ALBENDAZOLE tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Amneal Pharmaceuticals of New York LLC

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Albendazole is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . Albendazole is 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 There are limited data on use of albendazole in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published studies, single-dose albendazole exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes; however, this finding cannot be extrapolated to multiple-dose exposures (see Data ). In animal reproductive studies, oral administration of albendazole during gestation caused embryotoxicity and skeletal malformations in pregnant rats (at oral doses of 0.10 times and 0.32 times the recommended human dose based on body surface area in mg/m2 ) and pregnant rabbits (at oral doses of 0.60 times the recommended human dose based on body surface area in mg/m2 ). Albendazole was also associated with maternal toxicity in rabbits (at doses of 0.60 times the recommended human dose based on body surface area in mg/m2 ) (see Data ). Albendazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Albendazole should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. If a patient becomes pregnant while taking this drug, albendazole should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Cochrane review could not provide sufficient evidence of the impact of antihelminthics (including albendazole) on the pregnancy outcomes of low birthweight, perinatal mortality and preterm birth. In a large trial of about 2507 women, albendazole use during the second or third trimester of pregnancy had no overall effect on birth weight, perinatal mortality, or congenital anomalies. With a limited sample size and single-does exposure, another study could not rule out a two-fold increased risk of major malformations [4.7% vs. 2.2%; OR 2.2 (95% confidence interval (CI) 0.5 to 10.1); p = 0.26]. Animal Data Albendazole has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits. The teratogenic response in the rat was shown at oral doses of 10 and 30 mg/kg/day (0.10 times and 0.32 times the recommended human dose based on body surface area in mg/m2 , respectively) during gestation days 6 to 15 and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the recommended human dose based on body surface area in mg/m2 ) administered during gestation days 7 to 19. In the rabbit study, maternal toxicity (33% mortality) was noted at 30 mg/kg/day. In mice, no teratogenic effects were observed at oral doses up to 30 mg/kg/day (0.16 times the recommended human dose based on body surface area in mg/m2 ), administered during gestation days 6 to 15. Risk Summary There are no data on the presence of albendazole in human milk, the effects on the breast-fed infant or the effects on milk production. Albendazole is excreted in animal milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for albendazole and any potential adverse effects on the breastfed child from albendazole or from the underlying maternal condition. Pregnancy Testing Obtain pregnancy test prior to prescribing albendazole to women of reproductive potential. Contraception Females Advise women of reproductive potential to use effective birth control for the duration of albendazole therapy and for one month after end of therapy. Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of albendazole in children appears to be similar to that in adults. In patients aged 65 and older with either hydatid disease or neurocysticercosis, there was insufficient data to determine whether the safety and effectiveness of albendazole is different from that of younger patients. The pharmacokinetics of albendazole in patients with impaired renal function has not been studied. In patients with evidence of extrahepatic obstruction (n = 5), the systemic availability of albendazole sulfoxide was increased, as indicated by a 2-fold increase in maximum serum concentration and a 7-fold increase in area under the curve. The rate of absorption/conversion and elimination of albendazole sulfoxide appeared to be prolonged with mean Tmax and serum elimination half-life values of 10 hours and 31.7 hours, respectively. Plasma concentrations of parent albendazole were measurable in only 1 of 5 patients.

Descriptif du produit:

Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with “ap” and “550” and contains 200 mg of albendazole. Bottles of 2 Tablets             NDC 0115-1701-49 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

ALBENDAZOLE- ALBENDAZOLE TABLET, FILM COATED
AMNEAL PHARMACEUTICALS OF NEW YORK 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 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. (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: Obtain pregnancy test in women of reproductive
potential prior to therapy and
avoid usage in pregnant women except in clinical circumstances where
no alternative management is
appropriate. Discontinue therapy if pregnancy occurs and apprise
patient of potential hazard to the
fetus. (5.2)
Risk of Neurologic Symptoms: Neurocysticercosis patients may