Naropin 10mg/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; Voltage-gated Sodium Channel Blocker
Pregnancy Category
Category C
FDA Approved
Mar 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ropivacaine is a 'numbing medicine' (local anesthetic) that is injected into a specific area of your body to temporarily block nerve signals. This causes a loss of feeling and sometimes movement in that area, allowing for surgical procedures or pain relief without you being fully asleep.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. 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 medication 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. 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 medication schedule, be sure to discuss them with your healthcare provider.
Lifestyle & Tips
- Report any unusual sensations (e.g., dizziness, ringing in ears, metallic taste, numbness around mouth) immediately to your healthcare provider during or after the injection.
- Understand that the treated area will be numb and possibly weak for several hours; avoid activities that could cause injury to the numb area until full sensation and motor function return.
- Follow all post-procedure instructions carefully, especially regarding activity restrictions and pain management.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on procedure, site of injection, and desired effect (e.g., surgical anesthesia, pain management). Doses are expressed as total mg.
Dose Range:
5 - 300 mg
Condition-Specific Dosing:
epiduralBlockForSurgery:
150-250 mg (e.g., 15-25 mL of 0.75% or 1% solution)
epiduralBlockForCesareanSection:
100-150 mg (e.g., 20-30 mL of 0.5% solution)
epiduralInfusionForLaborAnalgesia:
10-20 mg/hr (e.g., 10-20 mL/hr of 0.1% solution)
majorNerveBlock:
75-300 mg (e.g., 15-30 mL of 0.5% or 0.75% solution)
fieldBlockLocalInfiltration:
5-200 mg (e.g., 1-40 mL of 0.25% or 0.5% solution)
maximumSingleDose:
250 mg (for single injection)
maximum24HourDose:
600-775 mg (for continuous infusion or repeated injections)
Pediatric Dosing
Neonatal:
Not established for routine use; limited data. Use with extreme caution.
Infant:
Dosing is weight-based and procedure-dependent. E.g., Caudal epidural block: 1-3 mg/kg of 0.2% solution.
Child:
Dosing is weight-based and procedure-dependent. E.g., Caudal epidural block: 1-3 mg/kg of 0.2% solution. Lumbar epidural infusion: 0.2-0.4 mg/kg/hr.
Adolescent:
Dosing similar to adults, adjusted for weight and procedure.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required for single dose.
Moderate:
No specific dose adjustment required for single dose.
Severe:
No specific dose adjustment required for single dose. Caution with prolonged infusions due to potential accumulation of metabolites.
Dialysis:
Not significantly removed by hemodialysis. No specific dose adjustment for single dose. Caution with prolonged infusions.
Hepatic Impairment:
Mild:
No specific dose adjustment required for single dose.
Moderate:
Caution advised. Consider reduced doses and monitor for signs of toxicity, especially with prolonged infusions, due to decreased clearance.
Severe:
Contraindicated or use with extreme caution. Significant reduction in clearance is expected. Consider substantial dose reduction and close monitoring.
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 neuronal membrane to sodium ions. This action stabilizes the membrane and inhibits depolarization, leading to a reversible loss of sensation and motor activity in the area innervated by the treated nerves.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable for injection; systemic absorption depends on injection site and vascularity.
Tmax:
Varies significantly with injection site: Epidural (10-30 min), Brachial plexus block (10-40 min), Intercostal block (5-15 min).
FoodEffect:
Not applicable (parenteral administration).
Distribution:
Vd:
47 Âą 22 L (at steady state in adults)
ProteinBinding:
Approximately 94% (primarily to alpha-1-acid glycoprotein, also to albumin)
CnssPenetration:
Limited at therapeutic doses; crosses blood-brain barrier, but high concentrations can cause CNS toxicity.
Elimination:
HalfLife:
1.9-4.2 hours (terminal elimination half-life after epidural administration); 1.4 hours (intravenous)
Clearance:
Approximately 0.44 L/min (26.4 L/hr)
ExcretionRoute:
Renal (primarily as metabolites; <1% as unchanged drug)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
1-15 minutes (depending on concentration, dose, and site of injection)
PeakEffect:
15-90 minutes (depending on concentration, dose, and site of injection)
DurationOfAction:
2-6 hours (dose and concentration dependent; longer with higher doses/concentrations)
Safety & Warnings
Side Effects
Urgent 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 condition can be life-threatening if left untreated.
