ropivacaine (Rx)

Brand and Other Names:Naropin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL
  • 5mg/mL
  • 7.5mg/mL
  • 10mg/mL

Epidural/Caudal Anesthesia

75-200 mg (15-30 mL of 0.5%-1% solution)

Major Nerve Block

175-250 mg (35-50 mL) of 0.5% solution

75-300 mg (10-40 mL) of 0.75% solution

Field Block

5-200 mg (1-40 mL) of 0.5% solution

Labor Pain

20-40 mg (10-20 mL) initial of 0.2% solution, THEN

12-28 mg/hr (6-14 mL/hr) of 0.2% solution OR

20-30 mg/hr (10-15 mL/hr) continuous infusion of 0.2% solution

Post-Op Pain

Peripheral Nerve Block

  • 5-10 mL/hr continuous infusion of 0.2% solution

Lumbar or Thoracic Epidural

  • 6-14 mL/hr continuous infusion of 0.2% solution

Infiltration/ Minor Nerve Block

  • 1-100 mL dose of 0.2% solution
  • 1-40 mL dose of 0.5% solution

Administration

Doses should not be repeated more frequently than q3hr, no more than 400 mg (770 mg for post-op pain) in 24 hr

Dosage Forms & Strengths

injectable solution

  • 2mg/mL
  • 5mg/mL
  • 7.5mg/mL
  • 10mg/mL

Caudal Epidural Block (Off-Label)

1.25-6.5 mg/kg or 1 mL/kg of 0.2% strength  

Epidural Continuous Infusion (Off-Label)

< 4 Months

  • Safety and efficacy not established

4 Months to 7 years

  • 1 mg/kg loading dose; follow with 0.2-0.4 mg/kg/hr for 48 hr  

7-12 years

  • 3.6 mg loading dose; follow with 3.2 mg/hr infusion; may titrate up to 27.2 mg/hr PRN  

>12 years

  • 75-200 mg (15-30 mL of 0.5%-1% solution)
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Interactions

Interaction Checker

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            Contraindicated (1)

            • bupivacaine liposome

              ropivacaine increases toxicity of bupivacaine liposome by Other (see comment). Contraindicated. Comment: Do not admix with other local nonbupivacaine-based local anesthetics; admixing results in a rapid increase in free (unencapsulated) bupivacaine.

            Serious - Use Alternative (10)

            • abametapir

              abametapir will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

              abametapir will increase the level or effect of ropivacaine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP1A2 substrates. If not feasible, avoid use of abametapir.

            • apalutamide

              apalutamide will decrease the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • bupivacaine implant

              ropivacaine, bupivacaine implant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid additional local anesthetic administration within 96 hr following bupivacaine implantation. If use of additional local anesthetics is unavoidable based on clinical need, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.

              ropivacaine, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.

            • fexinidazole

              fexinidazole will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • givosiran

              givosiran will increase the level or effect of ropivacaine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP1A2 substrates with givosiran. If unavoidable, decrease the CYP1A2 substrate dosage in accordance with approved product labeling.

            • idelalisib

              idelalisib will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

            • ivosidenib

              ivosidenib will decrease the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • lonafarnib

              lonafarnib will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

            • tucatinib

              tucatinib will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

            • voxelotor

              voxelotor will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            Monitor Closely (24)

            • atazanavir

              atazanavir will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • benazepril

              ropivacaine, benazepril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increases risk of hypotension.

            • cannabidiol

              cannabidiol, ropivacaine. affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Owing to the potential for both CYP1A2 induction and inhibition with the coadministration of CYP1A2 substrates and cannabidiol, consider reducing dosage adjustment of CYP1A2 substrates as clinically appropriate.

            • captopril

              ropivacaine increases effects of captopril by Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure. Monitor blood pressure.

            • cenobamate

              cenobamate will decrease the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

            • ciprofloxacin

              ciprofloxacin will increase the level or effect of ropivacaine by Mechanism: decreasing metabolism. Use Caution/Monitor. Monitor for increased ropivacaine toxicity.

            • conivaptan

              conivaptan will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • darunavir

              darunavir will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • elagolix

              elagolix decreases levels of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

            • encorafenib

              encorafenib, ropivacaine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • fedratinib

              fedratinib will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • fexinidazole

              fexinidazole will increase the level or effect of ropivacaine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

            • mitotane

              mitotane decreases levels of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

            • nadolol

              nadolol, ropivacaine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Use extreme caution during concomitant use of bupivacaine and antihypertensive agents.

            • pindolol

              pindolol, ropivacaine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Use extreme caution during concomitant use of bupivacaine and antihypertensive agents.

