Mebendazole

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Single and mixed helminth gastrointestinal infestations, such as:
  - Trichuriasis, such as Trichuris trichiura (whipworm)
  - Ancylostoma duodenale (hookworm)
  - Necator americanus (hookworm)
  - Asvariasis, such as Ascaris lumbricoides (large roundworm)
  - Enterobiasis, such as Enterobius vermicularis (pinworm)
  - Strongyloides stercoralis (threadworm)
  - Intestinal capillariasis
  - Ternidens deminutus 
  - Cestodes, such as Taenia spp (tapeworm)
• Treatment of infestations by Moniliformis moniliformis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy

Cautions

• Breastfeeding
• Hepatic impairment
• Children <2 years
• High doses
• Prolonged treatment
• Sodium restricted diets (tab)
• Fructose intolerance (sus)
• Glucose-galactose malabsorption (sus)
• Sucrase-isomaltase insufficiency (sus)
• Coadministration with metronidazole

Forms avail. in SA and covered in this monograph: tab, sus

Dosages below include:

• General dosing range
• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Nematode helminths, primarily ascariasis and trichuriasis; Trichuris trichuria, Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus, Oxyuris vermicularis

General dosing range

• Oral (tab, sus): 100-500mg/day

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Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guidelines indications and dosages

Helminthic infestations - excluding tapeworm (Taenia)
- Common roundworm (Ascaris lumbricoides)
- Hookworm (Necator americanus)
- Whipworm (Trichuris trichiura)
- Pinworm (Enterobiasis vermicularis) 

• Oral (tab, sus): 500mg, as a single dose
  (STG, PHC 2020)

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South African registered indications and dosages

Single and mixed helminth gastrointestinal infestations
- Trichuriasis, such as Trichuris trichiura (whipworm)
- Ancylostoma duodenale (hookworm)
- Necator americanus (hookworm)
- Asvariasis, such as Ascaris lumbricoides (large roundworm)
- Enterobiasis, such as Enterobius vermicularis (pinworm)
- Ternidens deminutus
Treatment of infestations by Moniliformis moniliformis

• Oral (tab, sus): 100mg, 12hrly; Treatment duration: 3 days; Repeat dosage in 3-4 weeks if still infested

OR

• Oral (sus): 500mg, as a single dose; Repeat dosage in 3-4 weeks if still infested

Tapeworm infestations, including Taenia species

• Oral (tab, sus): 100mg, 12hrly; Treatment duration: 6 days

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In worm-eradication campaigns, the standard course should be administered every quarter during the first year

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Threadworm infestation, including Strongyloides stercoralis

• Oral (tab, sus): 200mg, 12hrly; Treatment duration: 3 days; Repeat dosage in 3-4 weeks if still infested

Infestations of Capillaria philippinensis

• Oral (tab, sus): 200mg, 12hrly; Treatment duration: ≥20 days

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Indications and dosages registered in other jurisdictions

Trichuriasis, such as Trichuris trichuria (whipworm)
Ascariasis, such as Ascaris lumbricoides (roundworm)
Hookworm infestations, such as Acylostoma duodenale (common hookworm) and Necator americanus (American hookworm)

• Oral (tab, sus): 100mg, 12hrly; Treatment duration: 3 days

Enterobiasis, such as Enterobius vernicularis (pinworm or threadworm)

• Oral (tab, sus): 100mg, as a single dose; Repeat after two weeks if re-infection is suspected

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Tablets may be chewed or swallowed whole

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There is no evidence that mebendazole is effective in the treatment of cysticercosis

Paed. forms avail. in SA and covered in this monograph: tab, sus

Dosages below include:

• General dosing range
• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Nematode helminths, primarily ascariasis and trichuriasis; Trichuris trichuria, Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus, Oxyuris vermicularis

General dosing range

Younger than 1 year

• Not established for use

Older than 1 year

• Oral (tab, sus): 100-500mg/day

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WHO allows use of mebendazole in adult doses >2 years and as a single dose in children 12-24 months. However, mebendazole is not labeled for use <2 years of age in many countries

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Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guidelines indications and dosages

Helminthic infestations - excluding tapeworm (Taenia)
- Common roundworm (Ascaris lumbricoides)
- Hookworm (Necator americanus)
- Whipworm (Trichuris trichiura)
- Pinworm (Enterobiasis vermicularis) (PHC) 

Between 1-2 years

• Oral (sus): 100mg, 12hrly; Treatment duration: 3 days

Older than 2 years

• Oral (tab, sus): 500mg, immediately as a single dose
  (STG, Paed. 2017; PHC 2020) 

- Pinworm (Enterobius)

• Oral (tab, sus): 500mg, immediately as a single dose; Repeat dose after 2 weeks
  (STG, Paed. 2017)

Iron deficiency anaemia
- Empiric treatment for worms (excluding tapeworm)
Uncomplicated severe acute malnutrition (SAM)
- Empiric treatment for worms
Moderate acute malnutrition (MAM)
- Empiric treatment for worms 
Not growing well (including failure to thrive/growth faltering)
- Empiric treatment for worms (excluding tapeworm)

Between 1-2 years

• Oral (sus): 100mg, 12hrly; Treatment duration: 3 days

Between 2-5 years

• Oral (tab, sus): 500mg, immediately as a single dose
  (STG, PHC 2023) 

Acute malnutrition - severe
- Intestinal worm infestation
Worm bolus
- For treatment of the ascaris upon resolution of bolus

