Bupivacaine Hydrochloride Injection 0.25% USP 125 mg/50 mL Multiple Dose Vial 50 mL (RX)

Bupivacaine Hydrochloride Injection 0.25% is a local anesthetic used to provide prolonged pain relief by numbing specific areas during surgical, dental, or obstetric procedures. It works by blocking nerve signals in the body, making it essential for regional anesthesia, including epidurals and nerve blocks. Bupivacaine is commonly administered in medical settings to manage pain during and after procedures, ensuring patient comfort and facilitating recovery in surgeries and childbirth.

Somerset Therapeutics presents Bupivacaine Hydrochloride Injection 0.25% USP, a premium local anesthetic solution designed for precise pain management and surgical anesthesia. Contained in a 50 mL multiple-dose vial, this formulation delivers 125 mg of Bupivacaine Hydrochloride per vial, providing healthcare professionals with the reliability and flexibility required in diverse clinical applications, from minor surgical procedures to effective regional pain control.

Details and Features:

Concentration and Volume: Each vial contains 0.25% Bupivacaine Hydrochloride, equivalent to 2.5 mg/mL, for a total of 125 mg in a 50 mL vial. This concentration ensures an effective balance between anesthetic potency and duration, making it ideal for prolonged procedures.
Packaging: Offered in multiple-dose vials, this versatile packaging supports repeated withdrawals under sterile conditions, optimizing operating room efficiency and reducing waste.
Indications: Suitable for local or regional anesthesia, including peripheral nerve blockade, infiltration anesthesia, and caudal or lumbar epidural blocks.
Administration: Administered via injection, tailored for the specific site and depth of anesthesia required for each individual procedure.

Mechanism of Action:

Bupivacaine is an amide-type local anesthetic that operates by blocking sodium ion influx in nerve cells, which inhibits depolarization required for action potential initiation and propagation. This sodium channel blockade results in a reversible loss of sensation, beginning with pain, followed by temperature, touch, and finally motor functions. Bupivacaine’s unique pharmacokinetic profile ensures a prolonged duration of action, suited for surgeries that require an extensive anesthetic window.

Warnings:

• Cardiotoxicity Risk: High systemic levels can induce significant cardiovascular effects, including hypotension, arrhythmias, and in severe cases, cardiac arrest.
• Diligent monitoring is necessary, especially with higher doses.
  
• Central Nervous System Effects: Overdose or accidental intravascular injection may lead to central nervous system toxicity, characterized by CNS excitation, followed potentially by CNS depression.
  
• Hypersensitivity Reactions: Though rare, possible allergic reactions demand pre-procedure screening for known sensitivity to amide-type anesthetics.
  
• Intravascular Injection: Accidental intravascular administration can lead to systemic toxic reactions. Test dosages and vigilant aspiration are advisable during injections to avert inadvertent intravasal delivery.

Side Effects:

• Local: Prolonged numbness or tingling at the injection site, localized edema, or nerve irritation.
  
• Systemic: Dizziness, tinnitus, or metallic taste if significant systemic absorption occurs.
  
• Severe Reactions: Hypotension, bradycardia, or convulsions in the event of systemic overdose or accidental intravenous administration.

Clinical Considerations:

• Dosage Precision: Careful calculation of total dose is critical, based on the patient's weight, clinical condition, and procedural requirements to minimize risk.
  
• Monitoring: Essential to monitor cardiovascular and respiratory status throughout administration to detect early signs of adverse reactions.
  
• Patient Evaluation: A thorough patient history, including any previous anesthetic reactions, cardiovascular health assessment, and concurrent medications, should guide the analgesic protocol.

Bupivacaine Hydrochloride Injection from Somerset Therapeutics is formulated to meet the rigorous demands of surgical anesthesia and long-duration pain relief. It demands administration by professionals skilled in local anesthetic techniques, with a keen awareness of safety protocols to optimize both efficacy and patient safety. Detailed prescribing information should be consulted to support precise clinical application.