Naropin 2mg/ml Inj, 10ml
It is used to numb an area before a procedure.It is used to manage pain.
Drug Class
Local Anesthetic
Pharmacologic Class
Amide-type local anesthetic; Sodium channel blocker
Pregnancy Category
Category B
FDA Approved
Mar 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ropivacaine is a medication used to numb a specific part of your body, like an arm, leg, or an area for surgery or childbirth. It works by temporarily blocking nerve signals that send pain messages to your brain. It's given as an injection by a healthcare professional.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered via injection.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
Missing a Dose
This medication will be administered as needed in a healthcare setting, so you will not need to take it at home. If you have any questions or concerns about your treatment schedule, be sure to discuss them with your healthcare provider.
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered via injection.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
Missing a Dose
This medication will be administered as needed in a healthcare setting, so you will not need to take it at home. If you have any questions or concerns about your treatment schedule, be sure to discuss them with your healthcare provider.
Lifestyle & Tips
- Report any unusual sensations (e.g., tingling, numbness, dizziness, ringing in ears, metallic taste) during or after the injection.
- Remain still during the injection as instructed by your healthcare provider.
- Understand that the numb feeling will wear off over several hours; avoid activities that could cause injury to the numb area until sensation returns.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable, depends on procedure, site, and desired effect. Examples: Epidural (surgical): 75-200 mg (0.75-1% solution); Epidural (labor/delivery): 20-40 mg (0.2-0.5% solution) initially, then 6-16 mg/hr infusion; Major nerve block: 75-250 mg (0.5-1% solution); Infiltration: 2-200 mg (0.2-0.5% solution).
Dose Range:
2 - 250 mg
Condition-Specific Dosing:
Maximum single dose:
250 mg
Maximum 24-hour dose:
775 mg
Pediatric Dosing
Neonatal:
Not established for routine use; limited data. Use with extreme caution, if at all.
Infant:
Caudal epidural: 1-3 mg/kg (0.2% solution); Peripheral nerve block: 1-3 mg/kg (0.2-0.5% solution). Max single dose 3 mg/kg.
Child:
Caudal epidural: 1-3 mg/kg (0.2% solution); Peripheral nerve block: 1-3 mg/kg (0.2-0.5% solution). Max single dose 3 mg/kg.
Adolescent:
Dosing similar to adult, but consider weight and physiological maturity. Max single dose 3 mg/kg or 250 mg, whichever is less.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
No specific dose adjustment required, but monitor for signs of systemic toxicity due to potential accumulation of metabolites.
Dialysis:
Not significantly removed by hemodialysis. No specific dose adjustment, but monitor closely.
Hepatic Impairment:
Mild:
No specific dose adjustment required.
Moderate:
Consider dose reduction and monitor for signs of systemic toxicity due to decreased clearance.
Severe:
Significant dose reduction may be necessary; use with extreme caution and monitor closely for systemic toxicity due to impaired metabolism.
Pharmacology
Mechanism of Action
Ropivacaine is an amide-type local anesthetic. It reversibly blocks the initiation and conduction of nerve impulses by decreasing the permeability of the nerve cell membrane to sodium ions. This action stabilizes the neuronal membrane and inhibits depolarization, thereby preventing the propagation of the action potential.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable for injection; systemic absorption depends on injection site, dose, and concentration. Peak plasma concentrations vary widely.
Tmax:
Epidural: 10-25 minutes; Brachial plexus block: 10-60 minutes; Infiltration: 3-15 minutes.
FoodEffect:
Not applicable (parenteral administration).
Distribution:
Vd:
47-109 L (average 61 L in adults)
ProteinBinding:
~94% (primarily to alpha-1-acid glycoprotein)
CnssPenetration:
Limited at therapeutic doses; crosses blood-brain barrier, but high concentrations can lead to CNS toxicity.
Elimination:
HalfLife:
1.9-4.2 hours (terminal elimination half-life after epidural administration); 1.4 hours (IV infusion).
Clearance:
0.44 L/min (systemic clearance).
ExcretionRoute:
Renal (primarily as metabolites).
Unchanged:
<1% (of administered dose excreted unchanged in urine).
Pharmacodynamics
OnsetOfAction:
2-15 minutes (depending on concentration and site of injection).
PeakEffect:
15-90 minutes (depending on concentration and site of injection).
DurationOfAction:
2-6 hours (depending on concentration, dose, and site of injection; can be prolonged with epinephrine).
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
There have been reports of cardiac arrest with difficult resuscitation or death during use of ropivacaine for epidural anesthesia in obstetrical patients. In most cases, this has been associated with accidental intravascular injection of ropivacaine. Not for intravenous regional anesthesia (Bier's block) due to the risk of systemic toxicity.
