Precedex, dexmedetomidine dosing, indications, interactions. Dexmedetomidine hydrochloride injection is a central alpha2 adrenergic agonist indicated for sedation of nonintubated patients prior to andor during surgical and other procedures. Precedex dexmedetomidine hydrochloride for injection and dexmedetomidine injection is indicated for. When dexmedetomidine hydrochloride is used for shortterm iv sedation, dosage must be individualized and titrated to the desired clinical effect. Precedex is supplied as a clear, colorless, isotonic solution with a ph of 4. Ask a doctor before giving the patient a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures. Dexmedetomidine hydrochloride treatment was carried out after tracheal intubation in anesthesia induction. Oct 20, 2014 dexmedetomidine is an alpha 2 adrenergic receptor agonist, even ten times more selective than clonidine. Dexmedetomidine hydrochloride injection safely and. Dexmedetomidine why should i make it a part of my anaesthetic. Dexmedetomidine is a selective alpha2 receptor agonist with sedative, analgesic. Fda website list of drug master files dmf of dexmedetomidine hydrochloride active pharmaceutical ingredient api submitted to.
Due to the unprecedented nature of the covid19 pandemic, anyone reporting an adverse event andor a product complaint via phone, should you receive a network busy signal ie. Dexmedetomidine hydrochloride 200 mg this item has been identified as a potentially dangerous good. Dexmedetomidine hydrochloride injection should be administered only by persons skilled in the management of patients in the operating room setting. Stability of dexmedetomidine in polyvinyl chloride bags containing 0. Product name dexmedetomidine hydrochloride sigmaaldrich. Dexdomitor contains the new active substance dexmedetomidine hydrochloride, an. A shorthalf life could make dexmedetomidine easier to titrate, quicker to recover from and potentially associated with less prolonged sedation related adverse events. Dexmedetomidine is an alternative to traditional drugs for maintaining sedation in the icu.
Dexmedetomidine is an alpha 2 adrenergic receptor agonist, even ten times more selective than clonidine. Precedex dexmedetomidine hydrochloride drug information. However, the health canadaapproved label for dexmedetomidine. The effects of dexmedetomidine continuous rate infusion. Dexmedetomidine hydrochloride injection has been shown to be incompatible when administered with the following drugs. Dexmedetomidine for sedation in the critical care setting.
List of drug master files dmf of dexmedetomidine hydrochloride active pharmaceutical ingredient api submitted to the u. It is thought to carry a lower risk of some of the side effects caused by the more commonly used sedative agents. Dexmedetomidine hydrochloride injection is supplied as a clear, colorless, isotonic solution with a ph of 4. This leads to an inhibition of postsynaptic activation of adrenoceptors, which inhibit. An agonist of receptors, adrenergic alpha2 that is used in veterinary medicine for its analgesic and sedative properties. Due to the known pharmacological effects of dexmedetomidine hydrochloride injection, patients should be continuously monitored while receiving dexmedetomidine hydrochloride injection. 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. Dexmedetomidine is a selective alpha 2adrenergic receptor agonist used clinically as a preoperative adjunct of general anesthesia. Dexmedetomidine hydrochloride api dmfs us drug master. This product information is intended only for residents of the united states. Jul 11, 2011 dexmedetomidine undoubtedly is a useful sedative in the intensive care setting because it has a minimal effect on the respiratory system. Precedex dexmedetomidine hydrochloride injection, solution hospira inc. The effects of dexmedetomidine continuous rate infusion cri. Original article effect of dexmedetomidine hydrochloride.
The use of dexmedetomidine hydrochloride as a preanesthetic markedly reduces anesthetic requirements in dogs. Dexmedetomidine hydrochloride is a highly potent and selective. Guideline title dexmedetomidine hydrochloride precedex summary. Drug guideline guideline title nsw agency for clinical. Dexmedetomidine therapeutics brands precedex dexmedetomidine hydrochloride generic. Dexmedetomidine hydrochloride api manufacturers suppliers. Dexdomitor is supplied in a multidose vial containing 10 ml of a sterile aqueous solution of 0. Dexmedetomidine injection, usp is an aprated generic of precedex. Feb 01, 2020 dexmedetomidine hydrochloride injection infusion should not be coadministered through the same intravenous catheter with blood or plasma because physical compatibility has not been established. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Propofol or midazolam may be administered if needed. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext.
Oct 21, 2015 dexmedetomidine hydrochloride injection. Dexmedetomidine can interact with other drugs that can cause drowsiness or slowed breathing, leading to dangerous side effects or death. Dexmedetomidine selectively binds to presynaptic alpha2 adrenoceptors located in the brain, thereby inhibiting the release of norepinephrine from synaptic vesicles. Dexmedetomidine hydrochloride injection, usp mylan adds dexmedetomidine hydrochloride injection, usp to its product portfolio, arming hospitals, clinics and other health systems with the therapies they need. Dexmedetomidine why should i make it a part of my anaesthetic practice. Titrate infusion to achieve the desired clinical effect after 5 10 minutes of the start. 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. Dexmedetomidine hydrochloride as a longterm sedative.
