Mebendazole

Pharmacologic Category

Anthelmintic

Dosing: Adult

Ancylostoma duodenale or Necator americanus (hookworm): Oral: 100 mg twice daily for 3 days (manufacturer's labeling; CDC 2018b) or 500 mg as a single dose (CDC 2018b). Repeat in 3 weeks if not cured with initial treatment.

Ascariasis (roundworm): Oral: 100 mg twice daily for 3 days (manufacturer's labeling; CDC 2018a) or 500 mg as a single dose (CDC 2018a). Repeat in 3 weeks if not cured with initial treatment.

Capillariasis (off-label use): Oral: 200 mg twice daily for 20 days (CDC 2012).

Echinococcus, cystic (alternative agent) (off-label use): Oral: 40 to 50 mg/kg/day in 3 divided doses for 3 to 6 months (CDC 2014; Franchi 1999).

Enterobiasis (pinworm): Oral: 100 mg as a single dose (manufacturer's labeling); repeat in 2 weeks (CDC 2016a).

Toxocariasis (off-label use): Oral: 100 to 200 mg twice daily for 5 days (CDC 2013a).

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 2018c).

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

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

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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.

Dosing: Pediatric

Ancylostoma duodenale or Necator americanus (hookworm): Children and Adolescents (Limited data in children <2 years): Oral: 100 mg twice daily for 3 days or 500 mg once as a single dose; repeat in 3 weeks if not cured with initial treatment (CDC 2018b; Red Book [AAP 2018])

Ascariasis (roundworm): Children and Adolescents (Limited data in children < 2 years): Oral: 100 mg twice daily for 3 days or 500 mg once as a single dose; repeat in 3 weeks if not cured with initial treatment (CDC 2018a; Red Book [AAP 2018])

Capillariasis: Limited data available: Children and Adolescents: Oral: 200 mg twice daily for 20 to 30 days (CDC 2012; Red Book [AAP 2018])

Enterobiasis (pinworm): Children and Adolescents (Limited data in children <2 years): Oral: 100 mg as a single dose, repeat in 2 weeks. (Red Book [AAP 2018]).

Toxocariasis (roundworm, ocular larva migrans, visceral larva migrans): Limited data available: Children and Adolescents: Oral: 100 to 200 mg twice daily for 5 days (CDC 2013a; Red Book [AAP 2018])

Trichinellosis (trichinosis; Trichinella species): Limited data available: Children and Adolescents: Oral: 200 to 400 mg 3 times daily for 3 days, then 400 to 500 mg 3 times daily for 10 days (CDC 2018c; Red Book [AAP 2018])

Trichuriasis (whipworm): Children and Adolescents (Limited data in children <2 years): Oral: 100 mg twice daily for 3 days; repeat in 3 weeks if not cured with initial treatment (CDC 2013b; Red Book [AAP 2018]).

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; not significantly removed by hemodialysis (Allgayer 1984).

Dosing: Hepatic Impairment: Pediatric

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.

Use: Labeled Indications

Intestinal nematode infection: Treatment of patients ≥2 years of age with GI infections caused by Ancylostoma duodenale or Necator americanus (hookworms), Ascaris lumbricoides (roundworms), Enterobius vermicularis (pinworms), and Trichuris trichiura (whipworms).

* See Uses in AHFS Essentials for additional information.

Use: Off-Label: Adult

CapillariasisLevel of Evidence [C]

Data from case reports suggest that mebendazole may be beneficial for the treatment of capillariasis ^Ref. Clinical experience also suggests the utility of mebendazole in the treatment of capillariasis ^Ref.

Echinococcosis, cystic (Echinococcus granulosus)Level of Evidence [C]

Data from a case series suggest that mebendazole may be beneficial in the treatment of cystic echinococcosis ^Ref. Clinical experience also suggests the utility of mebendazole in the treatment of cystic echinococcosis ^Ref.

ToxocariasisLevel of Evidence [C]

Data from a small, randomized trial and an observational study support the use of mebendazole in the treatment of toxocariasis ^Ref. Clinical experience also suggests the utility of mebendazole in the treatment of toxocariasis ^Ref.

Trichinellosis (Trichinella spiralis)Level of Evidence [C]

Data from a limited number of patients studied suggest that mebendazole may be beneficial in the treatment of trichinellosis ^Ref. Clinical experience also suggests the utility of mebendazole in the treatment of trichinellosis ^Ref.

