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Metronidazole Denta, gel for gums

Drug formSoft

ATC categoryStomatology

ATC subcategoryOral topical antimicrobial agents

Brand nameMetronidazole Denta

Generic nameMetronidazole /Chlorhexidine gluconate

Composition

Each gram of Metronidazole Denta gel for gums, contains:

active ingredient: metronidazole (as metronidazole benzoate) – 10 mg, chlorhexidine gluconate (as 20% solution of chlorhexidine gluconate) – 0.5 mg;

excipients: propylene glycol, carbomer 940, disodium edetate, menthol, sodium saccharin, sodium hydroxide, water purified.

Pharmacological group and ATC code
Antimicrobic preparation for local use an oral cavity; A01AB17.
Pharmacology

The combined antimicrobic preparation for treatment and prophylaxes of infectious diseases-inflammatory of an oral cavity. Action of a preparation is caused by properties of the components entering into its composition.

Metronidazole is an antibiotic active against those organisms that are predominant in the subgingival flora in adult periodontitis. Metronidazole has a bactericidal effect against Bacteroides spp., Fusobacterium, Selemonas, Wolinella, Spirochetes, and other anaerobic organisms, but does not affect aerobic bacteria.

Chlorhexidine is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common dental conditions.

Pharmacokinetics
When applied topically there is little if any systemic absorption of metronidazole.

Because of its cationic nature, chlorhexidine bonds strongly to skin, mucosa and other tissues and is thus very poorly absorbed. No detectable blood levels have been found following oral use.

Uses
– Inhibition of formation of dental plaque.
– As an aid in the treatment and prevention of gingivitis.
– As an aid to maintaining oral hygiene.
– For use in a post-peridontal surgery or treatment regimen to promote gingival healing.
– It is useful in the management of recurrent aphthous ulceration.
– It is useful in the management of recurrent oral candidal infections.
– As an aid in the prevention of dental caries in high-caries-risk patients (for example xerostomia sufferers), when used in a regimen as an adjunct to fluoride.

Dosage and administration
Adults:
Brush the teeth thoroughly with one inch of gel on a moistened toothbrush, once or twice daily for about one minute.
For the treatment of gingivitis, a course of about one month is advisable.

When used for the management of aphthous ulceration and oral candidal infections an alternative method of delivery may be required which facilitates application of the gel to affected areas. This should be used once or twice daily for about one minute. The length of treatment time should be decided on the basis of clinical response.

When used as part of a regimen to prevent dental caries the gel should be applied for 5 minutes nightly for 14 days in a close fitting tray. This treatment should be repeated every 3-4 months or as directed by the dentist. When used as part of a regimen to prevent dental caries of remaining teeth in denture wearers the gel may be applied to the fitting surface of the denture before insertion.

Children and Elderly patients

The normal adult dose is appropriate for elderly patients and children of 12 years and over unless otherwise recommended by the dentist or the physician.

Children 6-12 years of age should not use the product unless recommended by a healthcare professional.

Route of administration
For oral (external) use only.

Contraindications
– Known hypersensitivity to metronidazole and componenets.
– Children up to 6 years of age.
– Pregnancy and lactation.

Adverse effects

Because of the low plasma concentration after local application of the dental gel, the risk of systemic side effects is low.

The following adverse experiences have been reported with the topical use of Metronidazole-Chlorhexidine combination: burning, irritation, dryness, transient redness, metallic taste, staining of teeth, tingling or numbness of extremities and nausea.

Adverse effects, caused by metronidazole
The most common are local and are related to the application, namely a bitter taste and temporary local tenderness. Headache has been reported.

Adverse effects, caused by chlorhexidine
Irritative skin reactions: irritative skin reactions to chlorhexidine preparations can occasionally occur.

Generalised reactions: allergic reactions, hypersensitivity & anaphylaxis to chlorhexidine have also been reported but are extremely rare.

A superficial discoloration of the dorsum of the tongue may occur. This disappears after treatment is discontinued. Discoloration of the teeth and silicate or composite restorations may also occur. The stain is not permanent and can largely be prevented by reducing the consumption of tea, coffee and red wine and brushing with a conventional toothpaste daily before using the gel. However, in certain cases a professional prophylaxis (scaling and polishing) may be required to remove the stain completely. Stained anterior tooth coloured restorations with poor margins or rough surfaces which are not adequately cleaned by professional prophylaxis may require replacement.

Transient disturbance of taste sensation and a burning sensation of the tongue may occur on initial use of the gel. These effects usually diminish with continued use.

Overdosage

This has not been reported.

Accidental ingestion: chlorhexidine and metronidazole taken orally are poorly absorbed. Systemic effects are unlikely even if large amounts are ingested. However, gastric lavage may be advisable using milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.

Precautions

For oral use only. Do not swallow. Keep out of the eyes and ears. If the gel comes into contact with the eyes, wash out promptly and thoroughly with water. In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional. Metronidazole Denta is incompatible with anionic agents which are usually present in conventional dentifrices. These should therefore be used before Metronidazole Denta (rinsing the mouth and toothbrush between applications) or at a different time of day.

In some patients, metronidazole may have an effect similar to that of disulfiram on the metabolism of alcohol, with symptoms of intolerance as result. This effect may persist for up to 48 hours after discontinuation of treatment.

Patients should be told not to drink alcohol or alcoholic beverages.

When treating mouth ulcers or oral thrush infections, treatment should be continued for two days after the symptoms have cleared up. When treating inflammation caused by denture rubbing, the dentures should be cleaned and soaked for 15 minutes twice a day in chlorhexidine mouthwash.

Pregnancy and breastfeeding
Metronidazole Denta should not be given during pregnancy and lactation.
Drug interactions

Concomitant ingestion of disulfiram can produce acute conditions of confusion.
Metronidazole may potentiate the anticoagulant effect of warfarin.
Chlorhexidine is incompatible with anionic agents.

Presentation

Metronidazole Denta gel for gums is supplied in a aluminum tube (20 g).

Expiry date

3 years. Do not use after the expiration date.

Prescription status

To be dispensed with prescription.

Storage conditions

Store at a room temperature, in a dry place, out of the reach of children. Protect from light.