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood): confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak
Signs of methemoglobinemia: blue or gray discoloration of the lips, nails, or skin, irregular heartbeat, seizures, severe dizziness or fainting, severe headache, excessive sleepiness, feeling tired or weak, or shortness of breath (this rare effect can be life-threatening if it occurs)
Extreme fatigue or weakness
Chest pain
Abnormal heartbeat (fast, slow, or irregular)
Unusual burning, numbness, or tingling sensations
Balance problems
Restlessness
Anxiety
Changes in speech
Numbness or tingling in the mouth
Metallic taste
Ringing in the ears
Dizziness or fainting
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Shakiness
Twitching
Feeling extremely hot or cold
Excessive nervousness or excitability
Depression
Seizures
Breathing difficulties, slow breathing, or shallow breathing
Sneezing
Excessive sweating
Additional Side Effects (Epidural Use)
If you are using this medication via epidural administration, you may also experience:
Urination difficulties
Loss of bladder or bowel control
Erectile dysfunction
Long-lasting burning, numbness, tingling, or paralysis in the lower half of the body
Back pain
Fever or chills
Stiff neck
Sensitivity to bright lights
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you have any concerns. Common side effects include:
Headache
Upset stomach or vomiting
Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood): confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak
Signs of methemoglobinemia: blue or gray discoloration of the lips, nails, or skin, irregular heartbeat, seizures, severe dizziness or fainting, severe headache, excessive sleepiness, feeling tired or weak, or shortness of breath (this rare effect can be life-threatening if it occurs)
Extreme fatigue or weakness
Chest pain
Abnormal heartbeat (fast, slow, or irregular)
Unusual burning, numbness, or tingling sensations
Balance problems
Restlessness
Anxiety
Changes in speech
Numbness or tingling in the mouth
Metallic taste
Ringing in the ears
Dizziness or fainting
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Shakiness
Twitching
Feeling extremely hot or cold
Excessive nervousness or excitability
Depression
Seizures
Breathing difficulties, slow breathing, or shallow breathing
Sneezing
Excessive sweating
Additional Side Effects (Epidural Use)
If you are using this medication via epidural administration, you may also experience:
Urination difficulties
Loss of bladder or bowel control
Erectile dysfunction
Long-lasting burning, numbness, tingling, or paralysis in the lower half of the body
Back pain
Fever or chills
Stiff neck
Sensitivity to bright lights
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you have any concerns. Common side effects include:
Headache
Upset stomach or vomiting
Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Dizziness or lightheadedness
- Numbness or tingling around the mouth
- Metallic taste in the mouth
- Ringing in the ears (tinnitus)
- Blurred vision
- Muscle twitching or tremors
- Feeling anxious or restless
- Difficulty breathing
- Slow or irregular heartbeat
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
To ensure your safety, avoid driving and engaging in activities that require alertness until the effects of this medication have worn off and you feel fully awake.
There is a risk of developing a severe blood disorder called methemoglobinemia associated with this type of medication. This risk may be increased in individuals with certain conditions, such as glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. Additionally, the risk may be higher when taking certain other medications or in infants under 6 months of age. If you have a history of methemoglobinemia, inform your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Epidural Administration
When this medication is administered via epidural, it may cause temporary loss of sensation and motor function in the lower half of your body. To avoid injury, do not attempt to get out of bed or engage in any activities until normal feeling and movement have returned.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
To ensure your safety, avoid driving and engaging in activities that require alertness until the effects of this medication have worn off and you feel fully awake.
There is a risk of developing a severe blood disorder called methemoglobinemia associated with this type of medication. This risk may be increased in individuals with certain conditions, such as glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. Additionally, the risk may be higher when taking certain other medications or in infants under 6 months of age. If you have a history of methemoglobinemia, inform your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Epidural Administration
When this medication is administered via epidural, it may cause temporary loss of sensation and motor function in the lower half of your body. To avoid injury, do not attempt to get out of bed or engage in any activities until normal feeling and movement have returned.
Overdose Information
Overdose Symptoms:
- Severe dizziness or lightheadedness
- Seizures
- Unconsciousness
- Respiratory depression or arrest
- Severe low blood pressure
- Bradycardia (slow heart rate)
- Cardiac arrest
What to Do:
Immediate medical attention is required. Call 911 or emergency services. Management involves airway management, oxygenation, ventilation, circulatory support, and administration of lipid emulsion therapy (Intralipid) for severe systemic toxicity. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Contraindicated Interactions
- Not for intravenous regional anesthesia (Bier's block) due to risk of systemic toxicity.
- Not for obstetric paracervical block due to risk of fetal bradycardia/death.
Major Interactions
- Other local anesthetics (additive systemic toxicity)
- Class I antiarrhythmics (e.g., mexiletine, lidocaine) - additive cardiac effects, increased risk of toxicity.
- CYP1A2 inhibitors (e.g., fluvoxamine, cimetidine) - increased ropivacaine plasma levels, increased risk of toxicity.
