Naropin

Ropivacaine Hydrochloride · Injection, Solution · Epidural, Infiltration, Perineural

Prescription (Rx) Amide Local Anesthetic In shortage 1 recall

Current shortage

Naropin, Injection, 5 mg/1 mL (NDC 63323-286-00) – Available (Fresenius Kabi USA, LLC, updated Sep 15, 2026)

Naropin, Injection, 7.5 mg/1 mL (NDC 63323-287-20) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Estimated recovery: TBD

Naropin, Injection, 5 mg/1 mL (NDC 63323-286-35) – Available (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
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Naropin, Injection, 5 mg/1 mL (NDC 63323-286-31) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Estimated recovery: TBD

Naropin, Injection, 2 mg/1 mL (NDC 63323-285-13) – Available (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
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Naropin, Injection, 2 mg/1 mL (NDC 63323-285-65) – Available (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
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Naropin, Injection, 5 mg/1 mL (NDC 63323-286-20) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Estimated recovery: TBD

Naropin, Injection, 10 mg/1 mL (NDC 63323-288-10) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Estimated recovery: TBD

Naropin, Injection, 2 mg/1 mL (NDC 63323-285-61) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Estimated recovery: TBD

Naropin, Injection, 2 mg/1 mL (NDC 63323-285-10) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Estimated recovery: TBD

Uses

1 INDICATIONS AND USAGE NAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration NAROPIN is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesi a: epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration

Dosage and administration

See Table 1 for Dosage Recommendations ( 2.2 ) 2.1 Important Administration Instructions There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. NAROPIN is not approved for this use [see Warnings and Precautions ( 5.3 )] . The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used. The smallest dose and concentration required to produce the desired result should be administered. The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients. To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient's condition before major blocks are performed, and the dosage should be adjusted accordingly. Use an adequate test dose (3 to 5 mL of a short acting local anesthetic solution containing epinephrine) prior to induction of complete block. This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter. Allow adequate time for onset of anesthesia following administration of each test dose. These products are intended for single dose and are free from preservatives. Any solution remaining from an opened container should be discarded promptly. In addition, continuous infusion bottles should not be left in place for more than 24 hours. 2.2 Dosage Recommendations Table 1 Dosage Recommendations * = Not Applicable † = The dose for a major nerve block must be adjusted according to site of administration and patient status. Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used [see Warnings and Precautions ( 5.7 )]. ‡ = Median dose of 21 mg per hour was administered by continuous infusion or by incremental injections (top-ups) over a median delivery time of 5.5 hours. § = Cumulative doses up to 770 mg of NAROPIN over 24 hours (intraoperative block plus postoperative infusion); Continuous epidural infusion at rates up to 28 mg per hour for 72 hours have been well tolerated in adults, i.e., 2016 mg plus surgical dose of approximately 100 to 150 mg as top-up. Conc. Volume mL Dose mg Onset min Duration hours mg/mL (%) SURGICAL ANESTHESIA Lumbar Epidural 5 (0.5%) 15 to 30 75 to 150 15 to 30 2 to 4 Administration 7.5 (0.75%) 15 to 25 113 to 188 10 to 20 3 to 5 Surgery 10 (1%) 15 to 20 150 to 200 10 to 20 4 to 6 Lumbar Epidural 5 (0.5%) 20 to 30 100 to 150 15 to 25 2 to 4 Administration 7.5 (0.75%) 15 to 20 113 to 150 10 to 20 3 to 5 Cesarean Section Thoracic Epidural 5 (0.5%) 5 to 15 25 to 75 10 to 20 n/a* Administration 7.5 (0.75%) 5 to 15 38 to 113 10 to 20 n/a* Surgery Major Nerve Block † 5 (0.5%) 35 to 50 175 to 250 15 to 30 5 to 8 (e.g., brachial plexus block) 7.5 (0.75%) 10 to 40 75 to 300 10 to 25 6 to 10 Field Block 5 (0.5%) 1 to 40 5 to 200 1 to 15 2 to 6 (e.g., minor nerve blocks and infiltration) LABOR PAIN MANAGEMENT Lumbar Epidural Administration Initial Dose 2 (0.2%) 10 to 20 20 to 40 10 to15 0.5 to 1.5 Continuous infusion ‡ 2 (0.2%) 6 to 14 mL/h 12 to 28 mg/h n/a* n/a* Incremental injections (top-up) ‡ 2 (0.2%) 10 to 15 mL/h 20 to 30 mg/h n/a* n/a* POSTOPERATIVE PAIN MANAGEMENT Lumbar Epidural Administration Continuous infusion § 2 (0.2%) 6 to 14 mL/h 12 to 28 mg/h n/a* n/a* Thoracic Epidural 2 (0.2%) 6 to 14 mL/h 12 to 28 mg/h n/a* n/a* Administration Continuous infusion § Infiltration 2 (0.2%) 1 to 100 2 to 200 1 to 5 2 to 6 (e.g., minor nerve block) 5 (0.5%) 1 to 40 5 to 200 1 to 5 2 to 6 The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults. Individual variations in onset and duration occur. The figures reflect the expected average dose range needed. For other local anesthetic techniques standard current textbooks should be consulted. When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered. Experience to date indicates that a cumulative dose of up to 770 mg NAROPIN administered over 24 hours is well tolerated in adults when used for postoperative pain management: i.e., 2016 mg. Caution should be exercised when administering NAROPIN for prolonged periods of time, e.g., >70 hours in debilitated patients. For treatment of postoperative pain, the following technique can be recommended: If regional anesthesia was not used intraoperatively, then an initial epidural block with 5 to 7 mL NAROPIN is induced via an epidural catheter. Analgesia is maintained with an infusion of NAROPIN, 2 mg/mL (0.2%). Clinical studies have demonstrated that infusion rates of 6 to 14 mL (12 to 28 mg) per hour provide adequate analgesia with nonprogressive motor block. With this technique a significant reduction in the need for opioids was demonstrated. Clinical experience supports the use of NAROPIN epidural infusions for up to 72 hours. 2.3 Other Administration Considerations Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema.

