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Ropivacaine

Pronunciation

(roe PIV a kane)

Index Terms

  • Ropivacaine Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection, as hydrochloride [preservative free]:

Naropin: 2 mg/mL (10 mL, 20 mL, 100 mL, 200 mL); 5 mg/mL (20 mL, 30 mL, 100 mL, 200 mL); 7.5 mg/mL (20 mL); 10 mg/mL (10 mL, 20 mL)

Generic: 2 mg/mL (10 mL, 20 mL); 5 mg/mL (30 mL); 7.5 mg/mL (20 mL); 10 mg/mL (10 mL, 20 mL)

Brand Names: U.S.

  • Naropin

Pharmacologic Category

  • Local Anesthetic

Pharmacology

Blocks both the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions, which results in inhibition of depolarization with resultant blockade of conduction

Distribution

Vd:

Children: Epidural infusion: 2.1 to 4.2 L/kg (Hansen 2000)

Adults: Intravascular infusion: 41 ± 7 L

Metabolism

Hepatic, via CYP1A2 to metabolites

Excretion

Urine (86% as metabolites)

Onset of Action

Anesthesia (route dependent): 3 to 15 minutes

Time to Peak

Serum (dose and route dependent): Caudal:

Infants: Median: 60 minutes (range: 15 to 90 minutes) (Wulf 2000)

Children: Mean: 60 minutes (range: 12 to 249 minutes (Lonnqvist 2000)

Duration of Action

Dose and route dependent: 3 to 15 hours

Half-Life Elimination

Children: Epidural: Terminal phase:4.9 hours (range: 3 to 6.7 hours) (Hansen 2000)

Adults: Epidural: 5 to 7 hours; IV: Terminal: 111 ± 62 minutes (Lee 1989)

Use: Labeled Indications

Acute pain management: For acute pain management administered as an epidural continuous infusion, intermittent bolus (eg, postoperative or labor), or local infiltration.

Surgical anesthesia: For the production of local or regional anesthesia for surgery administered as an epidural block, including cesarean section, major nerve block, or local infiltration.

Contraindications

Hypersensitivity to ropivacaine, amide-type local anesthetics (eg, bupivacaine, mepivacaine, lidocaine), or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Intravenous regional anesthesia (Bier block); obstetric paracervical block anesthesia

Dosing: Adult

Dose varies with procedure, onset and depth of anesthesia desired, vascularity of tissues, duration of anesthesia, and condition of patient: A test dose of short-acting local anesthestic containing epinephrine (eg, 3 to 5 mL) should be administered prior to induction of complete block with ropivacaine. Incremental ropivacaine dosing is recommended. Adults:

Surgical anesthesia:

Lumbar epidural block for surgery:

15 to 30 mL of 0.5% solution

15 to 25 mL of 0.75% solution

15 to 20 mL of 1% solution

Lumbar epidural block for cesarean section:

20 to 30 mL dose of 0.5% solution

15 to 20 mL dose of 0.75% solution

Thoracic epidural block:

5 to 15 mL dose of 0.5% solution

5 to 15 mL dose of 0.75% solution

Major nerve block:

35 to 50 mL dose of 0.5% solution

10 to 40 mL dose of 0.75% solution

Field block: 1 to 40 mL dose of 0.5% solution

Labor pain management: Lumbar epidural: Initial: 10 to 20 mL 0.2% solution; continuous infusion dose: 6 to 14 mL/hour of 0.2% solution with incremental injections of 10 to 15 mL/hour of 0.2% solution

Postoperative pain management:

Peripheral nerve block: Continuous infusion dose: 5 to 10 mL/hour of 0.2% solution (Bagry, 2008; Klein, 2000)

Lumbar or thoracic epidural: Continuous infusion dose: 6 to 14 mL/hour of 0.2% solution

Infiltration/minor nerve block:

1 to 100 mL dose of 0.2% solution

1 to 40 mL dose of 0.5% solution

Dosing: Geriatric

Refer to adult dosing. Use with caution; initial dose reductions may be necessary.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. However, ropivacaine and its metabolites are renally excreted, and the risk of toxic reactions may be greater.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; ropivacaine undergoes hepatic metabolism and patients may be at a greater risk for developing toxic drug levels.

