ALBENDAZOLE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Northstar Rx LLC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBENDAZOLE - ALBENDAZOLE TABLET, FILM COATED
NORTHSTAR RX 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 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