            • propranolol

              propranolol, ropivacaine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Use extreme caution during concomitant use of bupivacaine and antihypertensive agents.

            • rucaparib

              rucaparib will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

              rucaparib will increase the level or effect of ropivacaine by affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP1A2 substrates, if clinically indicated.

            • stiripentol

              stiripentol, ropivacaine. affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP1A2 inhibitor and inducer. Monitor CYP1A2 substrates coadministered with stiripentol for increased or decreased effects. CYP1A2 substrates may require dosage adjustment.

              stiripentol, ropivacaine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

            • tazemetostat

              tazemetostat will decrease the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tecovirimat

              tecovirimat will decrease the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • teriflunomide

              teriflunomide decreases levels of ropivacaine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.

            • timolol

              timolol, ropivacaine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Use extreme caution during concomitant use of bupivacaine and antihypertensive agents.

            Minor (2)

            • hyaluronidase

              hyaluronidase, ropivacaine. Other (see comment). Minor/Significance Unknown. Comment: Hyaluronidase hastens the onset of local analgesia and reduces swelling, but increases systemic absorption of anesthetic. This decreases the duration of action and increases incidence of systemic reaction.

            • ribociclib

              ribociclib will increase the level or effect of ropivacaine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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            Adverse Effects

            Frequency Not Defined

            Bradycardia, myocardial depression, , cardiac arrhythmias, edema, hypotension, cardiovascular collapse, cardiac arrest, palpitation, tachycardia, anginal pain, hypertension (epinephrine-containing solutions)

            Anxiety, apprehension, chills, headache, restlessness, nervousness, disorientation, confusion, dizziness, tremors, twitching, shivering, seizures; CNS depression manifested restlessness, tremors, drowsiness, unconsciousness, tinnitus

            Nausea, vomiting

            Blurred vision, miosis

            Respiratory arrest, status asthmaticus

            Anaphylactoid reactions (sometimes fatal)

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            Warnings

            Contraindications

            Hypersensitivity to ropivacaine or amide-type local anesthetics, sensitivity to parabens

            Cautions

            Use caution in patients with history of malignant hyperthermia

            DO NOT use solutions with epinephrine in distal areas of body (eg, digit, nose, ear)

            Use preservative-free preparations for spinal or epidural anesthesia

            Addition of vasoconstrictor, epinephrine, will promote local hemostasis, decrease systemic absorption, and increase duration of action

            Seizures reported with systemic toxicity

            This drug 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

            Patients treated with class III antiarrhythmic drugs (eg, amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive

            The plasma concentrations of this drug may approach threshold for central nervous system toxicity after administration of 300 mg of ropivacaine for brachial plexus block; exercise caution when using 300 mg dose; 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 local anesthetic used

            Major peripheral nerve blocks may result in administration of a large volume of local anesthetic in highly vascularized areas, often close to large vessels where there is increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations

            The use of this drug in retrobulbar blocks for ophthalmic surgery has not been studied; until appropriate experience gained, the use for such surgery is not recommended

            Inadvertent intravascular injection

            • In performing neural blocks, unintended intravenous injection possible and may result in cardiac arrhythmia or cardiac arrest; potential for successful resuscitation has not been studied in humans
            • There have been rare reports of cardiac arrest during use 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
            • Careful and constant monitoring of cardiovascular and respiratory vital signs (adequacy of ventilation) and patient's state of consciousness should be performed after each local anesthetic injection; it should be kept in mind at such times that restlessness, anxiety, incoherent speech, light-headedness, numbness, and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity
            • In some instances, resuscitation difficult; should cardiac arrest occur, prolonged resuscitative efforts may be required to improve probability of successful outcome
            • The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse events; the drug should be administered slowly in incremental doses, 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 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, consider 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 this drug 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 physical condition of 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
            • Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations; local anesthetics should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with prolongation of A-V conduction produced by these drugs
            • Not recommended for emergency situations, where a fast onset of surgical anesthesia 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
            • Prior to receiving major blocks the general condition of patient should be optimized and 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 diagnosis and management of dose-related toxicity and other acute emergencies which might arise from block to be employed, and then only after insuring 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
            • Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to development of acidosis, cardiac arrest and, possibly, death
            • Solutions from this drug should not be used for 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 lack of clinical experience and risk of attaining toxic blood levels
            • Many drugs used during conduct of anesthesia are considered potential triggering agents for malignant hyperthermia (MH); amide-type local anesthetics are not known to trigger this reaction; however, since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for MH management should be available

            Intra-articular infusions

            • Infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use; 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 glenohumeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48-72 hours; there is insufficient information to determine whether shorter infusion periods are not associated with these findings
            • The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as 2nd month after surgery; currently, there is no effective treatment for chondrolysis
            • Patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement; 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

