Rovanox

Approved Indications:

• Surgical Anesthesia: For the production of local or regional anesthesia during surgery, including:
• Epidural anesthesia for major surgery (e.g., orthopedic, abdominal, and lower limb surgery)
• Peripheral nerve block (e.g., brachial plexus block, intercostal block)
• Field block or infiltration anesthesia
• Obstetric Anesthesia:
• Epidural anesthesia during labor and delivery (including cesarean section)
• Postoperative Pain Management:
• Continuous epidural infusion or intermittent bolus administration for pain relief
• Peripheral nerve blocks for postoperative pain relief
• Chronic Pain Management (off-label):
• Continuous nerve blocks or infusions in patients with chronic pain syndromes

Route of Administration: Injectable solution; epidural, intrathecal, peripheral nerve block, infiltration

Adults:

• Epidural Block (Surgical Anesthesia): 15–30 mL of 0.5% to 0.75% solution
• Labor Analgesia:
• Initial: 10–20 mL of 0.1–0.2% solution via epidural
• Maintenance: Continuous infusion at 6–14 mL/hour or intermittent boluses
• Peripheral Nerve Block:
• Brachial Plexus: 20–40 mL of 0.5% to 0.75%
• Lower Limb Blocks: 10–30 mL of 0.5% to 0.75%
• Postoperative Pain:
• Epidural infusion: 6–14 mL/hour of 0.2% solution

Pediatrics:

• Dosing should be calculated per body weight and site of administration.
• Epidural (e.g., caudal block): 0.2% solution at 1–2 mg/kg
• Peripheral block: 2.5–3 mg/kg, not exceeding maximum daily limits

Elderly or Debilitated Patients:

• Use lower concentrations and doses, adjusted based on response.

Special Populations:

• Renal Impairment: No specific adjustments, but monitor due to potential reduced clearance.
• Hepatic Impairment: Use with caution; dose reduction may be required due to slower metabolism.

Max Dose:

• Should not exceed 3 mg/kg for a single administration or 770 mg in 24 hours.

Ropivacaine is a long-acting amide-type local anesthetic that works by reversibly blocking the influx of sodium ions through voltage-gated sodium channels in neuronal cell membranes. This inhibition of sodium ion influx prevents depolarization and transmission of nerve impulses, resulting in sensory and motor blockade. It exhibits greater sensory than motor blocking activity, particularly at lower concentrations, making it useful in situations where differential blockade is desired, such as in obstetric analgesia or postoperative pain control.

• Absorption: Absorbed based on the route and vascularity of the administration site. Peak plasma concentrations occur within 30–120 minutes depending on method.
• Distribution: High protein binding (~94%); volume of distribution is 41–47 L.
• Metabolism: Extensively metabolized in the liver primarily by CYP1A2 and CYP3A4 into inactive metabolites (e.g., 3-hydroxy-ropivacaine).
• Excretion: Eliminated via the kidneys, with ~86% of dose recovered in urine; <1% as unchanged drug.
• Half-Life:
• Adults: ~4.2 hours after epidural administration
• Elderly: ~4.9–7 hours (prolonged due to reduced clearance)

• Pregnancy: Not assigned a category under new FDA labeling. Use is considered safe in labor when clinically indicated. No known teratogenic effects in humans, but caution is advised.
• Lactation: Ropivacaine is excreted in small amounts in breast milk, but plasma levels in infants are negligible. Generally considered safe during breastfeeding with minimal risk to the infant.

• Primary Class: Local Anesthetic (Amide-type)
• Subclass: Long-acting amide anesthetic
• Generation: Newer-generation (safer alternative to bupivacaine)

• Hypersensitivity to ropivacaine or other amide-type anesthetics
• Severe hypotension or shock
• Obstetric paracervical block (contraindicated due to fetal bradycardia risk)
• Local infection at the injection site
• Complete heart block without pacemaker support

• High-Risk Groups: Elderly, patients with hepatic or cardiovascular impairment
• Cardiovascular Risks: Dose-related risk of hypotension, bradycardia, or arrhythmia
• CNS Effects: Potential for CNS toxicity with overdose (e.g., seizures, coma)
• Use in Pregnancy: Careful monitoring during labor; avoid paracervical block
• Accidental Intravascular Injection: May lead to systemic toxicity; aspiration before injection recommended
• Prolonged Use: Caution with continuous infusions—monitor for neurotoxicity or systemic effects
• Resuscitation Equipment: Should always be available during administration

Common:

• Neurological: Dizziness, headache, paresthesia
• Cardiovascular: Hypotension, bradycardia
• Gastrointestinal: Nausea, vomiting

Serious/Rare:

• CNS: Seizures, CNS depression, respiratory arrest
• Cardiac: Arrhythmias, cardiac arrest (in high systemic levels)
• Hypersensitivity: Anaphylaxis, rash, pruritus
• Urinary: Urinary retention (with epidural use)

Onset: Usually within 10–30 minutes depending on route
Severity: Dose-dependent and more likely with systemic absorption or overdose

• Antiarrhythmics (e.g., amiodarone): Increased risk of cardiotoxicity
• CYP1A2 and CYP3A4 inhibitors (e.g., fluvoxamine, ketoconazole): May reduce metabolism, increasing systemic exposure
• Local Anesthetics or CNS Depressants: Additive CNS and cardiac depressive effects
• Opioids (used concurrently in epidural infusions): Potential for increased respiratory depression

Food/Alcohol: No known food interactions. Alcohol may potentiate CNS effects.

• Recent practice guidelines continue to favor ropivacaine over bupivacaine for epidural and peripheral blocks due to lower cardiotoxicity and better motor-sensory differential.
• Ongoing studies are exploring low-dose continuous infusion techniques for chronic pain relief.
• No major regulatory changes to dosing or safety profiles by FDA or EMA as of 2025.

• Temperature: Store between 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C.
• Protection: Protect from light. Do not freeze.
• Packaging: Must be stored in original container until use.
• Handling: Use sterile technique. Single-use vials should be discarded after opening.
• Reconstitution: Not required. Do not use if solution is discolored or contains particulates.