Naropin 2mg/ml Inj, 200ml
It is used to numb an area before a procedure.It is used to manage pain.
Drug Class
Local Anesthetics
Pharmacologic Class
Amide-type Local Anesthetics; Sodium Channel Blockers
Pregnancy Category
Category B
FDA Approved
Mar 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ropivacaine is a medicine used to numb a part of your body, like an arm, leg, or a specific area for surgery or pain relief. It works by temporarily blocking nerve signals in that area, so you don't feel pain. 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. 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 feelings (e.g., dizziness, ringing in ears, numbness around the mouth, muscle twitching) immediately to your healthcare provider during or after the injection.
- Avoid activities requiring full motor function or sensation in the affected area until the anesthetic effect has completely worn off (e.g., driving, operating machinery, walking without assistance).
- Protect the numb area from injury (e.g., burns, cuts) as you won't feel pain.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable depending on the type of block, concentration, and volume. Examples include: Epidural for surgery: 150-200 mg (e.g., 15-25 mL of 0.75% or 1% solution). Epidural for labor analgesia: Initial 10-20 mg (e.g., 10-20 mL of 0.1% or 0.2% solution), followed by continuous infusion 6-14 mg/hr. Peripheral nerve block: 75-250 mg (e.g., 15-50 mL of 0.5% solution). Infiltration: 2-200 mg (e.g., 1-100 mL of 0.2% solution). Single maximum dose: 200-250 mg. Maximum 24-hour dose: 600-775 mg.
Dose Range:
2 - 775 mg
Condition-Specific Dosing:
epidural_surgical:
150-200 mg
epidural_labor_analgesia_initial:
10-20 mg
epidural_labor_analgesia_infusion:
6-14 mg/hr
peripheral_nerve_block:
75-250 mg
infiltration:
2-200 mg
single_max_dose:
200-250 mg
max_24_hour_dose:
600-775 mg
Pediatric Dosing
Neonatal:
Not established for routine use; limited data. Use with extreme caution and reduced doses.
Infant:
Dosing is weight-based and procedure-specific. E.g., Caudal epidural block: 1-3 mg/kg (0.2% solution).
Child:
Dosing is weight-based and procedure-specific. E.g., Caudal epidural block: 1-3 mg/kg (0.2% solution). Lumbar epidural block: 0.2-0.3 mg/kg/dose.
Adolescent:
Dosing similar to adult, but consider lower end of adult range based on weight and maturity.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
No specific dose adjustment generally required.
Severe:
No specific dose adjustment generally required, but caution is advised due to potential accumulation of metabolites. Monitor for signs of toxicity.
Dialysis:
Not significantly removed by hemodialysis. No specific dose adjustment, but monitor closely.
Hepatic Impairment:
Mild:
No specific dose adjustment.
Moderate:
Caution advised. Consider reducing dose or extending dosing interval, especially for prolonged infusions, due to reduced clearance.
Severe:
Significant caution advised. Substantial dose reduction may be necessary due to impaired metabolism. Monitor for signs of toxicity.
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 prevents depolarization, thereby blocking the propagation of the action potential and producing local anesthesia.
Pharmacokinetics
Absorption:
Bioavailability:
Systemic absorption depends on the site of administration, dose, concentration, and presence of vasoconstrictors. Peak plasma concentrations vary widely depending on the site of injection (e.g., intercostal block > epidural > brachial plexus > subcutaneous).
Tmax:
Varies significantly by site of injection: Epidural: 10-30 minutes. Brachial plexus block: 10-40 minutes. Caudal block: 10-30 minutes.
FoodEffect:
Not applicable for injectable formulation.
Distribution:
Vd:
Approximately 47-109 L (average 60 L in adults).
ProteinBinding:
Approximately 94% (primarily to alpha-1-acid glycoprotein and albumin).
CnssPenetration:
Yes, crosses the blood-brain barrier and placenta.
