Adult Dosing

Local Anesthesia

• Dosing varies; See package insert for recommendations
• Max: 2.5 mg/kg/dose or 300 mg, not to exceed 10 mg/minute
• Info: Onset 1-15 min, peak 20-45 minutes, duration 2-6 hrs

Regional Anesthesia

• Dosing varies; See package insert for recommendations
• Max: 2.5 mg/kg/dose or 300 mg, not to exceed 10 mg/minute
• Info: For surgical pain and obstetrical anesthesia; onset 1-15 minutes, peak 20-45 minutes, duration 2-6 hrs

Spinal Anesthesia

• Dosing varies; See package insert for recommendations
• Info: Onset <2 minutes, peak 10-13 minute, duration 2 hrs

Severe Postop Pain

• 8-30 mg/hr epidural infusion
• Max: 72 hrs

Pediatric Dosing

• Safety and efficacy of Naropin in pediatric patients have not been established

• Indicated for production of local and regional anesthesia for surgery and acute pain management

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to amide anesthetics
• Infection at site
• Patients <12 yrs
• Intra articular continuous infusion
• Morphine liposomal

• N/A

Renal Dose Adjustment

• Renal impairment: Decrease dose, exact dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Decrease dose, exact dose adjustments not defined

• Accidental or unintentional intravascular administration of ropivacaine can result in cardiac arrhythmia or cardiac arrest. All necessary precautions should be taken to avoid intravascular injection. If cardiac arrest occurs prolong resuscitative efforts is required to improve the probability of a successful outcome
• Should be administered by the clinicians who is experienced and is well versed in the diagnosis and management of dose-related toxicity and other acute emergencies and resuscitative equipment, drugs and personnel for treating adverse reactions should be immediately available
• Any delay in proper management of dose-related toxicity, underventilation and/or altered sensitivity can lead to the development of acidosis, cardiac arrest and, death
• Not recommended for emergency situations where a fast onset of surgical anesthesia is necessary
• Do not use for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block), intravenous regional anesthesia (bier block) due to insufficient data to support such use
• Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, as chondrolysis involving shoulder joint, gleno-humeral joint has been reported
• To avoid intravascular or subarachnoid injection, aspiration for blood, or cerebrospinal fluid is essential before injecting any local anesthetic, both the original dose and all subsequent doses
• It is recommended that a test dose be administered initially and monitor the effects before the full dose of epidural anesthesia is given. Monitor the patient for CNS and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding
• If clinically permits test dose should contain an appropriate dose of epinephrine to serve as a warning of unintentional intravascular injection, as epinephrine is likely to produce a transient epinephrine response within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient
• Ropivacaine should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive
• Monitor CV and respiratory vital signs and the patient's state of consciousness constantly after each local anesthetic injection
• Restlessness, anxiety, incoherent speech, light-headedness, metallic taste, numbness and tingling of the mouth and lips, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of CNS toxicity
• Patients with severe hepatic disease are at greater risk for developing toxic plasma concentrations. hence use cautiously, especially repeat doses
• Local anesthetics should also be used with caution in patients with impaired cardiovascular function, as they are less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs
• Malignant hyperthermia has been reported with amide local anesthetics. Standard protocol for management of malignant hyperthermia should be available
• Dose above 300 mg of ropivacaine for brachial plexus block can cause CNS toxicity, hence use cautiously. The dose for a major nerve block must be adjusted according to the site of administration and patient status
• Small doses of local anesthetics administered into the head and neck area can produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. Constantly monitor circulation and respiration of the patients receiving these blocks and resuscitative equipment and personnel for treating adverse reactions should be readily available

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Hypotension
• Hypovolemia
• Heart block
• Impaired cardiac function
• Elderly patients
• Debilitated patients
• Concomitant use of structurally related to amide-type local anesthetics

Pregnancy Category:B

Breastfeeding: Ropivacaine is poorly excreted into human milk and is not orally absorbed by breastfed infants. Hence small amounts of drug in breastmilk do not appear to affect the infants. Some reports that local anesthetics administered during labor and delivery with other anesthetics and analgesics interfere with breastfeeding. However, this assessment is controversial and complex. Published data on the use of ropivacaine and fentanyl used during labor and delivery found no adverse effects on breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 25 May 2011). Manufacturer advises caution.

• CV: Hypotension, bradycardia, hypertension, tachycardia, chest pain, myocardial depression, cardiac arrest
• CNS: Paraesthesia, headache, dizziness, anxiety, hypoesthesia, convulsions, unconsciousness
• GI: Nausea, vomiting
• RESP: Dyspnea
• HEMA: Anemia
• DERM: Pruritus
• MUSC: Back pain, cramps
• GU: Urinary retention, oliguria, UTI
• METABOLIC: Hypokalemia
• MISC: Fever, pain, postoperative complications, rigors

• Amino amide anesthetic; blocks the generation and the conduction of nerve impulses, by increasing the threshold for electrical excitation in the nerve, slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential
• Metabolized by liver; CYP450: 1A2 substrate
• Renally excreted 86% (1% unchanged)
• Half-life
• Intravascular administration: 1.8+/-0.7 hrs
• Epidural administration: 4.2+/-1 hrs

US Trade Name(s)

• Naropin

US Availability

Naropin

• INJ: 2 mg/mL (10, 20 mL amp)
• INJ: 2 mg/mL (100, 200 mL infusion bottle)
• INJ: 5 mg/mL (20 mL amp)
• INJ: 5 mg/mL (30 mL vial)
• INJ: 7.5 mg/mL (20 mL amp)
• INJ: 10 mg/mL (10, 20 mL amp)

Canadian Trade Name(s)

• Naropin

Canadian Availability

ropivacaine (generic)

• INJ: 5 mg/mL (20 mL amp)
• INJ: 10 mg/mL (10, 20 mL amp)

Naropin

• INJ: 2 mg/mL (100, 200 mL infusion bottle)
• INJ: 5 mg/mL (20 mL amp)
• INJ: 10 mg/mL (10, 20 mL amp)

UK Trade Name(s)

• Naropin

UK Availability

Naropin

• INJ: 2 mg/mL (10, 20 mL amp)
• INJ: 2 mg/mL (100, 200 mL infusion bottle)
• INJ: 7.5 mg/mL (10, 20 mL amp)
• INJ: 10 mg/mL (10, 20 mL amp)

Australian Trade Name(s)

• Naropin

Australian Availability

Naropin

• INJ: 2 mg/mL (10, 20 mL amp)
• INJ: 2 mg/mL (100, 200 mL infusion bottle)
• INJ: 7.5 mg/mL (10, 20 mL amp)
• INJ: 10 mg/mL (10, 20 mL amp)

Anesthesia

Local Anesthetics; Injectable