Instructions Metrogil denta gum gel tube 20 g
Composition
active ingredients: metronidazole benzoate, chlorhexidine gluconate;
1 gram of gel contains: metronidazole benzoate 16 mg, equivalent to metronidazole 10 mg; chlorhexidine gluconate solution (20%) 2.5 mg, equivalent to chlorhexidine gluconate 0.5 mg;
excipients: saccharin, sodium hydroxide, disodium edetate, levomenthol,
propylene glycol, carbomer homopolymer (type C), purified water.
Dosage form
Gum gel.
Main physicochemical properties: white or almost white opalescent soft gel.
Pharmacotherapeutic group
Means for use in dentistry. Antimicrobial and antiseptic agents for topical use in dentistry.
ATX code A01A B.
Pharmacological properties
Pharmacodynamics.
Antimicrobial combination drug for the complex treatment and prevention of certain infectious and inflammatory diseases of the oral cavity.
The effectiveness of the drug is due to the presence of two antibacterial components - metronidazole and chlorhexidine.
Metronidazole is a nitroimidazole derivative with antiprotozoal and antibacterial activity. It is active against anaerobic bacteria that cause periodontal disease: Porphyromonas gingivalis, Prevotella intermedia, Prevotella denticola, Fusobacterium fusiformis, Wolinella recta, Eikenella corrodens, Borrelia vincenti, Bacteroides melaninogenicus, Selenomonas spp.
Chlorhexidine is an antiseptic with bactericidal action. Its action is to increase the permeability of bacterial cell walls, as a result of which chlorhexidine penetrates into the bacterial cytoplasm, which leads to cell death. Active against a wide range of vegetative forms of gram-negative (Treponemaspp., Neisseriagonorrheae, Trichomonasspp., Chalmydiaspp., Ureaplasmaspp., Bacteroidesfragilis) and gram-positive microorganisms, as well as yeasts, dermatophytes and lipophilic viruses.
Some strains of Pseudomonas spp. and Proteus spp. have low sensitivity to chlorhexidine, while acid-fast bacteria and bacterial spores are not susceptible to the action of this substance. Chlorhexidine does not impair the functional activity of lactobacilli.
Pharmacokinetics.
The minimum inhibitory concentration (MIC50) of metronidazole for anaerobic bacteria is below 1 μg/ml. When the drug is applied topically (applied to the gums), the concentration of metronidazole in the gum area is significantly higher than when the drug is applied orally, and the level of systemic absorption of metronidazole when applied topically is significantly lower than when it is applied orally. The drug is well absorbed from the gastrointestinal tract and can be detected at an inhibitory level for bacteria in the blood and saliva within 1 hour after administration. Metronidazole is mainly metabolized in the liver. The main route of excretion of metronidazole and its metabolites is the kidneys. Reduced renal function does not change the pharmacokinetics of a single dose of metronidazole.
In case of ingestion of excess chlorhexidine during its topical application as part of a dental gel, approximately 1% of the dose that reaches the stomach is absorbed from the digestive tract. Chlorhexidine does not accumulate in the body and is minimally metabolized.
Indication
For the treatment of infectious and inflammatory diseases of the periodontal and oral mucosa.
Catarrhal, hypertrophic gingivitis, acute and chronic course.
Acute ulcerative-necrotic gingivitis (Vincent's gingivitis).
Generalized periodontitis, chronic and acute course.
Trauma to the oral mucosa caused by dentures.
Alveolitis (inflammation of the socket after tooth extraction).
For the prevention of exacerbations of chronic gingivitis and periodontitis.
Contraindication
Hypersensitivity to metronidazole, chlorhexidine, as well as nitroimidazole derivatives and any components included in the composition of the drug.
Contraindicated in patients with confirmed blood dyscrasias or a history of blood dyscrasias.
Contraindicated in patients with diseases of the peripheral and central nervous system.
Special safety precautions
Avoid getting the gel in your eyes.
Interaction with other medicinal products and other types of interactions
When applied topically at recommended doses, no systemic interactions of Metrogyl Denta gel with other drugs have been identified. However, caution should be exercised when prescribing Metrogyl Denta gel with certain drugs.
Warfarin and other coumarin anticoagulants. Metronidazole enhances the anticoagulant effect, leading to a prolongation of prothrombin time.
Disulfiram. Concomitant use increases the toxicity of the drugs, which may lead to the development of neurological symptoms.
Phenobarbital, phenytoin, hydantoin-based anticonvulsants. When used simultaneously with metronidazole, the antimicrobial activity of the latter decreases. The reason is the accelerated metabolism of metronidazole.
Alcohol: Metronidazole causes alcohol intolerance. Concomitant administration of alcohol and metronidazole may cause symptoms of toxic psychosis, nausea, hypotension, tachycardia, diaphoresis or dyspnea, and in rare cases severe hypotension and shock may occur. These reactions usually occur within 24 hours but may occur up to 2 weeks after alcohol intake.
Application features
The use of the drug Metrogil Denta does not replace hygienic tooth brushing.
