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Dexmedetomidine Hcl (Dexmedetomidine Hcl)

Trade Name : Dexmedetomidine HCl

West-Ward Pharmaceuticals Corp

INJECTION

Strength 100 ug/mL

DEXMEDETOMIDINE HYDROCHLORIDE Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Dexmedetomidine Hcl (Dexmedetomidine Hcl) which is also known as Dexmedetomidine HCl and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 100 ug/mL per ml. Read more

Dexmedetomidine Hcl (Dexmedetomidine Hcl) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
  • Dexmedetomidine hydrochloride injection is a relatively selective alpha-adrenergic agonist indicated for:
  • Sedation of non-intubated patients prior to and/or during surgical and other procedures. u00a0
  • No data
  • Dilute the 200 mcg/2mL (100 mcg/mL) vial contents in 0.9% sodium chloride solution to achieve required concentration (4 mcg/mL) prior to administration.u00a0n- Arrayn- Array
  • Dexmedetomidine hydrochloride injection, 200 mcg/2 mL (100 mcg/mL) in a glass vial. To be used after dilution. u00a0
  • Dexmedetomidine Hydrochloride Injection 200 mcg/2 mL (100 mcg/mL) in a glass vial. To be used after dilution.u00a0u00a0
  • None
  • None. u00a0
  • No data
  • Monitoring: Continuously monitor patients while receiving dexmedetomidine HCl. u00a0
  • Bradycardia and Sinus Arrest: Have occurred in young healthy volunteers with high vagal tone or with different routes of administration, e.g., rapid intravenous or bolus administration. u00a0
  • Hypotension and bradycardia: May necessitate medical intervention. May be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in the elderly. Use with caution in patients with advanced heart block or severe ventricular dysfunction. u00a0
  • Co-administration with other Vasodilators or Negative Chronotropic Agents: Use with caution due to additive pharmacodynamic effects. u00a0
  • Transient hypertension: Observed primarily during the loading dose. Consider reduction in loading infusion rate.u00a0u00a0
  • Arousability: Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacyu00a0
  • Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse eventsu00a0u00a0)u00a0u00a0
  • The most common adverse reactions (incidence greater than 2%) are hypotension, bradycardia, and dry mouth. (6.1)n
  • Arrayn- Array
  • Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of dexmedetomidine hydrochloride or the concomitant medication may be required. u00a0
  • Arrayn- Array
  • See 17 for PATIENT COUNSELING INFORMATION.
  • u00a0
  • Revised:05/2017
  • No data
  • The tolerability of dexmedetomidine hydrochloride was studied in one study in which healthy adult subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute.
  • One patient who received a loading bolus dose of undiluted dexmedetomidine hydrochloride (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.
  • Dexmedetomidine hydrochloride Injection is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as 4-[()-a,2,3-trimethylbenzyl]imidazole monohydrochloride. Dexmedetomidine hydrochloride has a molecular weight of 236.74 and the molecular formula is CHNu2022 HCl and the structural formula is:
  • Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7.0. Each mL contains 118 mcg of dexmedetomidine hydrochloride equivalent to 100 mcg (0.1 mg)u00a0of dexmedetomidine and 9 mg of sodium chloride in water and is to be used after dilution. The solution is preservative-free and contains no additives or chemical stabilizers.
  • No data
  • No data
  • The safety and efficacy of dexmedetomidine hydrochloride has been evaluated in two randomized, double-blind, placebo-controlled multicenter clinical trials in 431 adult patients.
  • The safety and efficacy of dexmedetomidine hydrochloride for sedation of non-intubated patients prior to and/or during surgical and other procedures was evaluated in two randomized, double-blind, placebo-controlled multicenter clinical trials. Study 1 evaluated the sedative properties of dexmedetomidine hydrochloride in patients having a variety of elective surgeries/procedures performed under monitored anesthesia care. Study 2 evaluated dexmedetomidine hydrochloride in patients undergoing awake fiberoptic intubation prior to a surgical or diagnostic procedure.
  • In Study 1, the sedative properties of dexmedetomidine hydrochloride were evaluated by comparing the percent of patients not requiring rescue midazolam to achieve a specified level of sedation using the standardized Observeru2019s Assessment of Alertness/Sedation Scale (Table 5).
  • Table 5 Observeru2019s Assessment of Alertness/Sedation
  • u00a0
  • Patients were randomized to receive a loading infusion of either dexmedetomidine hydrochloride 1 mcg/kg, dexmedetomidine hydrochloride 0.5 mcg/kg, or placebo (normal saline) given over 10 minutes and followed by a maintenance infusion started at 0.6 mcg/kg/hr. The maintenance infusion of study drug could be titrated from 0.2 mcg/kg/hr to 1 mcg/kg/hr to achieve the targeted sedation score (Observeru2019s Assessment of Alertness/Sedation Scale u22644). Patients were allowed to receive rescue midazolam as needed to achieve and/or maintain an Observeru2019s Assessment of Alertness/Sedation Scale 4. After achieving the desired level of sedation, a local or regional anesthetic block was performed. Demographic characteristics were similar between the dexmedetomidine hydrochloride and comparator groups. Efficacy results showed that dexmedetomidine hydrochloride was more effective than the comparator group when used to sedate non-intubated patients requiring monitored anesthesia care during surgical and other procedures. (see Table 7)
  • In Study 2, the sedative properties of dexmedetomidine hydrochloride were evaluated by comparing the percent of patients requiring rescue midazolam to achieve or maintain a specified level of sedation using the Ramsay Sedation Scale score 2 (see Table 6).
  • Table 6: Ramsay Level of Sedation Scale
  • Patients were randomized to receive a loading infusion of dexmedetomidine hydrochloride 1 mcg/kg or placebo (normal saline) given over 10 minutes and followed by a fixed maintenance infusion of 0.7 mcg/kg/hr. After achieving the desired level of sedation, topicalization of the airway occurred. Patients were allowed to receive rescue midazolam as needed to achieve and/or maintain a Ramsay Sedation Scale 2. Demographic characteristics were similar between the dexmedetomidine hydrochloride and comparator groups. For efficacy results see Table 7.
  • Table 7. Key Efficacy Results of Procedural Sedation Studies
  • Dexmedetomidine Hydrochloride Injection is available as:
  • NDC 0143-9532-25
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dexmedetomidine hydrochloride is indicated for short-term intravenous sedation. Dosage must be individualized and titrated to the desired clinical effect. Blood pressure, heart rate and oxygen levels will be monitored both continuously during the infusion of dexmedetomidine hydrochloride and as clinically appropriate after discontinuation.
  • u00a0
  • Manufactured by:
  • HIKMA FARMACu00caUTICA (PORTUGAL), S.A.
  • Estrada do Rio da Mu00f3, 8, 8A e 8B u2013 Fervenu00e7a u2013 2705-906 Terrugem SNT, PORTUGAL
  • Distributed by:
  • West-Ward Pharmaceuticals
  • Eatontown, NJ 07724 USA
  • Revised May 2017
  • PIN410-WES/4
  • NDC 0143-9532-01 Rx only 2 mL VialDexmedetomidineu00a0HCl Injection
  • 200 mcg/2mL
  • (100 mcg/mL)DexmedetomidineFor Intravenous UseMUST BE DILUTEDu00a0
  • NDC 0143-9532-25 Rx only u00a0Dexmedetomidineu00a0HCl Injection
  • 200 mcg/2mL
  • (100 mcg/mL)DexmedetomidineFor Intravenous UseMUST BE DILUTEDu00a0
  • Preservative-Free
  • 25 x 2 mL Single Dose Vials
  • No data

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