Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Immunology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: SmithKline Beecham
Approval Status: Approved June 1996
Treatment Area: parasitic infections
Albenza has been approved for the treatment of two parasitic
infections caused by worms:
- Hydatid cyst disease of the liver, lung, and peritoneum, caused
by the larval form of the dog tapeworm, Echinococcus
- Neurocysticercosis caused by larval forms of the pork tapeworm,
For hydatid disease, the recommended dose for Albenza is 400 mg
twice daily with meals for three cycles (each cycle consists of 28
days of dosing followed by a 14-day albendazole-free interval). For
neurocysticercosis, the recommended dose is 400 mg twice daily for
eight to 30 days.
Albendazole was first marketed outside the United States in 1982
for human use where it is currently marketed under the trade names
of Zentel and Eskazole.
Subjects treated with Albenza have shown improvement in more
than 80% of the neurocysticercosis subjects and cure or improvement
in up to 70%of the hydatid subjects.
Side effects were usually mild and resolved without treatment.
The most frequently reported side effects by hydatid disease
subjects included abnormal liver function, abdominal pain, nausea
and vomiting; those reported by neurocysticercosis subjects
included headache, nausea, and vomiting.
E. granulosus is considered endemic in the Western US
sheep-raising areas of Utah, Arizona, and Nevada, but the vast
majority of cases occur in new immigrants who have been exposed to
the infection years previously in their countries of origin, or in
travelers from the United States to endemic areas. Most cysts are
found in the liver where, after remaining asymptomatic for decades,
they finally produce abdominal pain or a mass. The incidence of
hydatid disease in the United States is estimated to be between 100
and 200 new cases diagnosed annually.
T. solium cysticercosis is rare in the United States except in
immigrants from endemic areas. It is most common in Latin America,
Asia, Russia, and Eastern Europe and is caused by inadequately
cooked or raw infected pork. Infection with the adult worm is
usually asymptomatic. Severe larval infection, a result of
ingestion of contaminated material, may cause muscle pains,
weakness, or fever. It can also cause epileptic seizures. The
incidence of neurocysticercosis is estimated to be less than 1,000
new cases diagnosed annually.
Worldwide, the prevalence of hydatid disease is estimated to be
about one million people mostly found in herding and animal-raising
countries and regions of North West China, parts of Northern and
Southern Africa, East Africa, Iraq, the Mediterranean basin,
Uruguay, Argentina, and Chile. It also occurs occasionally in other
countries including the United States, Great Britain, South and
East Europe, Australia, and New Zealand. The prevalence of
neurocysticercosis is estimated to be about 1.5 million people
worldwide. In both diseases, infection with the larva is accidental
and transmission from human-to-human does not normally occur.