Albendazole

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 or mixed intestinal parasites, including Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm), Enterobius vermicularis (pinworm/threadworm), Ancylostoma duodenale and Necator americanus (hookworm), Taenia spp. (tapeworm) and Strongyloides stercoralis
• Giardia (duodenalis, intestinalis or lamblia) infections in children

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy (or by women who are likely to become pregnant, during or shortly after the course of therapy)
• Breastfeeding

Cautions

• Hepatic impairment
• Women of child-bearing age (see Contraindications)
• Prolonged use
• Pre-existing neurocysticercosis (particularly in areas with high taenosis infection)
• Galactose intolerance
• Lapp lactose deficiency
• Glucose-galactose malabsorption
• May impair ability to drive and operate machinery

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

Dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages

Infections caused by: Protozoa such as Microsporidiosis, Giardia; Intestinal roundworms such as Enterobius vermicularis (pinworm), Trichostronglus orientalis, Ascaris lumbricoides (Ascariasis), Gongylonemiasis, Hookworm (Necator americanus and Ancylostoma duodenal), Trichuris trichiura (Whipworm), Strongyloides stercoralis (Strongyloidiasis), Capillaria philippinensis (Capillariasis); Extra-intestinal roundworms such as Cutaneous larval migrans (dog and cat hookworms), Baylisascariasis (Raccoon roundworm), Trichinella spiralis (Trichinosis), Angiostrongylus cantonensis, Loa Loa (Eyeworm), Mansonella perstans, Gnathostoma spinigerum; Cestodes such as Neurocysticercosis due to the larval form of T. solum

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 Guideline indications and dosages

Hydatid disease
- Medical therapy

• Oral (tab): 15mg/kg/day, in 2 divided doses; Max: 800mg/24hrs (as 400mg, 12hrly); Treatment duration: 3-6 months  
  (STG, Adult 2019)

Hydatid disease
- Before and after percutaneous aspiration injection of helminthicidal agent and re-aspiration (PAIR) or surgery

• Oral (tab): 15mg/kg/day, in 2 divided doses; Max: 800mg/24hrs (as 400mg, 12hrly); Treatment duration: 14-28 days before, and 28 days after PAIR/surgery  
  (STG, Adult 2019)

Neurocysticercosis (Additional agent required)
- Active or viable cysts

• Oral (tab):≥60kg: 400mg, 12hrly; <60kg: 7.5mg/kg, 12hrly; Max: 800mg/24hrs; Treatment duration: 8 days
  (STG, Adult 2019)

Helminthic infestation, tapeworm
Cutaneous larva migrans caused by Ancylostoma braziliense - sandworm

• Oral (tab, sus): 400mg, dly; Treatment duration: 3 days
  (STG, PHC 2020)

Helminthic infestation - excluding tapeworm

• Oral (tab, sus): 400mg, as a single dose
  (STG, PHC 2020)

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)

• Oral (tab, sus): 400mg, as a single dose
  (STG, PHC 2023)

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Administer with a high fat meal

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South African registered indications and dosages

Single or mixed intestinal parasites, including Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm), Enterobius vermicularis (pinworm/threadworm), Ancylostoma duodenale and Necator americanus (hookworm), Taenia spp. (tapeworm) and Strongyloides stercoralis 

• Oral (tab, sus): 400mg, as a single dose

Heavy mixed infestation involving Strongyloides or Taeniasis 

• Oral (tab, sus): 400mg, dly; Treatment duration: 3 days

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If the patient is not cured after 3 weeks, a second course of treatment may be given. No special procedures, such as fasting or purging, are required

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Tablets may be chewed or crushed and they should be taken with food

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

 Paed. dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages

Infections caused by: Protozoa such as Microsporidiosis, Giardia; Intestinal roundworms such as Enterobius vermicularis (pinworm), Trichostronglus orientalis, Ascaris lumbricoides (Ascariasis), Gongylonemiasis, Hookworm (Necator americanus and Ancylostoma duodenal), Trichuris trichiura (Whipworm), Strongyloides stercoralis (Strongyloidiasis), Capillaria philippinensis (Capillariasis); Extra-intestinal roundworms such as Cutaneous larval migrans (dog and cat hookworms), Baylisascariasis (Raccoon roundworm), Trichinella spiralis (Trichinosis), Angiostrongylus cantonensis, Loa Loa (Eyeworm), Mansonella perstans, Gnathostoma spinigerum; Cestodes such as Neurocysticercosis due to the larval form of T. solum

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 recommendations

Intestinal helminthiases - Taenia
Helminthic infestation - tapeworm 
Cutaneous larva migrans caused by Ancylostoma braziliense - sandworm

• Between 1-2 years: Oral (sus): 200mg, dly; Treatment duration: 3 days 
• 2 years and older: Oral (tab, sus): 400mg, dly; Treatment duration: 3 days
  (STG, Paed. 2017; PHC 2020)

