PRODUCT DESCRIPTION:

Dexmedetomidine HCL Injection is a highly selective alpha-2 adrenergic receptor agonist indicated for sedation of initially intubated and mechanically ventilated patients in the intensive care setting, and for procedural sedation in non-intubated patients prior to and/or during surgical and other procedures.

It provides sedation without causing significant respiratory depression, making it an ideal choice in critical care and surgical settings.

This formulation ensures controlled sedation with a rapid onset and predictable duration, supporting clinician confidence in acute and perioperative care.

Its opioid-sparing effects further reduce the need for additional analgesics, promoting safer recovery profiles.

Formulation & Presentation:

• Dosage Form: Sterile Injectable
• Presentation: Clear Sterile Solution in Clear/Amber Glass Vial/ Ampoule (customizable as per market demand)
• Available Strengths:
  • 100 MCG/ ML
• Route of Administration: Intravenous (IV) as per clinical indication. To be used after appropriate reconstitution or as per clinical indication and recommendation. Reconstituted as per protocol for injection in country of use. To be administered under strict supervision of a qualified doctor or as per physician’s discretion or decision only.

Therapeutic Indications:

• ICU Sedation of intubated and ventilated patients
• Procedural Sedation for diagnostic and minor surgical procedures
• Perioperative adjunct for sedation and anxiolysis
• Sedation during awake craniotomy, regional anesthesia procedures

Side Effects:

• COMMON:
  • Hypotension
  • Bradycardia
  • Dry mouth
  • Nausea
  • Dizziness
• SERIOUS (RARE):
  • Severe bradycardia requiring intervention
  • Atrioventricular block
  • Hypotension leading to syncope or cardiac arrest (rare)
  • Withdrawal symptoms upon abrupt discontinuation after prolonged use
• PRECAUTIONS:
  • Continuous monitoring of cardiac and respiratory function required during administration
  • Use cautiously in elderly or patients with hepatic impairment
  • Titrate dosage carefully to avoid oversedation or hemodynamic instability
  • Should not be used as sole agent for intubation or general anesthesia