Ropivacaine: Difference between revisions

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|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Ropivacaine in adult patients.
|fdaLIADAdult=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]
|offLabelAdultGuideSupport=        PainView additional information.
        Peribulbar infiltration of local anestheticView additional information.
        Spinal anesthesia - Surgical procedureView additional information.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Ropivacaine in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Ropivacaine in adult patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Ropivacaine in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Ropivacaine in pediatric patients.

Revision as of 00:22, 1 July 2014

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]

Disclaimer

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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)

There is limited information regarding Ropivacaine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

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

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

Warnings

There is limited information regarding Ropivacaine Warnings' in the drug label.

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

There is limited information regarding Ropivacaine Drug Interactions in the drug label.

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

{{#ask: Page Name::Ropivacaine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ropivacaine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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.