DEXMEDETOMIDINE 200 mcg/2 ml (Jiangsu Hengrui) Solution for Injection

What is DEXMEDETOMIDINE 200 mcg/2 ml (Jiangsu Hengrui)

DEXMEDETOMIDINE 200 mcg/2 ml, manufactured by Jiangsu Hengrui, is a sterile solution for injection used for sedation in critically ill patients and during medical procedures. The active ingredient, dexmedetomidine, is a highly selective alpha-2 adrenergic receptor agonist known for its sedative, anxiolytic, and analgesic properties without significant respiratory depression.

• Form: Injectable solution
• Strength: 200 micrograms per 2 ml (100 mcg/ml concentration)
• Packaging: 10 glass vials, each containing 2 ml solution
• Primary Uses: ICU sedation of intubated patients, procedural sedation for minor surgeries and diagnostic interventions in non-intubated adults
• Key Benefit: Provides cooperative sedation, allowing patients to remain calm yet arousable with minimal respiratory compromise

This formulation is especially useful in intensive care settings and operating rooms where precise and controlled sedation is required. Unlike many sedatives, dexmedetomidine allows patients to maintain a natural sleep-like state and makes it easier for clinicians to assess patient responsiveness and comfort.

How to use DEXMEDETOMIDINE 200 mcg/2 ml (Jiangsu Hengrui)

DEXMEDETOMIDINE should be administered only by healthcare professionals trained in the management of sedated patients. It is given intravenously, either as a loading dose followed by continuous infusion or as an infusion alone, depending on the clinical setting and desired sedation level.

• ICU Sedation: Start with an optional loading dose of 1 mcg/kg IV over 10 minutes, followed by maintenance infusion of 0.2–0.7 mcg/kg/hr, titrated based on response
• Procedural Sedation: Loading dose of 1 mcg/kg IV over 10 minutes, followed by 0.6–1 mcg/kg/hr infusion during the procedure
• Administration: Must be diluted to achieve target concentration; use a calibrated infusion device
• Monitoring: Continuous monitoring of ECG, blood pressure, oxygen saturation, and respiratory status is mandatory

Dexmedetomidine should not be administered via rapid IV bolus as this may cause transient hypertension or bradycardia. Dosage should be carefully adjusted in elderly patients and those with hepatic impairment. Discontinuation should be gradual to avoid rebound hypertension or agitation, especially after prolonged use.

Mode of Action DEXMEDETOMIDINE 200 mcg/2 ml (Jiangsu Hengrui)

Dexmedetomidine works by activating alpha-2 adrenergic receptors in the brain and spinal cord, particularly in the locus coeruleus region of the brainstem, which is involved in modulating arousal and alertness.

• Alpha-2 Agonism: Reduces norepinephrine release, promoting sedation and anxiolysis
• Analgesic Effect: Provides modest pain relief by inhibiting nociceptive neurotransmission
• Sympatholytic Action: Reduces sympathetic outflow, leading to lower heart rate and blood pressure
• Respiratory Safety: Unlike opioids and benzodiazepines, it does not cause significant respiratory depression

The sedative state induced by dexmedetomidine resembles natural sleep more closely than other sedatives, making it suitable for situations where patient cooperation or rapid arousal is beneficial. Its short distribution half-life allows quick adjustment of sedation depth, while its terminal half-life (~2 hours) facilitates a predictable recovery.

DEXMEDETOMIDINE 200 mcg/2 ml (Jiangsu Hengrui) Interactions DEXMEDETOMIDINE 200 mcg/2 ml (Jiangsu Hengrui)

Dexmedetomidine interacts with several drug classes, especially those affecting cardiovascular and central nervous systems. Awareness of these interactions is crucial to avoid potentiation of adverse effects.

• Opioids: Synergistic sedative and analgesic effects; monitor for enhanced bradycardia and hypotension
• Benzodiazepines: Additive sedation effects; may require dose adjustment
• Antihypertensives: Especially beta-blockers and calcium channel blockers may potentiate bradycardia and hypotension
• Volatile anesthetics: Enhanced anesthetic effects; use with caution during surgery
• Diuretics: May exacerbate hypotension due to volume depletion

Since dexmedetomidine is metabolized in the liver primarily via glucuronidation and CYP2A6 pathways, drug interactions via CYP450 enzymes are minimal. However, close monitoring is still recommended when administered with other sedatives or cardiovascular agents.

Dosage of DEXMEDETOMIDINE 200 mcg/2 ml (Jiangsu Hengrui)

Dosage must be individualized based on patient weight, age, clinical condition, and intended use (ICU vs procedural sedation). DEXMEDETOMIDINE should be diluted and administered via infusion under strict monitoring.

• Loading Dose (Optional): 1 mcg/kg IV over 10 minutes
• Maintenance Infusion (ICU): 0.2 to 0.7 mcg/kg/hr IV
• Procedural Sedation: Infuse at 0.6 to 1 mcg/kg/hr after initial loading dose
• Elderly or Hepatic Impairment: Consider starting at the lower end of dosing range

Continuous infusion is preferred over intermittent boluses to maintain stable plasma levels. Use an infusion pump and monitor sedation depth regularly. Discontinue gradually if used for longer than 24 hours to avoid withdrawal symptoms such as agitation or hypertension.

Possible side effects of DEXMEDETOMIDINE 200 mcg/2 ml (Jiangsu Hengrui)

While generally well-tolerated, DEXMEDETOMIDINE can cause cardiovascular and neurological side effects, particularly with high doses or rapid administration.

• Common: Hypotension, bradycardia, dry mouth, nausea
• Less Common: Hypertension (especially during loading), headache, fever, atrial fibrillation
• Serious: Asystole, advanced AV block, cardiac arrest (rare)
• Withdrawal: Agitation, confusion, tachycardia, rebound hypertension after abrupt discontinuation

Most side effects are dose-dependent and reversible. Risk is increased in hypovolemic patients, those on beta-blockers, or with baseline cardiac conduction disorders. Monitoring should be continuous during administration, and dosage adjusted promptly in response to adverse reactions.

DEXMEDETOMIDINE 200 mcg/2 ml (Jiangsu Hengrui) Contraindications DEXMEDETOMIDINE 200 mcg/2 ml (Jiangsu Hengrui)

Dexmedetomidine should not be used in certain clinical situations where its effects on heart rate and blood pressure may be harmful.

• Hypersensitivity: Known allergy to dexmedetomidine or excipients
• Severe Bradycardia: Especially in patients not on pacemaker support
• Advanced Heart Block: High-grade AV block unless pacemaker is present
• Hemodynamic Instability: Severe hypotension or shock states
• Acute Stroke: Due to potential worsening of cerebral perfusion

Patients with liver impairment should receive reduced doses due to slower metabolism. Use caution in elderly or those with underlying cardiovascular diseases. Always weigh risks versus benefits in borderline cases.

Storage of DEXMEDETOMIDINE 200 mcg/2 ml (Jiangsu Hengrui)

Proper storage is crucial to maintain the potency and sterility of DEXMEDETOMIDINE solution for injection.

• Temperature: Store below 25°C (77°F); do not freeze
• Protection: Keep vials in the original packaging to protect from light
• Diluted Solution: Once diluted, the solution should be used within 24 hours and stored between 2°C and 8°C if not used immediately
• Shelf Life: Refer to product packaging; typically stable for 24 months under recommended conditions
• Disposal: Discard any unused portion. Do not reuse single-use vials

Inspect visually for particulate matter and discoloration prior to use. Do not use if the solution is cloudy or if the vial is damaged. Store out of reach of children and only in controlled healthcare environments.