Dexmedetomidine Hydrochloride 145108-58-3 | TCI AMERICA Nesiritide There are fourteen drug master file entries for this compound. In the workplace, dexmedetomidine hydrochloride should be considered a potent drug. Precedex - FDA prescribing information, side effects and uses Drug Substances in a Sentence Concomitant use of barbiturates, alcohol, or other CNS depressants may increase risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect. Species/Class . Dexmedetomidine - Hospira/Orion/Baudax Bio - AdisInsight PDF 206628Orig1s000 Dexmedetomidine use in dogs | Vetlexicon Canis from ... Dexmedetomidine Hydrochloride Injection is a central alpha-2 adrenergic agonist indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. in the workplace, dexmedetomidine … The product's dosage form is injection, solution and is administered via intravenous form. PDF SAFETY DATA SHEET - editor.fresenius-kabi.us Neomycin: Dexmedetomidine may decrease the excretion rate of Neomycin which could result in a higher serum level. Dexmedetomidine Hydrochloride Injection has a formulation that i s very similar to that of Precedex with the exception of the addition of two preservatives: methylparaben and propylparaben. Please refer to your Supplemental New Drug Application (sNDA) dated January 22, 2010, received January 25, 2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Precedex (dexmedetomidine hydrochloride). PRECEDEX Nonclinical Toxicology (dexmedetomidine ... PRECEDEX Clinical Pharmacology (dexmedetomidine ... Class of drug. M. Indication . There are several limitations of this clinical research. Precedex (dexmedetomidine hydrochloride) injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. See full entry for Dexmedetomidine Accession Number DBSALT001013 Structure Similar Structures Synonyms Dexmedetomidine HCl UNII Carcinogenic Effects: 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 semi-rousable sedation. When dexmedetomidine hydrochloride is used for short-term IV sedation, dosage must be individualized and titrated to the desired clinical effect. DEXMEDETOMIDINE HYDROCHLORIDE: Sometimes called the generic name, this is usually the active ingredient(s) of the product. Dexmedetomidine hydrochloride. Cat . Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; DEXMEDETOMIDINE HYDROCHLORIDE: DEXMEDETOMIDINE HYDROCHLORIDE: EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) offspring at a dosage of 32 mcg/kg. The product's dosage form is injection, solution, and is administered via intravenous form. Therefore, it may be inferred that dexmedetomidine is inferior to remifentanil in terms of the analgesic effect. The invention discloses an industrial preparation method of dexmedetomidine hydrochloride, and belongs to the field of medicines. The method comprises the following steps: directly carrying out a Friedel-Crafts alkylation reaction on initial raw materials comprising 1-(2,3-dimethylphenyl)ethanol not subjected to a chlorination (thionyl chloride) reaction and protected imidazole under the . Monitor Closely (1) dexmedetomidine increases and midodrine decreases sedation. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 5.5. DEXDOMITOR is indicated for use as a sedative and analgesic in dogs and cats to . dosage form as the RLNAD, and contains no inactive ingredients that may significantly . It is an α2 adrenergic agonist that can be administered as an intravenous drug solution with sterile water. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 5.5. dexmedetomidine hydrochloride is the generic ingredient in two branded drugs marketed by accord hlthcare, actavis inc, akorn, am regent, amneal pharms co, baxter hlthcare corp, eugia pharma, fresenius kabi usa, gland, gland pharma ltd, hikma, hong kong, jiangsu pharms, mylan institutional, mylan labs ltd, par sterile products, piramal critical, … Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7.0. Field Name. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg of sodium chloride in water and is ready to be used. Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other. The product's dosage form is injection, solution, concentrate and is administered via intravenous form. (1) -----DOSAGE AND ADMINISTRATION----- Dilute in 0.9% Sodium Chloride Injection to concentration of 4 mcg/mL Dexmedetomidine hydrochloride is a highly potent and selective α2-adrenergic agonist with analgesic and sedative properties, the (+)-isomer of medetomidine. dosage of 5 mg/kg instead of the currently recommended 22-33 mg/kg induction dose. Before a ventilator is used, a breathing tube must be inserted through the mouth and into the patient's airway, a procedure called intubation. The product's dosage form is injection, solution, and is administered via intravenous form. Inhalation: Reported to be highly toxic by inhalation. Dexmedetomidine Hydrochloride Injection has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam. For cats receiving propofol, the primary variable was the Dexmedetomidine hydrochloride is a potent α 2 -adrenoceptor agonist, which produces and analgesia, about 8 times higher selective affinity for the α 2 /α 1 -adrenoceptor than clonidine [ D1353 ]. Click to see full answer Dexmedetomidine, sold under the trade name Precedex among others, is an anxiolytic, sedative, and pain medication. Medetomidine hydrochloride | C13H17ClN2 | CID 68601 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological . Dogs . Dexmedetomidine hydrochloride. To be used after dilution. Precedex is a drug marketed by Hospira and is included in one NDA. The generic ingredient in PRECEDEX is dexmedetomidine hydrochloride. Indication(s . We acknowledge receipt of your amendments dated August 26 and September 20, 2010. Alpha2 adrenergic agonist. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg sodium chloride in water and is ready to be used. midodrine. (The product is for research purpose only.) What class of drug is Dexdomitor? 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 a sedative that is used to sedate a patient who is under intensive medical care and needs a mechanical ventilator (breathing machine). Dexmedetomidine hydrochloride is a highly potent and selective α2-adrenergic agonist with analgesic and sedative properties, the (+)-isomer of medetomidine. The product's dosage form is injection and is administered via intravenous form. Dexmedetomidine infusions were weaned by 0.1 mcg/kg/hour every 12 to 24 hours, as tolerated. Dexmedetomidine Hydrochloride Injection is a central alpha-2 adrenergic agonist indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures Pharmacology Dexmedetomidine is a specific and selective alpha-2 adrenoceptor agonist. There are seven patents protecting this drug and three Paragraph IV challenges. Field Value. Dexmedetomidine may decrease the excretion rate of Nedocromil which could result in a higher serum level. Dexmedetomidine hydrochloride Drug Entry Dexmedetomidine An agonist of receptors, adrenergic alpha-2 that is used in veterinary medicine for its analgesic and sedative properties. Dexmedetomidine is an imidazole derivate and active d-isomer of medetomidine with analgesic, anxiolytic and sedative properties. Substance Name: DEXMEDETOMIDINE HYDROCHLORIDE: This is the active ingredient list. Visit cvs.com for more details. This drug has fifty patent family members in thirty-five countries. Dexmedetomidine selectively binds to and activates presynaptic alpha-2 adrenoceptors located in the brain, thereby inhibiting the release of norepinephrine . Enantiomeric preparation of medetomidine consisting of the dextro-rotary isomer only. DEXDOMITOR (dexmedetomidine hydrochloride) is a synthetic alpha 2-adrenoreceptor agonist with sedative and analgesic properties. The NDC Code 0338-9555-24 is assigned to a package of 24 bag in 1 carton > 50 ml in 1 bag of Dexmedetomidine Hydrochloride, a human prescription drug labeled by Baxter Healthcare Company. Perceived advantages are: Levo-rotatory isomer does not need to be metabolised. 0338-9555-24. Lactation: 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. National Drug Code 52584-638 is assigned to precedex with active ingredient(s) dexmedetomidine hydrochloride and is labeled by General Injectables and Vaccines, Inc. Dexmedetomidine is a selective alpha 2-adrenergic receptor agonist used clinically as a pre-operative adjunct of general anesthesia. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Analysis Note This leads to an inhibition of postsynaptic activation of adrenoceptors, which inhibit sympathetic . Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Alpha-2 adrenergic agonist. dexmedetomidine hydrochloride, the dextro-enantiomer of the racemic mixture of medetomidine. This is a challenging study evaluating the efficacy and safety of dexmedetomidine with respect to the reduction of postoperative delirium in adult cardiac surgery patients. It is the racemate of dexmedetomidine. . Call your doctor for medical advice about side effects. L. Species/Class . Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Analgesic duration may be prolonged (in dogs). Table 8 shows the main pharmacokinetic parameters when Precedex was infused (after appropriate loading doses) at maintenance infusion rates of 0.17 mcg/kg/hr (target plasma concentration of 0 . Dexmedetomidine Hydrochloride with NDC 63323-421 is a a human prescription drug product labeled by Fresenius Kabi Usa, Llc. Dexmedetomidine hydrochloride is used clinically as an anesthetic agent to reduce anxiety and tension and promote relaxation and sedation without causing respiratory depression. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride equivalent to 4 mcg (0.004 mg) of dexmedetomidine and 9 mg of sodium chloride in water and is ready to be used. The NDC Code 67457-924-50 is assigned to "Dexmedetomidine Hydrochloride " (also known as: "Dexmedetomidine Hydrochloride"), a human prescription drug labeled by "Mylan Institutional LLC". Dexmedetomidine hydrochloride | C13H17ClN2 - PubChem compound Summary Dexmedetomidine hydrochloride Contents 1 Structures 2 Names and Identifiers 3 Chemical and Physical Properties 4 Spectral Information 5 Related Records 6 Chemical Vendors 7 Drug and Medication Information 8 Pharmacology and Biochemistry 9 Use and Manufacturing Dexmedetomidine Hydrochloride Injection has been shown to be compatible when administered with the following intravenous fluids: • 0.9% sodium chloride in water • 5% dextrose in water Placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously to pregnant rats. The mean infusion rate was 0.6 mcg/kg/hour (range: 0.3 to 1.2 mcg/kg/hour) and mean duration of infusion was 12 days. Dexmedetomidine Hydrochloride sterile injectable solution cats . Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4- (S)- [1- (2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. REVERTIDINE™ is indicated for the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride and medetomidine hydrochloride in dogs. Dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine hydrochloride in 0.9% sodium chloride injection, a reduction in dosage of dexmedetomidine hydrochloride in 0.9% sodium chloride injection or the concomitant anesthetic, sedative, hypnotic or opioid may be required. The study-drugs (dexmedetomidine hydrochloride 200 μg/2 ml or normal saline 2 ml) were packed as clear aqueous solutions with the same characteristics in the same type of 3-ml ampoules. Dexmedetomidine exhibits linear pharmacokinetics in the dosage range of 0.2 to 0.7 mcg/kg/hr when administered by intravenous infusion for up to 24 hours. New Drug Application Filing and Review Form General Information About the Submission Information Information NDA/BLA Number 206628 Brand Name Dexmedetomidine HCl Injection OCPDivision (I, II, III, IV, V) DCP2 GenericName Dexmedetomidine HCl Injection Medical Division DAAAP Drug Class Sedative OCP Reviewer Srikanth C. Nallani, Ph.D. Nefazodone: The risk or severity of adverse effects can be increased when Dexmedetomidine is combined with Nefazodone. National Drug Code 0409-1660 is assigned to precedex with active ingredient(s) dexmedetomidine hydrochloride and is labeled by Hospira, Inc. C13H16N2.HCl; Molecular weight. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. BP, heart rate, and oxygen concentrations are continuously monitored during the infusion and as clinically appropriate after discontinuance. