Perth Children’s Hospital

Children’s Antimicrobial Management Program (ChAMP)

MONOGRAPH Albendazole Monograph - Paediatric Scope (Staff): Medical, Nursing, Pharmacy Scope (Area): Perth Children’s Hospital (PCH)

This document should be read in conjunction with this DISCLAIMER

DESCRIPTION Albendazole is a broad spectrum benzimidazole anthelmintic. It binds to beta tubulin inhibiting microtubule polymerisation resulting in the loss of cytoplasmic microtubules and inhibition of glucose uptake resulting in energy depletion and death in the susceptible (1-3) helminth.

INDICATIONS AND Albendazole is used in the treatment of intestinal and tissue RESTRICTIONS helminth infections including roundworm, threadworm, pinworm, hookworm, whipworm, some tapeworm species, strongyloides, and in hydatid disease as an adjunct to surgery. Refer to product literature for further information regarding the specific species covered.(1, 4) Oral: Unrestricted (green) antimicrobial This is not a restricted agent. Follow standard ChAMP guidelines where appropriate.

FORMULATIONS Available at PCH:  200mg chewable tablet (Zentel) Other formulations available:  400mg chewable tablet (Eskazole)

DOSAGE The doses listed below fall within the standard range. Higher doses may be prescribed for certain situations in consultation with an infectious diseases or clinical microbiology consultant. Neonates and children < 6 months old: Not routinely used in young infants. Contact infectious diseases or clinical microbiology service for advice. Oral: Roundworm, hookworm and threadworm:  Children < 10kg and ≥ 6months: 200mg as a single dose  Children ≥ 10kg: 400mg as a single dose.(1, 4)

Page 1 of 5 Albendazole Monograph - Paediatric Strongyloidiasis:  Children < 10kg and ≥ 6months: 200mg dose given twice daily for 3 days. Course should be repeated after 7-14 days.(4)  Children ≥ 10kg: 400mg dose given twice daily for 3 days. Course should be repeated after 7-14 days.(4) Cutaneous larva migrans and whipworm:  Children < 10kg and ≥ 6months: 200mg once daily for 3 days.  Children ≥ 10kg: 400mg once daily for 3 days.(1, 4) Hydatid disease, Larval taeniasis:  Children ≥ 6 years old: 7.5mg/kg/dose (to a maximum of 400mg) twice daily commencing 1 week prior to, and continuing for 4 weeks after surgery.  Repeat courses may be required.(1, 3-5) Neurocysticercosis:  Children ≥ 6 years old: 7.5mg/kg/dose (to a maximum of 400mg) twice daily for 8 to 30 days.(3, 6, 7)  Treatment of neurocysticercosis should include concurrent corticosteroid treatment for the first week and anticonvulsant therapy as necessary.(3, 6, 7) Please note albendazole does interact with some antiepileptics.

DOSAGE Dosage adjustment required in renal impairment: ADJUSTMENT  There is limited information regarding the use of albendazole in renal impairment.  No dosage adjustment is required, however care should be taken as there have been occasional reports of acute renal failure with the use of albendazole.(4, 7) Dosage adjustment required in hepatic impairment:  Use with caution in patients with abnormal liver function or decreased total leukocyte count due to the increased risk of hepatotoxicity and bone marrow suppression.(2)  Consider reducing the dose in patients requiring extended therapy with hepatic impairment.(2, 6)

RECONSTITUTION Not applicable

ADMINISTRATION  Albendazole tablets may be crushed, chewed or swallowed (1-3) whole to facilitate administration.  When treating systemic infections, albendazole should be taken with a fatty meal to improve absorption.(1, 3, 4)  When used for the treatment of intestinal worms, albendazole should be taken on an empty stomach to limit systemic absorption allowing it to act locally in the gut.(1)

ChAMP Manual Page 2 of 5 Albendazole Monograph - Paediatric

MONITORING  For patients on courses of treatment longer than 3 days, liver function tests and complete blood counts should be checked at the beginning of treatment and every 2 weeks whilst on therapy.  Faecal samples should also be taken to determine ova and parasite load.(3, 6, 7)