You should not drink alcohol while using the drug, as this may cause stomach cramps, nausea, vomiting, headache, and flushing.
Metronidazole should not be used concomitantly with disulfiram, as it may cause psychotic reactions and confusion.
Prolonged use may cause brown discoloration of the teeth and tongue.
The use of Metrogil Denta gel may cause temporary changes in taste sensations.
Use during pregnancy or breastfeeding
The medicine should not be used during pregnancy.
Breastfeeding should be discontinued during treatment with the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
The use of the drug in the specified dose does not affect the ability to drive vehicles or potentially dangerous mechanisms.
Method of administration and doses
Locally, for dental use only!
Use the drug after consulting a dentist.
For adults with gum inflammation (gingivitis), Metrogil Denta gel should be applied to the gums using a finger massage or a cotton swab 2 times a day. After applying the gel, you should not rinse your mouth, drink or eat for 30 minutes. The average duration of treatment is 7–10 days.
In case of periodontitis: after removing dental plaque, periodontal pockets should be treated with Metrogil Denta gel, and the gel should also be applied to the gums. The duration of the application is 30 minutes. The number of procedures depends on the severity of the disease. In the future, the patient applies the gel independently. Metrogil Denta should be applied to the gum area 2 times a day for 7–10 days.
To prevent exacerbations of chronic gingivitis and periodontitis, Metrogil Dentan gel is applied to the gums 2 times a day for 7–10 days. Preventive treatment courses should be carried out 2–3 times a year.
To treat post-extraction alveolitis after tooth extraction, treat the socket with Metrogil Denta gel, then the patient applies the gel independently 2–3 times a day for 7–10 days.
To prevent exacerbation of chronic gingivitis and periodontitis, Metrogil Denta gel should be applied 2 times a day to the affected areas for 7–10 days. Preventive courses should be carried out 2–3 times a year.
To prevent exacerbations of chronic gingivitis and periodontitis, with bleeding gums and bad breath, in the evening after hygienic brushing of teeth, Metrogil Denta gel should be rubbed into the gum area for 2–3 minutes using a finger massage or a cotton swab. After rubbing, spit it out, do not rinse your mouth.
In order to prevent exacerbations in patients with catarrhal gingivitis and mild generalized periodontitis, in the morning and evening after hygienic brushing of the teeth with a finger massage or a cotton swab, Metrogil Denta gel should be rubbed for 2–3 minutes, after the procedure, one should refrain from rinsing the mouth and drinking liquids for one hour. Prophylactic courses of treatment lasting 2 weeks should be carried out 2–3 times a year.
Children
It is not recommended to prescribe the drug to children under 18 years of age.
Overdose
Cases of overdose of Metrogil Denta gel when applied topically are unknown.
Accidental or intentional ingestion of large amounts of gel may lead to exacerbation of adverse reactions initially caused by metronidazole (chlorhexidine is practically not absorbed from the gastrointestinal tract). These reactions include nausea, vomiting, dizziness. In more serious cases, paresthesia and convulsions may occur. High doses and prolonged systemic treatment with metronidazole are associated with the development of leukopenia, neutropenia, an increased risk of peripheral neuropathy and central nervous system toxicity. Treatment of overdose should include gastric lavage and, if necessary, symptomatic therapy.
Adverse reactions
With topical application of Metrogil Denta gel, the risk of developing systemic side effects is insignificant, however, the reactions described below may sometimes be observed.
Immune system disorders: allergic reactions including skin rash, pruritus, urticaria, angioedema, anaphylaxis including anaphylactic shock. One case of eyelid edema as a manifestation of angioedema has been described.
From the nervous system: headache.
On the part of the organs of vision: if the gel gets on the area close to the eyes, tearing, dryness of the mucous membrane and short-term redness may occur.
Gastrointestinal: metallic taste in the mouth, bitter taste in the mouth, nausea, possible appearance of plaque in the oral cavity, on the surface of the teeth and tongue.
Post-marketing data.
Oral use of chlorhexidine may cause hypersensitivity reactions, including symptoms of anaphylaxis, mouth irritation, discoloration of teeth and tongue, increased tartar formation, altered taste, bitter taste in the mouth, and burning, numbness, dryness, and soreness of the oral mucosa.
In post-marketing use, urticaria with swelling of the face, lips, mouth, throat and itching sensation, difficulty breathing, hoarseness, fainting, as well as allergic reactions (anaphylaxis) in the oral cavity on open wounds have been reported.
If these or other undesirable effects occur, treatment should be discontinued and a doctor should be consulted.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
20 g in an aluminum or laminated plastic tube. 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
Unique Pharmaceutical Laboratories (a division of J. B. Chemicals & Pharmaceuticals Ltd.).
Location of the manufacturer and address of its place of business
Plot No. 304-308, GIDC Industrial Area, City: Panoli - 394 116, Dist: Bharuch, India.
Applicant
Johnson & Johnson Ukraine LLC.
Applicant's location
01010, Kyiv, Moskovska St., 32/2, Ukraine.
+38 (044) 498 0888
+38 (044) 498 7392
