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jiangsu hengrui medicine co., ltd. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine injection prior to extubation. dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none. pregnancy category c there are no adequate and well-controlled studies of dexmedetomidine use in pregnant women. in an in vitro human placenta study, placental transfer of dexmedetomidine occurred. in a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. thus, fetal exposure should be expected in human

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fresenius kabi usa, llc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none. pregnancy category c there are no adequate and well-controlled studies of dexmedetomidine hydrochloride injection use in pregnant women.  in an in vitro human placenta study, placental transfer of dexmedetomidine occurred.  in a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously.  thus, fetal exposure should be expected in humans, and dexmedetomidine hydrochloride injection should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 5 to 16) with doses up to 200 mcg/kg (representing a dose approximately equal to the maximum recommended human intravenous dose base

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actavis pharma, inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none teratogenic effects: pregnancy category c there are no adequate and well-controlled studies of dexmedetomidine hydrochloride injection use in pregnant women. in an in vitro human placenta study, placental transfer of dexmedetomidine occurred. in a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. thus, fetal exposure should be expected in humans, and dexmedetomidine hydrochloride injection should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 5 to 16) with doses up to 200 mcg/kg (representing a dose approximately equal to the maximum recommended human intra

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

hikma pharmaceuticals usa inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine injection prior to extubation. dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. pediatric use information is approved for hospira inc.’s precedextm (dexmedetomidine hydrochloride) injection and precedextm (dexmedetomidine hydrochloride) in sodium chloride injection. however, due to hospira inc.’s marketing exclusivity rights, this drug product is not labeled with that information. none risk summary available data from published randomized controlled trials and case reports ov

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wg critical care, llc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine hydrochloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine hydrochloride injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine hydrochloride injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine hydrochloride injection prior to extubation. dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none. risk summary there are no studies conducted with dexmedetomidine hydrochloride in pregnant women to inform any drug-associated risks. a published in vitro human placenta study reported placental transfer of dexmedetomidine hydrochloride. rats subcutaneously administered dexmedetomidine hcl during organogenesis showed pregnancy loss and reduced live pups at doses equivalent to the maximum recommended human dose (mrhd). reduced fetal weights were observed in rats administered subcutaneously dexmedetomidine hcl at a dose that is less than one-half of the mrhd during gestation and lactation. in this study, elevated fetal and embryocidal toxicity and delayed motor development were observed in second generation offspring. no fetal malformations were observed in animal reproduction studies with subcutaneous administration of dexmedetomidine hcl during organogenesis in rats and rabbits at doses approximately equal to and one-half the mrhd, respectively [see data]. the background risk in the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. data animal data teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine hcl during the period of fetal organogenesis (from gestation day 5 to 16) with doses up to 200 mcg/kg (representing a dose approximately equal to the mrhd based on body surface area) or in rabbits following intravenous administration of dexmedetomidine hcl during the period of fetal organogenesis (from gestation day 6 to 18) with doses up to 96 mcg/kg (representing approximately half the human exposure at the mrhd based on plasma area under the time-curve comparison). however, fetal toxicity, as evidenced by increased post-implantation losses and reduced live pups, was observed in rats at a subcutaneous dose of 200 mcg/kg. the no-effect dose in rats was 20 mcg/kg (representing a dose less than the mrhd based on a body surface area comparison). in another reproductive toxicity study when dexmedetomidine hcl was administered subcutaneously to pregnant rats at 8 mcg/kg and 32 mcg/kg (representing a dose less than the mrhd based on a body surface area comparison) from gestation day 16 through weaning, lower offspring weights were observed. additionally, when offspring of the 32 mcg/kg group were allowed to mate, elevated fetal and embryocidal toxicity and delayed motor development was observed in second generation offspring. risk summary there is no information regarding the presence of dexmedetomidine hydrochloride in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. radio-labeled dexmedetomidine administered subcutaneously to lactating female rats was excreted in milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dexmedetomidine hydrochloride and any potential adverse effects on the breastfed infant from dexmedetomidine hydrochloride or from the underlying maternal condition. clinical considerations a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 half-lives) after receiving dexmedetomidine hydrochloride in order to minimize potential drug exposure to a breastfed infant. safety and efficacy of dexmedetomidine hcl have not been established for procedural or icu sedation in pediatric patients. intensive care unit sedation a total of 729 patients in the clinical studies were 65 years of age and over. a total of 200 patients were 75 years of age and over. in patients greater than 65 years of age, a higher incidence of bradycardia and hypotension was observed following administration of dexmedetomidine hcl [see warnings and precautions (5.1, 5.2)]. therefore a dose reduction may be considered in patients over 65 years of age [see dosage and administration (2.3) and clinical pharmacology (12.3)]. procedural sedation a total of 131 patients in the procedural sedation clinical studies were 65 years of age and over. a total of 47 patients were 75 years of age and over. hypotension occurred in a higher incidence in dexmedetomidine hcl-treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients less than 65 years (47%). in patients greater than 65 years of age, reduce the loading infusion dosage for initiation of procedural sedation and consider reducing the maintenance infusion dosage for maintenance of procedural sedation [see dosage and administration (2.3) and clinical pharmacology ( 12.3)] . since dexmedetomidine hcl clearance decreases with increasing severity of hepatic impairment, consider dosage reduction in patients with hepatic impairment [see dosage and administration (2.4) and clinical pharmacology (12.3)] . the dependence potential of dexmedetomidine hcl has not been studied in humans. however, since studies in rodents and primates have demonstrated that dexmedetomidine hcl exhibits pharmacologic actions similar to those of clonidine, it is possible that dexmedetomidine hcl may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see warnings and precautions (5.5) ].

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

sandoz inc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine injection prior to extubation. dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none there are no adequate and well-controlled studies of dexmedetomidine hydrochloride use in pregnant women. in an in vitro human placenta study, placental transfer of dexmedetomidine occurred. in a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. thus, fetal exposure should be expected in humans, and

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

akorn - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none teratogenic effects. pregnancy category c there are no adequate and well controlled studies of dexmedetomidine hydrochloride injection use in pregnant women. in an in vitro human placenta study, placental transfer of dexmedetomidine occurred. in a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. thus, fetal exposure should be expected in humans, and dexmedetomidine hydrochloride injection should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 5 to 16) with doses up to 200 mcg/kg (representing a dose approximately equal to the maximum recommended human intra

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

sun pharmaceuticals industries, inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none pregnancy category c: there are no adequate and well-controlled studies of dexmedetomidine hydrochloride use in pregnant women.  in an in vitro human placenta study, placental transfer of dexmedetomidine occurred. in a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously.  thus, fetal exposure should be expected in humans, and dexmedetomidine hydrochloride should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 5 to 16) with doses up to 200 mcg/kg (representing a dose approximately equal to the maximum recommended human intravenous dose based on body surface

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

par pharmaceutical, inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine hydrochloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine hydrochloride injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine hydrochloride injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine hydrochloride injection prior to extubation. dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none. risk summary available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after the first trim

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

eugia us llc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine injection has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine injection prior to extubation. dexmedetomidine injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. pediatric use information is approved for hospira inc.’s precedextm (dexmedetomidine hydrochloride) injection and precedextm (dexmedetomidine hydrochloride) in sodium chloride injection. however, due to hospira inc.’s marketing exclusivity rights, this drug product is not labeled with that information. none. risk summary available data from published randomized controll