Naropin 10mg/ml Inj, 20ml
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
Pregnancy Category
Category C
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 area for surgery. It works by temporarily blocking nerve signals, so you don't feel pain during a procedure or for pain relief afterwards. 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 procedure.
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 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 procedure.
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., tingling, numbness, weakness) or discomfort immediately to your healthcare provider.
- Avoid activities requiring full motor and sensory function until the effects of the anesthetic have completely worn off (e.g., driving, operating machinery).
- Follow post-procedure instructions carefully, especially regarding care of the numb area to prevent accidental injury.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on procedure, site of administration, and desired effect (e.g., surgical anesthesia vs. pain relief). Examples: Epidural for surgery: 75-200 mg (0.75-1.0% solution); Epidural for labor: 25-50 mg (0.2-0.5% solution); Peripheral nerve block: 5-250 mg (0.2-1.0% solution); Infiltration: 5-200 mg (0.2-0.5% solution). Continuous epidural infusion: 6-20 mg/hr.
Dose Range:
5 - 250 mg
Condition-Specific Dosing:
epidural_surgical:
75-200 mg (0.75-1.0%)
epidural_labor:
25-50 mg (0.2-0.5%)
peripheral_nerve_block:
5-250 mg (0.2-1.0%)
infiltration:
5-200 mg (0.2-0.5%)
continuous_epidural_infusion:
6-20 mg/hr
Pediatric Dosing
Neonatal:
Not established for routine use; limited data. Use with extreme caution.
Infant:
Dosing varies by weight and procedure (e.g., caudal block: 1-3 mg/kg of 0.2% solution). Max single dose typically 2-3 mg/kg.
Child:
Dosing varies by weight and procedure (e.g., caudal block: 1-3 mg/kg of 0.2% solution; peripheral nerve block: 0.5-2 mg/kg of 0.2-0.5% solution). Max single dose typically 2-3 mg/kg.
Adolescent:
Similar to adult dosing, adjusted for weight and procedure, typically not exceeding 3 mg/kg.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required for single dose.
Moderate:
No specific dose adjustment required for single dose. Caution with repeated doses due to potential accumulation of metabolites.
Severe:
No specific dose adjustment required for single dose. Caution with repeated doses due to potential accumulation of metabolites.
Dialysis:
Not significantly removed by hemodialysis. Caution with repeated doses.
Hepatic Impairment:
Mild:
No specific dose adjustment required for single dose.
Moderate:
Reduced clearance may occur. Consider dose reduction for repeated or continuous infusions.
Severe:
Significantly reduced clearance. Dose reduction and careful monitoring are necessary for repeated or continuous infusions.
Pharmacology
Mechanism of Action
Ropivacaine is an amide-type local anesthetic that 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, leading to a reversible loss of sensation and motor activity.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (administered locally/regionally); systemic absorption depends on site of injection, dose, concentration, and vascularity of the tissue. Peak plasma concentrations typically occur within 10-25 minutes for epidural administration.
Tmax:
10-25 minutes (epidural), highly variable depending on site of administration.
FoodEffect:
Not applicable (parenteral administration).
Distribution:
Vd:
Approximately 47 L (in adults at steady state)
ProteinBinding:
Approximately 94% (primarily to alpha-1-acid glycoprotein and albumin)
CnssPenetration:
Limited at therapeutic doses; crosses the blood-brain barrier and placenta.
Elimination:
HalfLife:
Terminal elimination half-life: approximately 1.9-4.2 hours (epidural), 6 hours (IV infusion).
Clearance:
Approximately 0.44 L/min (systemic clearance).
ExcretionRoute:
Renal (primarily as metabolites).
Unchanged:
<1% of the administered dose is 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 longer with continuous infusion).
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Other serious side effects, such as:
+ Feeling extremely tired or weak
+ Chest pain
+ Abnormal heartbeat (fast, slow, or irregular)
+ 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
+ Lightheadedness, sleepiness, confusion, or 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 Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor:
Headache
Upset stomach or vomiting
* Back pain
Reporting Side Effects
If you have questions or concerns about side effects, contact 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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially life-threatening condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Other serious side effects, such as:
+ Feeling extremely tired or weak
+ Chest pain
+ Abnormal heartbeat (fast, slow, or irregular)
+ 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
+ Lightheadedness, sleepiness, confusion, or 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 Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor:
Headache
Upset stomach or vomiting
* Back pain
Reporting Side Effects
If you have questions or concerns about side effects, contact 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 or tongue
- Blurred vision or difficulty focusing
- Tremors or muscle twitching
- Feeling unusually sleepy or confused
- Difficulty breathing or shortness of breath
- Slow or irregular heartbeat
- Feeling faint or dizzy when standing up
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 is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, carefully review all your medications and health issues with your doctor and pharmacist. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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 is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, carefully review all your medications and health issues with your doctor and pharmacist. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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, which has been associated with drugs similar to this one. Certain factors may increase this risk, including:
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Heart problems
- Lung problems
- Concurrent use of certain other medications
- Age less than 6 months
If you have a history of methemoglobinemia, notify 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 are breast-feeding, 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 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, which has been associated with drugs similar to this one. Certain factors may increase this risk, including:
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Heart problems
- Lung problems
- Concurrent use of certain other medications
- Age less than 6 months
If you have a history of methemoglobinemia, notify 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 are breast-feeding, 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 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 lightheadedness, dizziness, or confusion
- Seizures
- Unconsciousness
- Respiratory arrest (stopping breathing)
- Severe low blood pressure
- Slow or irregular heart rate
- Cardiac arrest
What to Do:
If you experience any of these severe symptoms, or if you suspect an overdose, seek immediate medical attention. Call emergency services (e.g., 911 in the US) or your local poison control center (e.g., 1-800-222-1222 in the US).
