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Mebendazole

Pronunciation

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: 2% to 10%

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 (5% to 10%)

Time to Peak

Serum: Variable (0.5 to 7 hours)

Half-Life Elimination

2.8 to 9 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.

Canadian labeling: Additional uses (not in US labeling): Treatment of Strongyloides stercoralis (roundworms) and Taenia solium (tapeworms).

Use: Unlabeled

Treatment of Ancylostoma caninum (eosinophilic enterocolitis), Capillaria philippinensis (capillariasis), Giardia duodenalis (giardiasis), Mansonella perstans (filariasis), visceral larva migrans (toxocariasis)

Contraindications

Hypersensitivity to mebendazole or any component of the formulation

Dosing: Adult

Ancylostoma duodenale or Necator americanus (hookworm): Oral: 100 mg twice daily for 3 days; repeat in 3 weeks if not cured with initial treatment

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

Enterobiasis (pinworm): Oral: 100 mg as a single dose.

US labeling: Repeat in 3 weeks if not cured with initial treatment.

Canadian labeling: Repeat in 2 and 4 weeks.

Strongyloidiasis (roundworm): Canadian labeling (not in US labeling): Oral: 100 mg twice daily for 3 days; 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.

Taeniasis (tapeworm): Canadian labeling (not in US labeling): Oral: 100 mg twice daily for 3 days; repeat in 3 weeks if not cured with initial treatment.

Off-label dosing:

Ancylostoma duodenale (hookworm), Ascaris lumbricoides (roundworm), Necator americanus (hookworm), Trichuris trichiura (whipworm): Oral: 500 mg as a single dose (Med Lett 2007)

Off-label uses:

Ancylostoma caninum (eosinophilic enterocolitis): Oral: 100 mg twice daily for 3 days (Med Lett 2007)

Capillaria philippinensis (capillariasis): Oral: 200 mg twice daily for 20 days (Med Lett 2007)

Giardia duodenalis (giardiasis): Oral: 200 mg 3 times daily for 5 days (Canete 2006; Chandy 2009)

Mansonella perstans (filariasis): Oral: 100 mg twice daily for 30 days (Med Lett 2007)

Visceral larva migrans (toxocariasis): Oral: 100 to 200 mg twice daily for 5 days (Med Lett 2007)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Intestinal nematode infection: Children ≥2 years and Adolescents: 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). Canadian labeling recommends protecting tablets from light.

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. Adverse reactions listed below are reflective of both the US and Canadian product information.

Central nervous system: Convulsions, dizziness, drowsiness, headache, seizure

Dermatologic: Alopecia, pruritus, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria

Gastrointestinal: Abdominal pain, diarrhea, vomiting

Genitourinary: Casts in urine, hematuria

Hematologic & oncologic: Agranulocytosis, decreased hemoglobin, eosinophilia, leukopenia, neutropenia

Hepatic: Hepatitis, increased gamma-glutamyl transferase, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase

Hypersensitivity: Angioedema, hypersensitivity reaction (including anaphylactic, anaphylactoid)

Renal: Glomerulonephritis, increased blood urea nitrogen

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 in infants <1 year have been reported (rare) postmarketing in Canadian labeling.

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 or diarrhea (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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