Generic Name and Formulations:
Ropivacaine HCl 2mg/mL, 5mg/mL, 7.5mg/mL, 10mg/mL; soln for epidural inj; preservative-free.
Fresenius Kabi USA
Indications for NAROPIN:
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).
See full labeling. Avoid intravascular 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).
Should only be administered by trained medical professionals; have resuscitative equipment available. Unintended IV inj may result in cardiac arrest (esp. in elderly and patients with concomitant heart disease); prolonged resuscitative efforts may be required. Not for emergency situations. 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. Have protocol for malignant hyperthermia management available. Impaired cardiovascular function. Hypotension. Hypovolemia. Heart block. Hepatic disease. Renal impairment. Labor & delivery; monitor fetal heart rate. Pregnancy (Cat.B). Nursing mothers.
Local anesthetic (amide-type).
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.
Hypotension, GI upset, bradycardia, fever, pain, post-op complications, anemia, paresthesia, headache, pruritus, back pain.
Plastic ampule Sterile-Pak—5; Single-dose vials—1, 5, 25; Single-dose infusion bottles (2mg/mL, 5mg/mL)—1 (100mL, 200mL); Freeflex bags (2mg/mL)—1 (100mL, 250mL)