Vermox (Mebendazole)

VERMOX®

Janssen-Ortho

Mebendazole

Anthelmintic

Action And Clinical Pharmacology: Mebendazole induces in vitro and in vivo inhibition of the glucose uptake by parasitic helminths; this is associated with glycogen depletion and a decrease in the generation of ATP, leading to inhibition of larval development.

Mebendazole is poorly absorbed after oral administration. At the normal anthelmintic dosage, the bioavailability is poor due to a combination of high first-pass metabolism and the very low solubility of the drug.

Indications And Clinical Uses: Mebendazole has a broad spectrum of anthelmintic activity and is effective in the treatment of single or mixed helminthic infestations. Clinical studies have shown it effective in the treatment of Enterobius vermicularis (pinworm); Ascaris lumbricoides (roundworm); Trichuris trichiura (whipworm); Ankylostoma duodenale and Necator americanus (hookworm). It has also been used to treat infections due to Strongyloides stercoralis and Taenia solium (large tapeworms).

Contra-Indications: In persons who have shown hypersensitivity to the drug.

Manufacturers’ Warnings In Clinical States: Pregnancy: Animal trials conducted in a wide range of species revealed an embryotoxic and teratogenic effect in the rat. Also, the safety of use in pregnant women has not been established. Therefore, mebendazole should not be administered during pregnancy, particularly in the first trimester, unless the potential benefit to the patient outweighs the possible risk to the fetus.

Precautions: Patients should be carefully checked to detect any alteration in blood studies or hepatic or renal function tests following treatment with mebendazole. Special attention should be given to patients with intestinal pathology (e.g. Crohn’s ileitis, ulcerative colitis).

Lactation: It is not known whether mebendazole is excreted in human milk. Therefore caution should be exercised when mebendazole is administered to nursing women.

Children (under age 2): Since mebendazole has not been extensively studied in infants under 2 years of age, its use in such individuals should only be implemented in cases where the potential therapeutic effects outweigh the possible hazard to the patient. There have been very exceptional reports of convulsions in infants less than 1 year old.

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 are recommended in order to allow dose adjustments.

Adverse Reactions: Mebendazole is generally well tolerated. However, patients with high parasitic burdens when treated with mebendazole have manifested diarrhea, vomiting and/or abdominal pain. Other adverse reactions reported were drowsiness, itching, headache and dizziness. Reports from clinical trials also mentioned increased AST, ALT, alkaline phosphatase and BUN. Eosinophilia and decreased hemoglobin and/or white cell count, hematuria and cylindruria have been reported. Hypersensitivity reactions such as exanthema, rash, urticaria and angioedema have rarely been observed.

Symptoms And Treatment Of Overdose: Symptoms: In the event of accidental overdosage, abdominal cramps, nausea, vomiting and diarrhea may occur. Although the recommended maximum treatment duration of mebendazole is limited to 3 days, there have been rare reports of reversible liver function disturbances, hepatitis and neutropenia described in patients who were treated for hydatid disease with massive doses for prolonged periods of time.

Treatment: There is no specific antidote. Gastric lavage with aqueous potassium permanganate at 20 mg/100 mL may be performed. Activated charcoal may be given.

Dosage And Administration: Adults and Children 2 Years and Older: Enterobiasis: One tablet (100 mg) given as a single dose. Since reinfections by Enterobius are known to be very frequent, it is recommended that treatment be repeated after 2 or 4 weeks, especially in eradication programs.

Trichuriasis, ascariasis, ankylostomiasis, strongyloidiasis, taeniasis and mixed infections: One tablet (100 mg) in the morning and evening for 3 consecutive days.

If the patient is not cured 3 weeks after treatment, a second course of treatment is advised.

No special procedures such as fasting or purgation are required.

Tablets must be chewed.

Children Under 2 Years: See Precautions.

Availability And Storage: Each chewable, orange, scored, compressed tablet contains: mebendazole 100 mg. Nonmedicinal ingredients: colloidal silicon dioxide, dextrose, magnesium stearate, methylcellulose, natural orange flavor, sodium lauryl sulfate and sunset yellow (E110). Bisulfite-, gluten- and tartrazine-free. Amber glass bottles of 12. Store between 15 and 30°C. Protect from light.

VERMOX® Janssen-Ortho Mebendazole Anthelmintic

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