This is a significantly shorter halflife than that of pentobarbital and chloral hydrate. It is a white, or almost white, crystalline, water soluble substance having a molecular weight of 236. Dexmedetomidine hydrocholride hcl 3 dexmedetomidine on agitation during weaning of mechanical ventilation in critically ill patients. Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pka of 7. To prepare the infusion, withdraw 2 ml of dexmedetomidine hydrochloride injection, and add to 48 ml of 0. Intramuscular im dosing on the basis of body weight.
Identification of the substancemixture and of the companyundertaking product name. Dexmedetomidine hydrochloride should be administered only by persons skilled in anaesthetics or in the. Dexmedetomidine hydrochloride is used clinically as an anesthetic agent to reduce anxiety and tension and promote relaxation and sedation without causing respiratory depression. Dexmedetomidine hcl injection in 5% dextrose wg critical care. Rui xia department of anesthesia and critical care, the first affiliated hospital of yangtze university, jingzhou, hubei province, pr china abstract dexmedetomidine is a highly selective alpha2 adrenoreceptor with maximum affinity to alpha2a subunit. Welcome to the dexmedetomidine source, an interactive internet site designed to provide information to physicians and healthcare personnel about dexmedetomidine hydrochloride injection precedex, a novel therapeutic modality approved by the us food and drug administration fda in december 1999 for sedation in patients hospitalized in intensive care settings. Vision impaired people having problems accessing certain pages of a pdf file may call 301 7963634 for assistance. Dailymed dexmedetomidine hydrochloride injection, solution. For the april 12, 2016 meeting of the fdas pediatric advisory committee. Use of a loading dose of dexdor is not recommended and is associated with increased adverse reactions. Dexmedetomidine infusions lasting more than 24 hours have not been approved since the first approval was acquired in the us in 1999. Dexmedetomidine hydrochloride drug entry dexmedetomidine. Due to the known pharmacological effects of dexmedetomidine hydrochloride,patients shou dlbe continuously monitored huwhile receiving dexmedetomidine hydrochloride.
Dexmedetomidine premedication attenuates concanavalin ainduced hepatitis in mice article pdf available in the journal of toxicological sciences 395. Dexmedetomidine does not alter respiratory rate or oxygen saturation at the recommended dosage. Three presentations of the finished product are available. Intensive care unit sedation precedex is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting by continuous intravenous infusion. Dec, 2012 dexmedetomidine why should i make it a part of my anaesthetic practice. Stability of dexmedetomidine in polyvinyl chloride bags. Dexmedetomidine for pediatric sedation for computed. Dexmedetomidine hydrochloride injection fda prescribing. Each ml contains 118 mcg of dexmedetomidine hydrochloride equivalent to 100 mcg 0. Search results for dexmedetomidine hydrochloride at sigmaaldrich. In the workplace, dexmedetomidine hydrochloride should be considered a potent drug. Dexmedetomidine is notable for its ability to provide sedation without risk of. Dexmedetomidine hydrochloride monograph for professionals. It has a half life of 6 minutes and undergoes rapid distribution.
Dexmedetomidine, sold under the trade name precedex among others, is an anxiety reducing, sedative, and pain medication. It is a very versatile drug in anaesthesia practice, finding place in increasing number of clinical scenarios and is no more limited to intensive care unit icu sedation. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a white, or almost white, crystalline, seek medical advice immediately. Katina skylas icu cnc february 2015 najat nizamnahhas pharmacist july2014 govindasamy thanakrishnan, intensivist may 20. Dexmedetomidine is an alpha2 agonist, a novel sedative with analgesic properties that controls stress, anxiety and pain with stable respiratory rates. The nlm drug information portal gives users a gateway to selected drug information from the national library of medicine and other key government agencies.
United states court of appeals for the federal circuit. 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. Precedex dexmedetomidine hydrochloride injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. On average, dexmedetomidine hydrochloride treated patients received less morphine sulfate for pain than placebotreated patients 0. Dexmedetomidine hydrochloride injectionshould be administered only by persons skilled in the management of patients in the operating roo m setting. Dexmedetomidine is an imidazole derivate and active disomer of medetomidine with analgesic, anxiolytic and sedative properties. Dexmedetomidine hydrochloride injection is supplied as a clear, colorless, isotonic solution, free from visible particles, with a ph of 4. Dexmedetomidine is a selective alpha2 receptor agonist with sedative, analgesic and anaesthetic properties when given as a slow infusion.
Dexdomitor dexmedetomidine hydrochloride is a synthetic alpha 2adrenoreceptor agonist with sedative and analgesic properties. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. A small initial hypertensive response has been observed with iv injection of higher doses. In addition, 44% 79 of 178 patients of dexmedetomidine hydrochloride patients received no morphine sulfate for pain versus 19% 33 of 175 patients in the placebo group. Dexmedetomidine hydrochloride united states pharmacopeia usp. Nov 19, 2015 register now and get a free online msds binder. Dexmedetomidine is commercially available as a watersoluble hcl. Precedex contain a concentrate of dexmedetomidine hydrochloride. Dexmedetomidine hydrochloride injection should be administered by continuous infusion not to exceed 24 hours. Fda website list of drug master files dmf of dexmedetomidine hydrochloride active pharmaceutical ingredient api submitted to the u.
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