Dosage forms and strengths

3 DOSAGE FORMS AND STRENGTHS NAROPIN ® (ropivacaine hydrochloride) injection is a clear, colorless, preservative-free solution available as: NAROPIN ® Single Dose Vials 0.2%, 20 mg per 10 mL (2 mg/mL), in 10 mL single-dose vial 0.2%, 40 mg per 20 mL (2 mg/mL), in 20 mL single-dose vial 0.5%, 100 mg per 20 mL (5 mg/mL), 20 mL single-dose vial 0.5%, 150 mg per 30 mL (5 mg/mL), 30 mL single-dose vial 0.75%, 150 mg per 20 mL (7.5 mg/mL), 20 mL single-dose vial 1%, 100 mg per 10 mL (10 mg/mL), 10 mL single-dose vial 1%, 200 mg per 20 mL (10 mg/mL), 20 mL single-dose vial NAROPIN ® Single Dose Infusion Bottles 0.2%, 200 mg per 100 mL (2 mg/mL), 100 mL single-dose infusion bottle 0.2%, 400 mg per 200 mL (2 mg/mL ), 200 mL single-dose infusion bottle 0.5%, 500 mg per 100 mL (5 mg/mL), 100 mL single-dose infusion bottle 0.5%, 1,000 mg per 200 mL (5 mg/mL ), 200 mL single-dose infusion bottle NAROPIN ® Plastic Polypropylene Ampule 0.2%, 20 mg per 10 mL (2 mg/mL), 10 mL single-dose polypropylene ampule 0.2%, 40 mg per 20 mL (2 mg/mL), 20 mL single-dose polypropylene ampule 0.5%, 100 mg per 20 mL (5 mg/mL), 20 mL single-dose polypropylene ampule 0.75%, 150 mg per 20 mL (7.5 mg/mL), 20 mL single-dose polypropylene ampule 1%, 100 mg per 10 mL (10 mg/mL), 10 mL single-dose polypropylene ampule 1%, 200 mg per 20 mL (10 mg/mL), 20 mL single-dose polypropylene ampule NAROPIN ® Single-Dose, Ready-to-Use, Polypropylene Flexible Bags 0.2%, 200 mg per 100 mL (2 mg/mL), 100 mL single-dose, ready-to-use, polypropylene flexible bag 0.2%, 400 mg per 200 mL (2 mg/mL), 200 mL fill in 250 mL single-dose, ready-to-use, polypropylene flexible bag. Injection: 2 mg/mL (0.2%), 5 mg/mL (0.5%), 7.5 mg/mL (0.75%) or 10 mg/mL (1%) in single-dose vials ( 3 ) Injection: 2 mg/mL (0.2%) or 5 mg/mL (0.5%) in single-dose infusion bottles ( 3 ) Injection: 2 mg/mL (0.2%), 5 mg/mL (0.5%), 7.5 mg/mL (0.75%) or 10 mg/mL (1%) in single-dose polypropylene ampules ( 3 ) Injection: 2 mg/mL (0.2%) in single-dose, ready-to-use, polypropylene flexible bag ( 3 )

Contraindications

4 CONTRAINDICATIONS NAROPIN is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. History of hypersensitivity to local anesthetics of the amide type. ( 4 )