Moderate Interactions
- CYP1A2 inducers (e.g., rifampin) - decreased ropivacaine plasma levels, potential for reduced efficacy.
- Beta-blockers (may reduce hepatic blood flow, potentially affecting ropivacaine clearance, though less significant than CYP interactions).
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Patient assessment (medical history, allergies, current medications)
Rationale: To identify contraindications, potential drug interactions, and risk factors for complications.
Timing: Prior to administration
Vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation)
Rationale: To establish baseline and detect early signs of systemic toxicity or adverse reactions.
Timing: Prior to administration
Neurological status (e.g., mental status, sensory/motor function)
Rationale: To establish baseline and assess for pre-existing neurological deficits or signs of CNS toxicity.
Timing: Prior to administration
Routine Monitoring
Vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation)
Frequency: Every 5-15 minutes during and immediately after injection, then as clinically indicated.
Target: Within patient's normal physiological range.
Action Threshold: Significant deviations (e.g., bradycardia, hypotension, desaturation) warrant immediate intervention.
Neurological assessment (e.g., level of consciousness, signs of CNS toxicity)
Frequency: Continuously during and immediately after injection, then periodically.
Target: Alert, oriented, no signs of CNS excitation or depression.
Action Threshold: Signs of circumoral numbness, metallic taste, tinnitus, muscle twitching, dizziness, seizures, or somnolence require immediate intervention.
ECG monitoring (especially with large doses or high-risk patients)
Frequency: Continuous during and immediately after injection.
Target: Normal sinus rhythm, no arrhythmias or conduction abnormalities.
Action Threshold: Arrhythmias (e.g., bradycardia, ventricular tachycardia, asystole) require immediate intervention.
Symptom Monitoring
- Lightheadedness
- Dizziness
- Tinnitus
- Metallic taste
- Circumoral numbness
- Blurred vision
- Tremors
- Muscle twitching
- Seizures
- Somnolence
- Unconsciousness
- Bradycardia
- Hypotension
- Cardiac arrest
Special Patient Groups
Pregnancy
Category B. Studies in animals have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Accidental intravascular injection during obstetric epidural anesthesia has been associated with cardiac arrest and death.
Trimester-Specific Risks:
First Trimester:
Risk not ruled out; use only if clearly indicated.
Second Trimester:
Risk not ruled out; use only if clearly indicated.
Third Trimester:
Risk not ruled out; use with caution, especially for obstetric epidural due to potential for maternal systemic toxicity and fetal effects (e.g., bradycardia).
Lactation
L3 (Moderately safe). Ropivacaine is excreted into breast milk in small amounts. The amount ingested by the infant is generally low and unlikely to cause adverse effects. However, caution is advised, and monitoring the infant for sedation or feeding difficulties is prudent.
Infant Risk:
Low risk of adverse effects to the breastfed infant, but monitor for sedation or poor feeding.
Pediatric Use
Dosing must be carefully calculated based on weight and age. Children, especially infants and neonates, may have reduced protein binding and immature hepatic metabolism, leading to higher free drug concentrations and increased susceptibility to systemic toxicity. Close monitoring for signs of toxicity is crucial.
Geriatric Use
Elderly patients may have reduced hepatic blood flow, decreased protein binding, and reduced renal function, potentially leading to higher plasma concentrations and increased sensitivity to systemic toxicity. Lower doses and slower administration rates may be required. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Always aspirate carefully before and during injection to avoid accidental intravascular administration, which can lead to severe systemic toxicity.
- Ropivacaine provides a differential block, meaning it can produce effective sensory block with less motor block compared to bupivacaine, making it suitable for labor analgesia and ambulatory surgery.
- Systemic toxicity (LAST) can manifest as CNS excitation (e.g., tremors, seizures) followed by CNS depression (e.g., somnolence, respiratory arrest), and cardiovascular depression (e.g., bradycardia, hypotension, cardiac arrest). Be prepared to manage LAST with lipid emulsion therapy.
- The addition of epinephrine can prolong the duration of action and reduce systemic absorption, but it should be used with caution in areas with end-arteries (e.g., fingers, toes, penis) due to risk of ischemia.
Alternative Therapies
- Bupivacaine (another amide-type local anesthetic, often used for similar indications)
- Lidocaine (amide-type local anesthetic, shorter duration)
- Mepivacaine (amide-type local anesthetic, intermediate duration)
- Chloroprocaine (ester-type local anesthetic, very short duration, rapid metabolism)
Cost & Coverage
Average Cost:
Varies widely by concentration, volume, and supplier. Typically $5-$50 per 10ml vial. per 10ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often covered by most insurance plans as a generic or preferred brand).
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others, and do not take medication prescribed to someone else.
Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare providers deliver appropriate care.
Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare providers deliver appropriate care.