Aibeimei Dexmedetomidine Hydrochloride Nasal Spray

1. Indications and Usage
Adults: Preoperative sedation/anxiolysis for adult patients undergoing elective abdominal surgery under general anesthesia.
Pediatrics: Preoperative sedation/anxiolysis for children aged 2 to 6 years undergoing general anesthesia.
Setting: Must be administered by medical personnel in a setting equipped with appropriate monitoring and resuscitation devices.
2. Dosage and Administration
Route of Administration: Intranasal administration ONLY.
Recommended Dosage (Adults): 100 μg is the recommended dose, typically administered as 4 sprays per nostril (based on 25 μg/spray formulation).
Recommended Dosage (Children 2-6 years): Dosing is stratified by weight. For example, 30 μg (for 10.7 kg ≤ weight < 19.4 kg) or 50 μg (for 19.4 kg ≤ weight < 28.0 kg).
Critical Administration Instructions:
Device Handling: Keep the device upright at all times; do not place horizontally, invert, or drop.
Priming: Prime the pump (7 initial sprays) before the first use.
Monitoring: Continuously monitor circulatory and respiratory function during the preoperative sedation process. Airway support and resuscitation equipment must be readily available.
3. Mechanism of Action
α2A-Agonism: Dexmedetomidine is a highly selective α2A-adrenergic receptor agonist.
Sedation: It produces a unique, cooperative sedation characterized by reduced anxiety and drowsiness while maintaining spontaneous respiration and the ability to be easily aroused.
Central Action: It acts primarily within the locus coeruleus in the brainstem to inhibit sympathetic outflow.
4. Safety and Warnings
Cardiovascular Effects: Known to cause bradycardia, hypotension, and sinus arrest. Patients with advanced cardiac conduction blocks or severe cardiac dysfunction should be treated with caution.
Contraindications: Contraindicated in patients with known hypersensitivity to dexmedetomidine or any excipients.
Pediatric Limitations: Safety and efficacy data are lacking for children under 2 weeks of age and children over 6 years of age.
Geriatric Considerations: Elderly patients (≥60 years) and those with low body weight are at higher risk for bradycardia and hypotension; dose reduction should be considered.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Hypotension and bradycardia are very common (≥10%).
Other Common Adverse Reactions: Hypertension, sinus bradycardia, nausea, vomiting, dizziness, and sleepiness were observed in clinical trials.
Clinical Research Highlights: Clinical studies demonstrated that intranasal dexmedetomidine effectively reduces preoperative anxiety in both adult and pediatric populations compared to placebo.
6. Drug Interactions
CNS Depressants: Concomitant use with other anesthetics, sedatives, hypnotics, or opioids may lead to enhanced pharmacological effects, requiring potential dose reductions.
Cardiovascular Drugs: Concurrent use with antihypertensives or antiarrhythmics may potentiate hypotension and bradycardia.
Cholinesterase Inhibitors: May increase the risk of bradycardia.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Dexmedetomidine Hydrochloride. Excipients: Benzalkonium chloride, sodium chloride, purified water.
Appearance: Clear, colorless liquid.
Packaging: 1 mL single-dose vials (available in 300 μg/8 sprays or 500 μg/8 sprays per mL).
Storage: Store at controlled room temperature; protect from light.