Metronidazole denta

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Metronidazole denta (Metronidazole denta)

Composition:

Active substances: metronidazole benzoate, chlorhexidine gluconate;

1 g of gingival gel contains metronidazole benzoate equivalent to 10 mg of metronidazole, and 20% solution of chlorhexidine gluconate equivalent to 0.5 mg of chlorhexidine gluconate;

Excipients: propylene glycol, carbomer, disodium edetate (EDTA), menthol, sodium saccharin, sodium hydroxide, purified water.

Pharmaceutical form. Gingival gel.

Main physicochemical characteristics: white to almost white gel with a characteristic menthol odor.

Pharmacotherapeutic group. Agents for use in dentistry. Antimicrobial and antiseptic agents for local use in dentistry.

ATC code A01AB.

Pharmacological properties.

Pharmacodynamics.

The efficacy of the medicinal product is due to the presence of two antibacterial components – metronidazole and chlorhexidine.

Metronidazole is a nitroimidazole derivative with anti-protozoal and antibacterial activity. It is active against anaerobic bacteria causing periodontal diseases: Porphyromonas gingivalis, Prevotella intermedia, Prevotella denticola, Fusobacterium fusiformis, Wolinella recta, Eikenella corrodens, Borrelia vincenti, Bacteroides melaninogenicus, Selenomonas spp.

Chlorhexidine is a bactericidal antiseptic. It is active against a broad spectrum of vegetative forms of gram-negative and gram-positive microorganisms, as well as yeasts, dermatophytes, and lipophilic viruses.

The minimal inhibitory concentration (MIC50) of metronidazole against anaerobic bacteria is below 1 mcg/mL. With local application of the preparation (application to the gums), the concentration of metronidazole in the gingival area is significantly higher than with oral administration, while the level of systemic absorption of metronidazole with local application is considerably lower than with oral administration.

Pharmacokinetics.

The main route of elimination of metronidazole and its metabolites is via the kidneys. Impaired renal function does not alter the pharmacokinetics of a single dose of metronidazole.

In case of accidental swallowing of excess chlorhexidine during its local application as part of a dental gel, approximately 1% of the dose reaching the stomach is absorbed from the gastrointestinal tract. Chlorhexidine does not accumulate in the body and undergoes minimal metabolism.

Clinical characteristics.

Indications.

Infectious-inflammatory diseases of the periodontium and oral mucosa:

• Acute and chronic (edematous, hyperplastic, atrophic) gingivitis;
• Acute ulcerative-necrotic gingivitis (Vincent's gingivitis);
• Aphthous stomatitis;
• Periodontitis, periodontal abscess (as part of combination therapy).

Contraindications.

Hypersensitivity to metronidazole, chlorhexidine, nitroimidazole derivatives, or any component of the medicinal product.

Confirmed or history of blood dyscrasias.

Diseases of the peripheral and central nervous system.

Special precautions

Avoid contact of the gel with the eyes.

Interaction with other medicinal products and other types of interactions.

When applied topically at recommended doses, systemic interactions of "Metronidazole Denta" gel with other medicinal products have not been observed. However, caution should be exercised when prescribing "Metronidazole Denta" gel concomitantly with certain medications.

Warfarin and other coumarin anticoagulants. Metronidazole enhances anticoagulant effect, leading to prolonged prothrombin formation time.

Disulfiram. Concomitant use increases toxicity of the drugs, potentially leading to the development of neurological symptoms.

Phenobarbital, phenytoin, hydantoin-based anticonvulsants. Concurrent use with metronidazole reduces the latter's antimicrobial activity due to accelerated metabolism of metronidazole.

Cimetidine. Inhibits the metabolism of metronidazole, potentially leading to increased plasma concentrations of metronidazole.

Alcohol. Metronidazole causes alcohol intolerance. Concurrent intake of alcohol and metronidazole may cause symptoms of toxic psychosis, nausea, hypotension, tachycardia, diaphoresis, or dyspnea; in individual cases, severe hypotension and shock may occur. These reactions usually occur within 24 hours, but may occur up to 2 weeks after alcohol intake.

