CLINICAL PHARMACOLOGY:

Following administration of 100 mg twice daily for three consecutive days, plasma levels of 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, is excreted in urine and the remainder in the feces as unchanged drug or a primary metabolite.

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

WARNINGS:

There is no evidence that mebendazole, even at high doses, is effective for hydatid disease. There have been rare reports of neutropenia and agranulocytosis.

PRECAUTIONS: 

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 mebendazole during pregnancy, especially during the first trimester. Patients should also be informed that cleanliness is important to prevent reinfection and transmission of the infection.

Pregnancy: Pregnancy Category C.  

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

Pediatric Use: In the treatment of children under two years the relative benefit/risk should be considered.

Drug Interactions:

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

SIDE EFFECTS:

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.

Hematologic:   Neutropenia and agranulocytosis.

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: Each pack of Ruz-Mebendazole 100 mg tablets contains 100 chewable tablets in 10 blisters.

storage: Store at controlled room temperature 15°-25°C.

Reference: PDR 2000, page 1700

                  USPDI for Professional Health Care, 2004, Page 1864-1866

                  Martindale 2005, Page 108-109