Ropivacaine HCL Injection 0.5% USP 150 mg Per 30 mL Single-Dose Vial 30 mL (Rx)

Ropivacaine HCL Injection 0.5% is a local anesthetic commonly used to manage pain during surgical procedures, childbirth, and acute pain management. It works by blocking nerve impulses that transmit pain signals to the brain, providing long-lasting pain relief. Ropivacaine is favored due to its lower potential for toxicity and longer duration of action compared to other local anesthetics.

Introducing Ropivacaine HCL Injection 0.5% USP, meticulously crafted by Somerset Pharma. This local anesthetic stands out for its efficacy and safety in producing surgical anesthesia and providing analgesia. Formulated as a 0.5% concentration, each 30 mL single-dose vial contains 150 mg of Ropivacaine Hydrochloride, designed meticulously to cater to the clinical demands for acute pain management during and following surgical procedures.

Product Details and Features:

Active Ingredient: Ropivacaine Hydrochloride
Concentration: 0.5% (150 mg per 30 mL)
Formulation: Sterile solution in a single-dose vial ensures convenient and efficient administration.
Volume: 30 mL vial
Packaging: Hermetically sealed to maintain sterility and stability
Pharmacological Class: Amide-type local anesthetic

Directions for Use:

1. Preparation: Prior to administration, ensure the solution is free from particulate matter and discoloration.
2. Dosage: Individualize based on patient-specific factors including size, health status, procedure type, and anticipated analgesic requirement.
3. Administration: Suitable for epidural block, peripheral nerve block, and infiltration. Follow aseptic techniques and relevant guidelines for regional anesthesia.
4. Monitoring: Continually assess cardiovascular and respiratory vitals throughout the procedure following injection.

Mechanism of Action:

Ropivacaine functions by reversible inhibition of sodium ion influx, and thereby blockage of neuronal signal propagation along affected nerves. This suppression of nerve action potentials results in effective regional anesthesia. The relatively low lipid solubility and high water solubility contribute to its favorable safety and duration profile, promoting differential sensory-motor blockade.

Side Effects:

• Adverse effects primarily stem from extension of pharmacologic actions at elevated systemic concentrations. Potential side effects include:
  
• CNS manifestations: dizziness, convulsions, blurred vision, or drowsiness.
  
• Cardiovascular responses: hypotension, bradycardia, or in rare instances, cardiac arrest.
  
• Local reactions: tenderness or localized infection at the injection site.

Warnings:

• Allergic Reaction: Individuals with history of hypersensitivity to ropivacaine, or other amide-class anesthetics should not be administered this product.
  
• Systemic Toxicity: Overdosage or intravascular injection poses a significant risk; ensure meticulous dosage calculation and injection precision.
  
• Caution in Patients: Those with cardiovascular dysfunctions, hepatic impairment, or specific metabolic conditions should be carefully evaluated.
  
• Emergency Protocols: Facilities using this anesthetic should be equipped to handle acute management for systemic toxicity.

The use of Ropivacaine HCL Injection 0.5% USP by Somerset Pharma underscores a commitment to combining scientific precision with patient safety, assuring healthcare professionals and patients of exceptional analgesic outcomes.