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:
Difficulty urinating
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, although not everyone will experience them. If you encounter any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Headache
Upset stomach or vomiting
Back pain
This is not an exhaustive list of possible side effects. If you have concerns or questions, 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 condition can be life-threatening if left untreated.
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:
Difficulty urinating
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, although not everyone will experience them. If you encounter any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Headache
Upset stomach or vomiting
Back pain
This is not an exhaustive list of possible side effects. If you have concerns or questions, 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:
- Lightheadedness or dizziness
- Ringing in the ears (tinnitus)
- Metallic taste in the mouth
- Numbness or tingling around the mouth (circumoral numbness)
- Blurred vision or double vision
- Tremors or muscle twitching
- Seizures
- Difficulty breathing or shortness of breath
- Unusual drowsiness or confusion
- Slow or irregular heartbeat
- Feeling faint or unusually weak
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, any of 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 identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust 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, any of 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 identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust 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. Certain factors may increase this risk, including:
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Pre-existing heart problems
- Pre-existing lung problems
- Concurrent use of specific other medications
- Age, particularly in infants under 6 months old
If you have a history of methemoglobinemia, notify your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding:
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Epidural Administration:
When this medication is administered epidurally, it may cause temporary loss of sensation and motor function in the lower half of your body. To avoid accidents, do not attempt to get out of bed or perform 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. Certain factors may increase this risk, including:
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Pre-existing heart problems
- Pre-existing lung problems
- Concurrent use of specific other medications
- Age, particularly in infants under 6 months old
If you have a history of methemoglobinemia, notify your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding:
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
Epidural Administration:
When this medication is administered epidurally, it may cause temporary loss of sensation and motor function in the lower half of your body. To avoid accidents, do not attempt to get out of bed or perform any activities until normal feeling and movement have returned.
Overdose Information
Overdose Symptoms:
- Severe CNS toxicity (seizures, unconsciousness, respiratory arrest)
- Cardiovascular collapse (severe hypotension, bradycardia, arrhythmias, asystole)
- Metabolic acidosis
What to Do:
Immediate medical attention is required. Call 911 or your local emergency number. Management involves stopping the infusion, maintaining airway and ventilation, administering oxygen, treating seizures (e.g., benzodiazepines), and managing cardiovascular depression (e.g., vasopressors, atropine, lipid emulsion therapy for severe local anesthetic systemic toxicity (LAST)). Call 1-800-222-1222 (Poison Control) for additional guidance.
Drug Interactions
Major Interactions
- Other local anesthetics (additive systemic toxicity)
- Class I antiarrhythmics (e.g., mexiletine, lidocaine, quinidine, procainamide - increased risk of cardiac toxicity)
Moderate Interactions
- CYP1A2 inhibitors (e.g., fluvoxamine, cimetidine, verapamil, erythromycin - may increase ropivacaine plasma levels, especially with prolonged infusions)
- CYP1A2 inducers (e.g., rifampin, carbamazepine, phenytoin - may decrease ropivacaine plasma levels)
- Opioids (additive respiratory depression, but often used synergistically for analgesia)
- Sedatives/Hypnotics (additive CNS depression)
Monitoring
Baseline Monitoring
Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate)
Rationale: To establish baseline and detect early signs of systemic toxicity or adverse reactions.
Timing: Prior to administration
Allergy History
Rationale: To identify potential hypersensitivity reactions.
Timing: Prior to administration
Neurological Status (Level of Consciousness, Sensory/Motor Function)
Rationale: To establish baseline and monitor for CNS toxicity or effectiveness of block.
Timing: Prior to administration
ECG (if high risk or large dose)
Rationale: To assess cardiac function, especially in patients with pre-existing cardiac conditions or when large doses are anticipated.
Timing: Prior to administration
Routine Monitoring
Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate)
Frequency: Every 5-15 minutes during and immediately after administration, then as clinically indicated.
Target: Within patient's normal physiological range.
Action Threshold: Significant deviations (e.g., bradycardia, hypotension, tachypnea) or signs of systemic toxicity.
Neurological Status (Sensory/Motor Block, Signs of CNS Toxicity)
Frequency: Continuously during and after administration until block resolves.
Target: Desired level of anesthesia/analgesia; absence of CNS toxicity.
Action Threshold: Signs of CNS toxicity (e.g., circumoral numbness, tinnitus, dizziness, seizures, altered mental status).
