Placebo of dexmedetomidine hcl injection was spiked with dexmedetomidine hcl at three different levels. Apr 12, 2016 outpatient billing for dexmedetomidine hcl injection from u. Cn103694175a new method for preparing dexmedetomidine. Precedex dexmedetomidine hydrochloride product information. Although dexmedetomidine appears to be effective for sedation in children based on limited data, 4 of 10 infants and children who started with a dexmedetomidine infusion of 0. Product name dexmedetomidine hydrochloride cas number 145108583 chemical formula chcln. Antisedan is indicated for the reversal of the sedative and analgesic effects of dexdomitor dexmedetomidine hydrochloride, and domitor medetomidine hydrochloride in dogs. Dexmedetomidine hydrochloride injection dosing should be individualized and titrated to desired clinical response. Oct 19, 2012 dexmedetomidine hydrochloride, the dextroenantiomer of the racemic mixture of medetomidine.
Precedex tm dexmedetomidine hydrochloride injection, fda approved label, dated dec. Due to the known pharmacological effects of dexmedetomidine hydrochloride injection, patients should be continuously monitored while receiving dexmedetomidine hydrochloride injection. Precedex dexmedetomidine hydrochloride package insert 3. Dexmedetomidine hydrochloride is used clinically as an anesthetic agent to reduce anxiety and tension and promote relaxation and sedation without causing respiratory depression. Dexmedetomidine is notable for its ability to provide sedation without risk of respiratory depression and can provide cooperative or semirousable sedation. Mar, 20 fdca for precedex dexmedetomidine hydrochloride injection. Dexmedetomidine teva contains 118 microgramsml of dexmedetomidine hydrochloride equivalent to 100 microgramsml dexmedetomidine base as the active ingredient. Dexmedetomidine hydrochloride dexmedetomidine hydrochloride mouse oral ld 50 4gkg in vitro bacterial mutagenicity ames salmonella, e. Dexmedetomidine hydrochloride injection has been shown to be incompatible when administered with the following drugs. Jan 01, 2021 dexmedetomidine hydrochloride, usp has a molecular weight of 236. The proposed product will be presented in a 200 mcg 50. According to the method, lewis acid is used as a catalyst, and racemized medetomidine is prepared by a friedelcrafts reaction. Dexmedetomidine is notable for its ability to provide sedation without risk of respiratory depression unlike other commonly used drugs such as propofol and fentanyl and can provide cooperative or semirousable sedation similar to clonidine, it is a sympatholytic drug that acts. Dexmedetomidine hydrochloride injection fda prescribing.
Precedex dexmedetomidine hydrochloride pfizer canada. The invention provides a new method for preparing dexmedetomidine hydrochloride. Due to the known pharmacological effects of dexmedetomidine hydrochloride in 0. No such effects were observed at a dosage of 2 mcgkg.
Precedex is supplied as a clear, colorless, isotonic solution with a ph of 4. Dexmedetomidine hydrochloride dexmedetomidine is a potent, highly selective alpha2 adrenergic receptor agonist. Dexmedetomidineteva dexmedetomidine hydrochloride drug. Application of 975 mcg of dexmedetomidine to the skin of human volunteers produced sedation and reduced blood pressure with sedation appearing within 12 hours after application of dexmedetomidine. Precedex dexmedetomidine hydrochloride injection is a solution containing dexmedetomidine hydrochloride, the dextroenantiomer of the racemic mixture of medetomidine.
Dexmedetomidine hydrochloride is a white or almost white powder. Dexmedetomidine hydrochloride injection, 200 mcg2 ml dexmedetomidine 100 mcgml in a glass vial. Dexmedetomidine hydrochloride injection is not indicated for infusions lasting longer than 24 hours. Product name precedex dexmedetomidine hydrochloride injection, solution hospira inc. The crystal form c displays characteristic peaks at 7. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pka of 7. Dexmedetomidine hydrochloride injection has been shown to be compatible when administered with the following intravenous fluids. Dexmedetomidine is a selective alpha 2adrenergic receptor agonist used clinically as a preoperative adjunct of general anesthesia. Dexmedetomidine, sold under the trade name precedex among others, is an anxiolytic, sedative, and pain medication. Similar to clonidine, it is a sympatholytic drug that acts as an agonist of. This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. Dexmedetomidine hydrochloride pharmaceutical secondary. Pfizer msds for medetomidine hydrochloride sterile injectable solution.
Dexmedetomidine as to their complexity, published yield and atom economy. The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The dexmedetomidine is salified in hydrochloric acid to obtain. For research use only, not for human or veterinary use. Dexmedetomidine hydrochloride supplier cas 145108583. Material safety data sheet of dexmedetomidine hcl abmole. Dexmedetomidine hcl 145108583 reference standards for pharmacological research. Dexmedetomidine hydrochloride injection safety data sheet sds. It is mostly used for sedation in the intensive care unit icu.
Dexmedetomidine, a novel alpha2 adrenergic agonist. The product is intended for intravenous or intramuscular use in dogs and intramuscular use in cats. The dexmedetomidine is salified in hydrochloric acid to obtain dexmedetomidine hydrochloride. First aid measures dexmedetomidine hydrochloride injection fresenius kabi usa, llc revision. Product identifier product name dexmedetomidine hydrochloride product number fd167004 cas number 145108583 1. Active isomer of medetomidine, a potent, highly selective. Stability indicating hplc method validation for the assay of.
