Vermox Chewable Tablets (McNeil Consumer)

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DESCRIPTION

VERMOX® (mebendazole) is a (synthetic) broad-spectrum anthelmintic available as chewable tablets, each containing 100 mg of mebendazole. Inactive ingredients are: colloidal silicon dioxide, corn starch, hydrogenated vegetable oil, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium saccharin, sodium starch glycolate, talc, tetrarome orange, and FD&C yellow No. 6.

Mebendazole is methyl 5-benzoylbenzimidazole-2-carbamate and has the following structural formula:

Mebendazole is a white to slightly yellow powder with a molecular weight of 295.29. It is less than 0.05% soluble in water, dilute mineral acid solutions, alcohol, ether and chloroform, but is soluble in formic acid.

CLINICAL PHARMACOLOGY

Following administration of 100 mg twice daily for three consecutive days, plasma levels of VERMOX® (mebendazole) and its primary metabolite, the 2-amine, do not exceed 0.03 µg/ml and 0.09 µg/ml, respectively. All metabolites are devoid of anthelmintic activity. In man, approximately 2% of administered VERMOX® is excreted in urine and the remainder in the feces as unchanged drug or a primary metabolite.

Mode of Action:   VERMOX® inhibits the formation of the worms' microtubules and causes the worms' glucose depletion.

INDICATIONS AND USAGE

VERMOX® (mebendazole) is indicated for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections.

Efficacy varies as a function of such factors as pre-existing diarrhea and gastrointestinal transit time, degree of infection, and helminth strains. Efficacy rates derived from various studies are shown in the table below:
[See table below]

CONTRAINDICATIONS

VERMOX® (mebendazole) is contraindicated in persons who have shown hypersensitivity to the drug.

WARNINGS

There is no evidence that VERMOX® (mebendazole), even at high doses, is effective for hydatid disease. There have been rare reports of neutropenia and agranulocytosis when VERMOX® was taken for prolonged periods and at dosages substantially above those recommended.

PRECAUTIONS

General:   Periodic assessment of organ system functions, including hematopoietic and hepatic, is advisable during prolonged therapy.

Information for Patients:   Patients should be informed of the potential risk to the fetus in women taking VERMOX® (mebendazole) during pregnancy, especially during the first trimester (see Pregnancy ).

Patients should also be informed that cleanliness is important to prevent reinfection and transmission of the infection.

Drug Interactions:   Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentrations of mebendazole.

Carcinogenesis, Mutagenesis, Impairment of Fertility:   In carcinogenicity tests of mebendazole in mice and rats, no carcinogenic effects were seen at doses as high as 40 mg/kg (one to two times the human dose, based on mg/m ² ) given daily over two years. Dominant lethal mutation tests in mice showed no mutagenicity at single doses as high as 640 mg/kg (18 times the human dose, based on mg/m ² ). Neither the spermatocyte test, the F ₁ translocation test, nor the Ames test indicated mutagenic properties. Doses up to 40 mg/kg in mice (equal to the human dose, based on mg/m ² ), given to males for 60 days and to females for 14 days prior to gestation, had no effect upon fetuses and offspring, though there was slight maternal toxicity.

Pregnancy: Teratogenic effects. Pregnancy Category C.   Mebendazole has shown embryotoxic and teratogenic activity in pregnant rats at single oral doses as low as 10 mg/kg (approximately equal to the human dose, based on mg/m ² ). In view of these findings the use of VERMOX® is not recommended in pregnant women. Although there are no adequate and well-controlled studies in pregnant women, a post-marketing survey has been done of a limited number of women who inadvertently had consumed VERMOX® during the first trimester of pregnancy. The incidence of spontaneous abortion and malformation did not exceed that in the general population. In 170 deliveries on term, no teratogenic risk of VERMOX® was identified.

Nursing Mothers:   It is not known whether VERMOX® is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VERMOX® is administered to a nursing woman.

Pediatric Use:   The drug has not been extensively studied in children under two years; therefore, in the treatment of children under two years the relative benefit/risk should be considered.

ADVERSE REACTIONS

Gastrointestinal:   Transient symptoms of abdominal pain and diarrhea in cases of massive infection and expulsion of worms.

Hypersensitivity:   Rash, urticaria and angioedema have been observed on rare occasions.

Central Nervous System:   Very rare cases of convulsions have been reported.

Liver:   There have been liver function test elevations [AST (SGOT), ALT (SGPT), and GGT] and rare reports of hepatitis when VERMOX® was taken for prolonged periods and at dosages substantially above those recommended.

Hematologic:   Neutropenia and agranulocytosis. (See WARNINGS ).

OVERDOSAGE

In the event of accidental overdosage gastrointestinal complaints lasting up to a few hours may occur. Vomiting and purging should be induced.

DOSAGE AND ADMINISTRATION

The same dosage schedule applies to children and adults. The tablet may be chewed, swallowed, or crushed and mixed with food.

If the patient is not cured three weeks after treatment, a second course of treatment is advised. No special procedures, such as fasting or purging, are required.

HOW SUPPLIED

VERMOX® (mebendazole) is available as chewable tablets, each containing 100 mg of mebendazole, and is supplied in boxes of twelve tablets.

Store at controlled room temperature 59°-77°F (15°-25°C).

NDC 50580-070-12 (blister package of 12)

Distributed by:

McNeil Consumer Healthcare

DIVISION OF McNEIL-PPC, INC.

FORT WASHINGTON, PA 19034 USA

©MCN-PPC, INC. '99

Revised October 1999

U.S. Patent 3,657,267

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