Warnings and precautions

Delay in proper management of dose-related toxicity, underventilation, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. ( 5.1 ) In performing NAROPIN blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardia arrest. ( 5.2 ) Intra-articular infusions of local anesthetics may cause chondrolysis. NAROPIN is not approved for this use. ( 5.3 ). Signs of methemoglobinemia may occur. ( 5.4 ) 5.1 General Warnings and Precautions Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an IV line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only after insuring the immediate (without delay) availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Adverse Reactions ( 6 ) and Overdosage ( 10.1 )]. Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use [see Adverse Reactions ( 6 )] . The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse events. Injections should be made slowly and incrementally, with frequent aspirations before and during the injection to avoid intravascular injection. When a continuous catheter technique is used, syringe aspirations should also be performed before and during each supplemental injection. During the administration of epidural anesthesia, it is recommended that a test dose of a local anesthetic with a fast onset be administered initially and that the patient be monitored for central nervous system and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions, which contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular injection is still possible even if aspirations for blood are negative. Administration of higher than recommended doses of NAROPIN to achieve greater motor blockade or increased duration of sensory blockade may result in cardiovascular depression, particularly in the event of inadvertent intravascular injection. Tolerance to elevated blood levels varies with the physical condition of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical condition. Local anesthetics should also be used with caution in patients with hypotension, hypovolemia or heart block. Solutions of NAROPIN should not be used for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block) due to insufficient data to support such use. Intravenous regional anesthesia (bier block) should not be performed due to a lack of clinical experience and the risk of attaining toxic blood levels of ropivacaine. It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does not ensure against an intravascular or subarachnoid injection. 5.2 Unintended Intravenous Injection In performing NAROPIN blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. The potential for successful resuscitation has not been studied in humans. There have been rare reports of cardiac arrest during the use of NAROPIN for epidural anesthesia or peripheral nerve blockade, the majority of which occurred after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. NAROPIN should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/circulatory arrest and death when 0.75% bupivacaine (another member of the amino amide class of local anesthetics) was inadvertently rapidly injected intravenously. 5.3 Intra-Articular Infusions and Risk of Chondrolysis Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings.

Side effects

Reactions to ropivacaine are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to NAROPIN at concentrations up to 1% in clinical trials. Each patient was counted once for each type of adverse event. Because clinical trials are conducted under widely conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Incidence ≥ 5% For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the following treatment-emergent adverse events were reported with an incidence of ≥ 5% in all clinical studies (N=3988): hypotension (37%), nausea (24.8%), vomiting (11.6%), bradycardia (9.3%), fever (9.2%), pain (8%), postoperative complications (7.1%), anemia (6.1%), paresthesia (5.6%), headache (5.1%), pruritus (5.1%), and back pain (5%). Incidence 1 to 5% Urinary retention, dizziness, rigors, hypertension, tachycardia, anxiety, oliguria, hypoesthesia, chest pain, hypokalemia, dyspnea, cramps, and urinary tract infection. Incidence in Controlled Clinical Trials The reported adverse events are derived from controlled clinical studies with NAROPIN (concentrations ranged from 0.125% to 1% for NAROPIN and 0.25% to 0.75% for bupivacaine) in the U.S. and other countries involving 3,094 patients. Table 2 and Table 3 list adverse events (number and percentage) that occurred in at least 1% of NAROPIN-treated patients in these studies. The majority of patients receiving concentrations higher than 5 mg/mL (0.5%) were treated with NAROPIN. Table 2 Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Postoperative Pain Management, Peripheral Nerve Block and Local Infiltration) NAROPIN total N=1661 Bupivacaine total N=1433 Adverse Reaction N % N % Hypotension 536 (32.3) 408 (28.5) Nausea 283 (17) 207 (14.4) Vomiting 117 (7) 88 (6.1) Bradycardia 96 (5.8) 73 (5.1) Headache 84 (5.1) 68 (4.7) Paresthesia 82 (4.9) 57 (4) Back pain 73 (4.4) 75 (5.2) Pain 71 (4.3) 71 (5) Pruritus 63 (3.8) 40 (2.8) Fever 61 (3.7) 37 (2.6) Dizziness 42 (2.5) 23 (1.6) Rigors (Chills) 42 (2.5) 24 (1.7) Postoperative complications 41 (2.5) 44 (3.1) Hypoesthesia 27 (1.6) 24 (1.7) Urinary retention 23 (1.4) 20 (1.4) Progression of labor poor/failed 23 (1.4) 22 (1.5) Anxiety 21 (1.3) 11 (0.8) Breast disorder, breast-feeding 21 (1.3) 12 (0.8) Rhinitis 18 (1.1) 13 (0.9) Table 3 Adverse Events Reported in ≥1% of Fetuses or Neonates of Mothers Who Received Regional Anesthesia (Cesarean Section and Labor Studies) Adverse Reaction NAROPIN total N = 639 Bupivacaine total N = 573 N % N % Fetal bradycardia 77 (12.1) 68 (11.9) Neonatal jaundice 49 (7.7) 47 (8.2) Neonatal complication-NOS 42 (6.6) 38 (6.6) Apgar score low 18 (2.8) 14 (2.4) Neonatal respiratory disorder 17 (2.7) 18 (3.1) Neonatal tachypnea 14 (2.2) 15 (2.6) Neonatal fever 13 (2) 14 (2.4) Fetal tachycardia 13 (2) 12 (2.1) Fetal distress 11 (1.7) 10 (1.7) Neonatal infection 10 (1.6) 8 (1.4) Neonatal hypoglycemia 8 (1.3) 16 (2.8) Incidence <1% The following adverse events were reported during the NAROPIN clinical program in more than one patient (N=3988), occurred at an overall incidence of <1%, and were considered relevant: Application Site Reactions - injection site pain Cardiovascular System - vasovagal reaction, syncope, postural hypotension, non-specific ECG abnormalities Female Reproductive - poor progression of labor, uterine atony Gastrointestinal System - fecal incontinence, tenesmus, neonatal vomiting General and Other Disorders - hypothermia, malaise, asthenia, accident and/or injury Hearing and Vestibular - tinnitus, hearing abnormalities Heart Rate and Rhythm - extrasystoles, non-specific arrhythmias, atrial fibrillation Liver and Biliary System - jaundice Metabolic Disorders - hypomagnesemia Musculoskeletal System - myalgia Myo/Endo/Pericardium - ST segment changes, myocardial infarction Nervous System - tremor, Horner's syndrome, paresis, dyskinesia, neuropathy, vertigo, coma, convulsion, hypokinesia, hypotonia, ptosis, stupor Psychiatric Disorders - agitation, confusion, somnolence, nervousness, amnesia, hallucination, emotional lability, insomnia, nightmares Respiratory System - bronchospasm, coughing Skin Disorders - rash, urticaria Urinary System Disorders - urinary incontinence, micturition disorder Vascular - deep vein thrombosis, phlebitis, pulmonary embolism Vision - vision abnormalities For the indication epidural anesthesia for surgery, the 15 most common adverse events were compared between different concentrations of NAROPIN and bupivacaine. Table 4 is based on data from trials in the U.S. and other countries where NAROPIN was administered as an epidural anesthetic for surgery.

