Albendazol
Regulatory sources consulted
- AEMPS CIMA Ficha Técnica Eskazole 400 mg (60407)
- https://cima.aemps.es/cima/dochtml/ft/60407/FT_60407.html
- AEMPS CIMA · nº registro 60407 ↗
- RxNorm rxcui 430 ↗
Approved indications
- Cystic echinococcosis (hydatid disease) caused by Echinococcus granulosus, when surgery is not possible or to reduce cyst size before surgery.
- Alveolar echinococcosis caused by Echinococcus multilocularis, for post-surgical treatment or in patients with inoperable progressive disease.
- Neurocysticercosis caused by the larval form of the pork tapeworm, Taenia solium.
Contraindications
Absolute
- Hypersensitivity to albendazole or other benzimidazole derivatives.
- Pregnancy.
Clinical warnings
- Major warning · Myelosuppression: Cases of pancytopenia, agranulocytosis, and aplastic anemia have been reported. Perform blood counts at the start of each cycle and every 2 weeks during treatment. — AEMPS CIMA
- Major warning · Hepatotoxicity: Elevations in liver enzymes have been observed. Perform liver function tests before each cycle and at least every 2 weeks. Discontinue if elevations are significant. — AEMPS CIMA
- Major warning · Neurological reactions in Neurocysticercosis: Treatment can unmask pre-existing neurocysticercosis, causing an inflammatory reaction (seizures, increased ICP). Co-administration of steroid and anticonvulsant therapy is required. — AEMPS CIMA
Drug interactions
- ModerateDexamethasoneH02AB02
Mechanism: Dexamethasone increases plasma concentrations of the active metabolite of albendazole (albendazole sulfoxide) by approximately 50%.
Recommendation: No dose adjustment is required. This interaction is often used therapeutically in neurocysticercosis to increase CNS penetration and control inflammation. Monitor for adverse effects.
AEMPS CIMA
- HighCarbamazepineN03AF01
Mechanism: Carbamazepine, phenytoin, and phenobarbital (CYP inducers) may decrease plasma concentrations of the active metabolite of albendazole, potentially reducing efficacy.
Recommendation: Monitor clinical response. An increased dose of albendazole may be necessary, or consider an alternative anthelmintic. Avoid concomitant use if possible.
AEMPS CIMA
Adverse events
Common (≥1%)
elevated liver enzymes · headache · abdominal pain · nausea · vomiting · vertigo · reversible alopecia
Rare but serious
pancytopenia · agranulocytosis · aplastic anemia · acute liver failure · erythema multiforme · Stevens-Johnson syndrome
Pregnancy and lactation
FDA category: X
Contraindicated during pregnancy. It is teratogenic and embryotoxic in animals. Pregnancy must be ruled out before starting treatment, and effective contraception must be used during and for one month after completing therapy.