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

citron pharma llc - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 15 mg - stavudine capsules, usp in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (hiv)-1 infection [see clinical studies (14) ] . stavudine capsules are contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. teratogenic effects pregnancy category c reproduction studies have been performed in rats and rabbits with exposures (based on cmax ) up to 399 and 183 times, respectively, of that seen at a clinical dosage of 1 mg/kg/day and have revealed no evidence of teratogenicity. the incidence in fetuses of a common skeletal variation, unossified or incomplete ossification of sternebra, was increased in rats at 399 times human exposure, while no effect was observed at 216 times human exposure. a slight post-implantation loss was noted at 216 times the human exposure with no effect noted at approximately 135 times the human exposure. an increase in early rat ne

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

state of florida doh central pharmacy - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 20 mg - stavudine capsules, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (hiv)-1 infection [see clinical studies (14)] . stavudine capsules are contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. reproduction studies have been performed in rats and rabbits with exposures (based on cmax ) up to 399 and 183 times, respectively, of that seen at a clinical dosage of 1 mg/kg/day and have revealed no evidence of teratogenicity. the incidence in fetuses of a common skeletal variation, unossified or incomplete ossification of sternebra, was increased in rats at 399 times human exposure, while no effect was observed at 216 times human exposure. a slight post-implantation loss was noted at 216 times the human exposure with no effect noted at approximately 135 times the human exposure. an increase in early rat neonatal mortality (birth to 4 days of age) occurred at 399 t

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

aurobindo pharma limited - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 15 mg - stavudine capsules, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv)-1 infection [see clinical studies (14) ]. stavudine capsules are contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. co-administration of stavudine capsules with didanosine is contraindicated due to the potential for serious and/or life-threatening events notably lactic acidosis, hepatotoxicity, peripheral neuropathy, and pancreatitis [see warnings and precautions (5.1 , 5.2 , 5.3 , 5.4 ) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to stavudine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary fatal lactic acidosis has been reported in pregnant individuals who received

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

cipla ltd. - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 1 mg in 1 ml - stavudine in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv)-1 infection [see clinical studies (14) ]. stavudine is contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. co-administration of stavudine with didanosine is contraindicated due to the potential for serious and/or life-threatening events notably lactic acidosis, hepatotoxicity, peripheral neuropathy, and pancreatitis [see warnings and precautions (5.1, 5.2, 5.3, 5.4 )]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to stavudine for oral solution during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary fatal lactic acidosis has been reported in pregnant individuals who received the combination of stavudine and didano

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

rising pharmaceuticals, inc. - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 15 mg - stavudine capsules, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv)-1 infection [see clinical studies (14) ]. stavudine capsules are contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. co-administration of stavudine capsules with didanosine is contraindicated due to the potential for serious and/or life-threatening events notably lactic acidosis, hepatotoxicity, peripheral neuropathy, and pancreatitis [see warnings and precautions (5.1 , 5.2 , 5.3 , 5.4 ) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to stavudine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary fatal lactic acidosis has been reported in pregnant individuals who received

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

e.r. squibb & sons, l.l.c. - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 15 mg - zerit® , in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (hiv)-1 infection [see clinical studies (14)]. zerit is contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. co-administration of zerit with didanosine is contraindicated due to the potential for serious and/or life-threatening events notably lactic acidosis, hepatotoxicity, peripheral neuropathy, and pancreatitis [see warnings and precautions (5.1, 5.2, 5.3, 5.4)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to zerit during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary fatal lactic acidosis has been reported in pregnant individuals who received the combination of stavudine and didanosine with other antiretroviral ag

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

camber pharmaceuticals, inc. - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 15 mg - stavudine capsules , in combination with other antiretroviral agents, is indicated for the treatment of hiv-1 infection (see clinical studies). stavudine is contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. use of stavudine in pediatric patients from birth through adolescence is supported by evidence from adequate and well-controlled studies of stavudine in adults with additional pharmacokinetic and safety data in pediatric patients. adverse events and laboratory abnormalities reported to occur in pediatric patients in clinical studies were generally consistent with the safety profile of stavudine in adults. these studies include actg 240, where 105 pediatric patients ages 3 months to 6 years received stavudine 2 mg/kg/day for a median of 6.4 months; a controlled clinical trial where 185 newborns received stavudine 2 mg/kg/day either alone or in combination with didanosine from birth through 6 weeks of age; and a cli

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

state of florida doh central pharmacy - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 40 mg - stavudine capsules , in combination with other antiretroviral agents, is indicated for the treatment of hiv-1 infection (see clinical studies). stavudine is contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. use of stavudine in pediatric patients from birth through adolescence is supported by evidence from adequate and well-controlled studies of stavudine in adults with additional pharmacokinetic and safety data in pediatric patients. adverse events and laboratory abnormalities reported to occur in pediatric patients in clinical studies were generally consistent with the safety profile of stavudine in adults. these studies include actg 240, where 105 pediatric patients ages 3 months to 6 years received stavudine 2 mg/kg/day for a median of 6.4 months; a controlled clinical trial where 185 newborns received stavudine 2 mg/kg/day either alone or in combination with didanosine from birth through 6 weeks of age; and a cli

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

mylan pharmaceuticals inc. - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 15 mg

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

kaiser foundation hospitals - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 40 mg