Drug interactions

Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics [see Warnings and Precautions ( 5.4 )] : Examples of Drugs Associated with Methemoglobinemia Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine NAROPIN 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. Cytochrome P4501A2 is involved in the formation of 3-hydroxy ropivacaine, the major metabolite. In vivo, the plasma clearance of ropivacaine was reduced by 70% during coadministration of fluvoxamine (25 mg bid for 2 days), a selective and potent CYP1A2 inhibitor. Thus strong inhibitors of cytochrome P4501A2, such as fluvoxamine, given concomitantly during administration of NAROPIN, can interact with NAROPIN leading to increased ropivacaine plasma levels. Caution should be exercised when CYP1A2 inhibitors are coadministered. Possible interactions with drugs known to be metabolized by CYP1A2 via competitive inhibition such as theophylline and imipramine may also occur. Coadministration of a selective and potent inhibitor of CYP3A4, ketoconazole (100 mg bid for 2 days with ropivacaine infusion administered 1 hour after ketoconazole) caused a 15% reduction in in vivo plasma clearance of ropivacaine. Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (e.g., amiodarone) have not been performed, but caution is advised [see Warnings and Precautions ( 5.13 )] . Agents structurally related to amide-type local anesthetics: Concurrent use may cause additive effects. ( 7 )

Use in specific populations

8.1 Pregnancy Risk Summary There are no available human data on use of Naropin (ropivacaine) Injection in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone, and cardiac function (see Clinical Considerations ) . No teratogenicity was observed at doses up to 0.3 times the maximum recommended human dose of 770 mg/24 hours for epidural use, and equal to the MRHD of 250 mg for nerve block use, based on body surface area (BSA) comparisons and a 60 kg human weight (see Animal data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Labor or Delivery Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal, and neonatal toxicity [see Clinical Pharmacology ( 12 )] . The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal Adverse reactions Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. Elevating the patient's legs will also help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Data Animal data No malformations were reported in embryo-fetal development toxicity studies conducted in pregnant New Zealand white rabbits and Sprague-Dawley rats. During gestation days 6 to 18, rabbits received daily subcutaneous doses of ropivacaine at 1.3, 4.2, or 13 mg/kg/day (equivalent to 0.03, 0.10, and 0.33 times the maximum recommended human dose (MRHD) of 770 mg/24 hours, respectively, and 0.10, 0.32, and 1.0 times the MRHD of 250 mg for nerve block use, respectively based on body surface area (BSA) comparisons and a 60 kg human weight). Rats received daily subcutaneous doses of 5.3, 11, and 26 mg/kg/day (equivalent to 0.07, 0.14, and 0.33 times the MRHD for epidural use, respectively, and 0.21, 0.43, and 1.0 times the MRHD for nerve block use, respectively, based on BSA comparisons) during GD 6 to 15. No treatment-related effects on late fetal development, parturition, litter size, lactation, neonatal viability, or growth of the offspring were reported in a prenatal and postnatal reproductive and development toxicity study; however functional endpoints were not evaluated. Female rats were dosed daily subcutaneously from GD 15 to Lactation Day 20 at doses of 5.3, 11,and 26 mg/kg/day (equivalent to 0.07, 0.1, and 0.3 times the MRHD for epidural use, respectively, and 0.21, 0.43, and 1.0 times the MRHD for nerve block use, respectively), with maternal toxicity exhibited at the high dose. No adverse effects in physical developmental milestones or in behavioral tests were reported in a 2-generational reproduction study, in which rats received daily subcutaneous doses of 6.3, 12, and 23 mg/kg/day (equivalent to 0.08, 0.15, and 0.29 times the MRHD for epidural use, respectively, and 0.24, 0.45, and 0.88 times the MRHD for nerve block use, respectively, based on BSA comparisons) for 9 weeks before mating and during mating for males, and for 2 weeks before mating and during mating, pregnancy, and lactation, up to day 42 post coitus for females. Significant pup loss was observed in the high dose group during the first 3 days postpartum, from a few hours up to 3 days after delivery compared to the control group, which was considered secondary to impaired maternal care due to maternal toxicity. No differences were observed in litter parameters, or fertility, mean gestation time, or number of live births were observed between the control (saline) and treatment groups [see Carcinogenesis, Mutagenesis, Impairment of Fertility ( 13.1 )] . 