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Mebendazole

Class: Anthelmintics
VA Class: AP200
CAS Number: 31431-39-7
Brands: Emverm, Vermox

Medically reviewed on Jun 11, 2018

Introduction

Anthelmintic agent; benzimidazole derivative.100 107

Uses for Mebendazole

Ascariasis

Treatment of ascariasis caused by Ascaris lumbricoides (roundworm).100 105 107 134 Albendazole, mebendazole and ivermectin are drugs of choice.105 134

Enterobiasis

Treatment of enterobiasis caused by Enterobius vermicularis (pinworm).107 134 Albendazole, mebendazole, and pyrantel pamoate are drugs of choice.105 134

Hookworm Infections

Treatment of intestinal hookworm infections caused by Ancylostoma duodenale or Necator americanus in single or mixed infections.105 107 134 Drugs of choice are albendazole, mebendazole, and pyrantel pamoate.105 134

Treatment of eosinophilic enterocolitis caused by Ancylostoma caninum (dog hookworm).134 Treatment of choice is albendazole, mebendazole, or endoscopic removal of worms.134

Trichuriasis

Treatment of trichuriasis caused by Trichuris trichiura (whipworm).100 105 107 134 Albendazole is drug of choice; mebendazole and ivermectin are alternatives.105 134

Angiostrongyliasis

Has been used in conjunction with corticosteroids for treatment of eosinophilic meningitis caused by Angiostrongylus cantonensis.134 152 May shorten course of infection, but not number of relapses.134 152 Infection usually self-limited.134 No drug proven effective; some patients have worsened when treated.134

Baylisascariasis

Possible alternative for treatment of baylisascariasis caused by Baylisascaris procyonis (raccoon roundworm).105 134

Albendazole is drug of choice;105 134 153 154 some clinicians suggest that mebendazole, levamisole (not commercially available in US), and ivermectin may be alternatives if albendazole unavailable.134

Capillariasis

Treatment of capillariasis caused by Capillaria philippinensis (Philippine threadworm).134 Mebendazole is drug of choice; albendazole is an alternative.134

Toxocariasis (Visceral Larva Migrans)

Treatment of toxocariasis (visceral larva migrans) caused by Toxocara canis or T. cati (dog or cat roundworm).105 134 Albendazole and mebendazole are drugs of choice.105 134 Concomitant corticosteroids may be indicated in severe cases with cardiac, ocular, or CNS involvement.105 134 Antiparasitic treatment may not be effective for ocular larva migrans; inflammation may be reduced by corticosteroid injections; surgery may be necessary for secondary damage.105

Trichinellosis

Treatment of trichinellosis (trichinosis) caused by Trichinella spiralis (pork worm).105 134 Drug of choice is albendazole; mebendazole is an alternative.105 134 Concomitant corticosteroids usually recommended, especially for severe disease.105 125 127 134 Corticosteroids alleviate symptoms of the inflammatory reaction and can be lifesaving when cardiac or CNS systems are involved.105

Trichostrongyliasis

Treatment of trichostrongyliasis caused by Trichostrongylus.134 Pyrantel pamoate is drug of choice; albendazole and mebendazole are alternatives.134

Mebendazole Dosage and Administration

Administration

Oral Administration

Administer orally 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, place tablet on a spoon and add 2–3 mL of drinking water onto the tablet using a dosing syringe.100 Within 2 minutes, tablet should absorb the water and change into a soft, semi-solid mass that can be swallowed.100

Dosage

Pediatric Patients

Ascariasis (Roundworm)
Oral

Children ≥2 years of age (100-mg chewable tablets): 100 mg twice daily (morning and evening) for 3 consecutive days.107 134 Manufacturer recommends a second course of treatment if patient not cured 3 weeks after mebendazole treatment.107

Children ≥1 year of age (500-mg chewable tablets): Single 500-mg dose.100 134

Enterobiasis (Pinworm)
Oral

Children ≥2 years of age (100-mg chewable tablets): Single 100-mg dose.107 134 Some clinicians recommend a second 100-mg dose 2 weeks later.134 Manufacturer recommends a second course of treatment if patient not cured 3 weeks after mebendazole treatment.107

Some clinicians state consider treating all household contacts, especially when multiple or repeated symptomatic infections are occurring in the household.105 134

Hookworm Infections
Intestinal Hookworm Infections
Oral

Children ≥2 years of age (100-mg chewable tablets): 100 mg twice daily (morning and evening) for 3 consecutive days.107 134 Manufacturer recommends a second course of treatment if patient not cured 3 weeks after mebendazole treatment.107

Alternatively, single 500-mg dose has been recommended.134

Eosinophilic Enterocolitis Caused by Ancylostoma caninum (Dog Hookworm)
Oral

100 mg twice daily for 3 consecutive days has been recommended.134

Trichuriasis (Whipworm)
Oral

Children ≥2 years of age (100-mg chewable tablets): 100 mg twice daily (morning and evening) for 3 consecutive days.107 134 Manufacturer recommends a second course of treatment if patient not cured 3 weeks after mebendazole treatment.107