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride. Medetomidine is a synthetic drug used as both a surgical anesthetic and analgesic. Description: Dexmedetomidine is a selective α 2-adrenoceptor agonist w/ anaesth and sedative properties.Its action is thought to be due to activation of G-proteins by α 2a-adrenoceptors in the brainstem resulting in inhibition of norepinephrine release. Dexmedetomidine Solution for injection 4mcg Drug Medication Dosage information. More than 49,000 drugs can be searched. Drug Substances in a Sentence Manuscript Generator Search Engine NDC Package Code 0409-1638-02. ICU Sedation: Dexmedetomidine hydrochloride is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Table 8 shows the main pharmacokinetic parameters when Precedex was infused (after appropriate loading doses) at maintenance infusion rates of 0.17 mcg/kg/hr (target plasma concentration of 0 . This is not a complete list of side effects and others may occur. Dexmedetomidine infusions were titrated by 0.1 mcg/kg/hour increments every 12 hours as needed. Pregnancy: There are no studies conducted with dexmedetomidine hydrochloride in pregnant women to inform any drug-associated risks. Jiangsu Nhwa Pharmaceutical Co., Ltd. (Jiangsu, China) manufactured and provided the study-drugs. Duration: 60-120 min. Contraindications None Warnings and Precautions Drug Administration Dexmedetomidine hydrochloride injection should be administered only by persons skilled in the management of patients in the operating room setting. The NDC Code 0409-1638-02 is assigned to a package of 25 vial in 1 tray > 2 ml in 1 vial (0409-1638-32) of Precedex, a human prescription drug labeled by Hospira, Inc.. Dexmedetomidine hydrochloride is a highly potent and selective α2-adrenergic agonist with analgesic and sedative properties, the (+)-isomer of medetomidine. Dexmedetomidine also produced delayed motor development in pups at a dose of 32 mcg/kg. Each ingredient name is the preferred term of the UNII code submitted. Our Precedex (dexmedetomidine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. The. Pregnancy: There are no studies conducted with dexmedetomidine hydrochloride in pregnant women to inform any drug-associated risks. 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 . Precedex (dexmedetomidine hydrochloride) injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride. Dexmedetomidine hydrochloride is used clinically as an anesthetic agent to reduce anxiety and tension and promote relaxation and sedation without causing respiratory depression. L. Species/Class Cat M. Indication DEXDOMITOR is indicated for use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures,. The NDC Code 0143-9526-10 is assigned to "Dexmedetomidine Hydrochloride " (also known as: "Dexmedetomidine Hydrochloride"), a human prescription drug labeled by "Hikma Pharmaceuticals USA Inc.". Dexmedetomidine, as a kind of new sedative drug, has been applied in some surgical operations with significant effect, suggesting the feasibility of the application of dexmedeto- Pharmacokinetics: Absorption: Time to peak plasma concentration: 15-30 min. Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. It is often used as the hydrochloride salt, medetomidine hydrochloride, a crystalline white solid. The generic name of Dexmedetomidine Hydrochloride is dexmedetomidine hydrochloride. Evaluation of Class of drug. Dexmedetomidine hydrochloride has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. Description Chemical name [+]4-[1-[2,3-dimethylphenyl]-ethyl]-1H-imidazole (S)-4(5)-[1-(2,3-Dimethylphenyl) ethyl]imidazole tartrate; Molecular formula. Learn about the reported side effects, related class drugs, and how these medications will affect your daily lifestyle. Dexmedetomidine is a sedative that is used to sedate a patient who is under intensive medical care and needs a mechanical ventilator (breathing machine). 236.7; Physical properties. Hypotension occurred in a higher incidence in dexmedetomidine hydrochloride-treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients <65 years (47%). Dexmedetomidine hydrochloride Injection, 200 mcg/2 mL dexmedetomidine (100 mcg/mL) in a glass vial. Dexmedetomidine Hydrochloride Injection Dosage and Administration Dosing Guidelines Dexmedetomidine injection dosing should be individualized and titrated to desired clinical response. Dexmedetomidine Hydrochloride : RTECS Number: NI5156750 Skin: Application of 975 mcg of dexmedetomidine to the skin of human volunteers produced sedation and reduced blood pressure with sedation appearing within 1-2 hours after application of dexmedetomidine. Dexmedetomidine Hydrochloride is the hydrochloride salt form of dexmedetomidine, an imidazole derivate and active d-isomer of medetomidine with analgesic, anxiolytic and sedative activities. 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