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Albenza Side Effects, and Drug Interactions - Albendazole

Albenza Side Effects, and Drug Interactions - Albendazole

SIDE EFFECTS

The adverse event profile of albendazole differs between hydatid disease and neurocysticercosis. Adverse events occurring with a frequency of ≥1% in either disease are described in the table below.

These symptoms were usually mild and resolved without treatment. Treatment discontinuations were predominantly due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease). The following incidence reflects events that were reported by investigators to be at least possibly or probably related to albendazole.

 

Adverse Event Incidence ≥1% in Hydatid Disease and Neurocysticercosis
Adverse
Event
Hydatid Disease Neurocysticercosis
Abnormal Liver
Function Tests
15.6 <1.0
Abdominal Pain
6.0 0
Nausea/Vomiting
3.7 6.2
Headache
1.3 11.0
Dizziness/Vertigo
1.2 <1.0
Raised Intracranial Pressure
0 1.5
Meningeal Signs
0 1.0
Reversible Alopecia
1.6 <1.0
Fever
1.0 0

The following adverse events were observed at an incidence of <1%:

Hematologic:   Leukopenia. There have been rare reports of granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia. (See WARNINGS .)

Dermatologic:   Rash, urticaria.

Hypersensitivity:   Allergic reactions.

Renal:   Acute renal failure related to albendazole therapy has been observed.

 

DRUG INTERACTIONS

Dexamethasone: Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when 8 mg dexamethasone was coadministered with each dose of albendazole (15 mg/kg/day) in eight neurocysticercosis patients.

Praziquantel: In the fed state, praziquantel (40 mg/kg) increased mean maximum plasma concentration and area under the curve of albendazole sulfoxide by about 50% in healthy subjects (n=10) compared with a separate group of subjects (n=6) given albendazole alone. Mean T max and mean plasma elimination half-life of albendazole sulfoxide were unchanged. The pharmacokinetics of praziquantel were unchanged following coadministration with albendazole (400 mg).

Cimetidine: Albendazole sulfoxide concentrations in bile and cystic fluid were increased (about 2-fold) in hydatid cyst patients treated with cimetidine (10 mg/kg/day) (n=7) compared with albendazole (20 mg/kg/day) alone (n=12). Albendazole sulfoxide plasma concentrations were unchanged 4 hours after dosing.

Theophylline: The pharmacokinetics of theophylline (aminophylline 5.8 mg/kg infused over 20 minutes) were unchanged following a single oral dose of albendazole (400 mg) in 6 healthy subjects.

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