Elimination:
HalfLife:
Terminal elimination half-life: Approximately 1.8-4.2 hours after IV administration; 5-6 hours after epidural administration (due to continued absorption).
Clearance:
Plasma clearance: Approximately 380-840 mL/min (average 440 mL/min).
ExcretionRoute:
Primarily renal (as metabolites).
Unchanged:
Less than 1% of the administered dose is excreted unchanged in the urine.
Pharmacodynamics
OnsetOfAction:
1-15 minutes (depending on concentration, volume, and site of injection).
PeakEffect:
15-90 minutes.
DurationOfAction:
2-10 hours (dose, concentration, volume, and site dependent).
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
There have been reports of cardiac arrest with difficult resuscitation or death during use of local anesthetics for regional anesthesia, or in some cases, for local anesthesia. Inadvertent intravascular injection of local anesthetics, including ropivacaine, may be associated with cardiac arrest. Not for obstetric paracervical block due to fetal bradycardia and death.
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 effect can be life-threatening if it occurs)
Feeling extremely tired or weak
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, seek medical help right away if you 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. 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
If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. 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)
Feeling extremely tired or weak
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, seek medical help right away if you 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. 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
If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. 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 double vision
- Tremors or muscle twitching
- Feeling anxious or restless
- Difficulty breathing or slow breathing
- Unusual drowsiness or confusion
- Seizures
- Slow or irregular heartbeat
- Feeling faint or unusually tired
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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing health problems.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Natural products and vitamins you are using
* Any existing health problems or conditions
Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to take this medication in conjunction with your other drugs and health conditions. Do not start, stop, 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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing health problems.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Natural products and vitamins you are using
* Any existing health problems or conditions
Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to take this medication in conjunction with your other drugs and health conditions. Do not start, stop, 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 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 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 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 CNS toxicity (e.g., seizures, unconsciousness, respiratory arrest)
- Cardiovascular collapse (e.g., severe hypotension, bradycardia, ventricular arrhythmias, asystole)
- Metabolic acidosis
What to Do:
Immediate medical attention is required. Call 911 or emergency services. Management includes maintaining airway, providing oxygen, managing seizures (e.g., with benzodiazepines), supporting circulation (e.g., IV fluids, vasopressors), and administering lipid emulsion therapy (Intralipid) for severe systemic toxicity. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Major Interactions
- Other local anesthetics (additive systemic toxicity)
- Antiarrhythmic drugs (e.g., mexiletine, lidocaine, amiodarone - additive cardiac effects, increased risk of cardiotoxicity)
- Strong CYP1A2 inhibitors (e.g., fluvoxamine, cimetidine - significantly increase ropivacaine plasma levels, increasing risk of toxicity)
Moderate Interactions
- Moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin - may increase ropivacaine levels)
- CYP2B6 inhibitors (e.g., ticlopidine - may affect ropivacaine metabolism)
- Opioids (additive CNS depression, respiratory depression when used intrathecally/epidurally)
- 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 (e.g., bradycardia, hypotension, respiratory depression).
Timing: Prior to administration.
Allergy History
Rationale: To identify potential hypersensitivity reactions.
Timing: Prior to administration.
Neurological Status (e.g., mental status, sensory/motor function)
Rationale: To establish baseline and detect early signs of CNS toxicity.
Timing: Prior to administration.
Routine Monitoring
Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate)
Frequency: Every 5-15 minutes during and immediately after injection, then periodically as clinically indicated.
Target: Within patient's normal physiological range.
Action Threshold: Significant deviations (e.g., hypotension, bradycardia, respiratory depression) require immediate intervention.
Neurological Status (e.g., signs of CNS toxicity: circumoral numbness, tinnitus, dizziness, visual disturbances, tremors, seizures)
Frequency: Continuously during and for at least 30 minutes after injection, then periodically.
Target: Absence of CNS toxicity symptoms.
