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

pharma packaging solutions, llc dba tjoapack 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 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 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 adverse mater

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

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

zydus lifesciences limited - 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)

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

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

salama pharmaceuticals limited, tanzania - albendazole - solution, oral - 2.5%

Uganda - English - National Drug Authority

hebei kexing pharmaceutical co., ltd. - albendazole - oral liquid ordinary suspensions - 10%w/v

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

amneal pharmaceuticals of new york llc - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - 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.

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

amneal pharmaceuticals llc - albendazole (unii: f4216019ln) (albendazole - unii:f4216019ln) - albendazole 200 mg - albenza is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, taenia solium . albenza 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 . albenza is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albenza. risk summary there are limited data on use of albenza 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 ). albenza should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. albenza 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, albenza 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 albenza and any potential adverse effects on the breastfed child from albenza or from the underlying maternal condition. pregnancy testing obtain pregnancy test prior to prescribing albenza to women of reproductive potential. contraception females advise women of reproductive potential to use effective birth control for the duration of albenza therapy and for one month after end of therapy. hydatid disease is uncommon in infants and young children. in neurocysticercosis, the efficacy of albenza 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 albenza is different from that of younger patients. the pharmacokinetics of albenza 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 albenza were measurable in only 1 of 5 patients.

Kenya - English - Pharmacy and Poisons Board

vetagro and pulpers company ltd po box 2345-00100 nairobi - albendazole 25mg - oral suspension - albendazole - antinematodal anthelmintic agents: