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  • Vermox
    / Janssen


    Active Ingredient
    Mebendazole 100 mg, 20 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Suspension

    20 mg/ml X 30 ml

    full basket chart 2373 22061

    Tablets

    6 x 100 mg

    not in the basket chart 20436 22038

    Dosage

    Enterobiasis: Adults and children over 2 years: 1 tablet or 5 ml oral suspension given as a single dose. Since reinfections by Enterobius vermicularis are known to be very frequent, it is recommended that the treatment be repeated after 2 and 4 weeks, particularly in eradication programs.
    Ascariasis, trichuriasis, hookworm and mixed infestations: Adults and children over 2 years 1 tablet b.i.d. or 5 ml oral suspension in the morning and in the evening for 3 consecutive days.
    Taeniasis and strongyloidiasis: Adults: Although favorable results have been obtained with lower dosages, it is suggested that 2 tablets b.i.d. or 10ml oral suspension be prescribed in the morning and the evening for 3 consecutive days, to obtain complete cure. Even at this higher dosage undesirable effects are rare.
    Children over 2 years –  1 tablet b.i.d. or 5 ml oral suspension b.i.d. for 3 consecutive days. No special procedures, such as diet or use of laxatives, are required.
    For children < 2 year –  see Special precautions.
    Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine.


    Indications

    Treatment in single or mixed infections of Trichuris trichiura (whipworm), Ascaris lumbricoides (large roundworm), Ancylostoma duodenale, Necator americanus (hookworm), Strongyloides stercoralis, Enterobius vermicularis (threadworm/pinworm) and Taenia species.


    Contra-Indications

    VERMOX is contraindicated in pregnancy and in persons with a known hypersensitivity to the drug or its components.


    Special Precautions

    Vermox is not recommended in the treatment of children under 2 years. Convulsions in children, including in infants below one 2 year of age: have been reported very rarely during post-marketing experience with VERMOX
    VERMOX is not recommended in children below 2 years of age. VERMOX 100 mg should only be given to very young children if their worm infestation interferes significantly with their nutritional status and physical development Results from a case-control study investigating an outbreak of Stevens- Johnson syndrome /toxic epidermal necrolysis (SJS/TEN) suggested a possible relationship between SJS/TEN and the concomitant use of mebendazole and metronidazole. Further data suggesting such a drug-drug interaction are not available. Therefore, concomitant use of mebendazole and metronidazole should be avoided.Vermox oral suspension contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption of
    sucrose-isomaltase insufficiency should not take this medicine.


    Side Effects

    Throughout this section adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of VERMOX based on the comprehensive assessment of the available adverse event information. A causal relationship with VERMOX cannot be reliably established in individual casesFurther, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates
    observed in clinical practice. The safety of VERMOX was evaluated in 6276 subjects who participated in 39
    clinical trials for the treatment of single or mixed parasitic infestations of the gastrointestinal tract. In these 39 clinical trials, no adverse drug reactions (ADRs) occurred in ≥1% of VERMOX-treated subjects.


    Drug interactions

    Concomitant treatment with cimetidine may inhibit the metabolism of mebendazole in the liver, resulting in increased plasma concentrations of the drug, especially during prolonged treatment. In the latter case, determination of plasma concentrations is recommended in order to allow dose adjustments. Concomitant use of mebendazole and metronidazole should be avoided.


    Pregnancy and Lactation

    Mebendazole has shown embryotoxic and teratogenic activity in rats and in mice at single oral doses. No harmful effects on reproduction were noted in other animal species tested. The possible risks associated with prescribing VERMOX during pregnancy, particularly during the first trimester, should be weighed against the expected therapeutic benefits.
    Mebendazole is only absorbed to a small extent. It is not known whether mebendazole is excreted in human breast milk. Therefore, caution should be exercised when VERMOX is administered to nursing women.


    Overdose

    In patients treated at dosages substantially higher than recommended or for prolonged periods of time, the following adverse reactions have been reported rarely: alopecia, reversible liver function disturbances, hepatitis, agranulocytosis, neutropoenia, and glomerulonephritis. With the exception of agranulocytosis and glomerulonephritis, these also have been reported in patients who were treated with mebendazole at standard dosages.
    Symptoms: In the event of accidental overdose, abdominal cramps, nausea, vomiting and diarrhea may occur.
    Treatment: There is no specific antidote. Within the first hour after ingestion, gastric lavage may be performed. Activated charcoal may be given if considered appropriate.


    Manufacturer
    Janssen Pharmaceuticals
    Licence holder
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