8.2 Lactation Risk Summary One publication reported that ropivacaine is present in human milk at low levels following administration of ropivacaine in women undergoing cesarean section. No adverse reactions were reported in the infants. There is no available information on the drug's effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for NAROPIN and any potential adverse effects on the breastfed child from NAROPIN or from the underlying maternal condition. 8.4 Pediatric Use The safety and efficacy of NAROPIN in pediatric patients have not been established. 8.5 Geriatric Use Of the 2,978 subjects that were administered NAROPIN Injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older which includes 127 patients (4%) 75 years of age and over. NAROPIN Injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age.

Pregnancy

8.1 Pregnancy Risk Summary There are no available human data on use of Naropin (ropivacaine) Injection in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone, and cardiac function (see Clinical Considerations ) . No teratogenicity was observed at doses up to 0.3 times the maximum recommended human dose of 770 mg/24 hours for epidural use, and equal to the MRHD of 250 mg for nerve block use, based on body surface area (BSA) comparisons and a 60 kg human weight (see Animal data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Labor or Delivery Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal, and neonatal toxicity [see Clinical Pharmacology ( 12 )] . The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal Adverse reactions Maternal hypotension has resulted from regional anesthesia. Local anesthetics produce vasodilation by blocking sympathetic nerves. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished. Elevating the patient's legs will also help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Data Animal data No malformations were reported in embryo-fetal development toxicity studies conducted in pregnant New Zealand white rabbits and Sprague-Dawley rats. During gestation days 6 to 18, rabbits received daily subcutaneous doses of ropivacaine at 1.3, 4.2, or 13 mg/kg/day (equivalent to 0.03, 0.10, and 0.33 times the maximum recommended human dose (MRHD) of 770 mg/24 hours, respectively, and 0.10, 0.32, and 1.0 times the MRHD of 250 mg for nerve block use, respectively based on body surface area (BSA) comparisons and a 60 kg human weight). Rats received daily subcutaneous doses of 5.3, 11, and 26 mg/kg/day (equivalent to 0.07, 0.14, and 0.33 times the MRHD for epidural use, respectively, and 0.21, 0.43, and 1.0 times the MRHD for nerve block use, respectively, based on BSA comparisons) during GD 6 to 15. No treatment-related effects on late fetal development, parturition, litter size, lactation, neonatal viability, or growth of the offspring were reported in a prenatal and postnatal reproductive and development toxicity study; however functional endpoints were not evaluated. Female rats were dosed daily subcutaneously from GD 15 to Lactation Day 20 at doses of 5.3, 11,and 26 mg/kg/day (equivalent to 0.07, 0.1, and 0.3 times the MRHD for epidural use, respectively, and 0.21, 0.43, and 1.0 times the MRHD for nerve block use, respectively), with maternal toxicity exhibited at the high dose. No adverse effects in physical developmental milestones or in behavioral tests were reported in a 2-generational reproduction study, in which rats received daily subcutaneous doses of 6.3, 12, and 23 mg/kg/day (equivalent to 0.08, 0.15, and 0.29 times the MRHD for epidural use, respectively, and 0.24, 0.45, and 0.88 times the MRHD for nerve block use, respectively, based on BSA comparisons) for 9 weeks before mating and during mating for males, and for 2 weeks before mating and during mating, pregnancy, and lactation, up to day 42 post coitus for females. Significant pup loss was observed in the high dose group during the first 3 days postpartum, from a few hours up to 3 days after delivery compared to the control group, which was considered secondary to impaired maternal care due to maternal toxicity. No differences were observed in litter parameters, or fertility, mean gestation time, or number of live births were observed between the control (saline) and treatment groups [see Carcinogenesis, Mutagenesis, Impairment of Fertility ( 13.1 )] .

