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Mebendazole

Pronunciation

(me BEN da zole)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Chewable, Oral:

Emverm: 100 mg [contains fd&c yellow #6 (sunset yellow), saccharin sodium]

Brand Names: U.S.

  • Emverm

Pharmacologic Category

  • Anthelmintic

Pharmacology

Inhibits the formation of helminth microtubules; selectively and irreversibly blocks glucose uptake and other nutrients in susceptible adult intestine-dwelling helminths

Absorption

Oral: Poor; 5% to 10%; increased with food (Dayan 2003)

Distribution

Vd: 1 to 2 L/kg; to liver, fat, muscle, plasma, and hepatic cysts

Metabolism

Extensively hepatic

Excretion

Primarily feces (as unchanged drug and primary metabolite); urine (~2%)

Time to Peak

Serum: Variable (0.5 to 6 hours)

Half-Life Elimination

3 to 6 hours

Protein Binding

90% to 95%

Special Populations: Hepatic Function Impairment

Plasma levels may be increased.

Use: Labeled Indications

Intestinal nematode infection: Treatment of Ancylostoma duodenale or Necator americanus (hookworms), Ascaris lumbricoides (roundworms), Enterobius vermicularis (pinworms), and Trichuris trichiura (whipworms) in single or mixed infections.

Off Label Uses

Capillariasis

Data from case reports suggest that mebendazole may be beneficial for the treatment of capillariasis [Chunlertrith 1992]. Clinical experience also suggests the utility of mebendazole in the treatment of capillariasis [CDC 2012]. Additional data may be necessary to further define the role of mebendazole in this condition.

Echinococcosis, cystic (Echinococcus granulosus)

Data from a case series suggest that mebendazole may be beneficial in the treatment of cystic echinococcosis [Franchi 1999]. Clinical experience also suggests the utility of mebendazole in the treatment of cystic echinococcosis [CDC 2014]. Additional trials may be necessary to further define the role of mebendazole in this condition.

Trichinellosis (Trichinella spiralis)

Data from a limited number of patients studied suggest that mebendazole may be beneficial in the treatment of trichinellosis [Horstmann 1982]. Clinical experience also suggests the utility of mebendazole in the treatment of trichinellosis [CDC 2016]. Additional trials may be necessary to further define the role of mebendazole in this condition.

Trichostrongyliasis

Data from a randomized trial supports the use of mebendazole in the treatment of trichostrongyliasis [Farahmandian 1977]. Additional trials may be necessary to further define the role of mebendazole in this condition.

Toxocariasis

Data from a small, randomized trial and an observational study support the use of mebendazole in the treatment of toxocariasis [Magnaval 1995], [Wisniewska-Ligier 2012]. Clinical experience also suggests the utility of mebendazole in the treatment of toxocariasis [CDC 2013]. Additional trials may be necessary to further define the role of mebendazole in this condition.

Contraindications

Hypersensitivity to mebendazole or any component of the formulation

Dosing: Adult

Ancylostoma duodenale or Necator americanus (hookworm): Oral:

Manufacturer’s labeling: 100 mg twice daily for 3 days; repeat in 3 weeks if not cured with initial treatment

Alternate dosing: 500 mg as a single dose (Parasitic Infections 2013)

Ascariasis (roundworm): Oral:

Manufacturer’s labeling: 100 mg twice daily for 3 days; repeat in 3 weeks if not cured with initial treatment.

Alternate dosing: 500 mg as a single dose (Parasitic Infections 2013)

Enterobiasis (pinworm): Oral: 100 mg as a single dose; repeat in 3 weeks if not cured with initial treatment.

Trichuriasis (whipworm): Oral: 100 mg twice daily for 3 days; repeat in 3 weeks if not cured with initial treatment.

Capillariasis (off-label use): Oral: 200 mg twice daily for 20 days (CDC 2012). Additional data may be necessary to further define the role of mebendazole in this condition.

Echinococcus, cystic (off-label use): Oral: 40 to 50 mg/kg/day in 3 divided doses for 3 to 6 months (CDC 2014; Franchi 1999). Additional data may be necessary to further define the role of mebendazole in this condition.

Trichinellosis (Trichinella spiralis) (off-label use): Oral: 200 to 400 mg 3 times daily for 3 days, followed by 400 to 500 mg 3 times daily for 10 days (CDC 2016). Additional data may be necessary to further define the role of mebendazole in this condition.

Trichostrongyliasis (off-label use): Oral: 100 mg twice daily for 3 days (Farahmandian 1977)

Toxocariasis (off-label use): Oral: 100 to 200 mg twice daily for 5 days (CDC 2013). Additional data may be necessary to further define the role of mebendazole in this condition.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Intestinal nematode infection (hookworm, pinworm, roundworm, whipworm): Children ≥2 years and Adolescents: Oral: Refer to adult dosing.

Capillariasis (off-label use): Limited data available: Children and Adolescents: Oral: Refer to adult dosing.

Trichinellosis (off-label use): Limited data available: Children and Adolescents: Oral: Refer to adult dosing.

Toxocariasis (off-label use): Children and Adolescents: Oral: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling; however, undergoes extensive hepatic metabolism; use with caution as systemic exposure may be increased.

Administration

Oral: Administer with or without food. Tablets may be chewed, swallowed whole, or crushed and mixed with food.

Storage

Store at 20°C to 25°C (68°F to 77°F).

Drug Interactions

Aminoquinolines (Antimalarial): May decrease the serum concentration of Anthelmintics. Monitor therapy

CarBAMazepine: May decrease the serum concentration of Mebendazole. Monitor therapy

Cimetidine: May increase the serum concentration of Mebendazole. Monitor therapy

Fosphenytoin: May decrease the serum concentration of Mebendazole. Monitor therapy

MetroNIDAZOLE (Systemic): Mebendazole may enhance the adverse/toxic effect of MetroNIDAZOLE (Systemic). Particularly the risk for Stevens-Johnson syndrome or toxic epidermal necrolysis may be increased. Avoid combination

Phenytoin: May decrease the serum concentration of Mebendazole. Monitor therapy

Adverse Reactions

Frequency not defined.

Gastrointestinal: Abdominal pain, anorexia, diarrhea, flatulence, nausea, vomiting

Hepatic: Hepatitis

<1% (Limited to important or life-threatening): Abnormal hepatic function tests, agranulocytosis, alopecia, anaphylaxis, angioedema, decreased ejaculate volume (Parasitic Infections 2013), dizziness, glomerulonephritis, hepatitis, hypersensitivity reaction, leukopenia (Parasitic Infections 2013), neutropenia, seizure, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Neutropenia and agranulocytosis have been reported rarely with high doses and prolonged use.

Disease-related concerns:

• Hepatic impairment: Use with caution; systemic exposure may be increased with hepatic impairment.

• Hydatid disease: Not effective for hydatid disease.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: Experience with use in children <2 years of age is limited; convulsions have been reported postmarketing in pediatric patients <1 year.

Monitoring Parameters

Periodic hematologic, hepatic, and renal function; check for helminth ova in feces within 3-4 weeks following the initial therapy

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Based on available data, adverse pregnancy outcomes have not been observed following use in pregnancy (Diav-Citrin 2003; Gyorkos 2006). Treatment of pinworm in pregnancy may be considered; however, the CDC suggests postponing therapy until the third trimester when possible (CDC 2016).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience abdominal pain, lack of appetite, flatulence, nausea, vomiting, or diarrhea. Have patient report immediately to prescriber seizures (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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