Children ≥1 year of age (500-mg chewable tablets): Single 500-mg dose.100

Capillariasis (Philippine Threadworm)
Oral

200 mg twice daily for 20 days has been recommended.134

Toxocariasis (Visceral Larva Migrans Caused by Dog or Cat Roundworm)
Oral

100–200 mg twice daily for 5 days has been recommended.134 Optimum duration of treatment not known; some clinicians recommend up to 20 days of treatment.134 For severe symptoms or eye involvement, some clinicians state treatment may be extended to 2–4 weeks.134

Trichinellosis (Pork Worm)
Oral

200–400 mg 3 times daily for 3 days followed by 400–500 mg 3 times daily for 10 days has been recommended.134

Trichostrongyliasis
Oral

100 mg twice daily for 3 consecutive days has been recommended.134

Adults

Ascariasis (Roundworm)
Oral

100-mg chewable tablets: 100 mg twice daily (morning and evening) for 3 consecutive days.107 134 Manufacturer recommends a second course of treatment if patient not cured 3 weeks after mebendazole treatment.107

500-mg chewable tablets: Single 500-mg dose.100

Enterobiasis (Pinworm)
Oral

100-mg chewable tablets: Single 100-mg dose.107 134 Some clinicians recommend a second 100-mg dose 2 weeks later.134 Manufacturer recommends a second course of treatment if patient not cured 3 weeks after mebendazole treatment.107

Some clinicians state consider treating all household contacts, especially when multiple or repeated symptomatic infections are occurring in the household.105 134

Hookworm Infections
Intestinal Hookworm Infections
Oral

100-mg chewable tablets: 100 mg twice daily (morning and evening) for 3 consecutive days.107 134 Manufacturer recommends a second course of treatment if patient not cured 3 weeks after mebendazole treatment.107

500-mg chewable tablets: Single 500-mg dose.100

Eosinophilic Enterocolitis Caused by Ancylostoma caninum (Dog Hookworm)
Oral

100 mg twice daily for 3 consecutive days has been recommended.134

Trichuriasis (Whipworm)
Oral

100-mg chewable tablets: 100 mg twice daily (morning and evening) for 3 consecutive days.107 134 Manufacturer recommends a second course of treatment if patient not cured 3 weeks after mebendazole treatment.107

500-mg chewable tablets: Single 500-mg dose.100

Capillariasis (Philippine Threadworm)
Oral

200 mg twice daily for 20 days has been recommended.134

Toxocariasis (Visceral Larva Migrans Caused by Dog or Cat Roundworm)
Oral

100–200 mg twice daily for 5 days has been recommended.134 Optimum duration of treatment not known; some clinicians recommend up to 20 days of treatment.134 For severe symptoms or eye involvement, some clinicians state treatment may be extended to 2–4 weeks.134

Trichinellosis (Pork Worm)
Oral

200–400 mg 3 times daily for 3 days followed by 400–500 mg 3 times daily for 10 days has been recommended.134

Trichostrongyliasis
Oral

100 mg twice daily for 3 consecutive days has been recommended.134

Special Populations

No special population dosage recommendations.

Cautions for Mebendazole

Contraindications

  • Hypersensitivity to the drug or any ingredient in the formulation.100 107

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylactic reactions, reported rarely.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 reported rarely.

Hematologic Effects

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

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

Monitor blood counts if mebendazole given using higher dosage or more prolonged duration of treatment than usually recommended.100 107

Specific Populations

Pregnancy

In rats, adverse developmental effects (i.e., skeletal malformations, soft tissue malformations, decreased pup weight, embryolethality) observed when single oral dose as low as 10 mg/kg (about 0.2 times total maximum daily human dosage) was administered during period of organogenesis.100 107

Published data to date regarding use in pregnant women have not indicated a clear association between mebendazole and a potential risk of major birth defects or miscarriage.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

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

Lactation

Limited data indicate small amounts of mebendazole distributed into human milk following oral administration.100 107 Effects on milk production and on breast-fed infant unknown.100 107

Consider benefits of breast-feeding and importance of mebendazole to the woman; also consider potential adverse effects on breast-fed child from the drug or underlying maternal condition.100 107

Pediatric Use

100-mg chewable tablets: Safety and efficacy not established in children <2 years of age.107

500-mg chewable tablets: Safety and efficacy not established in children <1 year of age.100 Safety profile of single 500-mg chewable tablet in pediatric patients 1–16 years of age is similar to that in adults.100

Seizures reported when mebendazole used in children <1 year of age.100 107

Geriatric Use

Data insufficient to determine whether patients ≥65 years of age respond differently to mebendazole than younger patients.100 107