There are no generic pets animal health international. Dexmedetomidine premix formulation patent us8648106b2. Dexmedetomidine hcl injection in 5% dextrose wg critical care. Stability indicating hplc method validation for the assay. Cn105481774a dexmedetomidine hydrochloride crystal form c. Adrenergic alpha2 receptordexmedetomidine, acting at alpha2a adrenoceptors, must be present during the encoding process to decrease discrete cue fear memory. The invention provides dexmedetomidine hydrochloride c. Commission regulation eu no 2015830 of 28 may 2015. Precedex dexmedetomidine hydrochloride for injection 100 mcgml dexmedetomidine as dexmedetomidine hydrochloride concentrate, 2 ml vial dexmedetomidine hydrochloride injection 4 mcgml dexmedetomidine as dexmedetomidine hydrochloride ready to use, 20 ml, 50 ml and 100 ml vials alpha 2adrenergic agonist. Veterinarians use dexmedetomidine for similar purposes in treating cats, dogs, and horses. Selected citations for dexmedetomidine hydrochloride include. Dexmedetomidine hydrochloride according to regulation ec no 19072006, annex ii, as amended. Dexmedetomidine hydrochloride injection product userestriction.
Excipients the remaining components of th e formula are well known pharmaceutical ingredients and their quality. Dexmedetomidine selectively binds to and activates presynaptic alpha2 adrenoceptors located in the brain, thereby inhibiting the release of norepinephrine from synaptic vesicles. The active substance of sedadex is dexmedetomidine hydrochloride, a n. Dexdomitor dexmedetomidine hydrochloride is a synthetic alpha 2adrenoreceptor agonist with sedative and analgesic properties. Uchida et al 2019 induction of nonapoptotic cell death by adrenergic agonists in human oral squamous cell carcinoma cell lines. Dexmedetomidine hydrochloride injection should be administered using a controlled infusion device. Description of first aid measures general information get medical adviceattention if you feel unwell. Dexmedetomidine hydrochloride, usp is a solid, white or almost white powder that is freely soluble in water and alcohols, slightly soluble in methylene chloride and acetone and has a pka of 7.
Dexdomitor dexmedetomidine hydrochloride is a synthetic alpha 2 adrenoreceptor agonist with sedative and analgesic properties. Canadian regulations limit the scope of information we are permitted to give on prescription drugs via the internet or other means. The use of dexmedetomidine hydrochloride as a preanesthetic markedly reduces anesthetic requirements in dogs. We acknowledge receipt of your amendments dated, february 1, 20, march 5, 20 and march 6, 20. Dexmedetomidine hydrochloride injection should be administered only by persons skilled in the management of patients in the operating room setting. Download safety data sheet sds pdf cayman chemical. Citations are publications that use tocris products.
Cvmp assessment report for cepedex emeavc0043760000. Inhalation remove person to fresh air and keep comfortable for breathing. Injectable induction drug requirements for intubation will be reduced between 30% and 60%, depending on the choice of anesthetic and the dexmedetomidine hydrochloride preanesthetic dose. This prior approval supplemental new drug application provided for an alternate premix formulation of precedex injection. Dexmedetomidine hcl dexmedetomidine hydrochloride is a synthetic alpha 2adrenoreceptor agonist with sedative and analgesic properties. Each of the sample preparations were injected in duplicate and the average area count to be taken for calculation. Injection is a clear, colorless, isotonic solution. Precedex dexmedetomidine hydrochloride injection, solution hospira inc. Cvmp assessment report for sedadex emeavc0042020000. Sigmaaldrich offers a number of dexmedetomidine hydrochloride products. Precedex dexmedetomidine hydrochloride dose, indications. This material is for use as an adjunct to general anesthesia producing sedation, stabilizing heart rate and blood pressure, and producing analgesia. Identification of the substancemixture and of the companyundertaking 1.
Placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously to pregnant rats. Use of dexmedetomidine hydrochloride dexmedetomidine hydrochloride is an agonist of adrenergic alpha2 receptor, which is used in veterinary medicine for its analgesic and sedative properties. Dexmedetomidine hydrochloride is a highly potent and selective. Dexmedetomidine hydrochloride is the hydrochloride salt form of dexmedetomidine, an imidazole derivate and active disomer of medetomidine with analgesic, anxiolytic and sedative activities. Functional effect of activation of alpha1 adrenoceptors by dexmedetomidine. Dexmedetomidine hcl injection athenex pharmaceuticals. Dec 07, 2020 dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pka of 7. Precedex dexmedetomidine hydrochloride injection, solution. Dexmedetomidine hydrochloride 145108583 118 mcg sodium chloride 7647145 9 mg water for injection 7732185 quantity sufficient 1 ml section 4. It is a white, or almost white, crystalline, water soluble substance having a molecular weight of 236. Product monograph download pdf, 193kb patient information download pdf, 142kb product communication. Precedex dexmedetomidine hydrochloride injection precedex dexmedetomidine hydrochloride injection, concentrate for intravenous infusion of injection following dilution of concentrate initial u. Dexmedetomidine also produced delayed motor development in pups at a dose of 32 mcgkg. Dexmedetomidine hydrochloride 145108583 not listed muta.
Dexmedetomidine hydrochloride is an agonist of adrenergic alpha2 receptor, which is used in veterinary medicine for its analgesic. Dailymed precedex dexmedetomidine hydrochloride injection. Dexdomitor dexmedetomidine hydrochloride is a synthetic alpha 2adrenoceptor agonist with sedative and analgesic properties. Dexmedetomidine hydrochloride injection for intravenous use. Dexmedetomidine selectively binds to and activates presynaptic alpha2 adrenoceptors located in the brain, thereby inhibiting the release of norepinephrine. Center for drug evaluation and research approval package for.
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