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

athenex pharmaceutical division, llc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - 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. 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 trimester. most of the available data are based on studies with exposures that occurred at the time of caesarean section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant apgar scores. available data indicate that dexmedetomidine crosses the placenta. in animal reproduction studies, fetal toxicity that lower fetal viability and reduced live fetuses occurred with subcutaneous administration of dexmedetomidine to pregnant rats during organogenesis at doses 1.8 times the maximum recommended human dose (mrhd) of 17.8 mcg/kg/day. developmental toxicity (low pup weights and adult offspring weights, decreased f1 grip strength, increased early implantation loss and decreased viability of second-generation offspring) occurred when pregnant rats were subcutaneously administered dexmedetomidine at doses less than the clinical dose from late pregnancy through lactation and weaning (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, 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 increased post-implantation losses and reduced live fetuses in the presence of maternal toxicity (i.e. decreased body weight) were noted in a rat embryo-fetal development study in which pregnant dams were administered subcutaneous doses of dexmedetomidine 200 mcg/kg/day (equivalent to 1.8 times the intravenous mrhd of 17.8 mcg/kg/day based on body surface area [bsa]) during the period of organogenesis (gestation day [gd] 6 to 15). no malformations were reported. no malformations or embryo-fetal toxicity were noted in a rabbit embryo-fetal development study in which pregnant does were administered dexmedetomidine intravenously at doses of up to 96 mcg/kg/day (approximately half the human exposure at the mrhd based on auc) during the period of organogenesis (gd 6 to 18). reduced pup and adult offspring birth weights, and grip strength were reported in a rat developmental toxicology study in which pregnant females were administered dexmedetomidine subcutaneously at doses of 8 mcg/kg/day (0.07 times the mrhd based on bsa) during late pregnancy through lactation and weaning (gd 16 to postnatal day [pnd] 25). decreased viability of second generation offspring and an increase in early implantation loss along with delayed motor development occurred in the 32 mcg/kg/day group (equivalent to less than the clinical dose based on bsa) when first generation offspring were allowed to mate. this study limited dosing to hard palate closure (gd 15 to 18) through weaning instead of dosing from implantation (gd 6 to 7) to weaning (pnd 21). in a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. risk summary available published literature reports the presence of dexmedetomidine in human milk following intravenous administration (see data) . there is no information regarding the effects of dexmedetomidine on the breastfed infant or the effects on milk production. advise women to monitor the breastfed infant for irritability. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for dexmedetomidine and any potential adverse effects on the breastfed infant from dexmedetomidine or from the underlying condition. data in two published clinical studies, a total of 14 women were given intravenous dexmedetomidine 6 mcg/kg/hour for 10 minutes after delivery followed by continuous infusion of 0.2 to 0.7 mcg/kg/hour. breast milk and maternal blood samples were collected at 0, 6, 12, and 24 hours after discontinuation of dexmedetomidine. plasma and milk dexmedetomidine concentrations were detectable up to 6 hours in most subjects, up to 12 hours in one subject and undetectable in all at 24 hours. the milk-to-plasma ratio from single paired maternal milk and plasma concentrations at each time point ranged from 0.53 to 0.95. the relative infant dose was estimated to range from 0.02 to 0.098%. safety and efficacy have not been established for procedural or icu sedation in pediatric patients. one assessor-blinded trial in pediatric patients and two open label studies in neonates were conducted to assess efficacy for icu sedation. these studies did not meet their primary efficacy endpoints and the safety data submitted were insufficient to fully characterize the safety profile of dexmedetomidine for this patient population. the use of dexmedetomidine for procedural sedation in pediatric patients has not been evaluated. 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 [see warnings and precautions ( 5.2)] . therefore, a dose reduction may be considered in patients over 65 years of age [see dosage and administration ( 2.2, 2.3), clinical pharmacology ( 12.3)]. procedural sedation a total of 131 patients in the 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-treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients <65 years (47%). a reduced loading dose of 0.5 mcg/kg given over 10 minutes is recommended and a reduction in the maintenance infusion should be considered for patients greater than 65 years of age. since dexmedetomidine clearance decreases with increasing severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see dosage and administration ( 2.2, 2.3), clinical pharmacology ( 12.3)] . dexmedetomidine hydrochloride is not a controlled substance. the dependence potential of dexmedetomidine has not been studied in humans. however, since studies in rodents and primates have demonstrated that dexmedetomidine exhibits pharmacologic actions similar to those of clonidine, it is possible that dexmedetomidine may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see warnings and precautions ( 5.5)] .

European Union - English - EMA (European Medicines Agency)

vetcare oy - medetomidine hydrochloride, vatinoxan hydrochloride - psycholeptics, hypnotics and sedatives - dogs - to provide restraint, sedation and analgesia during conduct of non-invasive, non-painful or mildly painful procedures and examinations intended to last no more than 30 minutes.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ceva animal health pty ltd - medetomidine hydrochloride - unknown - medetomidine hydrochloride imidazole active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

jurox pty limited - medetomidine hydrochloride - unknown - medetomidine hydrochloride imidazole active 0.0 - active constituent

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - dexmedetomidine hydrochloride - concentrate for solution for infusion - 100 microgram(s)/millilitre - dexmedetomidine

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - dexmedetomidine hydrochloride - concentrate for solution for infusion - 100 microgram(s)/millilitre - dexmedetomidine

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

dechra veterinary products llc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 0.5 mg in 1 ml - indications: dexmedesed is indicated for use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. dexmedesed is also indicated for use as a preanesthetic to general anesthesia in dogs and cats. contraindications: do not use dexmedesed in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. as with all alpha2 -adrenoceptor agonists, the potential for isolated cases of hypersensitivity, including paradoxical response (excitation), exists.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - dexmedetomidine hydrochloride 118 µg/ml equivalent to equivalent to 100 micrograms/ml dexmedetomidine - concentrate for injection - 200 mcg/2ml - active: dexmedetomidine hydrochloride 118 µg/ml equivalent to equivalent to 100 micrograms/ml dexmedetomidine excipient: sodium chloride water for injection - icu sedation: for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine accord by continuous infusion in these patients should not exceed 24 hours. procedural sedation: for sedation of non-intubated patients prior to and/or during surgical and other procedures.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100mg/ml;   - concentrate for infusion - 200 mcg/2ml - active: dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100mg/ml   excipient: sodium chloride water for injection - icu sedation: for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine viatris by continuous infusion in these patients should not exceed 24 hours. procedural sedation: for sedation of non-intubated patients prior to and/or during surgical and other procedures.

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

ax pharmaceutical corp - medetomidine hydrochloride (unii: bh210p244u) (medetomidine - unii:mr15e85mqm) - medetomidine hydrochloride 24.75 g in 1 g