ALBENZA- albendazole tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Amedra Pharmaceuticals LLC

INN (nume internaţional):

ALBENDAZOLE

Compoziție:

ALBENDAZOLE 200 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

ALBENZA is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . 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 . ALBENZA is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of ALBENZA. Pregnancy Category C. There are no adequate and well-controlled studies of ALBENZA administration in pregnant women. ALBENZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ALBENZA should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Obtain pregnancy test prior to prescribing ALBENZA to women of reproductive potential. Advise women of reproductive potential to use effective birth control for the duration of ALBENZA therapy and for

Rezumat produs:

Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with “ap” and “550” and contains 200 mg of albendazole. Bottles of 2 Tablets       NDC 52054-550-22 Bottles of 28 Tablets     NDC 52054-550-28 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

ALBENZA- ALBENDAZOLE TABLET, FILM COATED
AMEDRA PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALBENZA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ALBENZA.
ALBENZA (ALBENDAZOLE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
ALBENZA is an anthelmintic drug indicated for:
Treatment of parenchymal neurocysticercosis due to active lesions
caused by larval forms of the pork tapeworm,
_Taenia solium_. (1.1)
Treatment of cystic hydatid disease of the liver, lung, and
peritoneum, caused by the larval form of the dog tapeworm,
_Echinococcus granulosus_. (1.2)
DOSAGE AND ADMINISTRATION
Patients weighing 60 kg or greater, 400 mg twice daily; less than 60
kg, 15 mg/kg/day in divided doses twice daily
(maximum total daily dose 800 mg). ALBENZA tablets should be taken
with food. (2)
Hydatid disease: 28-day cycle followed by 14-day albendazole-free
interval for a total of 3 cycles. (2)
Neurocysticercosis: 8 to 30 days. (2)
See additional important information in the Full Prescribing
Information. (2)
DOSAGE FORMS AND STRENGTHS
Tablet: 200 mg (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to the benzimidazole class of
compounds or any components of ALBENZA. (4)
WARNINGS AND PRECAUTIONS
Bone Marrow Suppression: Fatalities have been reported due to bone
marrow suppression; monitor blood counts in all
patients at the beginning of each 28-day cycle of therapy, and every 2
weeks while on therapy. Discontinue ALBENZA if
clinically significant changes in blood counts occur. (5.1, 5.4)
Teratogenic Effects: Obtain pregnancy test in women of reproductive
potential prior to therapy and avoid usage in
pregnant women except in clinical circumstances where no alternative
management is appropriate. Discontinue therapy
if pregnancy occurs and apprise patient of potential hazard to the
fetus. (5.2)
Risk of Neurologic Symptoms: Neurocysticercosis patients may
experience cerebral hypertensive episodes, seizu