ALBENDAZOLE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Edenbridge Pharmaceuticals LLC.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 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 outc

ملخص المنتج:

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 42799‑110‑02 Bottles of 28 Tablets   NDC 42799‑110‑01 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

ALBENDAZOLE - ALBENDAZOLE TABLET
EDENBRIDGE PHARMACEUTICALS LLC.
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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 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). 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
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
of contraception. (2.3, 5.2,8.1, 8.3)
Risk of Neurologic Symptoms: Neurocysticercosis patients may
experience cerebral hypertensi