Drug Interactions
Major Interactions
- Other local anesthetics (additive systemic toxicity)
- Class I antiarrhythmics (e.g., lidocaine, mexiletine, tocainide - additive cardiac effects, increased risk of toxicity)
Moderate Interactions
- CYP1A2 inhibitors (e.g., fluvoxamine, cimetidine, verapamil, quinidine - 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 pain control)
- Sedatives/Hypnotics (additive CNS depression)
Monitoring
Baseline Monitoring
Patient assessment (medical history, allergies, current medications)
Rationale: To identify contraindications, potential drug interactions, and risk factors for adverse events.
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 (mental status, sensory/motor function)
Rationale: To establish baseline and assess for pre-existing neurological deficits.
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 administration, then as clinically indicated.
Target: Within patient's normal physiological range.
Action Threshold: Significant deviations (e.g., bradycardia, hypotension, respiratory depression) require immediate intervention.
Neurological status (level of consciousness, sensory/motor block progression, signs of CNS toxicity)
Frequency: Continuously during and immediately after administration, then periodically.
Target: Appropriate level of block for procedure; absence of CNS toxicity symptoms.
Action Threshold: Signs of local anesthetic systemic toxicity (LAST) such as circumoral numbness, tinnitus, dizziness, muscle twitching, seizures, or altered mental status require immediate intervention.
ECG monitoring (especially with large doses or continuous infusions)
Frequency: Continuous during and immediately after administration, then as clinically indicated.
Target: Normal sinus rhythm; absence of arrhythmias.
Action Threshold: Arrhythmias (e.g., bradycardia, ventricular tachycardia, asystole) require immediate intervention.
Symptom Monitoring
- Lightheadedness
- Dizziness
- Tinnitus
- Metallic taste
- Numbness of tongue/circumoral region
- Blurred vision
- Tremors
- Muscle twitching
- Seizures
- Drowsiness
- Unconsciousness
- Respiratory depression/arrest
- Bradycardia
- Hypotension
- Cardiac arrhythmias
- 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 crosses the placenta. Fetal bradycardia and death have been reported with other local anesthetics used for paracervical block, though ropivacaine is generally considered safer for obstetric epidural anesthesia.
Trimester-Specific Risks:
First Trimester:
Limited data; theoretical risk of teratogenicity, but not well-established for local anesthetics.
Second Trimester:
Generally considered safer than first trimester, but still Category C. Use only if clearly needed.
Third Trimester:
Can be used for labor and delivery (epidural anesthesia). Monitor mother and fetus closely for signs of toxicity or adverse effects (e.g., fetal bradycardia).
Lactation
Ropivacaine is excreted into breast milk in small amounts. The amount ingested by the infant is very low and unlikely to cause adverse effects. Considered L3 (moderately safe) by some sources. Caution is advised, but generally considered compatible with breastfeeding when used as a single dose or short-term infusion.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to low levels in milk and high protein binding.
Pediatric Use
Dosing must be carefully calculated based on weight and age, and the specific procedure. Infants and young children may be more susceptible to systemic toxicity due to differences in metabolism and distribution. Close monitoring for signs of toxicity is crucial.
Geriatric Use
Elderly patients may have reduced hepatic clearance and may be more sensitive to the systemic effects of ropivacaine due to decreased physiological reserve. Lower doses and slower administration rates may be required. Close monitoring for signs of toxicity is essential.
Clinical Information
Clinical Pearls
- Ropivacaine is an amide-type local anesthetic with a relatively favorable safety profile compared to bupivacaine, particularly regarding cardiotoxicity.
- The concentration and volume of ropivacaine used significantly impact the onset, duration, and extent of sensory and motor block.
- Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to systemic toxicity.
- Monitor patients closely for signs of Local Anesthetic Systemic Toxicity (LAST), especially during and immediately after administration. Early symptoms include circumoral numbness, tinnitus, and lightheadedness.
- Lipid emulsion therapy (Intralipid) is the antidote for severe LAST and should be readily available where local anesthetics are administered.
- Use with caution in patients with severe hepatic impairment due to reduced metabolism and increased risk of accumulation.
Alternative Therapies
- Bupivacaine (another amide-type local anesthetic, often used for longer duration)
- Lidocaine (amide-type local anesthetic, faster onset, shorter duration)
- Levobupivacaine (S-enantiomer of bupivacaine, similar profile to ropivacaine with reduced cardiotoxicity compared to racemic bupivacaine)
- Chloroprocaine (ester-type local anesthetic, very rapid onset, very short duration, metabolized by plasma esterases)
Cost & Coverage
Average Cost:
Varies widely by concentration, volume, and supplier. Typically ranges from $10-$50 per 20ml vial. per 20ml vial
Generic Available:
Yes
Insurance Coverage:
Typically covered under medical benefit for hospital/clinic administered procedures. Outpatient pharmacy coverage is rare.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective use of your medication, never share your prescription with others, and do not take medication prescribed for someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Proper disposal of unused or expired medications is crucial. Do not dispose of medications by flushing them down the toilet or pouring them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the proper disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate 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 taken, the amount, and the time it was taken, to ensure prompt and effective treatment.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Proper disposal of unused or expired medications is crucial. Do not dispose of medications by flushing them down the toilet or pouring them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the proper disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate 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 taken, the amount, and the time it was taken, to ensure prompt and effective treatment.