Pediatric use

8.4 Pediatric Use The safety and efficacy of NAROPIN in pediatric patients have not been established.

Geriatric use

8.5 Geriatric Use Of the 2,978 subjects that were administered NAROPIN Injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older which includes 127 patients (4%) 75 years of age and over. NAROPIN Injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function [see Clinical Pharmacology ( 12.3 )] .

Overdosage

Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution [see Adverse Reactions ( 6 ) and Warnings and Precautions ( 5.1 , 5.2 , 5.6 )]. 10.1 Treatment Therapy with NAROPIN should be discontinued at the first sign of toxicity. No specific information is available for the treatment of toxicity with NAROPIN; therefore, treatment should be symptomatic and supportive. The first consideration is prevention, best accomplished by incremental injection of NAROPIN, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic and during continuous infusion. At the first sign of change in mental status, oxygen should be administered. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Circulation should be assisted as necessary. This may prevent convulsions if they have not already occurred. If necessary, use drugs to control convulsions. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force). Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. The mean dosages of ropivacaine producing seizures, after intravenous infusion in dogs, nonpregnant and pregnant sheep were 4.9, 6.1 and 5.9 mg/kg, respectively. These doses were associated with peak arterial total plasma concentrations of 11.4, 4.3 and 5 mcg/mL, respectively. In human volunteers given intravenous NAROPIN, the mean (min-max) maximum tolerated total and free arterial plasma concentrations were 4.3 (3.4 to 5.3) and 0.6 (0.3 to 0.9) mcg/mL respectively, at which time moderate CNS symptoms (muscle twitching) were noted. Clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen which may avoid cardiac arrest. If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels should be accomplished. Resuscitation of obstetrical patients may take longer than resuscitation of non- pregnant patients and closed-chest cardiac compression may be ineffective. Rapid delivery of the fetus may improve the response to resuscitative efforts.

Description

11 DESCRIPTION NAROPIN ® Injection is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. NAROPIN ® Injection is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula: C 17 H 26 N 2 O
• HCl
• H 2 O M.W. 328.89 At 25 °C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n -octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. NAROPIN (ropivacaine hydrochloride) injection is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of NAROPIN Injection solutions range from 1.002 to 1.005 at 25°C. Structural Formula

Mechanism of action

12.1 Mechanism of Action Ropivacaine is a member of the amino amide class of local anesthetics and is supplied as the pure S-(-)-enantiomer. Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.

