Taj ALL Products
View Products According to Category
Product Name & Description
Generic Name :Dexmedetomidine Hydrochloride Injection
Brand Name / Company
Brucedex ® (Taj Pharmaceuticals Ltd.)
Therapeutic Class : Relatively selective alpha2-adrenergic
agonist with sedative
Brucedex Injection, Concentrate, 200 mcg/2 mL (100 mcg/mL) in a
Brucedex Injection 200 mcg/50 mL (4 mcg/mL) in a 50 mL glass
Brucedex Injection 400 mcg/100 mL (4 mcg/mL) in a 100 mL glass
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
Each ml contains:
Equivalent to....... Dexmedetomidine 100 mcg / 200 mcg or 400
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
Brucedex (dexmedetomidine hydrochloride) Injection
Brucedex (dexmedetomidine hydrochloride) Injection, Concentrate
For intravenous infusion of injection following dilution of
DOSAGE AND ADMINISTRATION
• Individualize and titrate Brucedex dosing to desired clinical
• Administer Brucedex using a controlled infusion device.
• Dilute the 200 mcg/2 mL (100 mcg/mL) vial contents in 0.9%
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
• Sedation of initially intubated and mechanically ventilated
patients during treatment in an intensive care setting.
Administer Brucedex by continuous infusion not to exceed 24
• 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
• 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
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, 200 mcg/50 mL (4 mcg/mL) in a 50 mL glass
Brucedex Injection, 400 mcg/100 mL (4 mcg/mL) in a 100 mL glass
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