United States - English - NLM (National Library of Medicine)

vivimed labs usa - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - 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 tablets. pregnancy category c. there are no adequate and well-controlled studies of albendazole administration in pregnant women. 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. obtain pregnancy test prior to prescribing albendazole to women of reproductive potential. advise women of reproductive potential to use effective b

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - 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 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 animal re

United States - English - NLM (National Library of Medicine)

avkare - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - 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 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 1 st 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 adv

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - 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 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 animal re

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - 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 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 animal re

United States - English - NLM (National Library of Medicine)

mark cuban cost plus drug company, pbc - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - 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 outcomes. in animal reproductive studies, oral administration of albendazole during the period of organogenesis caused embryotoxicity and skeletal malformations in pregnant rats (at doses of 0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m2 ) and pregnant rabbits (at doses of 0.60 times the maximum 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). advise a pregnant woman of the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. 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 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 maximum recommended human dose based on body surface area in mg/m2 , respectively) during organogenesis (gestation days 6 to 15) and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the maximum recommended human dose based on body surface area in mg/m2 ) administered during organogenesis (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 concentrations of albendazole and the active metabolite, albendazole sulfoxide, have been reported to be low in human breast milk. there are no reports of adverse effects on the breastfed infant and no information on the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for albendazole tablets and any potential adverse effects on the breastfed infant from albendazole tablets or from the underlying maternal condition. pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiating albendazole tablets. contraception females albendazole tablets may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1) ]. advise females of reproductive potential to use effective contraception during treatment with albendazole tablets and for 3 days after the final dose. hydatid disease is uncommon in infants and young children. in neurocysticercosis, the efficacy of albendazole tablets 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 tablets is different from that of younger patients. the pharmacokinetics of albendazole tablets in patients with impaired renal function has not been studied. in patients with evidence of extra-hepatic 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.

United States - English - NLM (National Library of Medicine)

lineage therapeutics inc - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - albendazole is indicated for the treatment of the following infections: neurocysticercosis: albendazole is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, taenia solium . lesions considered responsive to albendazole therapy appear as nonenhancing cysts with no surrounding edema on contrast-enhanced computerized tomography. clinical studies in patients with lesions of this type demonstrate a 74% to 88% reduction in number of cysts; 40% to 70% of albendazole-treated patients showed resolution of all active cysts. hydatid disease: 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 . this indication is based on combined clinical studies which demonstrated non-infectious cyst contents in approximately 80 to 90% of patients given albendazole for 3 cycles of therapy of 28 days each (see dosage and administration

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - 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

United States - English - NLM (National Library of Medicine)

northstar rx llc. - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - 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

United States - English - NLM (National Library of Medicine)

cipla usa inc. - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - 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