ALBENDAZOLE tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

ALBENDAZOLE (UNII: F4216019LN) (ALBENDAZOLE - UNII:F4216019LN)

Disponible des:

Lineage Therapeutics Inc

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Albendazole is indicated for the treatment of the following infections: Neurocysticercosis: Albendazole 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: Albendazole 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 to 90% of patients given albendazole for 3 cycles of therapy of 28 days each (see DOSAGE AND ADMINISTRATION

Resumen del producto:

Albendazole is supplied as 200 mg, white to off white, circular, biconvex, bevel-edged, film coated TILTAB tablet embossed "ap" and "550". They are supplied as follows: Bottles of 2        NDC 54505-055-22 Bottles of 28      NDC 54505-055-28 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. TILTAB is a registered trademarks of GlaxoSmithKline, used with permission. Manufactured by: GlaxoSmithKline Mississauga, Ontario L5N 6L4 Canada Distributed by: Lineage Therapeutics Inc. Horsham, PA 19044 LB#  610-02                       Rev. December, 2017 70012585

Estat d'Autorització:

New Drug Application

Fitxa tècnica

ALBENDAZOLE- ALBENDAZOLE TABLET, FILM COATED
LINEAGE THERAPEUTICS INC
----------
ALBENDAZOLE TABLETS
RX ONLY
DESCRIPTION
Albendazole is an orally administered broad-spectrum anthelmintic.
Chemically, it is methyl 5-
(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C
H N O S. Its molecular weight is
265.34. It has the following chemical structure:
Albendazole is a white to off-white powder. It is soluble in
dimethylsulfoxide, strong acids, and
strong bases. It is slightly soluble in methanol, chloroform, ethyl
acetate, and acetonitrile. Albendazole
is practically insoluble in water. Each white to off-white,
film-coated tablet contains 200 mg of
albendazole.
Inactive ingredients consist of: carnauba wax, hypromellose, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium
saccharin, sodium starch glycolate,
and starch.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS :
_ABSORPTION AND METABOLISM:_ Albendazole is poorly absorbed from the
gastrointestinal tract due to its
low aqueous solubility. Albendazole concentrations are negligible or
undetectable in plasma as it is
rapidly converted to the sulfoxide metabolite prior to reaching the
systemic circulation. The systemic
anthelmintic activity has been attributed to the primary metabolite,
albendazole sulfoxide. Oral
bioavailability appears to be enhanced when albendazole is
coadministered with a fatty meal (estimated
fat content 40 g) as evidenced by higher (up to 5-fold on average)
plasma concentrations of albendazole
sulfoxide as compared to the fasted state.
Maximal plasma concentrations of albendazole sulfoxide are typically
achieved 2 to 5 hours after
dosing and are on average 1.31 mcg/mL (range 0.46 to 1.58 mcg/mL)
following oral doses of
albendazole (400 mg) in 6 hydatid disease patients, when administered
with a fatty meal. Plasma
concentrations of albendazole sulfoxide increase in a
dose-proportional manner over the therapeutic
dose range following ingestion of a fatty meal (fat content 43.1 g).
The