How supplied

(ropivacaine hydrochloride) Injection is a clear colorless, and preservative-free solution, available in single-dose containers in 2 mg/mL (0.2%), 5 mg/mL (0.5%), 7.5 mg/mL (0.75%) and 10 mg/mL (1%) concentrations. Storage Solutions should be stored at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. NAROPIN® Single-Dose Vials Product Code Unit of Sale Strength Each 278513 NDC 63323-285-13 Unit of 25 0.2%, 20 mg per 10 mL (2 mg per mL) NDC 63323-285-03 10 mL Single-Dose Vial 278523 NDC 63323-285-23 Unit of 25 0.2%, 40 mg per 20 mL (2 mg per mL) NDC 63323-285-07 20 mL Single-Dose Vial 278623 NDC 63323-286-23 Unit of 25 0.5%,100 mg per 20 mL (5 mg per mL) NDC 63323-286-05 20 mL Single-Dose Vial 278630 NDC 63323-286-30 Packaged Individually 0.5%, 150 mg per 30 mL (5 mg per mL) NDC 63323-286-30 30 mL Single-Dose Vial 278631 NDC 63323-286-31 Unit of 5 0.5%, 150 mg per 30 mL (5 mg per mL) NDC 63323-286-09 30 mL Single-Dose Vial 278635 NDC 63323-286-35 Unit of 25 0.5%, 150 mg per 30 mL (5 mg per mL) NDC 63323-286-11 30 mL Single-Dose Vial 278721 NDC 63323-287-21 Unit of 25 0.75%, 150 mg per 20 mL (7.5 mg per mL) NDC 63323-287-03 20 mL Single-Dose Vial 278811 NDC 63323-288-11 Unit of 25 1%, 100 mg per 10 mL (10 mg per mL) NDC 63323-288-03 10 mL Single-Dose Vial 278821 NDC 63323-288-21 Unit of 25 1%, 200 mg per 20 mL (10 mg per mL) NDC 63323-288-07 20 mL Single-Dose Vial NAROPIN® Single-Dose Infusion Bottles Product Code Unit of Sale Strength Each 278565 NDC 63323-285-65 Individual bottles sold as a case of 12 0.2%, 200 mg per 100 mL (2 mg per mL) NDC 63323-285-51 100 mL Single-Dose Infusion Bottle 278564 NDC 63323-285-64 Individual bottles sold as a case of 12 0.2%, 400 mg per 200 mL (2 mg per mL) NDC 63323-285-57 200 mL Single-Dose Infusion Bottle 278600 NDC 63323-286-00 Unit of 12 0.5%, 500 mg per 100 mL (5 mg per mL) NDC 63323-286-03 100 mL Single-Dose Infusion Bottle 278663 NDC 63323-286-63 Unit of 12 0.5%, 1,000 mg per 200 mL (5 mg per mL) NDC 63323-286-33 200 mL Single-Dose Infusion Bottle For single-dose vials: Discard unused portion. NAROPIN container closure is not made with natural rubber latex. NAROPIN ® Single-Dose Plastic Polypropylene Ampule Sterile-Pak: Unit of 5 polypropylene ampules fitting both Luer-lock and Luer-slip (tapered syringes) Product Code Unit of Sale Strength Each 278510 NDC 63323-285-10 Unit of 5 0.2%, 20 mg per 10 mL (2 mg per mL) NDC 63323-285-01 10 mL Plastic Ampule 278520 NDC 63323-285-20 Unit of 5 0.2%, 40 mg per 20 mL (2 mg per mL) NDC 63323-285-06 20 mL Plastic Ampule 278620 NDC 63323-286-20 Unit of 5 0.5%, 100 mg per 20 mL (5 mg per mL) NDC 63323-286-01 20 mL Plastic Ampule 278720 NDC 63323-287-20 Unit of 5 0.75%, 150 mg per 20 mL (7.5 mg per mL) NDC 63323-287-01 20 mL Plastic Ampule 278810 NDC 63323-288-10 Unit of 5 1%, 100 mg per 10 mL (10 mg per mL) NDC 63323-288-01 10 mL Plastic Ampule 278820 NDC 63323-288-20 Unit of 5 1%, 200 mg per 20 mL (10 mg per mL) NDC 63323-288-06 20 mL Plastic Ampule NAROPIN ® single-dose, ready-to-use, polypropylene flexible bags. The flexible bag container is not made with natural rubber latex or polyvinyl chloride (PVC), Non-DEHP. Product Code Unit of Sale Strength Each 278561 NDC 63323-285-61 Unit of 24 0.2%, 200 mg per 100 mL (2 mg per mL) NDC 63323-285-02 100 mL Single-Dose, ready-to-use, polypropylene flexible bag 278563 NDC 63323-285-63 Unit of 24 0.2%, 400 mg per 200 mL (2 mg per mL) NDC 63323-285-04 250 mL Single-Dose, ready-to-use, polypropylene flexible bag NAROPIN container closure is not made with natural rubber latex. Single Dose Only - Discard unused portion.

