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PHARMA DOCTOR: CHLORHEXIDINE, METRONIDAZOLE



METROGYL DENTA (CHLORHEXIDINE GLUCONATE WITH METRONIDAZOLE BENZOATE) DENTAL GEL: PRESCRIBING INFORMATION

DESCRIPTION

Pharmaceutical form: stomatological gel

Opalescent, white or almost white homogeneous gel.

International non-proprietary name: Metronidazole plus Chlorhexidine

Composition

Active ingredients: 1 g of Metrogyl Denta gel contains 16 mg Metronidazole Benzoate (equivalent to Metronidazole 10 mg), 2,5 mg Chlorhexidine Digluconate 20% solution (equivalent to Chlorhexidine Digluconate 0,5 mg).

Auxiliary substances: carbomer 940, propylene glycol, disodium edetate, levomenthol, sodium saccharine, sodium hydroxide.

Pharmacotherapeutic group: antimicrobial medication.


CLINICAL PHARMACOLOGY

The formulation of Metrogyl Denta gel is effective because it contains two antibacterial components:

  • Metronidazole has antibacterial action against anaerobic bacteria, which cause diseases of the parodontium: Prevotella intermedia, Porphyromonas gingivalis, Fusobacterium fusiformis, Eikenella corrodens, Wolinella recta, Borrelia vincenti, Bacteroides melaninogenicus, Selenomonas spp.

  • Chlorhexidine is an antiseptic and antibacterial, which is effective against gram-positive and gramnegative aerobic and anaerobic bacteria (Neisseria gonorrhoeae, Treponema spp., Trichomonas spp., Chlamydia spp., Ureaplasma spp., Bacteroides fragilis). Some strains of Pseudomonas spp. and Proteus spp. are slightly sensitive to this formulation. Acid-resistant forms of bacteria and spores of bacteria are also resistant to this medication. This medicine does not damage the functional activity of lactobacilli.

    When used locally, Metrogyl Denta gel is practically not absorbed.


    INDICATIONS AND USAGE

    Metrogyl Denta is used for infectious-inflammatory diseases of the parodontium and mucosa of the oral cavity:

  • acute necrotizing ulcerative gingivitis (Vincent's gingivitis);
  • acute and chronic gingivitis;
  • acute and chronic parodontitis;
  • parodontosis complicated by gingivitis;
  • juvenile parodontitis;
  • pulpitis;
  • cheilitis;
  • aphthous stomatitis;
  • inflammation of the mucosa in the oral cavity caused by use of dentures;
  • post-extraction alveolitis (inflammation of the cavity after removal of the tooth);
  • periodontitis, periodontal abscess (as part of combination therapy).


    CONTRAINDICATIONS

  • Individual intolerance of metronidazole, chlorhexidine, as well as of nitroimidazole derivatives.
  • Intolerance to any components of Metrogyl Denta gel included in the composition of remedy.
  • Children under 6 years old.


    WARNINGS

    Use of Metrogyl Denta gel does not replace the hygienic cleaning of teeth. Therefore, patients must continue to clean their teeth during the course of treatment.

    If this medication has come into disrepair or expired - do not throw it in the waste water or on the street. Place Metrogyl Denta in the package and put it in the dumpster. These measures will help protect the environment.


    PRECAUTIONS

    Pregnancy and Lactation

    Metrogyl Denta should not be prescribed for pregnant women in the first trimester of pregnancy. It is necessary to consider discontinuation of breast feeding, if this medication is to be prescribed during the lactation period.


    DRUG INTERACTIONS

    Systemic interaction of Metrogyl Denta gel with other medicines has not been observed when it is used locally at the recommended dosage.


    DOSAGE AND ADMINISTRATION

    Local, only for stomatological use.

    Adults and children over 6 years for inflammation of the gums (gingivitis): apply Metrogyl Denta as a thin layer on the gums twice daily using a finger or swab. Avoid drinking and eating for 30 minutes after applying the gel. Do not remove the gel by rinsing. The average duration of treatment is 7-10 days.

    In parodontitis: after removing the dental deposits, treat the parodontal pockets with Metrogyl Denta gel and apply the gel on the gums. The exposure time should be 30 minutes. The number of treatments depends upon the severity of the disease. Further application of the gel can be carried out by the patient independently: apply Metrogyl Denta gel on the gums twice daily during 7-10 days.

    In aphthous stomatitis: apply Metrogyl Denta gel on the affected part of the mucosa in the oral cavity twice daily during 7-10 days.

    Prophylaxis of aggravation of chronic gingivitis and parodontitis

    Apply Metrogyl Denta gel on the gums twice daily during 7-10 days. Prophylactic courses of treatment can be conducted 2-3 times yearly.

    Prophylaxis of post-extraction alveolitis

    After the extraction of a tooth the cavity treated with Metrogyl Denta gel, then gel applied outpatient 2-3 times daily during 7-10 days.


    ADVERSE EFFECTS

    When Metrogyl Denta gel is used locally there may be allergic reaction (skin rash, itching, urticaria), as well as headache.


    OVERDOSE

    Accidental or deliberate ingestion of large amounts of Metrogyl Denta gel may be reason increasing of side effects, mainly due metronidazole (chlorhexidine is practically not absorbed from the gastrointestinal tract). May be occur: vomiting, nausea, dizziness, in more severe cases - seizures, paresthesias. Treatment: gastric lavage, as necessary symptomatic therapy.


    STORAGE / HOW SUPPLIED

  • Metrogyl Denta 20 g gel in a plastic laminated tube with nozzle sealed with aluminium foil laminated with polyethylene and screw cap made of polypropylene. One tube with instructions for use is put in a cardboard packing.
  • Metrogyl Denta 20 g gel in a plastic laminated tube with nozzle sealed with aluminium foil laminated with polyethylene and screw cap made of polypropylene with a spike for piercing the foil. One tube with instructions for use is put in a cardboard packing.

    Storage

    Store at a temperature not exceeding 25°C.

    Keep out of the reach and sight of children.

    Shelf life: 3 years. Do not use after expiration date.

    Conditions of sale from pharmacies: OTC (without prescription).

    Manufactured and distributed by Unique Pharmaceutical Laboratories, Johnson & Johnson pharmaceutical companies and their divisions.



    Metrogyl Denta (Chlorhexidine Gluconate, Metronidazole Benzoate) dental gel related pharmaceutical drugs and medications

    Trade name of the drug Pharmaceutical forms and doses Companies
    Malaseb prescribing information
  • Shampoo; Topical; Chlorhexidine Gluconate 2%; Miconazole Nitrate 2%
  • Bayer
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