Between 1-2 years

• Oral (sus): 100mg, 12hrly; Treatment duration: 3 days

Older than 2 years

• Oral (tab, sus): 500mg, immediately as a single dose
  (STG, Paed. 2017)

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South African registered indications and dosages

Single and mixed helminth gastrointestinal infestations
- Trichuriasis, such as Trichuris trichiura (whipworm)
- Ancylostoma duodenale (hookworm)
- Necator americanus (hookworm)
- Asvariasis, such as Ascaris lumbricoides (large roundworm)
- Enterobiasis, such as Enterobius vermicularis (pinworm)
- Ternidens deminutus
Treatment of infestations by Moniliformis moniliformis

100mg/5ml suspension and 100mg tablet

Younger than 2 years

• Oral (sus, tab): Not established for use

Older than 2 years

• Oral (sus, tab): See adult dosage

500mg/10ml suspension and 500mg tablet

Younger than 1 year

• Oral (sus, tab): Contraindicated

Older than 1 year

• Oral (sus, tab): See adult dosage

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In worm-eradication campaigns, the standard course should be administered every quarter during the first year

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Tapeworm infestations, including Taenia species

Younger than 2 years

• Oral (sus, tab): Not established for use

Older than 2 years

• Oral (sus, tab): See adult dosage

Threadworm infestation, including Strongyloides stercoralis

Younger than 2 years

• Oral (sus, tab): Not established for use

Older than 2 years

• Oral (tab, sus): 100mg, 12hrly; Treatment duration: 3 days; Repeat dosage in 3-4 weeks if still infested

Infestations of Capillaria philippinensis

Younger than 12 years

• Oral (tab, sus): Not recommended for use

Older than 12 years

• Oral (tab, sus): 200mg, 12hrly; Treatment duration: ≥20 days

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Indications and dosages registered in other jurisdictions

Trichuriasis, such as Trichuris trichuria (whipworm)
Ascariasis, such as Ascaris lumbricoides (roundworm)
Hookworm infestations, such as Acylostoma duodenale (common hookworm) and Necator americanus (American hookworm)
Enterobiasis, such as Enterobius vernicularis (pinworm or threadworm)

Younger than 2 years

• Oral (sus, cap): Not recommended for use

Older than 2 years

• Oral (sus, cap): See adult dosage

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Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine

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There is no evidence that mebendazole is effective in the treatment of cysticercosis

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Mebendazole should only be given to very young children if their worm infestation interferes significantly with their nutritional status and physical development

Convulsions in children, including in infants <1 year of age, have been reported very rarely during post-marketing experience. Because of the risk of convulsions, mebendazole should not be used particularly in children <1 year. Mebendazole has not been extensively studied in children below the age of 2 years

Pregnancy

• Contraindicated
• Patients who think they are or may be pregnant should not take this preparation

Breastfeeding

• Caution
• Limited data from case reports demonstrate that a small amount of mebendazole is present in breastmilk following oral administration. Therefore, caution should be exercised when mebendazole is administered to breastfeeding women

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Seizures
• Dizziness

Gastrointestinal Disorders

• Abdominal pain
• Abdominal discomfort
• Diarrhoea
• Flatulence
• Nausea and vomiting

Hepatobiliary Disorders

• Hepatitis
• Abnormal hepatic function tests

Genitourinary Disorders

• Glomerulonephritis

Skin and Subcutaneous Tissue Disorders

• Rash
• Toxic epidermal necrolysis
• Stevens-Johnson Syndrome
• Exanthema
• Angioedema
• Urticaria
• Alopecia

Immune, Blood and Lymphatic System Disorders

• Neutropenia
• Agranulocytosis
• Hypersensitivity
  - Anaphylactic reaction
  - Anaphylactoid reaction

• Metronidazole
• Cimetidine

None routine. Specific cases may require

• Renal function
• Hepatic function
• Full blood count

Additional observations

• Signs of helminth ova in faeces (within 3-4 weeks after initial therapy)

Tablet 100mg, 500mg - Primary

In vitro and in vivo work suggests that mebendazole blocks the uptake of glucose by adult and larval forms of helminths, in a selective and irreversible manner. Inhibition of glucose uptake appears to lead to endogenous depletion of glycogen stores within the helminth. Lack of glycogen leads to decreased formation of adenosine triphosphate (ATP) and ultrastructural changes in the cells.

Spectrum of activity: Nematode helminths, primarily ascariasis and trichuriasis; Trichuris trichuria, Enterobius vermicularis, Ascaris lumbricoides,  Ancylostoma duodenale, Necator americanus, Oxyuris vermicularis

Tablet 100mg

• Adco-Wormex (Adcock Ingram)
• Cipex (Cipla)
• D-Worm (Pharmacare)
• Rolab-Anthex (Sandoz)
• Vermox (Johnson & Johnson) originator
• Wormgo (Pharmacare)
• Wormstop (Be-Tabs)

Tablet 500mg

• Adco-Wormex SD (Adcock Ingram)
• D-Worm SD (Pharmacare)
• Vermox SD (Johnson & Johnson) originator
• Wormstop (Be-Tabs)

Suspension (per 5ml) 100mg

• Cipex (Cipla)
• Vermox (Johnson & Johnson) originator
• Wormstop (Ranbaxy)

Suspension (per 10ml) 500mg

• Vermox SD (Johnson & Johnson) originator