Common Adverse Effects

Nausea,100 103 107 108 119 120 vomiting,100 103 107 108 120 abdominal pain,100 107 anorexia,100 107 diarrhea,100 107 flatulence,100 107 headache,105 108 114 116 119 rash,100 107 tinnitus,119 numbness,119 dizziness,100 105 107 108 114 116 119 fever,103 104 106 109 114 116 119 122 abnormal liver function tests.100 107

Interactions for Mebendazole

Specific Drugs

Drug

Interaction

Comments

Anticonvulsants (carbamazepine, phenytoin)

Decreased plasma mebendazole concentrations101 102 118

Unlikely to be clinically important when treating intestinal infections101 102 118

Metronidazole

Stevens-Johnson syndrome/toxic epidermal necrolysis reported with concomitant use100 107

Avoid concomitant use100 107

Mebendazole Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed from GI tract.a Following oral administration, majority of dose remains in the GI tract where it exerts an anthelmintic effect locally.100 107

Mebendazole 100-mg chewable tablets: Oral dosage of 100 mg twice daily for 3 consecutive days results in plasma concentrations of mebendazole or the 2-amino metabolite (the major metabolite) that are ≤30 or ≤90 ng/mL, respectively.107

Mebendazole 500-mg chewable tablets: Single oral dose of 500 mg in healthy adults under fasted conditions results in peak plasma mebendazole concentration of 14 ng/mL attained within 1.5 hours.100

Food

Mebendazole 100-mg chewable tablets: Administration with high-fat meal increases bioavailability of mebendazole, but effect on amount of drug remaining in GI tract not expected to be substantial.107

Mebendazole 500-mg chewable tablets: Administration with high-fat meal increases bioavailability, increasing peak plasma mebendazole concentration following single oral dose of 500 mg in healthy adults to 56 ng/mL, and prolongs time to peak plasma concentration by approximately 2.5 hours.100

Special Populations

Children 1–16 years of age with single or mixed infections of Trichuris trichiura and/or Ascaris lumbricoides: Following a single 500-mg chewable tablet, limited data indicate that systemic exposures in those 1–3 years of age is 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

Extent

Limited data indicate small amounts distributed into human milk following oral administration.100 107

Plasma Protein Binding

90–95%.100 107

Elimination

Metabolism

Extensively metabolized principally in the liver.100 107 Metabolized via decarboxylation to 2-amino-5(6)-benzimidazolyl phenylketone.a

Metabolites do not have anthelmintic activity.100 107

Elimination Route

<2% of an oral dose of mebendazole is excreted in urine; the remainder is excreted in feces as unchanged drug and metabolites.100 107

Mebendazole and its metabolites likely undergo some degree of enterohepatic recirculation.100 107

Half-life

3–6 hours.100 107

Stability

Storage

Oral

Chewable Tablets

Mebendazole 100-mg chewable tablets: 20–25°C.107

Mebendazole 500-mg chewable tablets: <30°C in tightly closed container.100 Discard unused tablets 1 month after opening the container.100

Actions and Spectrum

  • Benzimidazole derivative anthelmintic agent100 107 structurally related to albendazole and thiabendazole (not commercially available in US).a

  • Interferes with cellular tubulin formation and causes ultrastructural degenerative changes in intestine of susceptible helminths.100 107 Disrupts glucose uptake and digestive and reproductive functions, leading to immobilization, inhibition of egg production, and death of the helminth.100 107

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

  • Resistance to mebendazole may occur.100 107 Although clinical importance unknown, mechanism of resistance may involve changes in parasite β-tubulin protein resulting in reduced binding of the drug to β-tubulin.100 107

Advice to Patients

  • Advise patients that mebendazole may be taken with or without food.100 107

  • Inform patients taking mebendazole 100-mg chewable tablets that the tablets may be chewed, swallowed whole, or crushed and mixed with food.107

  • Inform patients taking mebendazole 500-mg chewable tablets that the tablet must be chewed completely before swallowing and should not be swallowed whole.100 Advise those who have difficulty chewing to place tablet on a spoon and add 2–3 mL of drinking water onto tablet using a dosing syringe.100 Within 2 minutes, tablet should change into a soft, semi-solid mass that can be swallowed.100

  • Advise patients that metronidazole and mebendazole should not be used concomitantly since serious skin reactions have been reported.100 107

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.100 107

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.100 107

  • Importance of informing patients of other important precautionary information.100 107 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Mebendazole

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, chewable

100 mg

Emverm

Impax

500 mg

Vermox

Janssen

AHFS DI Essentials. © Copyright 2018, Selected Revisions June 11, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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a. AHFS drug information 2018. McEvoy GK, ed. Mebendazole. Bethesda, MD: American Society of Health-System Pharmacists; 2018.

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