ECG (if continuous infusion or high risk)
Frequency: Continuous monitoring during and after administration.
Target: Normal sinus rhythm; absence of arrhythmias.
Action Threshold: Arrhythmias, QRS widening, PR prolongation, signs of cardiac depression.
Oxygen Saturation
Frequency: Continuous monitoring.
Target: >92-94%
Action Threshold: Hypoxia.
Symptom Monitoring
- Lightheadedness
- Dizziness
- Tinnitus
- Metallic taste
- Numbness of tongue or lips (circumoral numbness)
- Blurred vision
- Tremors
- Muscle twitching
- Seizures
- Drowsiness
- Unconsciousness
- Respiratory depression
- Bradycardia
- Hypotension
- Cardiac arrest
Special Patient Groups
Pregnancy
Category C. Ropivacaine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is commonly used for epidural analgesia during labor and delivery, but careful monitoring is essential.
Trimester-Specific Risks:
First Trimester:
Limited data. Potential risks generally outweigh benefits unless medically necessary.
Second Trimester:
Limited data. Use with caution.
Third Trimester:
Commonly used for labor and delivery. Accidental intravascular injection can cause maternal and fetal toxicity (e.g., fetal bradycardia). Paracervical block with ropivacaine is not recommended due to potential for fetal bradycardia/acidosis.
Lactation
L3 (Moderately Safe). Ropivacaine is excreted into breast milk in very small amounts. The amount ingested by the infant is likely to be clinically insignificant. Caution is advised, but generally considered compatible with breastfeeding, especially after single doses.
Infant Risk:
Low risk of adverse effects in breastfed infants due to low levels in milk and poor oral bioavailability.
Pediatric Use
Dosing must be carefully calculated based on weight and age, and the specific procedure. Children, especially infants and neonates, may be more susceptible to systemic toxicity due to differences in pharmacokinetics (e.g., lower protein binding, immature metabolic pathways). Close monitoring for signs of toxicity is crucial.
Geriatric Use
Elderly patients may be more susceptible to the systemic effects of ropivacaine due to decreased hepatic and renal function, reduced protein binding, and altered body composition. Reduced doses and slower administration rates may be necessary. Close monitoring for signs of toxicity is essential.
Clinical Information
Clinical Pearls
- Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to severe systemic toxicity.
- Administer in incremental doses, especially for epidural or major nerve blocks, to minimize the risk of systemic toxicity.
- Be prepared to manage Local Anesthetic Systemic Toxicity (LAST) with lipid emulsion therapy (Intralipid) readily available when administering large volumes or high concentrations.
- Ropivacaine has a lower cardiotoxicity profile compared to bupivacaine, making it a preferred choice in some high-risk situations.
- The 10 mg/mL (1%) concentration is typically used for surgical anesthesia requiring a dense motor block, while lower concentrations (e.g., 2 mg/mL or 0.2%) are used for continuous infusions for pain management with minimal motor block.
Alternative Therapies
- Bupivacaine (another amide-type local anesthetic, often used for similar indications)
- Lidocaine (amide-type local anesthetic, shorter duration of action)
- Mepivacaine (amide-type local anesthetic, intermediate duration of action)
- Levobupivacaine (S-enantiomer of bupivacaine, similar profile to ropivacaine with potentially lower cardiotoxicity than racemic bupivacaine)
Cost & Coverage
Average Cost:
Varies significantly by concentration, volume, and supplier. Typically ranges from $10-$50 per 10mL vial. per 10mL vial
Generic Available:
Yes
Insurance Coverage:
Generally covered by most medical insurance plans when administered in a clinical setting (e.g., hospital, surgical center) as part of a procedure. Coverage for outpatient use or self-administration is rare.
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 use, never share your prescription medications with others, and do not take medications 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, avoid flushing medications down the toilet or pouring them down the drain. Many communities offer drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet; consult your pharmacist if you have questions or concerns. If you have any questions or concerns about your medication, it is crucial to discuss them 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 critical information, including the name of the medication, the amount taken, and the time it was ingested, to ensure prompt and effective treatment.
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, avoid flushing medications down the toilet or pouring them down the drain. Many communities offer drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet; consult your pharmacist if you have questions or concerns. If you have any questions or concerns about your medication, it is crucial to discuss them 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 critical information, including the name of the medication, the amount taken, and the time it was ingested, to ensure prompt and effective treatment.