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Colgate Duraphat Varnish 50mg/ml Dental Suspension

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Colgate Duraphat Varnish 50mg/ml Dental Suspension
2.26% (22,600ppm) Sodium Fluoride


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CTS 01737 765 400
Dental Directory 01376 500 222
DHB 0845 601 7086
Dent-O-Care 0208 459 7550
Henry Schein 08700 102 043
Survival 32 01189 516 161 -
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
Dental suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
For the prevention of caries in children and adults as part of a comprehensive control programme.

For the:
  • 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.
    4.3 Contra-Indications
    Hypersensitivity to colophony and/or any other constituents.
    Ulcerative gingivitis.
    Bronchial asthma.
    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
    None known.
    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.
    4.9 Overdose
    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
    Ethanol 96%
    White Wax (E901)
    Shellac (E904)
    Saccharin (E954)
    Raspberry Essence (containing Ethyl Butyrate, Geraniol, Iris Resinoid, Isoamyl Acetate, Jasmine Absolute, Vanillin and Propylene Glycol).
    6.2 Incompatibilities
    None known.
    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
    Middleton Road
    Surrey GU2 8JZ
    8. Marketing Authorisation Number
    PL 00049/0042
    9. Date of First Authorisation/Renewal of Authorisation
    6 March 1998/6 March 2003
    10. Date of (Partial) Revision of the Text
    October 2003
    11. Legal Classification
    12. Manufacturer's Recommended Retail Price
    19.11 excluding VAT (10ml tube).

    1Marinho V et al (2002) Cochrane Database Syst. Rev. No. 3

    2Clark RE, et al (1992) J Clin Res; 71 (Spec Issue): 628

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