Dentamet (Gel) Instructions for Use

Marketing Authorization Holder

Altayvitamins, JSC (Russia)

ATC Code

A01AB11 (Other drugs)

Active Substances

Metronidazole (Rec.INN registered by WHO)

Chlorhexidine (Rec.INN registered by WHO)

Dosage Form

Dentamet

Dental gel 10 mg/1 g+1 mg/1 g: tubes 10 g or 25 g

Dosage Form, Packaging, and Composition

Dental gel from white to white with a yellowish tint, homogeneous.

Excipients: levomenthol (L-menthol), glycerol (glycerin), propylene glycol, trolamine (thermostable triethanolamine), carbomer, sodium saccharin dihydrate, purified water.

10 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with antimicrobial action for topical use in dentistry

Pharmacotherapeutic Group

Drugs used in dentistry; antimicrobial drugs and antiseptics for the local treatment of oral diseases

Pharmacological Action

Combined antimicrobial drug for topical application.

Metronidazole is a nitroimidazole derivative with antiprotozoal and antibacterial action against anaerobic protozoa and anaerobic bacteria causing periodontitis: Porphyromonas gingivalis, Prevotella intermedia, Prevotella denticola, Fusobacterium fusiformis, Wolinella recta, Treponema spp., Eikenella corrodens, Borrelia vincenti, Bacteroides melaninogenicus, Selenomonas spp.

It is inactive against aerobic bacteria.

The mechanism of action involves the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole interacts with the DNA of the microorganism cell, inhibiting the synthesis of their nucleic acids, which leads to bacterial death.

Chlorhexidine is a disinfectant active against a wide range of vegetative forms of gram-negative and gram-positive microorganisms, yeasts, dermatophytes, and lipophilic viruses. It acts on bacterial spores only at elevated temperatures. The bactericidal effect is due to the binding of cations (a result of the dissociation of the chlorhexidine salt in a physiological environment) with the negatively charged walls of bacterial cells and extramicrobial complexes. In low concentrations, by disrupting the osmotic balance of bacterial cells and the release of potassium and phosphorus ions from them, it has a bacteriostatic effect; in high concentrations, the cytoplasmic content of the bacterial cell precipitates, ultimately leading to bacterial death.

Indications

Acute gingivitis; acute necrotizing ulcerative Vincent’s gingivitis; chronic edematous gingivitis; chronic hyperplastic gingivitis; chronic atrophic (desquamative) gingivitis; chronic periodontitis; periodontal abscess; recurrent aphthous (ulcerative) stomatitis; gangrenous pulpitis; post-extraction alveolitis; juvenile periodontitis; toothache of infectious origin.

ICD codes

Dosage Regimen

For dental use only.

Apply the gel topically after thorough teeth brushing.

Dry the affected gum area with a gauze pad before application.

Apply a thin layer of gel directly to the gingival margin and interdental spaces.

Use the gel twice daily, typically in the morning and evening.

Refrain from eating or drinking for at least 30 minutes after application.

For preventive purposes, mix a small amount of gel with your toothpaste.

The standard treatment course is 7 to 10 days.

Do not exceed the recommended duration of use without consulting a dentist.

If symptoms persist after a full course, seek professional dental advice.

Adverse Reactions

Local reactions: “metallic” taste in the mouth.

Systemic reactions: headache, allergic reactions (skin rash, itching, urticaria).

Contraindications

Hypersensitivity (including to metronidazole, chlorhexidine, and nitroimidazole derivatives); children under 18 years of age (depending on the drug form used).

Use in Pregnancy and Lactation

Use during pregnancy is not recommended.

If use during lactation is necessary, the issue of discontinuing breastfeeding should be considered.

Pediatric Use

Contraindication – children under 18 years of age.

Special Precautions

The use of the drug does not replace hygienic teeth cleaning, so during the course of treatment with the drug, teeth brushing should be continued. However, the application of the gel should not be combined simultaneously with toothpaste.

Avoid contact with eyes.

Drug Interactions

It enhances the anticoagulant effect of warfarin (increased prothrombin formation time).

Concomitant use with disulfiram increases toxicity, which may lead to the development of neurological symptoms.

The antimicrobial activity of metronidazole is reduced with simultaneous use of phenobarbital and phenytoin due to accelerated metabolism of metronidazole.

Cimetidine inhibits the metabolism of metronidazole, which may lead to an increase in the concentration of metronidazole in the blood serum.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.