Gekmet (Gel) Instructions for Use

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

A01AB11 (Other drugs)

Active Substances

Metronidazole (Rec.INN registered by WHO)

Chlorhexidine (Rec.INN registered by WHO)

Dosage Form

Gekmet

Dental gel 1%+0.05%: tubes from 10 g to 100 g

Dosage Form, Packaging, and Composition

Dental gel opalescent, soft, white or almost white in color with a characteristic odor.

Excipients: propylene glycol – 50 mg, carbomer 980 – 15 mg, disodium edetate – 0.5 mg, saccharin – 1 mg, levomenthol – 5 mg, sodium hydroxide – 4 mg, purified water – up to 1 g.

5 g – aluminum tubes (1) – cardboard packs.
10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
35 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.
70 g – aluminum tubes (1) – cardboard packs.
80 g – aluminum tubes (1) – cardboard packs.
90 g – aluminum tubes (1) – cardboard packs.
100 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

A combined antimicrobial drug for topical use.

Metronidazole is a nitroimidazole derivative with antiprotozoal and antibacterial action against anaerobic protozoa and anaerobic bacteria that cause 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 contents of the bacterial cell are precipitated, which ultimately leads to the death of bacteria.

Indications

Acute gingivitis; acute necrotizing ulcerative gingivitis (Vincent’s); 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 after thorough teeth brushing and oral hygiene procedures.

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 using a finger or a cotton swab.

Use the gel twice daily, typically in the morning and evening. Do not rinse your mouth after application. Refrain from eating or drinking for at least 30 minutes post-application to ensure optimal contact time.

The standard course of treatment is 7 to 10 days. Do not exceed this duration without consulting a dentist.

For preventive purposes, mix a small, pea-sized amount of gel with your toothpaste during brushing. This preventive application should not replace the therapeutic regimen for active conditions.

If no improvement is observed within 3-5 days, or if symptoms worsen, discontinue use and 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 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 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 time).

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

The antimicrobial activity of metronidazole is reduced when used concomitantly with phenobarbital and phenytoin due to accelerated metabolism of metronidazole.

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

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.