ALBENDAZOLE 200 MG- albendazole tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Vivimed Labs USA

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole tablets. Pregnancy Category C. There are no adequate and well-controlled studies of albendazole administration in pregnant women. Albendazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Albendazole should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Obtain pregnancy test prior to prescribing albendazole to women of reproductive potential. Advise women of reproductive potential to use effective b

Dettagli prodotto:

Albendazole Tablets USP, 200 mg are white to off-white round, biconvex, film coated tablets with "32" debossed on one side and plain on other side and contains 200 mg of albendazole. They are supplied as follows: Bottles of 2 Tablets NDC 62980-513-01 Bottles of 28 Tablets NDC 62980-513-02

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ALBENDAZOLE 200 MG- ALBENDAZOLE TABLET, FILM COATED
VIVIMED LABS USA
----------
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.ALBENDAZOLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Albendazole tablets are 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) (1)
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)
• 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
Tablets: 200 mg (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to the benzimidazole class of
compounds or any components of albendazole tablets.
(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
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: Neurocystice