TrichostrongyliasisLevel of Evidence [B]

Data from a randomized trial support the use of mebendazole in the treatment of trichostrongyliasis ^Ref.

Level of Evidence Definitions

Level of Evidence Scale

Administration: Oral

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

Administration: Pediatric

Oral: Administer with or without food; tablet can be crushed and mixed with food, swallowed whole, or chewed

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F).

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat infections caused by worms.

Frequently reported side effects of this drug

• Abdominal pain

• Lack of appetite

• Passing gas

• Nausea

• Vomiting

• Diarrhea

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Seizures

• Signs of a significant reaction like 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. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Prescribing and Access Restrictions

Vermox 500 mg chewable tablets are only available through Johnson & Johnson's Vermox Donation Program to help reduce the burden of soil-transmitted helminths in endemic countries. There are currently no plans to make Vermox 500 mg chewable tablets commercially available.

Contraindications

Hypersensitivity to mebendazole or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Neutropenia and agranulocytosis have been reported with high doses and prolonged use. Monitor CBC if used at higher doses or for a prolonged duration.

Disease-related concerns:

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

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.

* See Cautions in AHFS Essentials for additional information.

Pregnancy Considerations

Information following first trimester exposure to mebendazole is limited; however, an increased risk of birth defects has not been observed in the available studies (Gyorkos 2019). Most pregnancy outcome information is available from studies using mebendazole during the second or third trimester (Akpan 2018; Gyorkos 2019).

Untreated soil-transmitted helminth infections during pregnancy are associated with adverse maternal outcomes (eg, maternal iron deficiency anemia, low birth weight, neonatal and maternal death).

The World Health Organization (WHO) recommends preventive therapy with a benzimidazole, such as mebendazole, in pregnant women after the first trimester who live in areas where the baseline prevalence of soil-transmitted helminth infections is ≥20% (WHO 2017). The WHO also recommends treatment of soil-transmitted helminthiases (such as hookworm) in pregnant patients after the first trimester (WHO 1996).

WHO recommends preventive therapy with a benzimidazole, such as mebendazole, in females of reproductive potential who live in areas where the baseline prevalence of soil-transmitted helminth infections is ≥20% (WHO 2017).

Breast-Feeding Considerations

Mebendazole is present in breast milk.

Systemic absorption of mebendazole is limited, which also limits potential transfer to breast milk. In one patient, milk concentrations were no longer measurable ~13 hours after a single maternal dose of mebendazole 100 mg orally (Stoukides 1994). Inhibition of lactation was observed following the initiation of mebendazole therapy in one woman ~3 months' postpartum who was exclusively breastfeeding her child (Rao 1983). A transient decrease in milk production was observed in one of 45 women (postpartum age not specified) who participated in a prospective study that evaluated mebendazole and breastfeeding (Karra 2016). Available reports have not noted adverse events in breastfed infants (Karra 2016; Kurzel 1994; Stoukides 1994).

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. However, mebendazole is generally considered compatible with breastfeeding (WHO 2002).

Briggs' Drugs in Pregnancy & Lactation

• Mebendazole

Adverse Reactions

Frequency not defined.

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

Hepatic: Hepatitis

<1%, postmarketing, and/or case reports: 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

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• Benzimidazole Anthelmintics Allergy

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

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

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

Fosphenytoin: May decrease the serum concentration of Mebendazole. Risk C: 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. Risk X: Avoid combination

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

Ritonavir: May decrease the serum concentration of Mebendazole. Risk C: Monitor therapy

Food Interactions

Mebendazole serum levels may be increased if taken with food. Management: Administer without regard to meals.

Monitoring Parameters

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

Advanced Practitioners Physical Assessment/Monitoring

Since worm infestations are easily transmitted, all persons sharing same household should be treated. Teach transmission prevention.

Nursing Physical Assessment/Monitoring

Since worm infestations are easily transmitted, all persons sharing same household should be treated. Teach transmission prevention.

