VA Class:AP200

AHFS Class:

• Anthelmintics 8:08

Generic Name(s):

• Mebendazole

Mebendazole, a benzimidazole derivative, is a synthetic anthelmintic agent.100,107

Mebendazole is used for the treatment of a variety of nematode (roundworm) infections, including ascariasis caused by Ascaris lumbricoides ,100,105,107,134 enterobiasis (pinworm infection) caused by Enterobius vermicularis ,107,134 trichuriasis (whipworm infection) caused by Trichuris trichiura ,100,105,107,134 and hookworm infections caused by Ancylostoma duodenale ,105,107,134 Necator americanus ,105,107,134 or Ancylostoma caninum †.134 Mebendazole has produced egg reduction percentages and/or cure rates of 95-98% in patients with ascariasis, enterobiasis, or hookworm infection caused by A. duodenale or N. americanus and has produced egg reduction percentages of 93% and cure rates of 68% in patients with trichuriasis.107

Nematode (Roundworm) Infections

Ascariasis

Mebendazole is used for the treatment of ascariasis caused by Ascaris lumbricoides .100,105,107,134 Albendazole, mebendazole, and ivermectin are considered the drugs of choice for the treatment of ascariasis.105,134

Enterobiasis

Mebendazole is used for the treatment of enterobiasis caused by Enterobius vermicularis (pinworm).107,134 Albendazole, mebendazole, and pyrantel pamoate are considered the drugs of choice for the treatment of enterobiasis.105,134

Hookworm Infections

Intestinal Hookworm Infections

Mebendazole is used for the treatment of intestinal hookworm infections caused by Ancylostoma duodenale or Necator americanus in single or mixed infections.105,107,134 Albendazole, mebendazole, or pyrantel pamoate are considered the drugs of choice for intestinal hookworm infections.105,134

Eosinophilic Enterocolitis Caused by Ancylostoma caninum

Albendazole, mebendazole, or endoscopic removal of worms is recommended for the treatment of eosinophilic enterocolitis† caused by Ancylostoma caninum (dog hookworm).134

Trichuriasis

Mebendazole is used in the treatment of trichuriasis caused by Trichuris trichiura (whipworm).100,105,107,134 Albendazole is the drug of choice and mebendazole and ivermectin are alternatives for the treatment of trichuriasis.105,134

Angiostrongyliasis

Mebendazole (with or without a corticosteroid) may shorten the course of infection (but not the number of relapses) in patients with eosinophilic meningitis caused by Angiostrongylus cantonensis †.134,152 Most patients experience a self-limited course of infection with complete recovery.134 No drug is proven to be effective in the treatment of this infection and some patients have worsened when treated.134

Baylisascariasis

Although albendazole is the drug of choice for the treatment of baylisascariasis† caused by Baylisascaris procyonis (raccoon roundworm),105,134,153,154 some clinicians suggest that mebendazole, levamisole (not commercially available in the US), or ivermectin may be alternatives if albendazole is unavailable.134

Capillariasis

Mebendazole is considered the drug of choice and albendazole is an alternative for the treatment of capillariasis† caused by Capillaria philippinensis (Philippine threadworm).134

Toxocariasis (Visceral Larva Migrans)

Mebendazole is used for the treatment of toxocariasis† (visceral larva migrans) caused by Toxocara canis or T. cati (dog or cat roundworm), and albendazole or mebendazole are considered the drugs of choice for these infections.105,134 In severe cases with cardiac, ocular, or CNS involvement, corticosteroids also may be indicated.105,134 Antiparasitic treatment may not be effective in ocular larva migrans;105 inflammation may be reduced by corticosteroid injections and surgery may be necessary for secondary damage.105

Trichinellosis

Mebendazole is used for the treatment of trichinellosis† (trichinosis) caused by Trichinella spiralis (pork worm).105,134 Although some clinicians state that albendazole and mebendazole are equally effective for the treatment of trichinosis,105 other clinicians consider albendazole the drug of choice and mebendazole the alternative.134 Use of corticosteroids in addition to the anthelmintic usually is recommended, especially when symptoms are severe.105,125,127,134 Corticosteroids alleviate symptoms of the inflammatory reaction and can be lifesaving when cardiac or CNS systems are involved.105

Trichostrongyliasis

Mebendazole is used in the treatment of trichostrongyliasis†.134 Pyrantel pamoate is considered the drug of choice for the treatment of Trichostrongylus infections and albendazole and mebendazole are alternatives.134

Administration

Mebendazole is administered orally and may be taken without regard to meals.100,107

Mebendazole 100-mg chewable tablets may be chewed, swallowed whole, or crushed and mixed with food.107