ADVERSE EFFECTS  Albendazole is well tolerated. Adverse effects are more common with high dose or extended duration of treatment. Adverse effects may be due to death of the parasite or heavy parasite burden.(1, 7)  Common: nausea, vomiting, diarrhoea, increased liver function tests, dizziness, abdominal pain, neurological symptoms (in treatment for neurocysticercosis), fever, headache.(1, 3, 7)  Rare: itch, rash, urticaria, bone pain, anaemia, hepatotoxicity (including hepatitis and cholestatic jaundice), severe hepatic abnormalities, bone marrow depression, alopecia, Stevens Johnson Syndrome, hypersensitivity.(1, 3, 7)

COMPATIBLE FLUIDS Not applicable

STORAGE Store tablets below 30˚C(2)

PRECAUTIONS  Long duration of treatment at higher doses increases the risk of hepatic abnormalities and bone marrow suppression. Regular monitoring should occur.(6, 7)  Albendazole is not recommended in ocular cysticercosis without specialist advice, due to the risk of severe eye damage due to death of parasites.(1)

CONTRAINDICATIONS  Albendazole is contraindicated in patients with hypersensitivity to albendazole or other benzimidazole drug.(2, 3)  For females of child-bearing potential, pregnancy should be excluded before treatment is commenced and avoided for at least one month following cessation of therapy.(1, 6)

INTERACTIONS  Albendazole has few drug interactions; please consult PCH approved references, your ward pharmacist or Pharmacy on 6456 0190 (option 1) for more information.  Carbamazepine, phenobarbital (phenobarbitone) and phenytoin may increase albendazole metabolism, resulting in a reduced concentration and efficacy when used in the treatment of systemic disease. Higher doses of albendazole may be required.(1)  Ritonavir may reduce the concentration and efficacy of albendazole when used in the treatment of systemic disease. Higher doses of albendazole may be required.(1)

COMMENTS Treatment of neurocysticercosis should include concurrent corticosteroid treatment for the first week and anticonvulsant therapy

ChAMP Manual Page 3 of 5 Albendazole Monograph - Paediatric as necessary.(3, 6, 7) Please note albendazole does interact with some antiepileptics.

MANUFACTURER To access the Manufacturer SDS for this product, use the following SAFETY DATA SHEET link to ChemAlert. (SDS)

Related internal policies, procedures and guidelines

Antimicrobial Stewardship Policy (Medication Management Manual)

ChAMP Empiric Guidelines (ChAMP Manual)

References

1. Rossi S, editor. Australian Medicines Handboook 2019. Adelaide, S. Aust.: Australian Medicines Handbook; 2019. 2. MIMS Australia. MIMS online [full product information]. St Leonards, N.S.W: CMP Medica Australia.; 2019. p. 1v. (various pagings). 3. Taketomo CK, Hodding JH, Kraus DM, Hodding JH. Pediatric and Neonatal dosage handbook with international trade names index. 25th ed. Ohio: Lexi-comp; 2018-2019. 4. Antibiotic Writing Group. Therapeutic Guidelines - Antibiotic. West Melbourne: Therapeutic Guidelines Ltd; 2019. Available from: http://online.tg.org.au.pklibresources.health.wa.gov.au/ip/. 5. Paediatric Formulary Committee. BNF for Children: 2019. London: BMJ Group Pharmaceutical Press; 2019. 6. Micromedex 2.0 [Internet]. Truven Health Analytics. 2019 [cited 02/04/2019]. 7. Clinical Pharmacology [Internet]. Elsvier BV. 2019 [cited 02/04/2019]. Available from: http://pklibresources.health.wa.gov.au/login?url=http://www.clinicalpharmacology- ip.com/?id=24317714.

ChAMP Manual Page 4 of 5 Albendazole Monograph - Paediatric

This document can be made available in alternative formats on request for a person with a disability.

File Path: W:\Safety & Quality\CAHS\CLOVERS MEDICAL Pharmacy\Procedures Protocols and Guidelines\ChAMP Document Owner: Infectious Diseases Head of Department Reviewer / Team: Children’s Antimicrobial Management Program Pharmacist Date First Issued: September 2013 Last Reviewed: July 2019 Review Date: July 2022 Approved by: Drug and Therapeutics Committee Date: July 2019 Endorsed by: Drug and Therapeutics Committee Date: July 2019 Standards Applicable: NSQHS Standards: Printed or personally saved electronic copies of this document are considered uncontrolled

ChAMP Manual Page 5 of 5