Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ALBENDAZOLE (UNII: F4216019LN) (ALBENDAZOLE - UNII:F4216019LN)
Northstar Rx 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 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 1st 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 maternal or fetal outcomes. In
Albendazole Tablets USP, 200 mg are white to off-white, round, film coated tablets debossed '1021' on one side and plain on the other side and are supplied as: NDC 16714-907-01 in bottle of 2 tablets (1 x 2 unit-dose blister pack) with child-resistant closure NDC 16714-907-02 in bottle of 2 tablets with child-resistant closure Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
ALBENDAZOLE - ALBENDAZOLE TABLET, FILM COATED NORTHSTAR RX 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. 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) 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 Tablet: 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) Risk of Neurologic Symptoms: Neurocysticercosis patients may experience cerebral hypertensive episodes, seizures or focal neurologic deficits after initiation of therapy; begin appropriate steroid and anticonvulsant therapy. (5.3) Risk of Retinal Damage in Retinal Cysticercosis: Cases of retinal involvement have been reported; examine the patient for the presence of retin Prečítajte si celý dokument