WORMAZOL

A benzimidazole that acts by interfering with carbohydrate metabolism and inhibiting polymerization of microtubules.

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.

Mebendazole is a (synthetic) broad-spectrum anthelmintic.

The principal mode of action for

Mebendazole is by its inhibitory effect on tubulin polymerization which results in the loss of cytoplasmic microtubules.

Poorly absorbed (approximately 5-10%) from gastrointestinal tract.

Fatty food increases absorption.

Primarily hepatic.

Primary metabolite is 2-amino-5-benzoylbenzimidazole, but also metabolized to inactive hydroxy and hydroxyamino metabolites.

All metabolites are devoid of anthelmintic activity.

Hover over products below to view reaction partners Mebendazole 2-amino-5-benzoylbenzimidazole.

In man, approximately 2% of administered mebendazole is excreted in urine and the remainder in the feces as unchanged drug or a primary metabolite.

2.5-5.5 hours (range 2.5-9 hours) in patients with normal hepatic function.

Approximately 35 hours in patients with impaired hepatic function (cholestasis).

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Acute oral toxicity (LD 50 ): 620 mg/kg.

Symptoms of overdose include elevated liver enzymes, headaches, hair loss, low levels of white blood cells (neutropenia), fever, and itching.

VERMOX™ CHEWABLE is contraindicated in persons with a known hypersensitivity to the drug or its excipients.

Patients with a known hypersensitivity to the drug or its excipients.

The recommended dosage in patients one year of age and older is one VERMOX™ CHEWABLE 500 mg tablet taken as a single dose.

VERMOX™ CHEWABLE 500 mg tablet completely before swallowing.

Do not swallow the tablet whole.

For patients who have difficulty chewing the tablet, approximately 2 mL to 3 mL of drinking water can be added to a suitably sized spoon and the VERMOX™ CHEWABLE 500 mg tablet placed into the water.

Within 2 minutes, the tablet absorbs the water and turns into a soft mass with semi-solid consistency, which can then be swallowed.

VERMOX™ CHEWABLE 500 mg tablet can be taken without regard to food intake.

The recommended dosage in patients one year of age and older is one single tablet of VERMOX™ CHEWABLE 500 mg taken as a single dose, chewed completely before swallowing.

Information for administration instructions for patients who have difficulty chewing the tablets.

VERMOX™ CHEWABLE tablets are supplied as 500 mg, round, flat radius-edged white to yellowish chewable tablets that are debossed with "M/500" on one side and "J" on the other side.

They are supplied as follows

Bottles of 200 tablets NDC 50458-675-20 Store below 30°C. Keep container tightly closed.

Unused tablets should be discarded 1 month after the bottle is first opened.

When the bottle is first opened this Discard After date should be written on the bottle label in the place provided.

Store below 30°C. Keep container tightly closed.

Unused tablets should be discarded 1 month after the bottle is first opened.

When the bottle is first opened this Discard After date should be written on the bottle label in the place provided.

The available published literature on mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages.

There are risks to the mother and fetus associated with untreated helminthic infection during pregnancy.

In animal reproduction studies, adverse developmental effects (i.e., skeletal malformations, soft tissue malformations, decreased pup weight, embryolethality) were observed when mebendazole was administered to pregnant rats during the period of organogenesis at single oral doses as low as 10 mg/kg (approximately 0.2-fold the maximum recommended human dose (MRHD)).

Maternal toxicity was present at the highest of these doses.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the

U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Maternal and/or Embryo/Fetal Risks Untreated soil-transmitted helminth infections in pregnancy are associated with adverse outcomes including maternal iron deficiency anemia, low birth weight, neonatal and maternal death.

Several published studies, including prospective pregnancy registries, case-control, retrospective cohort, and randomized controlled studies, have reported no association between mebendazole use and a potential risk of major birth defects or miscarriage.

Overall, these studies did not identify a specific pattern or frequency of major birth defects with mebendazole use.

However, these studies cannot definitely establish the absence of any mebendazole-associated risk because of methodological limitations, including recall bias, confounding factors and, in some cases, small sample size or exclusion of first trimester mebendazole exposures.

Embryo-fetal developmental toxicity studies in rats revealed no adverse effects on dams or their progeny at doses up to 2.5 mg/kg/day on gestation days 6–15 (the period of organogenesis).

Dosing at ≥10 mg/kg/day resulted in a lowered body weight gain and a decreased pregnancy rate.

Maternal toxicity, including body weight loss in one animal and maternal death in of 20 animals, was seen at 40 mg/kg/day. At 10 mg/kg/day, increased embryo-fetal resorption (100% were resorbed at 40 mg/kg/day), decreased pup weight and increased incidence of malformations (primarily skeletal) were observed.

Mebendazole was also embryotoxic and teratogenic in pregnant rats at single oral doses during organogenesis as low as 10 mg/kg (approximately 0.2-fold the MRHD, based on mg/m 2 ).

In embryo-fetal developmental toxicity studies in mice dosed on gestation days 6–15, doses of 10 mg/kg/day and higher resulted in decreased body weight gain at and 40 mg/kg/day and a higher mortality rate at 40 mg/kg/day. At doses of 10 mg/kg/day (approximately 0.1-fold the MRHD, based on mg/m 2 ) and higher, embryo-fetal resorption increased (100% at 40 mg/kg) and fetal malformations, including skeletal, cranial, and soft tissue anomalies, were present.

Dosing of hamsters and rabbits did not result in embryotoxicity or teratogenicity at doses up to 40 mg/kg/day (0.6 to 1.6-fold the MRHD, based on mg/m 2 ).

In a peri.

• and post-natal toxicity study in rats, mebendazole did not adversely affect dams or their progeny at 20 mg/kg/day. At 40 mg/kg (0.8-fold the MRHD, based on mg/m 2 ), a reduction of the number of live pups was observed and there was no survival at weaning.

No abnormalities were found on gross and radiographic examination of pups at birth.

The safety and effectiveness of

VERMOX™ CHEWABLE 500 mg tablets have been established in pediatric patients to 16 years of age.

Use of

VERMOX™ CHEWABLE 500 mg tablets in children is supported by evidence from adequate and well-controlled studies of VERMOX™ CHEWABLE 500 mg tablets.

The safety and effectiveness of mebendazole, including VERMOX™ CHEWABLE have not been established in pediatric patients less than one year of age.

Convulsions have been reported with mebendazole use in this.

Clinical studies of mebendazole did not include sufficient numbers of subjects aged and older to determine whether they respond differently from younger subjects.