Administration

Administered via local infiltration, epidural block and epidural infusion, or intermittent bolus. Prior to ropivacaine administration, a test dose of short-acting local anesthestic with epinephrine (eg, 3 to 5 mL) should be administered. Incremental ropivacaine dosing is recommended. Do not administer large volume of anesthetic rapidly. The On-Q infusion pump is used to slowly administer local anesthetics (eg, bupivacaine, lidocaine, ropivacaine) to or around surgical wound sites and/or in close proximity to nerves for pre- or postoperative regional anesthesia. When infused directly into the shoulder, destruction of articular cartilage (chondrolysis) has occurred. On-Q pumps should never be placed directly into any joint (see https://www.ismp.org/Newsletters/acutecare/archives/May09.asp).

Storage

Store at 20°C to 25°C (68°F to 77°F). Infusions should be discarded after 24 hours.

Drug Interactions

Abiraterone Acetate: May increase the serum concentration of CYP1A2 Substrates. Monitor therapy

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Bupivacaine (Liposomal): Local Anesthetics may enhance the adverse/toxic effect of Bupivacaine (Liposomal). Management: Liposomal bupivacaine should not be administered with local anesthetics. Liposomal bupivacaine may be administered 20 minutes or more after the administration of lidocaine, but the optimal duration of dose separation for other local anesthetics is unknown Avoid combination

Ciprofloxacin (Systemic): May increase the serum concentration of Ropivacaine. Monitor therapy

CYP1A2 Inhibitors (Moderate): May decrease the metabolism of CYP1A2 Substrates. Monitor therapy

CYP1A2 Inhibitors (Strong): May decrease the metabolism of CYP1A2 Substrates. Consider therapy modification

Deferasirox: May increase the serum concentration of CYP1A2 Substrates. Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

FluvoxaMINE: May increase the serum concentration of Ropivacaine. Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Hyaluronidase: May enhance the adverse/toxic effect of Local Anesthetics. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Obeticholic Acid: May increase the serum concentration of CYP1A2 Substrates. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Peginterferon Alfa-2b: May increase the serum concentration of CYP1A2 Substrates. Monitor therapy

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Propofol: May increase the serum concentration of Ropivacaine. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Technetium Tc 99m Tilmanocept: Local Anesthetics may diminish the diagnostic effect of Technetium Tc 99m Tilmanocept. Management: Avoid mixing and simultaneously co-injecting technetium Tc 99m tilmanocept with local anesthetics. This interaction does not appear to apply to other uses of these agents in combination. Monitor therapy

Vemurafenib: May increase the serum concentration of CYP1A2 Substrates. Management: Consider alternatives to such combinations whenever possible, particularly if the CYP1A2 substrate has a relatively narrow therapeutic index. Consider therapy modification

Adverse Reactions

>10%:

Cardiovascular: Hypotension (dose-related and age-related: 32% to 69%), bradycardia (6% to 20%)

Gastrointestinal: Nausea (11% to 29%), vomiting (7% to 14%)

Neuromuscular & skeletal: Back pain (7% to 16%)

1% to 10%:

Cardiovascular: Hypertension, tachycardia, chest pain (1% to 5%)

Central nervous system: Fever (3% to 9%), headache (5% to 8%), dizziness (3%), chills (2% to 3%), anxiety (1%), lightheadedness

Dermatologic: Pruritus (1% to 5%)

Endocrine & metabolic: Hypokalemia

Genitourinary: Urinary retention (1% to 5%), urinary tract infection (1% to 5%)

Hematologic: Anemia (6%)

Neuromuscular & skeletal: Paresthesia (2% to 6%), hypoesthesia, rigors, circumoral paresthesia