Helminthic infestation - excluding tapeworm 

• Between 1-2 years: Oral (sus): 200mg, as a single dose
• 2 years and older: Oral (tab, sus): 400mg, as a single dose
  (STG, PHC 2020)

Hydatid disease

• Oral (tab, sus): 10mg/kg, dly; Treatment duration: 3 months  
  (STG, Paed. 2017)

Neurocysticercosis - active cysts

• Oral (tab, sus): 7.5mg/kg, 12hrly; Max: 400mg/24hrs; Treatment duration: 7 days  
  (STG, Paed. 2023)

Persistent diarrhoea - Microsporidia

• Oral (tab, sus): 7.5mg/kg, 12hrly
  (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): 200mg, as a single dose
• 2 years and older: Oral (tab, sus): 400mg, as a single dose
  (STG, PHC 2023)

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South African registered indications and dosages

Single or mixed intestinal parasites, including Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm), Enterobius vermicularis (pinworm/threadworm), Ancylostoma duodenale and Necator americanus (hookworm), Taenia spp. (tapeworm) and Strongyloides stercoralis 

Younger than 12 months

• Not established for use

Between 1-2 years

• Oral (sus): 200mg, as a single dose

2 years and older

• Oral (tab, sus): See adult dosage

Heavy mixed infestation involving Strongyloides or Taeniasis

Younger than 12 months

• No information available

Between 1-2 years

• Oral (sus): 200mg dly; Treatment duration: 3 days

2 years and older

• Oral (tab, sus): See adult dosage

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Albendazole has not been adequately studied in children <1 year, although the above dose recommendation has been made in South African manufacturer recommendations

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If the patient is not cured after 3 weeks, a second course of treatment may be given. No special procedures, such as fasting or purging, are required

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Giardiasis 
- Giardia duodenalis
- Giardia intestinalis
- Giardia lambia

Younger than 2 years

• No information available

2 years and older

• Oral (tab, sus): 400mg, dly; Treatment duration: 5 days

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Tablets may be chewed or crushed and they should be taken with food

Pregnancy

• Contraindicated
• Albendazole is known to be teratogenic and embryotoxic in animals. The safety of albendazole during pregnancy has not been established, and albendazole should not be taken by pregnant women at any stage of their pregnancy or by women who are likely to become pregnant, during or shortly after the course of therapy
• In order to avoid administering albendazole during early pregnancy, women of childbearing age should initiate treatment during the first week of menstruation or after a negative pregnancy test

Breastfeeding

• Contraindicated
• Adequate human data during breastfeeding are not available
• Albendazole is excreted into breastmilk. A decision has to be made taking into consideration the benefits of breastfeeding to the infant and the benefits of treatment to the mother and the risk of infant exposure

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

•  Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness

Gastrointestinal Disorders

• Gastrointestinal discomfort
• Diarrhoea
• Epigastric pain
• Abdominal pain
• Nausea and vomiting

Hepatobiliary Disorders

• Elevations of hepatic enzymes

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Urticaria
• Erythema multiforme
• Stevens-Johnson syndrome

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions

• Praziquantel
• Ritonavir
• Phenytoin
• Carbamazepine
• Phenobarbital

None routine. Specific cases may require

• Hepatic function
• Full blood count
• Pregnancy test
• Ophthalmic examination
• Magnetic resonance imaging

Tablet 400mg - EML (Primary)

Tablet 200mg - Non EML

Suspension 100mg/5ml - Non EML

Albendazole is a benzimidazole carbamate with anthelmintic and antiprotozoal activity against intestinal and tissue parasites. Albendazole exhibits vermicidal, ovacidal and larvacidal activity and exerts its anthelmintic effect by inhibiting tubulin polymerization. This causes the disruption of the helminth metabolism, including energy depletion, which immobilises and then kills the susceptible helminth.

Spectrum of activity: Protozoa such as Microsporidiosis, Giardia; Intestinal roundworms such as Enterobius vermicularis (pinworm), Trichostronglus orientalis, Ascaris lumbricoides (Ascariasis), Gongylonemiasis, Hookworm (Necator americanus and Ancylostoma duodenal), Trichuris trichiura (Whipworm), Strongyloides stercoralis (Strongyloidiasis), Capillaria philippinensis (Capillariasis); Extra-intestinal roundworms such as Cutaneous larval migrans (dog and cat hookworms), Baylisascariasis (Raccoon roundworm), Trichinella spiralis (Trichinosis), Angiostrongylus cantonensis, Loa Loa (Eyeworm), Mansonella perstans, Gnathostoma spinigerum; Cestodes such as Neurocysticercosis due to the larval form of T. solum

Tablet 200mg

• Zentel (GSK) originator

Tablet 400mg

• Bendex (Cipla)
• Wormadole (Dezzo trading)
• Zentel (GSK) originator

Suspension (per 5ml) 100mg

• Zentel (GSK) originator