Storage

Storage Solutions should be stored at 20ºC to 25°C (68ºF to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. NAROPIN® Single-Dose Vials Product Code Unit of Sale Strength Each 278513 NDC 63323-285-13 Unit of 25 0.2%, 20 mg per 10 mL (2 mg per mL) NDC 63323-285-03 10 mL Single-Dose Vial 278523 NDC 63323-285-23 Unit of 25 0.2%, 40 mg per 20 mL (2 mg per mL) NDC 63323-285-07 20 mL Single-Dose Vial 278623 NDC 63323-286-23 Unit of 25 0.5%,100 mg per 20 mL (5 mg per mL) NDC 63323-286-05 20 mL Single-Dose Vial 278630 NDC 63323-286-30 Packaged Individually 0.5%, 150 mg per 30 mL (5 mg per mL) NDC 63323-286-30 30 mL Single-Dose Vial 278631 NDC 63323-286-31 Unit of 5 0.5%, 150 mg per 30 mL (5 mg per mL) NDC 63323-286-09 30 mL Single-Dose Vial 278635 NDC 63323-286-35 Unit of 25 0.5%, 150 mg per 30 mL (5 mg per mL) NDC 63323-286-11 30 mL Single-Dose Vial 278721 NDC 63323-287-21 Unit of 25 0.75%, 150 mg per 20 mL (7.5 mg per mL) NDC 63323-287-03 20 mL Single-Dose Vial 278811 NDC 63323-288-11 Unit of 25 1%, 100 mg per 10 mL (10 mg per mL) NDC 63323-288-03 10 mL Single-Dose Vial 278821 NDC 63323-288-21 Unit of 25 1%, 200 mg per 20 mL (10 mg per mL) NDC 63323-288-07 20 mL Single-Dose Vial NAROPIN® Single-Dose Infusion Bottles Product Code Unit of Sale Strength Each 278565 NDC 63323-285-65 Individual bottles sold as a case of 12 0.2%, 200 mg per 100 mL (2 mg per mL) NDC 63323-285-51 100 mL Single-Dose Infusion Bottle 278564 NDC 63323-285-64 Individual bottles sold as a case of 12 0.2%, 400 mg per 200 mL (2 mg per mL) NDC 63323-285-57 200 mL Single-Dose Infusion Bottle 278600 NDC 63323-286-00 Unit of 12 0.5%, 500 mg per 100 mL (5 mg per mL) NDC 63323-286-03 100 mL Single-Dose Infusion Bottle 278663 NDC 63323-286-63 Unit of 12 0.5%, 1,000 mg per 200 mL (5 mg per mL) NDC 63323-286-33 200 mL Single-Dose Infusion Bottle For single-dose vials: Discard unused portion. NAROPIN container closure is not made with natural rubber latex. NAROPIN ® Single-Dose Plastic Polypropylene Ampule Sterile-Pak: Unit of 5 polypropylene ampules fitting both Luer-lock and Luer-slip (tapered syringes) Product Code Unit of Sale Strength Each 278510 NDC 63323-285-10 Unit of 5 0.2%, 20 mg per 10 mL (2 mg per mL) NDC 63323-285-01 10 mL Plastic Ampule 278520 NDC 63323-285-20 Unit of 5 0.2%, 40 mg per 20 mL (2 mg per mL) NDC 63323-285-06 20 mL Plastic Ampule 278620 NDC 63323-286-20 Unit of 5 0.5%, 100 mg per 20 mL (5 mg per mL) NDC 63323-286-01 20 mL Plastic Ampule 278720 NDC 63323-287-20 Unit of 5 0.75%, 150 mg per 20 mL (7.5 mg per mL) NDC 63323-287-01 20 mL Plastic Ampule 278810 NDC 63323-288-10 Unit of 5 1%, 100 mg per 10 mL (10 mg per mL) NDC 63323-288-01 10 mL Plastic Ampule 278820 NDC 63323-288-20 Unit of 5 1%, 200 mg per 20 mL (10 mg per mL) NDC 63323-288-06 20 mL Plastic Ampule NAROPIN ® single-dose, ready-to-use, polypropylene flexible bags. The flexible bag container is not made with natural rubber latex or polyvinyl chloride (PVC), Non-DEHP. Product Code Unit of Sale Strength Each 278561 NDC 63323-285-61 Unit of 24 0.2%, 200 mg per 100 mL (2 mg per mL) NDC 63323-285-02 100 mL Single-Dose, ready-to-use, polypropylene flexible bag 278563 NDC 63323-285-63 Unit of 24 0.2%, 400 mg per 200 mL (2 mg per mL) NDC 63323-285-04 250 mL Single-Dose, ready-to-use, polypropylene flexible bag NAROPIN container closure is not made with natural rubber latex. Single Dose Only - Discard unused portion.

Patient information

17.1 Information for Patients and Caregivers When appropriate, patients should be informed in advance that they may experience temporary loss of sensation and motor activity in the anesthetized part of the body following proper administration of lumbar epidural anesthesia. Also, when appropriate, the physician should discuss other information including adverse reactions in the NAROPIN package insert. Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue. NAROPIN is a trademark of Fresenius Kabi USA, LLC. Lake Zurich, IL 60047 www.fresenius-kabi.com/us Fresenius Kabi Logo

Label text from the FDA structured product label by Fresenius Kabi USA, LLC (revised Aug 6, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Naropin NDC products (5)

NDCStrength & formLabelerType
63323-285Ropivacaine Hydrochloride 2 mg/mL
Injection, Solution		Fresenius Kabi USA, LLCNDA
63323-286Ropivacaine Hydrochloride 5 mg/mL
Injection, Solution		Fresenius Kabi USA, LLCNDA
63323-287Ropivacaine Hydrochloride 7.5 mg/mL
Injection, Solution		Fresenius Kabi USA, LLCNDA
63323-288Ropivacaine Hydrochloride 10 mg/mL
Injection, Solution		Fresenius Kabi USA, LLCNDA
0404-9924Ropivacaine Hydrochloride 5 mg/mL
Injection, Solution		Henry Schein, Inc.NDA

Naropin recalls

Frequently asked questions

What is Naropin used for?

1 INDICATIONS AND USAGE NAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration NAROPIN is an amide…

What are the side effects of Naropin?

Reactions to ropivacaine are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and… See the full label for the complete list.

Who makes Naropin?

Naropin is listed by 2 labelers in the FDA NDC directory, including Fresenius Kabi USA, LLC, Henry Schein, Inc..

Has Naropin been recalled?

The FDA enforcement database lists 1 recall for Naropin, most recently D-0727-2026 (class ii): Presence of Particulate Matter: Hair was found in products