            Methemoglobinemia

            • Cases of methemoglobinemia reported in association with local anesthetic use; although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition
            • If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia recommended; Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by cyanotic skin discoloration and/or abnormal coloration of the blood
            • Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death; discontinue the drug and any other oxidizing agents
            • Depending on severity of signs and symptoms, patients may respond to supportive care, eg, oxygen therapy, hydration; a more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen

            Epidural anesthesia

            • During epidural administration, this drug should be administered in incremental doses of 3 to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection
            • Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques; an intravascular injection is still possible even if aspirations for blood are negative
            • During administration of epidural anesthesia, it is recommended that a test dose be administered initially and effects monitored before full dose is given; when clinical conditions permit, the test dose should contain an appropriate dose of epinephrine to serve as a warning of unintentional intravascular injection
            • If injected into a blood vessel, this amount of 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
            • The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for15 or more seconds; therefore, following the test dose, the heart should be continuously monitored for a heart rate increase; patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect a rise in systolic blood pressure
            • A test dose of a short-acting amide anesthetic such as lidocaine is recommended to detect an unintentional intrathecal administration; this will be manifested within a few minutes by signs of spinal block (eg, decreased sensation of buttocks, paresis of legs, or, in sedated patient, absent knee jerk)
            • An intravascular or subarachnoid injection is still possible even if results of test dose are negative; test dose itself may produce a systemic toxic reaction, high spinal or epinephrine-induced cardiovascular effects

            Use in head and neck area

            • Small doses of local anesthetics injected into head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses; injection procedures require utmost care; confusion, convulsions, respiratory depression, and/or respiratory arrest, and cardiovascular stimulation or depression reported
            • These reactions may be due to intra-arterial injection of local anesthetic with retrograde flow to cerebral circulation
            • Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed; resuscitative equipment and personnel for treating adverse reactions should be immediately available; dosage recommendations should not be exceeded

            Drug interaction overview

            • This drug 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
            • When administered concurrently some drugs increase risk of methemoglobinemia, including local anesthetics, nitrates/nitrites, antibiotics, antineoplastic agents, anticonvulsants, antimalarials, in addition to other types of drugs
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate or well-controlled studies in pregnant women of effects of this drug on developing fetus; this drug should only be used during pregnancy if the benefits outweigh risk

            Local anesthetics rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal and neonatal toxicity; the incidence and degree of toxicity depend upon procedure performed, the type and amount of drug used, and technique of drug administration; adverse reactions in parturient, fetus and neonate involve alterations of central nervous system, peripheral vascular tone and cardiac function

            Maternal hypotension has resulted from regional anesthesia with this drug for obstetrical pain relief; local anesthetics produce vasodilation by blocking sympathetic nerves; elevating the patient's legs and positioning her on her left side will help prevent decreases in blood pressure; the fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable; epidural anesthesia has been reported to prolong second stage of labor by removing the patient's reflex urge to bear down or by interfering with motor function; spontaneous vertex delivery occurred more frequently in patients receiving this drug than in those receiving bupivacaine

            Animal data

            • Reproduction toxicity studies have been performed in pregnant New Zealand white rabbits and Sprague-Dawley rats; there were no treatment-related effects on late fetal development, parturition, lactation, neonatal viability, or growth of the offspring
            • Teratogenicity studies in rats and rabbits did not show evidence of any adverse effects on organogenesis or early fetal development in rats (26 mg/kg sc) or rabbits (13 mg/kg); the doses used were approximately equal to total daily dose based on body surface area
            • There were no treatment-related effects on late fetal development, parturition, lactation, neonatal viability, or growth of offspring in 2 perinatal and postnatal studies in rats, at dose levels equivalent to maximum recommended human dose based on body surface area
            • In another study at 23 mg/kg, an increased pup loss was seen during the first 3 days postpartum, which was considered secondary to impaired maternal care due to maternal toxicity

            Lactation

            One publication reported that ropivacaine is present in human milk at low levels following administration in women undergoing cesarean section; no adverse reactions were reported in the infants; there is no available information on drug’s effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Local anesthetics prevent generation/conduction of nerve impulses by reducing sodium permeability & increasing action potential threshold

            Pharmacokinetics

            Duration: 3-15 hr; dose and route dependent; the greater the degree of vasodilation produced by the local anesthetic, the faster the rate of absorption & shorter the duration of action

            Onset of action: 3-15 min (route dependent)

            Protein bound: 94%

            Metabolism: Liver

            Half-life: 5-7 hr (IV)

            Metabolites: ester- & amide-type local anesthetics

            Excretion: Urine (86%)

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            Formulary

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            Tier Description
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.