Action Threshold: Any CNS symptoms require immediate assessment and management (e.g., airway support, benzodiazepines for seizures).
ECG Monitoring
Frequency: Continuous during and immediately after injection, especially with large doses or high-risk patients.
Target: Normal sinus rhythm, absence of arrhythmias.
Action Threshold: Arrhythmias (e.g., bradycardia, ventricular arrhythmias) or conduction delays require immediate intervention.
Level of Anesthesia/Analgesia
Frequency: Periodically, as needed to assess efficacy and adjust dose.
Target: Adequate sensory and/or motor block for the procedure.
Action Threshold: Inadequate block requires dose adjustment or re-administration; excessive block may indicate systemic spread.
Symptom Monitoring
- Lightheadedness
- Dizziness
- Tinnitus
- Metallic taste
- Numbness of the tongue or circumoral region
- Visual disturbances
- Tremors
- Muscle twitching
- Seizures
- Drowsiness
- Unconsciousness
- Respiratory depression or arrest
- Bradycardia
- Hypotension
- Cardiac arrest
Special Patient Groups
Pregnancy
Ropivacaine is commonly used for labor analgesia and surgical anesthesia during pregnancy. It is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus. Human data from labor and delivery indicate it is generally safe when used appropriately.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally not associated with increased risk of congenital anomalies based on its mechanism and use.
Second Trimester:
Generally considered safe for use when indicated.
Third Trimester:
Commonly used for epidural analgesia/anesthesia during labor and delivery. Not recommended for obstetric paracervical block due to risk of fetal bradycardia and death.
Lactation
Ropivacaine is excreted into breast milk in very small amounts. The amount ingested by the infant is considered clinically insignificant. It is generally considered compatible with breastfeeding (L3 - Moderately Safe).
Infant Risk:
Low risk of adverse effects to the breastfed infant due to low levels in milk and poor oral bioavailability.
Pediatric Use
Use with caution. Dosing must be carefully calculated based on weight and age, and the specific procedure. Children, especially younger ones, may be more susceptible to systemic toxicity. Close monitoring for signs of toxicity is crucial.
Geriatric Use
Elderly patients may be more susceptible to the systemic toxic effects of ropivacaine due to decreased hepatic metabolism, reduced renal clearance of metabolites, and/or decreased protein binding. Lower doses or slower administration rates may be required. Monitor closely for signs of toxicity.
Clinical Information
Clinical Pearls
- Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to severe systemic toxicity including cardiac arrest.
- Administer local anesthetics in incremental doses, especially for epidural or large nerve blocks, while continuously monitoring the patient's vital signs and neurological status.
- The addition of epinephrine to ropivacaine is generally not recommended for prolonging block duration as it has less effect than with other local anesthetics like lidocaine or bupivacaine, and may increase the risk of systemic toxicity.
- Be prepared to manage systemic toxicity with appropriate resuscitation equipment, including lipid emulsion therapy (Intralipid), which is the antidote for severe local anesthetic systemic toxicity (LAST).
- Ropivacaine has a differential block, meaning it can produce sensory block with less motor block compared to bupivacaine at equipotent doses, which can be advantageous for labor analgesia or ambulatory surgery.
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)
- Other regional anesthesia techniques (e.g., spinal anesthesia, general anesthesia, multimodal analgesia)
Cost & Coverage
Average Cost:
Varies widely by concentration, volume, and supplier (e.g., $50-$200+ per 200mL bag/vial) per 200mL injection
Generic Available:
Yes
Insurance Coverage:
Typically covered under medical benefit for procedures or pharmacy benefit for hospital use. Coverage tier varies by plan (often Tier 1 or 2 for generic, higher for 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 guidance. To ensure safe use, never share your medication with others or take someone else's medication.
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. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which can be an alternative disposal option.
Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. 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 information about the medication taken, the amount, and the time it was taken, as this will aid in providing 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. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which can be an alternative disposal option.
Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. 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 information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate care.