Aihengping Bupivacaine Liposome Injection

1. Indications and Usage
Primary Indication: Indicated for the production of local analgesia by local infiltration and for the production of regional analgesia by interscalene brachial plexus block.
Patient Population: Indicated for postoperative analgesia in adult and pediatric patients aged 12 years and older.
2. Dosage and Administration
Adult Local Infiltration: The maximum recommended dose is 266 mg.
Adult Interscalene Brachial Plexus Block: The maximum recommended dose is 133 mg.
Pediatric Local Infiltration: The recommended dose is 4 mg/kg (maximum 266 mg) for patients aged 12 to17 years.
Administration Precautions: The product must not be diluted with sterile water or other hypotonic fluids. It should be diluted with preservative-free 0.9% Sodium Chloride or Lactated Ringer’s Injection immediately before use and used within 4 hours.
Injection Technique: The suspension must be slowly injected with frequent aspiration to check for blood return, and a needle with an internal diameter of 5号/25 G or larger must be used.
3. Mechanism of Action
Liposomal Encapsulation: The active ingredient is encapsulated within DepoFoam technology, which consists of multiple internal aqueous compartments separated by lipid bilayers.
Mechanism: The encapsulation causes a slow, sustained release of bupivacaine into the surrounding tissue, significantly prolonging the duration of analgesia compared to standard non-liposomal bupivacaine formulations.
4. Safety and Warnings
Cardiovascular and CNS Toxicity: Systemic absorption of bupivacaine can lead to local anesthetic systemic toxicity (LAST), manifesting as cardiovascular collapse, arrhythmias, seizures, and respiratory arrest.
Contraindications: Contraindicated for epidural administration, intrathecal administration, and use in obstetric paracervical blocks.
Chondrolysis: Intra-articular infusion of local anesthetics following arthroscopic and other surgical procedures has been associated with chondrolysis, particularly in the shoulder joint.
5. Adverse Reactions and Clinical Research
Adverse Reactions: The most common adverse reactions include nausea, constipation, vomiting, pyrexia, and headache.
Clinical Research: Clinical studies have demonstrated that liposomal bupivacaine provides significantly longer duration of postoperative pain relief and reduced opioid consumption compared to standard bupivacaine HCl.
6. Drug Interactions
Other Local Anesthetics: Concomitant use with other amide-type local anesthetics may lead to additive effects on systemic toxicity.
CYP450 Inhibitors: Drugs that inhibit CYP1A2 or CYP3A4 may decrease the metabolism of bupivacaine, potentially increasing systemic exposure.
Beta-Blockers: May increase the risk of bradycardia and cardiovascular complications.
7. Pharmaceutical Information
Composition: The active ingredient is bupivacaine. It contains no preservatives.
Appearance: A white to off-white liposomal suspension.
Storage: Store under refrigeration at 2-8℃. Do not freeze or expose to temperatures above 40℃.