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Dexmedetomidine Hydrochloride Injection
 
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Dexmedetomidine Hydrochloride Injection

 
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Dexmedetomidine Hydrochloride Injection

Product Name & Description
Dexmedetomidine Hydrochloride
Generic Name :Dexmedetomidine Hydrochloride Injection

Brand Name / Company
Brucedex ® (Taj Pharmaceuticals Ltd.)
Therapeutic Class : Relatively selective alpha2-adrenergic agonist with sedative
properties

Brucedex Injection, Concentrate, 200 mcg/2 mL (100 mcg/mL) in a glass
Brucedex Injection 200 mcg/50 mL (4 mcg/mL) in a 50 mL glass bottle.
Brucedex Injection 400 mcg/100 mL (4 mcg/mL) in a 100 mL glass bottle.

DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Each ml contains:
Dexmedetomidine Hydrochloride
Equivalent to....... Dexmedetomidine 100 mcg / 200 mcg or 400 mcg
Vehicle/Solvent Water for Injection BP... q.s.

DEXMEDETOMIDINE IS NOTABLE FOR ITS ABILITY TO PROVIDE SEDATION WITHOUT RISK OF RESPIRATORY DEPRESSION (UNLIKE OTHER COMMONLY USED SEDATIVES SUCH AS PROPOFOL, FENTANYL, AND MIDAZOLAM) AND CAN PROVIDE COOPERATIVE OR SEMI-AROUSABLE SEDATION.

Brucedex (dexmedetomidine hydrochloride) Injection
Brucedex (dexmedetomidine hydrochloride) Injection, Concentrate
For intravenous infusion of injection following dilution of concentrate

DOSAGE AND ADMINISTRATION
• Individualize and titrate Brucedex dosing to desired clinical effect.
• Administer Brucedex using a controlled infusion device.
• Dilute the 200 mcg/2 mL (100 mcg/mL) vial contents in 0.9% sodium
chloride solution to achieve required concentration (4 mcg/mL) prior to administration.
• The 200 mcg/50mL and 400 mcg/100 mL single-use bottles do not require further dilution prior to administration.


INDICATIONS AND USAGE
Brucedex is a relatively selective alpha2-adrenergic agonist indicated for:
• Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer Brucedex by continuous infusion not to exceed 24 hours.
• Sedation of non-intubated patients prior to and/or during surgical and other procedures.

WARNINGS AND PRECAUTIONS : Drug Administration
Brucedex should be administered only by persons skilled in the management of patients in the
intensive care or operating room setting. Due to the known pharmacological effects of Brucedex, patients should be continuously monitored while receiving Brucedex.

Note: In a controlled clinical trial, Brucedex was compared to midazolam for ICU sedation exceeding 24 hours duration in adult patients. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Brucedex group is provided in Table.

PATIENT COUNSELING INFORMATION
Brucedex 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 Brucedex and as clinically appropriate after discontinuation. When Brucedex is infused for more than 6 hours, patients should be informed to report
nervousness, agitation, and headaches that may occur for up to 48 hours.
• Additionally, patients should be informed to report symptoms that may occur within 48 hours after the administration of Brucedex such as: weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness or light-headedness.

Store at controlled room temperature, 25°C (77°F) with excursions
allowed from 15 to 30°C (59 to 86°F)
.

DOSAGE FORMS AND STRENGTHS
Brucedex Injection, Concentrate
Brucedex Injection, 200 mcg/2 mL (100 mcg/mL) in a glass vial
Brucedex Injection
Brucedex Injection, 200 mcg/50 mL (4 mcg/mL) in a 50 mL glass bottle
Brucedex Injection, 400 mcg/100 mL (4 mcg/mL) in a 100 mL glass bottle





Note :
This product information is intended only for residents of the India. Taj Pharmaceuticals Limited,  medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.

Information for Health Care Professionals

*** Please consult local Prescribing Information for any product before use. This website is an international information resource for healthcare professionals with an interest in disease management. This website is not intended to replace the advice of a qualified healthcare professional. Above brand is a trademark of the Taj group of companies (Taj Pharmaceuticals Limited).
 

 

 

 


Ability to provide sedation without risk of respiratory depression
 

  Dexmedetomidine HCl Injection
 Prescription Products (Rx)
 


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Dexmedetomidine Hydrochloride Injection
 

 


              
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Dexmedetomidine Hydrochloride Injection



 

 

 

 

 

 

 

 

 

 

 

 

 
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