Ropivacaine

Ropivacaine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Overview

Ropivacaine is a local anesthetic that is FDA approved for the {{{indicationType}}} of cesarean section - local anesthetic lumbar epidural block, epidural anesthesia - surgical procedure, labor pain, local anesthetic nerve block - surgical procedure, postoperative pain. Common adverse reactions include cardiovascular: fetal bradycardia (12.1% ), hypotension (32% to 37% ), dermatologic: pruritus (5.1% ), gastrointestinal: nausea (24.8% .), vomiting (11.6% ), musculoskeletal: backache (4% to 40% ), neurologic: headache (5.1% ), paresthesia (5.6% ), other: fever (9.2% ).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Cesarean section - Local anesthetic lumbar epidural block: 20 to 30 mL of 0.5% solution (100 to 150 mg) OR 15 to 20 mL of 0.75% solution (113 to 150 mg) Epidural anesthesia - Surgical procedure: 15 to 30 mL (75 to 150 mg) of 0.5% solution Labor pain: initial, lumbar EPIDURAL 10 to 20 mL (20 to 40 mg) of 0.2% solution Labor pain: continuous lumbar EPIDURAL infusion, 6 to 14 mL/hr (12 to 28 mg/hr) of 0.2% solution Labor pain: incremental lumbar EPIDURAL injections (top-up), 10 to 15 mL/hr (20 to 30 mg/hr) of 0.2% solution Local anesthetic nerve block - Surgical procedure: Field block 1 to 40 mL of 0.5% solution (5 to 200 mg) Local anesthetic nerve block - Surgical procedure: Major nerve block 35 to 50 mL of 0.5% solution (175 to 250 mg) OR 10 to 40 mL of 0.75% solution (75 to 300 mg) Postoperative pain: lumbar or thoracic EPIDURAL continuous infusion: 6 to 14 mL/hr (12 to 28 mg/hr) of a 0.2% (2 mg/mL) solution [1] Postoperative pain: local INFILTRATION: 1 to 100 mL (2 to 200 mg) of a 0.2% (2 mg/mL) solution OR 1 to 40 mL (5 to 200 mg) of a 0.5% (5 mg/mL) solution [1]

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

PainView additional information.

       Peribulbar infiltration of local anestheticView additional information.
       Spinal anesthesia - Surgical procedureView additional information.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ropivacaine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

safety and efficacy in pediatric patients has not been established

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ropivacaine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ropivacaine in pediatric patients.

Contraindications

Naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.

Warnings

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.

Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an i.v. 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 ensuring 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 also ADVERSE REACTIONS, PRECAUTIONS, and MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES). 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. 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.

A well-known risk of epidural anesthesia may be an unintentional subarachnoid injection of local anesthetic. Two clinical studies have been performed to verify the safety of Naropin at a volume of 3 mL injected into the subarachnoid space since this dose represents an incremental epidural volume that could be unintentionally injected. The 15 and 22.5 mg doses injected resulted in sensory levels as high as T5 and T4, respectively. Anesthesia to pinprick started in the sacral dermatomes in 2 to 3 minutes, extended to the T10 level in 10 to 13 minutes and lasted for approximately 2 hours. The results of these two clinical studies showed that a 3 mL dose did not produce any serious adverse events when spinal anesthesia blockade was achieved.

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.

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

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Ropivacaine Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Ropivacaine Postmarketing Experience in the drug label.

Drug Interactions

Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (eg, amiodarone) have not been performed, but caution is advised (see WARNINGS).

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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Ropivacaine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ropivacaine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ropivacaine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ropivacaine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Ropivacaine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Ropivacaine in geriatric settings.

Gender

There is no FDA guidance on the use of Ropivacaine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ropivacaine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ropivacaine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ropivacaine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ropivacaine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ropivacaine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Ropivacaine Administration in the drug label.

Monitoring

There is limited information regarding Ropivacaine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ropivacaine and IV administrations.

Overdosage

There is limited information regarding Ropivacaine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Ropivacaine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Ropivacaine Mechanism of Action in the drug label.

Structure

There is limited information regarding Ropivacaine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Ropivacaine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ropivacaine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Ropivacaine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ropivacaine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Ropivacaine How Supplied in the drug label.

Storage

There is limited information regarding Ropivacaine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Ropivacaine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Ropivacaine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Ropivacaine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Ropivacaine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.