen which includes the daily use of a suitable toothpaste.
4.2 Posology and Method of Administration
Duraphat 50/mg/ml Dental Suspension is to be applied by the dentist. Before applying Duraphat, excess plaque should be removed and the teeth dried. Duraphat is applied as a thin layer to the most susceptible areas of dentition using a brush, probe or swab.
Recommended dosage for single application:
For milk teeth: up to 0.25/ml (=5.65/mg Fluoride)
For mixed dentition: up to 0.40/ml (=9.04/mg Fluoride)
For permanent dentition: up to 0.75/ml (=16.95/mg Fluoride)
For caries prophylaxis, the application is usually repeated every six months but more frequent applications (every three months) may be made.
For hypersensitivity, two or three applications should be made within a few days.
The patient should not brush the teeth or chew food for four hours after treatment.
Hypersensitivity to colophony and/or any other constituents.
4.4 Special Warnings and Special Precautions for Use
Application of Duraphat 50/mg/ml Dental Suspension to the whole dentition should not be carried out on an empty stomach.
On the day when 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 Duraphat.
4.5 Interactions with Other Medicaments and Other Forms of Interaction
The presence of alcohol in the Duraphat formula should be considered.
4.6 Pregnancy and Lactation
As this product contains 33.8 percent of ethanol (each dose contains up to 0.2/g of alcohol), it is recommended to avoid its use in pregnant women and during lactation.
4.7 Effects on Ability to Drive and Use Machines
4.8 Undesirable Effects
In subjects with a tendency to allergic reactions, oedematous swelling of the oral mucosa has been observed in exceptional cases, especially after extensive application. If necessary, the dental suspension layer can easily be removed from the mouth by brushing and rinsing. 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 may exceptionally occur after a high dosage and extensive application.
In very high doses, fluoride has an acute toxic action through inhibition of enzymes resulting in hypocalcaemia. Doses of several milligrams of fluoride per kg body weight cause nausea and vomiting.
The dental suspension layer can easily be removed from the mouth by brushing and rinsing.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Sodium fluoride applied topically after tooth eruption reduces caries by inhibiting demineralisation and promoting remineralisation of the tooth surface and by inhibiting the cariogenic microbial process.
Duraphat 50/mg/ml dental suspension also reduces dentinal hypersensitivity.
In the management of dental erosion associated with the frequent consumption of acidic beverages or gastric reflux, high concentration topical fluoride agents are considered to be of value. Duraphat is at least as effective as 2% sodium fluoride solution in inhibiting erosion in vitro.
5.2 Pharmacokinetic Properties
After oral administration, fluoride absorption is rapid and extensive (90-100 percent) with peak fluoride plasma levels reached within 30 to 60 minutes after ingestion. Fluoride is widely distributed through the body and concentrates in bone and teeth. About 50 percent of Fluoride is stored. Excretion is primarily through the kidneys with less than 10 percent being excreted in the faeces and less than 1 percent in sweat and saliva.
Duraphat covers teeth with a film of suspension which hardens in the presence of saliva and then persists, and which over the following hours causes fluoride to accumulate at a measurable depth in the tooth enamel.
5.3 Pre-clinical Safety Data
The product is used under total control of the dentist and the amount of fluoride introduced to the patient at one time is within acceptable safety limits. The recommended doses are up to 0.75/ml for permanent dentition. Treatment is recommended every six months or a maximum of every three months. For hypersensitivity, two to three applications are recommended within a few days. These levels of fluoride introduced are again within acceptable safety limits.
Due to the slow release of fluoride, the plasma levels are even lower than levels known to produce no side effects in children.
6. Pharmaceutical Particulars
6.1 List of Excipients
White Wax (E901)
Raspberry Essence (containing Ethyl Butyrate, Geraniol, Iris Resinoid, Isoamyl Acetate, Jasmine Absolute, Vanillin and Propylene Glycol).
6.3 Shelf Life
Unopened three years. For aluminium tube: after opening, use within three months.
6.4 Special Precautions for Storage
Do not store above 25°C.
6.5 Nature and Contents of Container
Boxes of 1 x 10/ml tube made of internally lacquer-coated aluminium, externally printed, with white plastic screw cap with sealing plug.
Boxes of 1 x 1.6/ml or 5 x 1.6/ml glass cylinders with a cream bromobutyl rubber stopper and gold aluminium cap at the top and dark blue chlorobutyl rubber stopper at the bottom.
6.6 Instruction for Use/Handling
If necessary the teeth should be cleaned, especially at the sites most susceptible to caries. When groups of patients (e.g. children) are to be treated, they should clean the teeth themselves using a toothbrush.
To start, clear one or two quadrants of excessive saliva using an air syringe (or dabbing with cellulose). Duraphat 50/mg/ml dental suspension is applied from the tube using a miniature cotton swab, probe or brush, painting and dabbing repeatedly to form a thin layer. Then treat the next quadrants in the same manner. It is advisable to begin by applying the dental suspension to teeth in the lower jaw before too much saliva collects and interferes. It may not be necessary to paint the lingual surfaces since these are generally more caries-resistant; Duraphat should preferably be applied to those spots most susceptible to caries attack.
Application of Duraphat from the cylinder is particularly suited to targeted, low-dose application. A blunt cannula is used with the end bent to an angle to facilitate application to approximal and distal surfaces. For application to approximal surfaces place the cannula between adjacent teeth and deliver a small amount of Duraphat. The dental suspension should be applied from both sides of the interproximal space and occlusally.
For fissures, a drop of Duraphat should be spread along the fissure using the cannula. Edges of fillings and crowns and hypersensitive tooth necks can be treated in the same way.
The smooth surfaces of the teeth should be treated when caries activity is high, particularly if decalcification is evident. The cannula should be placed tangentially to the teeth and Duraphat distributed with the side of the curved cannula end.
Areas around fixed orthodontic devices can be treated with Duraphat using the cannula.
The yellowish colour of Duraphat facilitates its application and control. Duraphat sets in the presence of saliva. The effect of Duraphat depends upon the prolonged activity of the fluoride. The dental suspension film should not be removed prematurely. Patients should be advised not to brush their teeth or chew food for at least four hours after treatment; during this time, soft foods and liquids may be consumed. However, if you need to, the dental suspension layer can easily be removed by brushing or rinsing.
Instruments, clothing, etc. which come into contact with Duraphat can be cleaned with alcohol.
7 Marketing Authorisation Holder
Colgate-Palmolive (U.K.) Ltd
Guildford Business Park
Surrey GU2 8JZ
8. Marketing Authorisation Number
9. Date of First Authorisation/Renewal of Authorisation
6 March 1998/6 March 2003
10. Date of (Partial) Revision of the Text
11. Legal Classification
12. Manufacturer's Recommended Retail Price
£19.11 excluding VAT (10ml tube).