Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
ALBENDAZOLE (UNII: F4216019LN) (ALBENDAZOLE - UNII:F4216019LN)
Amedra Pharmaceuticals LLC
ALBENDAZOLE
ALBENDAZOLE 200 mg
ORAL
PRESCRIPTION DRUG
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
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].
New Drug Application
ALBENZA- ALBENDAZOLE TABLET, FILM COATED AMEDRA PHARMACEUTICALS LLC ---------- 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 Belgenin tamamını okuyun