Naropin 2mg/ml Inj, 100ml
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 B
FDA Approved
Mar 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ropivacaine is a numbing medicine, also called a local anesthetic. It works by temporarily blocking nerve signals in a specific part of your body, which helps to relieve pain or make an area numb for a medical procedure or surgery. It's given as an injection.
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 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 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 or symptoms immediately during or after the injection, such as dizziness, ringing in the ears, numbness around the mouth, or feeling lightheaded.
- 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 sensation returns.
- Follow all post-procedure instructions given by your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on procedure, concentration, and volume. Examples: Epidural for surgery: 75-200 mg (e.g., 15-25 mL of 0.75% or 1% solution). Epidural for labor: 20-40 mg initial (e.g., 10-20 mL of 0.2% solution), followed by continuous infusion 6-20 mg/hr (e.g., 6-10 mL/hr of 0.1% or 0.2% solution). Peripheral nerve block: 5-300 mg depending on block type and site (e.g., 5-30 mL of 0.2% to 0.75% solution). Infiltration: 2-200 mg.
Dose Range:
2 - 300 mg
Condition-Specific Dosing:
epidural_surgery:
75-200 mg
epidural_labor:
Initial 20-40 mg, infusion 6-20 mg/hr
peripheral_nerve_block:
5-300 mg
infiltration:
2-200 mg
Pediatric Dosing
Neonatal:
Not established for routine use; extreme caution if used.
Infant:
Caudal epidural block: 1 mg/kg (0.25 mL/kg of 0.2% solution). Peripheral nerve block: 0.2-0.5 mL/kg of 0.2% or 0.5% solution.
Child:
Caudal epidural block: 1 mg/kg (0.25 mL/kg of 0.2% solution). Peripheral nerve block: 0.2-0.5 mL/kg of 0.2% or 0.5% solution. Max single dose: 2.5-3 mg/kg.
Adolescent:
Similar to adult dosing, but consider weight and physiological maturity. Max single dose: 2.5-3 mg/kg.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required for single dose. Caution with continuous infusions due to potential accumulation of metabolites.
Moderate:
No specific dose adjustment required for single dose. Caution with continuous infusions due to potential accumulation of metabolites.
Severe:
No specific dose adjustment required for single dose. Caution with continuous infusions due to potential accumulation of metabolites.
Dialysis:
Ropivacaine is not significantly removed by hemodialysis. No specific dose adjustment for single dose. Caution with continuous infusions.
Hepatic Impairment:
Mild:
No specific dose adjustment for single dose. Caution with continuous infusions.
Moderate:
Reduced clearance observed. Consider dose reduction for continuous infusions, especially if signs of toxicity appear. Monitor closely.
Severe:
Significantly reduced clearance. Contraindicated for continuous infusions. Use with extreme caution for single doses, consider reduced dose and monitor closely.
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, resulting in a reversible loss of sensation and motor activity in the area of administration.
Pharmacokinetics
Absorption:
Bioavailability:
Site-dependent: Epidural (90-100%), Brachial plexus (80-90%), Infiltration (variable).
Tmax:
Epidural: 10-25 minutes; Brachial plexus: 10-40 minutes; Intercostal block: 5-15 minutes.
FoodEffect:
Not applicable for injectable formulation.
Distribution:
Vd:
47-109 L (adults at steady state); 2.4-6.1 L/kg (pediatric).
ProteinBinding:
Approximately 94% (primarily to alpha-1-acid glycoprotein and albumin).
CnssPenetration:
Yes, but limited at therapeutic doses; crosses blood-brain barrier.
Elimination:
HalfLife:
Terminal elimination half-life: 6-10 hours (IV); 4-6 hours (epidural); 1.5-3 hours (pediatric).
Clearance:
Approximately 440 mL/min (adults).
ExcretionRoute:
Renal (primarily as metabolites; <1% unchanged drug).
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
1-15 minutes (dose, concentration, and site dependent).
PeakEffect:
15-90 minutes.
DurationOfAction:
2-6 hours (dose, concentration, and site dependent; longer with higher doses/concentrations).
Confidence:
Medium
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 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
If you are using the epidural form of this medication, also 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, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Headache
Upset stomach or vomiting
Back pain
This is not a comprehensive list of all 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)
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
If you are using the epidural form of this medication, also 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, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Headache
Upset stomach or vomiting
Back pain
This is not a comprehensive list of all 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
- Ringing in the ears (tinnitus)
- Numbness or tingling around the mouth (circumoral numbness)
- Metallic taste in the mouth
- Blurred vision or double vision
- Tremors or muscle twitching
- Feeling anxious or restless
- Unusual drowsiness or confusion
- Slow or fast 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, 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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or worsen certain health problems.
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 and ensure safe use.
Any existing health problems, as these may affect the safety and efficacy of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or worsen certain health problems.
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 and ensure safe use.
