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  • Flagyl
    / Sanofi


    Active Ingredient
    Metronidazole 250 mg, 40 mg/ml (benzoate)

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    20 X 250 mg

    full basket chart 89581 6420

    Oral Suspension

    120 ml

    full basket chart 83833 6441

    Related information


    Dosage

    Amebiosis
    Adults: 0..1 g/day in 3 intakes
    Children: 01 mg to 40 mg/kg/day in 3 intakes In the event of amebic liver abscess, drainage or aspiration of pus should be performed in conjunction with metronidazole therapy . Treatment duration is 7 consecutive days.
    Trichomoniasis: In women (trichomonas urethritis and vaginitis), a 10-day treatment period associating : 1..1 g/day in two oral intakes 0 pessary/day
    The sexual partner should be treated concomitantly, whether presenting with clinical signs of trichomonas vaginalis infection or not, even if laboratory test results are negative . in men (trichomonas urethritis) : 1..1 g/day in two oral intakes for 10 days In very rare cases, it may be necessary to increase the daily dose to 0.750 g or 1 g Lambliasis
    Adults: 1.7.1 g to 1 g/day for 5 consecutive days
    Children: Tablets: 6 to 10 years: 375 mg/day 01 to 15 years: 500 mg/day  Suspension : 2 to 5 years: 250 mg/day . to 10 years: 375 mg/day 01 to 15 years: 500 mg/day.
    Non-specific vaginitis 11 mg (2X250mg) oral tablets or suspension twice daily for 7 days or pessary daily per vaginal route during 7 days in combination with oral treatment , if required . The partner should be treated concomitantly. Treatment of infections caused by susceptible anaerobic micro-organisms (first line treatment or replacement treatment).
    Adults: 0 g to 1.5g/day
    Children: 20 mg to 30 mg/kg/day


    Indications

    Urethritis, vaginitis due to trichomonas vaginalis.Amoebiasis (intestinal and hepatic), giardiasis. Vincent’s infection of mouth and gums.


    Contra-Indications

    Known hypersensitivity to nitroimidazoles, metronidazole or any of the excipients.


    Special Precautions

    For all presentations: Regular clinical and laboratory monitoring (especially leucocyte count) are advised if administration of Flagyl for more than 10 days is considered to be necessary and patients should be monitored for adverse reactions, such as peripheral or central neuropathy (such as paraesthesia, ataxia, dizziness, convulsive seizures). Metronidazole should be used with caution in patients with active or chronic severe peripheral and central nervous system disease due to the risk of neurological aggravation. There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist. The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Flagyl need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD). Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Flagyl should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine. Due to inadequate evidence on the mutagenicity risk in humans, the use of flagyl for longer treatment than usually required should be carefully considered.
    For full details see prescribing information.


    Side Effects

    Serious adverse reactions occur rarely with standard recommended regimens. Clinicians who contemplate continuous therapy for the relief of chronic conditions, for periods longer than those recommended, are advised to consider the possible therapeutic benefit against the risk of peripheral neuropathy.
    For full details see prescribing information.


    Drug interactions

    Alcohol, barbiturates, coumarin anticoagulants, cimetidine, phenytoin, disulfiram, lithium.
    For full details see prescribing information.


    Pregnancy and Lactation

    There is inadequate evidence of the safety of metronidazole in pregnancy. Flagyl should not be given during pregnancy or during lactation unless the physician considers it essential; in these circumstances the short, high-dosage regimens are not recommended.


    Overdose

    Single oral doses of metronidazole, up to 12g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdose. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.


    Manufacturer
    Sanofi Aventis, S.P.A., Spain Unither Liquid Manufacturing, France
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