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:

Actavis Pharma, Inc.

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 is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole. 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 animal reproduct

Product summary:

Albendazole Tablets, USP are available as follows: 200 mg — Each white to off white, round, film-coated, unscored tablet debossed with ‘A210’ on one side and plain on the other contains 200 mg of albendazole, USP. Tablets are supplied in bottles of 2 (NDC 0591-2712-02) with a child-resistant closure.   Store at 20° to 25°C (68° to 77°F)[See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ALBENDAZOLE- ALBENDAZOLE TABLET, FILM COATED
ACTAVIS PHARMA, INC.
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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. (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)
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 hypertensive episodes,