Dosage Forms: US

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

Tablet Chewable, Oral:

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

Dosage Forms: Canada

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

Tablet, Oral:

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

Anatomic Therapeutic Chemical (ATC) Classification

• P02CA01

Generic Available (US)

No

Pricing: US

Chewable (Emverm Oral)

100 mg (per each): $558.37

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

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

Pharmacodynamics/Kinetics

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

Distribution: V_d: 1 to 2 L/kg

Protein binding: 90% to 95%

Metabolism: Extensively hepatic

Half-life elimination: 3 to 6 hours

Excretion: Primarily feces (as unchanged drug and primary metabolite); urine (<2%)

Pharmacodynamics/Kinetics: Additional Considerations

Hepatic function impairment: Plasma levels may be increased.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

FDA Approval Date

January 15, 2016

References

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Allgayer H, Zähringer J, Bach P, Bircher J. Lack of effect of haemodialysis on mebendazole kinetics: studies in a patient with echinococcosis and renal failure. Eur J Clin Pharmacol. 1984;27(2):243-245.[PubMed 6499904]

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Centers for Disease Control and Prevention (CDC). Parasites - ascariasis. 2018a. Available at https://www.cdc.gov/parasites/ascariasis/health_professionals/index.html

Centers for Disease Control and Prevention (CDC). Parasites - capillariasis (also known as capillaria infection). http://www.cdc.gov/parasites/capillaria/health_professionals/index.html. Updated January 2012.

Centers for Disease Control and Prevention (CDC). Parasites - echinococcus. Available at https://www.cdc.gov/parasites/echinococcosis/health_professionals/index.html#tx. Updated July 2014.

Centers for Disease Control and Prevention (CDC). Parasites - hookworm. 2018b. Available at https://www.cdc.gov/parasites/hookworm/health_professionals/index.html

Centers for Disease Control and Prevention (CDC). Parasites - toxocariasis (also known as roundworm infection). http://www.cdc.gov/parasites/toxocariasis/health_professionals/index.html. Updated January 2013a.

Centers for Disease Control and Prevention (CDC). Parasites - trichinellosis (also known as Trichonosis). 2018c. Available at http://www.cdc.gov/parasites/trichinellosis/health_professionals/index.html

Centers for Disease Control and Prevention (CDC). Parasites - trichuriasis (also known as whipworm infection). 2013b. Available at http://www.cdc.gov/parasites/whipworm/health_professionals/index.html

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Brand Names: International

Adec (TW); Anelmin (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Antiox (PH); Antiver (EG); Astazole (ET); Azoel (PY); Benda (TH, VN); Bendazole (JO); Benhol (LK); Big-Ben (TH); Combantrin-1 (NZ); Conquer (TW); Cremox (BD); D-Worm (ZA); Daxol (PY); Diacor (CL); Diazolen (CR, DO, GT, HN, NI, PA, SV); Endal (LK); Fugacar (TH); Helben (BD); Hitolin (TW); Kaizole (TW); L-Ombrix (MX); Lomper (ES); Madnil (BD); Mebedal (MX); Mebendazol (MX); Mebensole (MX); Mebex (ET, IN); Mebez (ET); Mebezol (TW); Mebzol (AE, BH, KW, QA); Nemasole (AR); Pantelmin (AT, BR, CO, EC, PE, PT, PY, UY, VE); Permax (EG); Quemox (ET, MY, TH); Revapol (MX); Ribamox (BD); Surfont (DE); Thelmox (BH, ET); Toloxim (PT); Vermazol (TR); Vermicol (CR, DO, GT, HN, NI, PA, SV); Vermid (KR); Vermin (EG); Vermin-Dazol (MX); Vermox (AE, AU, BB, BE, BF, BG, BH, BJ, BM, BS, BZ, CH, CI, CN, CR, CY, CZ, DE, DK, DO, EE, ET, GB, GH, GM, GN, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IQ, IR, IS, IT, JM, JO, KE, KW, LB, LK, LR, LT, LU, LV, LY, MA, ML, MR, MT, MU, MW, MX, NE, NG, NI, NO, NZ, OM, PA, PK, PL, PR, QA, RO, RU, SA, SC, SD, SE, SI, SK, SL, SN, SR, SV, SY, TN, TR, TT, TZ, UG, YE, ZA, ZM, ZW); Vertizole (MX); Warca (TH); Wormazol (AE, QA, SA); Wormgo (ZA); Wormin (AE, BF, BJ, CI, CY, ET, GH, GM, GN, IN, IQ, IR, JO, KE, KW, LB, LK, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, QA, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW); Wormizol (LK); Zadomen (MY)

Last Updated 3/3/20