Metrodent (Gel) Instructions for Use

Marketing Authorization Holder

Kb-Pharma LLC (Republic Of Belarus)

Manufactured By

Synmedic Laboratories Ltd. (India)

ATC Code

A01AB11 (Other drugs)

Active Substances

Chlorhexidine (Rec.INN registered by WHO)

Metronidazole (Rec.INN registered by WHO)

Dosage Forms

	Metrodent	Dental gel 10 mg/g + 0.5 mg/g: 20 g tubes
		Dental gel, lemon 10 mg/g + 0.5 mg/g: 20 g tubes
		Dental gel, strawberry 10 mg/g + 0.5 mg/g: 20 g tubes
		Dental gel, pineapple 10 mg/g + 0.5 mg/g: 20 g tubes

Dosage Form, Packaging, and Composition

Dental gel homogeneous, from colorless to colorless with a slightly yellowish tint, with a specific smell of menthol.

Excipients: carbomer 934P – 12 mg, methylparaben – 1 mg, propylparaben – 0.1 mg, propylene glycol – 148.5 mg, sodium saccharin dihydrate – 1 mg, polysorbate 60 – 5 mg, levomenthol – 2.5 mg, trolamine – 5 mg, pineapple or lemon or strawberry flavor – 0.0013 ml, purified water – up to 1 g.

20 g – aluminum tubes (1) – cardboard packs.

Dental gel homogeneous, from colorless to colorless with a slightly yellowish tint, with a specific smell of menthol and a faint smell of lemon.

Excipients: carbomer 934P – 12 mg, methylparaben – 1 mg, propylparaben – 0.1 mg, propylene glycol – 148.5 mg, sodium saccharin dihydrate – 1 mg, polysorbate 60 – 5 mg, levomenthol – 2.5 mg, trolamine – 5 mg, pineapple or lemon or strawberry flavor – 0.0013 ml, purified water – up to 1 g.

20 g – aluminum tubes (1) – cardboard packs.

Dental gel homogeneous, from colorless to colorless with a slightly yellowish tint, with a specific smell of menthol and a faint smell of strawberry.

Excipients: carbomer 934P – 12 mg, methylparaben – 1 mg, propylparaben – 0.1 mg, propylene glycol – 148.5 mg, sodium saccharin dihydrate – 1 mg, polysorbate 60 – 5 mg, levomenthol – 2.5 mg, trolamine – 5 mg, pineapple or lemon or strawberry flavor – 0.0013 ml, purified water – up to 1 g.

20 g – aluminum tubes (1) – cardboard packs.

Dental gel homogeneous, from colorless to colorless with a slightly yellowish tint, with a specific smell of menthol and a faint smell of pineapple.

Excipients: carbomer 934P – 12 mg, methylparaben – 1 mg, propylparaben – 0.1 mg, propylene glycol – 148.5 mg, sodium saccharin dihydrate – 1 mg, polysorbate 60 – 5 mg, levomenthol – 2.5 mg, trolamine – 5 mg, pineapple or lemon or strawberry flavor – 0.0013 ml, purified water – up to 1 g.

20 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with antimicrobial action for topical use in dentistry

Pharmacotherapeutic Group

Antimicrobial agent

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 the death of bacteria.

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, which ultimately leads to the death of bacteria.

Indications

Acute gingivitis; acute necrotizing ulcerative gingivitis (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

Apply topically to the oral cavity only. Use twice daily, typically in the morning and evening, following thorough tooth brushing.

Dry the affected gum area with a gauze pad before application. Apply a thin layer of gel directly to the gingival margin, interdental spaces, and periodontal pockets using a clean finger or a cotton swab.

After application, avoid rinsing the mouth, eating, or drinking for at least 30 minutes to maximize local drug contact time.

The standard treatment course is 7 to 10 days, unless otherwise directed by a dental professional. Do not exceed the recommended duration of use without medical supervision.

For preventive purposes, a small pea-sized amount may be mixed with toothpaste during brushing, but this should not replace the primary therapeutic application method.

In cases of periodontal abscess or post-extraction alveolitis, the gel may be applied directly into the socket or abscess cavity after professional debridement.

If a dose is missed, apply it as soon as remembered. If it is nearly time for the next dose, skip the missed dose and continue with the regular schedule. Do not double the dose.

Discontinue use and consult a dentist if no improvement is observed within 3-5 days, or if symptoms worsen.

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 dosage 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 brushing of teeth, so during the course of treatment with the drug, tooth brushing should be continued. However, the application of the gel should not be combined with toothpaste at the same time.

Avoid contact with eyes.

Drug Interactions

It enhances the anticoagulant effect of warfarin (increased prothrombin 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 with 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.