Naropin Generic Name & Formulations
Ropivacaine HCl 2mg/mL, 5mg/mL, 7.5mg/mL, 10mg/mL; soln for epidural inj; preservative-free.
Local anesthetic (amide-type).
Single-dose vials—1, 5, 25; Single-dose infusion bottles (2mg/mL, 5mg/mL)—1, 12 (100mL, 200mL); Plastic ampule Sterile-Pak—5; Ready-to-use flexible bags (2mg/mL)—24 (100mL, 250mL)
For the production of local or regional anesthesia for surgery (epidural block including cesarean section, major nerve block, local infiltration) and for acute pain management (epidural continuous infusion or intermittent bolus, eg, postop or labor; local infiltration).
Naropin Dosage and Administration
See full labeling. Avoid intravascular, subarachnoid, or rapid inj of large volumes. Use test dose (3–5mL of short acting local anesthetic soln containing epinephrine) prior to induction of complete block. Individualize. A cumulative dose of up to 770mg administered over 24 hours is well tolerated in adults with post-op pain management. Debilitated: caution with prolonged periods of administration (eg, >70hrs).
Naropin Boxed Warnings
Should only be administered by trained clinicians. Have resuscitative equipment immediately available. Unintended IV inj may result in cardiac arrhythmia or arrest (esp. in elderly and those with concomitant heart disease); prolonged resuscitative efforts may be required. Not for emergency situations. Risk of chondrolysis (with intra-articular infusions after arthroscopic or other procedures). Risk of methemoglobinemia (esp. in G6PD deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants <6 months of age, concurrent exposure to oxidizing agents or metabolites); monitor closely. Have protocol for malignant hyperthermia management available. Impaired cardiovascular function. Hypotension. Hypovolemia. Heart block. In brachial plexus block: caution when using ropivacaine 300mg dose. Use in ophthalmic surgery (retrobulbar blocks): not recommended. Hepatic disease. Renal impairment. Debilitated, elderly, acutely ill: reduce dose. Labor & delivery; monitor fetal heart rate. Pregnancy. Nursing mothers.
Additive toxic effects with other products containing local anesthetics. Additive cardiac effects possible with concomitant Class III antiarrhythmics (eg, amiodarone); consider ECG monitoring. May be potentiated by CYP1A2 inhibitors (eg, fluvoxamine, theophylline, imipramine) and potent CYP3A4 inhibitors (eg, ketoconazole). Increased risk of methemoglobinemia when concurrently exposed to nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, others.
Naropin Adverse Reactions
Hypotension, GI upset, bradycardia, fever, pain, post-op complications, anemia, paresthesia, headache, pruritus, back pain; CNS toxicity.
Naropin Clinical Trials
Naropin Patient Counseling