Special precautions for use.

The use of the medicinal product "Metronidazole Denta" does not replace hygienic tooth cleaning.

Alcohol consumption must be avoided during treatment, as it may cause gastric spasms, nausea, vomiting, headache, and facial flushing.

Metronidazole should not be used concomitantly with disulfiram, as it may cause psychotic reactions and confusion.

Prolonged use may lead to brown discoloration of teeth and tongue.

The use of "Metronidazole Denta" gel may cause temporary disturbances in taste sensation.

Propylene glycol contained in the medicinal product may cause skin irritation.

Use during pregnancy or breastfeeding.

Pregnancy.

The medicinal product should not be used during pregnancy.

Breastfeeding.

Since serious adverse reactions may occur during treatment with metronidazole in gel form, women are advised not to breastfeed.

Ability to affect reaction speed when driving or operating machinery.

The use of the medicinal product at the recommended dose does not impair the ability to drive or operate potentially hazardous machinery.

Dosage and Administration.

Adults: For gingivitis, apply Metronidazole Denta gel to the gums twice daily. Do not rinse the mouth or eat for 15 minutes after application. The average duration of treatment is 7–10 days.

For aphthous stomatitis, apply Metronidazole Denta to the affected area of the oral mucosa twice daily for 7–10 days.

Children:
The use of this medicinal product is not recommended in children under 18 years of age.

Overdose.

Cases of overdose with topical application of Metronidazole Denta gel are unknown.

Accidental or intentional ingestion of a large amount of the gel may exacerbate adverse reactions, primarily those caused by metronidazole (chlorhexidine is practically not absorbed from the gastrointestinal tract). These reactions include nausea, vomiting, and dizziness. In more severe cases, paresthesia and seizures may occur. High doses and prolonged systemic treatment with metronidazole are associated with the development of leukopenia, neutropenia, increased risk of peripheral neuropathy, and central nervous system toxicity. In case of overdose, gastric lavage should be performed and symptomatic therapy administered as needed.

Side effects.

When Metronidazole Denta gel is used topically, the risk of developing systemic adverse effects is negligible; however, the following reactions may occasionally occur.

Immune system disorders: Allergic reactions, including skin rash, pruritus, urticaria, angioneurotic edema. One case of eyelid swelling as a manifestation of angioneurotic reaction has been reported.

Nervous system disorders: Headache.

Eye disorders: If the gel comes into contact with areas near the eyes, lacrimation, dryness of mucous membranes, and transient conjunctival redness may occur.

Gastrointestinal disorders: Metallic taste in the mouth, bitter taste in the mouth, nausea, possible development of coatings in the oral cavity, on the surface of teeth and tongue.

Application site reactions: Burning sensation at the site of application, irritation at the site of application.

Post-marketing data.

With oral use of chlorhexidine, hypersensitivity reactions including symptoms of anaphylaxis, irritation of the mouth, discoloration of teeth and tongue, increased formation of dental calculus, altered taste sensations, bitter taste in the mouth, as well as burning, numbness, dryness, and pain of the oral mucosa may occur.

During post-marketing use, cases of urticaria with facial, lip, oral, or pharyngeal swelling, sensation of pruritus, dyspnea, hoarseness, and syncope have been reported. Allergic reactions (including anaphylaxis) in the oral cavity on open wounds have also been reported.

If any of these or other adverse effects occur, treatment should be discontinued and medical advice should be sought.

During the post-marketing period, peripheral neuropathy has been reported with topical use of metronidazole.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after a medicinal product has been authorized is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging, in a place inaccessible to children, at a temperature not exceeding 25 °C.

Packaging.

20 g of gingival gel in a tube, 1 tube per cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

LLC "Arpimed".

Manufacturer's address and location of business activity.

Building 19, 2nd microdistrict, city of Abovyan, Kotayk region, Republic of Armenia.