1. Trade Name of the Medicinal Product
Elyzol® 25% Dental Gel.
2. Qualitative and Quantitative Composition
1g contains: metronidazole benzoate, corresponding to 250mg metronidazole.
3. Pharmaceutical Form
Dental gel.
4.1 Therapeutic Indications
An adjunct to conventional therapy in the treatment of chronic periodontal disease in adults.
4.2 Posology and Method of Administration
Elyzol 25% dental gel is administered into the periodontal pocket twice with a one-week interval.
Dosage is individual, depending upon the number of teeth to be treated.
Treatment should not normally be repeated within six months of initial therapy.
4.3 Contraindications
Known hypersensitivity to metronidazole.
4.4 Special Warnings and Precautions for Use
In some patients, metronidazole may have an effect similar to that of disulphram on the metabolism of alcohol, resulting in intolerance symptoms.
Use each applicator on one patient during one session of treatment only. If just part of the gel is used the remainder should be discarded.
4.5 Interactions with Other Medicaments and Other Forms of Interaction
Some potentiation of anticoagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants. Metronidazole and disulphiram taken concurrently may cause a confusional state.
4.6 Pregnancy and Lactation
Pregnancy: metronidazole should not be given during the first stage of pregnancy unless it is considered essential.
Lactation: metronidazole is excreted in milk, but the risk of affecting the child seems unlikely with therapeutic doses.
4.7 Effects on Ability to Drive and Use Machines
None.
4.8 Undesirable Effects
Because of the low plasma concentrations after local application of the dental gel, the risk of systemic side effects is low. The most frequent side effects are local and occur directly in connection with the application, such as bitter taste and temporary local tenderness. Headache has been reported.
4.9 Overdose
Not applicable.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Metronidazole is an antibiotic active against most of the organisms that are predominant in the subgingival flora in adult periodontitis. Metronidazole has a bactericidal effect against Bacteroides spp., Fusobacterium, Selemonas, Wolinelia, Spirochetes, and other obligate anaerobic organisms, but does not affect aerobic bacteria. Also some facultatively anaerobic bacteria, such as Actinobacillus actinomycetemcomitans, are sensitive to the concentrations of metronidazole after local application of Elyzol 25% dental gel.
5.2 Pharmacokinetic Properties
After application of Elyzol 25% dental gel, metronidazole concentrations of above 100mg/ml are measured locally in the crevicular fluid for at least eight hours. At thirty six hours, concentrations above 1mg/ml are still measured. Metronidazole is released slowly from the dental gel with a bioavailability of about 70 per cent. The maximal plasma concentration is found after about four hours. Systemic concentrations above 1.3mg/ml have not been measured.
5.3 Preclinical Safety Data
An irritancy study in hamsters (oral mucosa) did not give rise to local reactions of irritative character, whereas a mild primary cutaneous reaction was seen in rabbits. A test for delayed contact hypersensitivity in guinea pigs was negative.
6. Pharmaceutical Particulars
6.1 List of Excipients
Glyceryl mono-oleate, sesame oil and water for injection.
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
Three years.
6.4 Special Precautions for Storage
Below 25°C.
6.5 Nature and Contents of Container
Disposable applicator: packs contain 2 or 6 x 0.3g ampoules, or 2 x 1.0g.
6.6 Instruction for Use/Handling
Elyzol 25% dental gel may be stored in a refrigerator, but should be taken out before use, as it is easiest to apply when at room temperature.
The needle is screwed onto the applicator preloaded with a cartridge, the protective cover on the needle is removed and the needle is bent to the required angle.
Elyzol 25% dental gel is applied in the gingival pocket, the needle is carefully moved down to the bottom of the pocket where the gel is applied until visible at the gingival margin. At the same time, the needle is gently moved around the entire circumference of the pocket. This procedure is repeated for all teeth to be treated.
The patient may eat and drink as usual and normal dental hygiene may be observed. Dental floss and tooth picks should not be used on the day following application of the gel.
7.1 Marketing Authorisation Holder
Colgate-Palmolive (UK) Limited
Guildford Business Park
Middleton Road
Guildford
Surrey GU2 8JZ
United Kingdom
8. Marketing Authorisation Number
PL 00049/0045
9. Date of First Authorisation/Renewal of Authorisation
18 September 2000
10. Date of (Particular) Revision of the Text
August 2000
11. Legal Classification
POM
12. Manufacturer's Recommended Retail Price
£42.50 excluding VAT (2 x 1g applicators).
