ALBENZA is indicated for the treatment of the following infections:

Neurocysticercosis

ALBENZA is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.

Lesions considered responsive to albendazole therapy appear as nonenhancing cysts with no surrounding edema on contrast-enhanced computerized tomography. Clinical studies in patients with lesions of this type demonstrate a 74% to 88% reduction in number of cysts; 40% to 70% of albendazole-treated patients showed resolution of all active cysts.

Hydatid Disease

ALBENZA is indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.

This indication is based on combined clinical studies which demonstrated non-infectious cyst contents in approximately 80-90% of patients given ALBENZA for 3 cycles of therapy of 28 days each (see DOSAGE AND ADMINISTRATION). Clinical cure (disappearance of cysts) was seen in approximately 30% of these patients, and improvement (reduction in cyst diameter of ≥ 25%) was seen in an additional 40%.

NOTE: When medically feasible, surgery is considered the treatment of choice for hydatid disease. When administering ALBENZA in the pre- or post-surgical setting, optimal killing of cyst contents is achieved when 3 courses of therapy have been given.

NOTE: The efficacy of albendazole in the therapy of alveolar hydatid disease caused by Echinococcus multilocularis has not been clearly demonstrated in clinical studies.

Dosing of ALBENZA will vary, depending upon which of the following parasitic infections is being treated. In young children, the tablets should be crushed or chewed and swallowed with a drink of water.

Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment.

ALBENZA is supplied as 200 mg, white to off-white, circular, biconvex, bevel-edged, film-coated TILTAB tablets in bottles of 112.

NDC 0007-5500-40 Bottles of 112

Store between 20° and 25°C (68° and 77°F).

GlaxoSmithKline., Research Triangle Park, NC 27709. ALBENZA and TILTAB are registered trademarks of GlaxoSmithKline. Month 2007. FDA rev date: 8/20/2007

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