Renal: Oliguria

Respiratory: Dyspnea

Miscellaneous: Shivering

<1% (Limited to important or life-threatening): Accidental IV injection (0.2%), angioedema, allergic reaction, apnea (usually associated with epidural block in head/neck region), bronchospasm, cardiac arrest, cardiovascular collapse, chondrolysis (continuous intra-articular administration), dyskinesia, hallucination, hyperthermia, laryngeal edema, myocardial depression, MI, rash, seizure, syncope, tinnitus, urticaria, ventricular arrhythmia

Warnings/Precautions

Concerns related to adverse effects:

• CNS toxicity: Careful and constant monitoring of the patient's state of consciousness should be done following each local anesthetic injection; at such times, restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression, or drowsiness may be early warning signs of CNS toxicity. Treatment is primarily symptomatic and supportive.

• Intra-articular infusion related chondrolysis: Continuous intra-articular infusion of local anesthetics after arthroscopic or other surgical procedures is not an approved use; chondrolysis (primarily in the shoulder joint) has occurred following infusion, with some cases requiring arthroplasty or shoulder replacement.

• Respiratory arrest: Local anesthetics have been associated with rare occurrences of sudden respiratory arrest.

• Seizures: Convulsions due to systemic toxicity leading to cardiac arrest have also been reported, presumably following unintentional intravascular injection.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with hypotension, hypovolemia, heart block, or cardiovascular disease; may be at greater risk for toxicity.

• Hepatic impairment: Use with caution in patients with hepatic impairment; may be at greater risk for toxicity.

• Neurological disorders: Use with caution in patients with neurological disorders; may be at greater risk for toxicity.

• Porphyria: Use with caution in patients with acute porphyria; consider use of alternative agents.

• Psychiatric disorders: Use with caution in patients with psychiatric disorders; may be at greater risk for toxicity.

• Renal impairment: Use with caution in patients with severe renal impairment; may be at greater risk for toxicity.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Acutely ill patients: Use with caution in acutely ill; may be at greater risk for toxicity.

• Debilitated patients: Use with caution in debilitated patient; may be at greater risk for toxicity.

• Elderly: Use with caution in the elderly: may be at greater risk for toxicity. Cardiovascular adverse events (bradycardia, hypotension) may be age-related (more common in patients >61 years of age).

Other warnings/precautions:

• Administration: Intravascular injections should be avoided; aspiration should be performed prior to administration; the needle must be repositioned until no return of blood can be elicited by aspiration; however, absence of blood in the syringe does not guarantee that intravascular injection has been avoided.

• Rapid administration: Ropivacaine is not recommended for use in emergency situations where rapid administration is necessary.

• Trained personnel: Clinicians using local anesthetic agents should be well trained in diagnosis and management of emergencies that may arise from the use of these agents. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use.

Monitoring Parameters

Heart rate, blood pressure, ECG monitoring (if used with antiarrhythmics)

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. When used for epidural block during labor and delivery, systemically absorbed ropivacaine may cross the placenta, resulting in varying degrees of fetal or neonatal effects (eg, CNS or cardiovascular depression). Fetal or neonatal adverse events include fetal bradycardia (12%), neonatal jaundice (8%), low Apgar scores (3%), fetal distress (2%), neonatal respiratory disorder (3%). Maternal hypotension may also result from systemic absorption. In cases of hypotension, position pregnant woman in left lateral decubitus position to prevent aortocaval compression by the gravid uterus. Epidural anesthesia may prolong the second stage of labor.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience back pain. Have patient report immediately to prescriber severe loss of strength and energy, bradycardia, tachycardia, arrhythmia, fast breathing, change in balance, burning or numbness feeling, difficult urination, confusion, agitation, anxiety, difficulty speaking, metallic taste, blurred vision, tinnitus, severe dizziness, passing out, tremors, twitching, fatigue, depression, severe headache, seizures, difficulty breathing, slow breathing, shallow breathing, angina, severe vomiting, or severe nausea (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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