Mebendazole 500-mg chewable tablets must be chewed completely before swallowing and should not be swallowed whole.100 In individuals who have difficulty chewing, the 500-mg tablet should be placed on a spoon and about 2-3 mL of drinking water added onto the tablet using a dosing syrin 100 within 2 minutes, the tablet should absorb the water and change into a soft, semi-solid mass that can be swallowed.100

Dosage

Nematode (Roundworm) Infections

Ascariasis

For the treatment of ascariasis caused by Ascaris lumbricoides in adults and pediatric patients 2 years of age or older, the recommended dosage of mebendazole is 100 mg twice daily (morning and evening) for 3 consecutive days.107,134 The manufacturer states that if the patient is not cured 3 weeks after mebendazole treatment, a second course of treatment is advised.107

Alternatively, a single 500-mg dose of mebendazole may be given as a single 500-mg chewable tablet for the treatment of ascariasis in adults and pediatric patients 1 year of age or older.100,134

Enterobiasis

For the treatment of enterobiasis caused by Enterobius vermicularis (pinworm) in adults and pediatric patients 2 years of age or older, the recommended dosage of mebendazole is a single 100-mg dose.107,134

Some clinicians recommend that adults and pediatric patients receive a second 100-mg dose of mebendazole given 2 weeks later.134 The manufacturer states that if the patient is not cured within 3 weeks following the initial dose, a second 100-mg dose is advised.107

Because other family members often are infected, some clinicians recommend that all household contacts of patients with enterobiasis receive treatment, especially when multiple or repeated symptomatic infections are occurring in the household.105,134

Hookworm Infections

For the treatment of intestinal hookworm infections caused by Ancylostoma duodenale or Necator americanus , the recommended dosage of mebendazole for adults and pediatric patients 2 years of age or older is 100 mg twice daily (morning and evening) for 3 consecutive days.107,134 The manufacturer states that if the patient is not cured 3 weeks after mebendazole therapy, a second course of treatment is advised.107

Alternatively, some clinicians recommend that adults and pediatric patients receive a single 500-mg dose of mebendazole for the treatment of hookworm infections caused by A. duodenale or N. americanus .134

For the treatment of eosinophilic enterocolitis† caused by Ancylostoma caninum (dog hookworm), some clinicians recommend that adults and pediatric patients receive mebendazole in a dosage of 100 mg twice daily for 3 consecutive days.134

Trichuriasis

For the treatment of trichuriasis caused by Trichuris trichiura (whipworm) in adults and pediatric patients 2 years of age or older, the recommended dosage of mebendazole is 100 mg twice daily (morning and evening) for 3 consecutive days.107,134 The manufacturer states that if the patient is not cured 3 weeks after mebendazole treatment, a second course of treatment is advised.107

Alternatively, a single 500-mg dose of mebendazole may be given as a single 500-mg chewable tablet for the treatment of ascariasis in adults and pediatric patients 1 year of age or older.100,134

Capillariasis

For the treatment of capillariasis† caused by Capillaria philippinensis (Philippine threadworm), some clinicians recommend that adults and pediatric patients receive mebendazole in a dosage of 200 mg twice daily for 20 days.134

Toxocariasis (Visceral Larva Migrans)

For the treatment of toxocariasis† (visceral larva migrans) caused by dog or cat roundworms, some clinicians recommend that adults and pediatric patients receive mebendazole in a dosage of 100-200 mg twice daily for 5 days.134 However, optimum duration of therapy is not known and some clinicians recommend that treatment be continued for up to 20 days.134 For severe symptoms or eye involvement, some clinicians state that treatment may be extended to 2-4 weeks.134

Trichinellosis

For the treatment of trichinellosis† (trichinosis) caused by Trichinella spiralis (pork worm) in adults and pediatric patients, some clinicians recommend a mebendazole dosage of 200-400 mg 3 times daily for 3 days followed by 400-500 mg 3 times for 10 days.134

Trichostrongyliasis

For the treatment of infections caused by Trichostrongylus †, some clinicians recommend that adults and pediatric patients receive mebendazole in a dosage of 100 mg twice daily for 3 consecutive days.134

Adverse Effects

GI Effects

Diarrhea100,107,108,119 and abdominal pain100,107,108,119 have been reported during mebendazole treatment.

Nausea,100,103,107,108,119,120 vomiting,100,103,107,108,120 anorexia,100,107 and flatulence100,107 also have been reported.

