Naropin 2mg/ml Inj, 20ml

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 failure of the propagation of the action potential and subsequent loss of sensation and motor function in the anesthetized area.

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 experience 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
+ Abnormal 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
+ Abnormal 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
+ Speech changes
+ 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
Epidural-specific side effects, such as:
+ Urination difficulties
+ Loss of bladder or bowel control
+ Erectile dysfunction
+ Long-lasting burning, numbness, tingling, or paralysis in the lower half of the body
+ Back pain
+ Fever or chills
+ Stiff neck
+ Sensitivity to bright lights

Other 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're bothered by any of the following:

Headache
Upset stomach or vomiting
Back pain

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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 allergic reaction you experienced, including any symptoms that occurred.
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 health problems you have, 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 other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.

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 specific other medications
- Age, particularly in infants under 6 months old

If you have a history of methemoglobinemia, notify your doctor promptly.

If you are 65 years or older, exercise caution when using this medication, 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 both 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.

• Other local anesthetics (additive systemic toxicity)
• Class III antiarrhythmics (e.g., amiodarone, sotalol - increased risk of cardiac effects)

• CYP1A2 inhibitors (e.g., fluvoxamine, cimetidine - may increase ropivacaine plasma levels)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole - may increase ropivacaine plasma levels, though less significant than CYP1A2)
• Other CNS depressants (e.g., opioids, sedatives, hypnotics - additive CNS depression)
• Anticoagulants/antiplatelets (increased risk of hematoma with neuraxial blocks)

• Not available

• Lightheadedness
• Dizziness
• Tinnitus
• Metallic taste
• Circumoral numbness
• Visual disturbances (blurred vision, diplopia)
• Muscle twitching
• Tremors
• Shivering
• Anxiety
• Restlessness
• Confusion
• Drowsiness
• Seizures
• Unconsciousness
• Respiratory depression
• Apnea
• Bradycardia
• Hypotension
• Arrhythmias (ventricular fibrillation, asystole)
• Cardiac arrest

Category B. Animal studies have not shown harm, but human studies are limited. Generally considered safe for use during labor and delivery when administered by trained personnel. Use during early pregnancy should be carefully considered, weighing benefits against potential risks.

L2 (Likely Compatible). Ropivacaine is excreted into breast milk in very small amounts. The relative infant dose is low, and adverse effects in breastfed infants are unlikely. Breastfeeding can generally continue after administration.

Dosing must be carefully calculated based on weight and age to avoid systemic toxicity. Lower concentrations and volumes are typically used. Close monitoring for signs of toxicity is crucial due to potential for higher plasma levels and increased sensitivity in younger children.

Reduced doses may be necessary due to decreased hepatic clearance, reduced protein binding, and increased sensitivity to local anesthetics. Monitor closely for signs of systemic toxicity. Start with lower doses and titrate slowly.

• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to rapid systemic toxicity.
• Use the lowest effective dose and concentration to achieve the desired effect and minimize the risk of systemic toxicity.
• Be prepared for systemic toxicity: have resuscitative equipment, oxygen, and intravenous lipid emulsion (ILE) immediately available.
• Ropivacaine has a favorable safety profile compared to bupivacaine regarding cardiac toxicity, especially at higher concentrations, due to its lower lipid solubility and faster dissociation from cardiac sodium channels.
• The onset and duration of action are dose and concentration dependent; higher concentrations provide a more dense motor block, while lower concentrations are suitable for sensory block with minimal motor impairment (e.g., labor analgesia).

• 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 potentially less cardiac toxicity than racemic bupivacaine)
• Chloroprocaine (ester-type local anesthetic, very rapid onset, very short duration, metabolized by plasma cholinesterase)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. 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. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. 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 quantity, and the time of ingestion.