Any existing health problems, as these may affect the safety and efficacy of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 CNS toxicity (seizures, coma, respiratory arrest)
- Severe cardiovascular toxicity (profound hypotension, bradycardia, ventricular arrhythmias, asystole)
What to Do:
Immediate medical attention is required. Management includes maintaining airway, providing oxygen, managing seizures (e.g., with benzodiazepines), and treating cardiovascular collapse. Intravenous lipid emulsion therapy is a critical antidote for severe local anesthetic systemic toxicity (LAST). Call 1-800-222-1222 (Poison Control) for advice in non-emergency situations.
Drug Interactions
Major Interactions
- Other local anesthetics (additive systemic toxicity)
- Antiarrhythmics (e.g., lidocaine, mexiletine, amiodarone - additive cardiac effects)
- Strong CYP1A2 inhibitors (e.g., fluvoxamine, cimetidine - increased ropivacaine plasma levels)
Moderate Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole - potential for increased ropivacaine levels)
- Opioids (synergistic analgesic effect, but increased risk of respiratory depression and CNS effects)
- Sedatives/Hypnotics (additive CNS depression)
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 toxicity.
Timing: Prior to administration
Vital signs (heart rate, blood pressure, respiratory rate)
Rationale: To establish baseline and detect early signs of systemic toxicity.
Timing: Prior to administration
ECG (if cardiac risk factors present)
Rationale: To assess cardiac status before administration, especially in patients with pre-existing cardiac conditions.
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: Maintain within patient's normal physiological range.
Action Threshold: Significant deviations (e.g., bradycardia, hypotension, tachypnea) warrant immediate intervention.
Neurological status (level of consciousness, signs of CNS toxicity)
Frequency: Continuously during and after administration.
Target: Alert and oriented, no signs of CNS excitation or depression.
Action Threshold: Dizziness, tinnitus, circumoral numbness, metallic taste, visual disturbances, tremors, muscle twitching, seizures, somnolence.
Pain assessment/Sensory and motor block assessment
Frequency: As needed to assess efficacy and progression of block.
Target: Adequate analgesia/anesthesia for the procedure.
Action Threshold: Inadequate block or signs of excessive motor block.
Symptom Monitoring
- Lightheadedness
- Dizziness
- Tinnitus
- Circumoral numbness
- Metallic taste
- Visual disturbances (blurred vision, diplopia)
- Tremors
- Muscle twitching
- Seizures
- Somnolence
- Loss of consciousness
- Bradycardia
- Hypotension
- Cardiac arrhythmias (ventricular fibrillation, asystole)
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks. Often used for epidural anesthesia during labor.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified, but generally avoided if possible due to organogenesis.
Second Trimester:
Generally considered safer if needed.
Third Trimester:
Commonly used for labor and delivery; potential for fetal bradycardia or decreased variability if maternal hypotension occurs.
Lactation
Ropivacaine is excreted into breast milk in very small amounts. The amount ingested by the infant is considered clinically insignificant. Generally considered compatible with breastfeeding.
Infant Risk:
Low risk
Pediatric Use
Increased risk of systemic toxicity due to higher relative dose per kg, immature metabolic pathways, and potential for rapid absorption. Careful dose calculation based on weight and age is crucial. Monitor closely for signs of toxicity.
Geriatric Use
Reduced hepatic clearance and increased sensitivity to the systemic effects of local anesthetics may occur. Lower doses or slower infusion rates may be required. Monitor closely for signs of toxicity.
Clinical Information
Clinical Pearls
- Always aspirate prior to injection to avoid accidental intravascular administration, which can lead to rapid systemic toxicity.
- Administer in incremental doses, especially for epidural or nerve blocks, to minimize the risk of systemic toxicity.
- Have resuscitation equipment and medications (including lipid emulsion therapy) immediately available when administering ropivacaine, especially for large volumes or high concentrations.
- Ropivacaine provides good sensory block with less motor block compared to bupivacaine at equipotent analgesic doses, making it favorable for labor analgesia and ambulatory surgery.
- Monitor for signs of local anesthetic systemic toxicity (LAST), which can manifest as CNS symptoms (e.g., circumoral numbness, tinnitus, seizures) or cardiovascular symptoms (e.g., bradycardia, hypotension, arrhythmias).
Alternative Therapies
- Bupivacaine (another amide-type local anesthetic, often used for similar indications)
- Levobupivacaine (S-enantiomer of bupivacaine, similar profile to ropivacaine)
- Lidocaine (amide-type local anesthetic, shorter duration of action)
- Chloroprocaine (ester-type local anesthetic, very short duration of action)
Cost & Coverage
Average Cost:
Varies significantly by concentration, volume, and supplier. per 100ml vial
Generic Available:
Yes
Insurance Coverage:
Generally covered by most insurance plans for approved indications, often as a Tier 1 or Tier 2 medication, especially in hospital or surgical settings.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the proper disposal method, consult your pharmacist, as they may be aware of 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. If you have any questions or concerns about your medication, 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.