Hematologic Effects

Myelosuppression manifested as neutropenia (including agranulocytosis) and/or thrombocytopenia has been reported in patients receiving mebendazole, especially when the drug was given using higher dosages or more prolonged treatment than usually recommended.100,103,107,111,113,120 Myelosuppression usually was reversible following discontinuance of the drug,113 but death has occurred rarely.113

Decreased hemoglobin concentration and/or hematocrit,103,108,120 leukopenia,108,120 and eosinophilia108 also have been reported rarely.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylactic reactions, have been reported rarely in patients receiving mebendazole.100,107

Rash,100,107,114,119,122 pruritus,108,114,119,122 exanthema,100,107 urticaria,100,107 angioedema,100,107 toxic epidermal necrolysis,100,107 and Stevens-Johnson syndrome100,107 also have been reported rarely.

Other Adverse Effects

Headache,108,114,116,119 dizziness,100,107,108,114,116,119 seizures,100,107 numbness,119 and tinnitus119 have been reported occasionally during mebendazole therapy. Fever103,104,106,109,114,116,119,122 has occurred in some patients, particularly in those receiving high-dose therapy for extraintestinal infections†.103,104,114,116

Other adverse effects reported rarely in patients receiving mebendazole include alopecia,100,103,107,108,111,120,146 flushing,119 hiccups,103 cough,122 weakness,103,119 drowsiness,108 chills,119 hypotension,119 abnormal liver function tests (e.g., increased serum concentrations of aminotransferases, glutamyltransferase (GGT, β-glutamyltranspeptidase, GGTP), alkaline phosphatase, and/or bilirubin),100,103,107,108,122 hepatitis,100,107 glomerulonephritis,100,107 increased BUN,108 hematuria,108 and cylindruria.108

Precautions and Contraindications

Mebendazole is contraindicated in patients who are hypersensitive to the drug or any component in the formulation.100,107

Blood counts should be monitored if mebendazole is given using higher dosage or a more prolonged duration of treatment than usually recommended.100,107 (See Hematologic Effects under Cautions: Adverse Effects.)

Pediatric Precautions

Safety and efficacy of mebendazole 100-mg chewable tablets have not been established in children younger than 2 years of age.107

Safety and efficacy of mebendazole 500-mg chewable tablets have not been established in children younger than 1 year of age.100 The safety profile of mebendazole given as a single 500-mg chewable tablet in pediatric patients 1-16 years of age is similar to that in adults.100

Seizures have been reported when mebendazole was used in children younger than 1 year of age.100,107

Geriatric Precautions

Data are insufficient to determine whether patients 65 years of age or older respond differently to mebendazole than younger patients.100,107

Mutagenicity and Carcinogenicity

Mebendazole was not mutagenic in some in vitro studies (e.g., bacterial reverse gene mutation test).100,107 The drug was mutagenic in the absence of S-9 in a 24-hour treatment incubation period in the mouse lymphoma thymidine kinase assay.100,107 Mebendazole was aneugenic in vitro in mammalian somatic cells.100,107 In an in vivo mouse micronucleus assay, mebendazole given orally induced an increased frequency of micronucleated polychromatic erythrocytes with evidence suggestive of aneugenicity.100,107

No evidence of carcinogenicity was seen in rats and mice receiving mebendazole dosages as high as 40 mg/kg daily (approximately 1-2 times the maximum recommended human dosage) for more than 2 years.100,107

Pregnancy, Fertility, and Lactation

Pregnancy

In rat reproduction studies, adverse developmental effects (i.e., skeletal malformations, soft tissue malformations, decreased pup weight, embryolethality) were observed when a single oral dose of mebendazole as low as 10 mg/kg (about 0.2 times the total maximum daily human dosage) was administered during the period of organogenesis.100,107 Maternal toxicity was reported at higher dosages.100,107

Published data to date regarding use of mebendazole in pregnant women (e.g., prospective pregnancy registries, case-control retrospective cohort studies, randomized controlled studies) have not indicated a clear association between mebendazole and a potential risk of major birth defects or miscarriage.100,107 Overall, these studies did not identify a specific pattern or frequency of major birth defects with mebendazole use.100,107 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.100,107

Clinicians should consider that untreated soil-transmitted helminth infections in pregnancy can be associated with adverse outcomes, including maternal iron deficiency anemia, low birthweight, and neonatal and maternal death.100,107

Fertility

Reproduction studies in male or female rats using mebendazole dosages up to 40 mg/kg daily (approximately 1-2 times the maximum recommended human dosage) for 60 days or 14 days prior to gestation, respectively, had no effect on fetus and offspring.100,107

Lactation

Limited data indicate that mebendazole is distributed into milk in low concentrations following oral administration.100,107 Effects of the drug on human milk production and effects on the breast-fed infant are unknown.100,107

The benefits of breast-feeding and the importance of mebendazole to the woman should be considered along with potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.100,107

