Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
ALBENDAZOLE (UNII: F4216019LN) (ALBENDAZOLE - UNII:F4216019LN)
Pharma Packaging Solutions, LLC dba Tjoapack LLC
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
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 Przeczytaj cały dokument