ALBENDAZOLE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Pharma Packaging Solutions, LLC dba Tjoapack LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Albendazole Tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. Albendazole Tablets are 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. Albendazole Tablets are contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of Albendazole Tablets. Risk Summary Based on findings from animal reproduction studies, Albendazole Tablets may cause fetal harm when administered to a pregnant woman. However, available human data from a small number of published case series and reports on the use of multiple-dose albendazole in the 1 st trimester of pregnancy, and several published studies on single-dose albendazole use later in pregnancy, have not identified any drug-associated risks for major birth defects, miscarriage, or adverse mater

Resumen del producto:

Albendazole Tablets USP are white to off-white, round, convex, film-coated tablets, debossed with “110” with an arch overhead on one side and plain on the other side and contain 200 mg of albendazole. Bottles of 2 Tablets NDC 75929-184-92 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ALBENDAZOLE- ALBENDAZOLE TABLET
PHARMA PACKAGING SOLUTIONS, LLC DBA TJOAPACK LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
ALBENDAZOLE TABLETS, FOR ORAL USE
(PACKAGED BY PHARMA PACKAGING SOLUTIONS. LLC DBA TJOAPACK,LLC)
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALBENDAZOLE TABLETS
SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ALBENDAZOLE TABLETS.
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Albendazole Tablets is an anthelmintic drug indicated for: (1)
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). Albendazole Tablets should be taken with
food. (2) (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) (2)
DOSAGE FORMS AND STRENGTHS
Tablet: 200 mg (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to the benzimidazole class of
compounds or any components of
Albendazole Tablets. (4) (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 Albendazole Tablets if clinically significant
changes in blood counts occur. (5.1,
5.4)
Embryo-Fetal Toxicity: May cause fetal harm. Pregnancy testing is
recommended for females of
reproductive potential prior to therapy. Advise females of
reproductive potential of the potential risk to
a fetus and to use an effective method