Anticonvulsants

Limited data suggest that both carbamazepine and phenytoin may enhance the metabolism of mebendazole, probably by inducing hepatic microsomal enzymes, resulting in decreased plasma mebendazole concentrations.101,102,118 This interaction is unlikely to be clinically important in patients receiving mebendazole for the management of intestinal helminth infections.101,102,118

Metronidazole

Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported when metronidazole and mebendazole were used concomitantly.100,107

Concomitant use of metronidazole and mebendazole should be avoided.100,107

Acute Toxicity

Overdosage of mebendazole may result in GI symptoms.100,107 Alopecia, reversible aminotransferase elevations, hepatitis, agranulocytosis, neutropenia, and glomerulonephritis have been reported when mebendazole was given in dosages substantially higher than recommended or for prolonged periods of time.100,107

There is no specific antidote if acute overdosage of mebendazole occurs.100,107

Mechanism of Action

Mebendazole interferes with cellular tubulin formation in the helminth and causes ultrastructural degenerative changes in its intestine.100,107 As a result, glucose uptake and digestive and reproductive functions are disrupted, leading to immobilization, inhibition of egg production, and death of the helminth.100,107

Mebendazole does not inhibit glucose uptake in mammals and has no effect on blood glucose concentrations in humans. Examination of the intestine and other organs of treated animals has shown an intact microtubular system and normal subcellular organelles. The presence of food in the digestive tract of the definitive host does not affect the action of the drug during treatment of intestinal helminthic infections.

Spectrum

Mebendazole is active against certain nematodes (roundworms) pathogenic to humans, including Ancylostoma duodenale (hookworm),107 Angiostrongylus cantonensis , Ascaris lumbricoides ,100,107 Capillaria philippinensis (Philippine threadworm), Enterobius vermicularis (pinworm),107 Gnathostoma spinigerum , Necator americanus (hookworm),107 Trichinella spiralis (pork worm), and Trichuris trichiura (whipworm).100,107

Pharmacokinetics

Absorption

Mebendazole appears to be minimally absorbed from the GI tract. Following oral administration of mebendazole, the majority of the dose remains in the GI tract where it exerts an anthelmintic effect locally.100,107

Following oral administration of mebendazole 100-mg chewable tablets in a dosage of 100 mg twice daily for 3 consecutive days, plasma mebendazole concentrations did not exceed 30 ng/mL and plasma concentrations of the 2-amino metabolite of the drug (the major metabolite) did not exceed 90 ng/mL.107 Administration with a high-fat meal increases bioavailability of mebendazole, although a substantial effect on the amount of drug remaining in the GI tract is not expected.107

In healthy adults who received a single 500-mg chewable tablet of mebendazole under fasted or fed (high-fat meal) conditions, peak plasma concentrations of the drug were 14 or 56 ng/mL, respectively, and were attained within 1.5 or 4 hours, respectively.100

Limited data from children 1-16 years of age with single or mixed infections of Trichuris trichiura and/or Ascaris lumbricoides who received a single 500-mg chewable tablet of mebendazole indicated that systemic exposures to the drug in children 1-3 years of age were higher than exposures reported in adults.100

Plasma concentrations of mebendazole may be increased in patients with impaired hepatic function, impaired metabolism, or impaired biliary elimination.100,107

Distribution

Mebendazole is 90-95% bound to plasma proteins.100,107 The volume of distribution of the drug is 1-2 L/kg.100,107

Limited data indicate that mebendazole is distributed into human milk in low concentrations.100,107

Elimination

Mebendazole is extensively metabolized principally in the liver.100,107 Although the exact metabolic fate of mebendazole has not been fully determined, the drug is metabolized via decarboxylation to 2-amino-5(6)-benzimidazolyl phenylketone. Mebendazole metabolites do not have anthelmintic activity.100,107

Less than 2% of an oral dose of mebendazole is excreted in urine and the remainder of the dose is excreted in feces as unchanged drug and metabolites.100,107 Mebendazole and its metabolites likely undergo some degree of enterohepatic recirculation.100,107

The apparent elimination half-life of mebendazole ranges from 3-6 hours in most patients.100,107

Chemistry and Stability

Chemistry

Mebendazole is a synthetic, benzimidazole-derivative anthelmintic agent.100,107 The drug is structurally related to albendazole and thiabendazole (not commercially available in the US). Mebendazole occurs as a white or almost white to slightly yellow powder100,107 and is practically insoluble in water and in alcohol.100

Stability

Mebendazole 100-mg chewable tablets should be stored at 20-25°C.107

Mebendazole 500-mg chewable tablets should be stored at less than 30°C in a tightly closed container.100 Any unused tablets in the container should be discarded 1 month after the container is opened.100

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