Naropin 5mg/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 stabilizes the membrane and inhibits depolarization, leading to a reversible loss of sensation and motor activity.

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, 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 is essential to contact your doctor or seek medical help if you are 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 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 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. Always consult your doctor before starting, stopping, or changing the dose of any medication.

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
- Taking specific other medications
- Being an infant 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. Until feeling and motor activity have returned to normal, do not attempt to get out of bed or perform any activities that require mobility.

• Other local anesthetics (increased risk of systemic toxicity)
• Antiarrhythmics (e.g., Class I antiarrhythmics like mexiletine, lidocaine; Class III antiarrhythmics like amiodarone): Additive cardiac effects, increased risk of cardiotoxicity.
• CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin): May increase ropivacaine plasma concentrations, increasing risk of toxicity.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, protease inhibitors): May increase ropivacaine plasma concentrations, increasing risk of toxicity.

• CYP1A2 inducers (e.g., rifampin, omeprazole): May decrease ropivacaine plasma concentrations, potentially reducing efficacy.
• CYP3A4 inducers (e.g., phenytoin, carbamazepine, St. John's Wort): May decrease ropivacaine plasma concentrations, potentially reducing efficacy.
• Opioids (e.g., fentanyl, sufentanil): Used in combination for synergistic analgesic effect, but may increase risk of respiratory depression if systemic absorption is high.
• Sedatives/Hypnotics (e.g., benzodiazepines): May mask early signs of CNS toxicity from ropivacaine.

• Lightheadedness
• Dizziness
• Tinnitus (ringing in ears)
• Perioral numbness or tingling
• Metallic taste
• Visual disturbances (blurred vision, difficulty focusing)
• Muscle twitching or tremors
• Slurred speech
• Anxiety or restlessness
• Confusion
• Seizures
• Drowsiness
• Unconsciousness
• Bradycardia (slow heart rate)
• Hypotension (low blood pressure)
• Arrhythmias (irregular heart beat)
• Cardiac arrest
• Respiratory depression or arrest

Ropivacaine is Pregnancy Category B. Animal studies have not shown evidence of harm to the fetus. It is commonly used for epidural anesthesia during labor and delivery. However, caution is advised, and the lowest effective dose should be used. Accidental intravascular injection or high doses can lead to maternal and fetal toxicity.

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 (Lactation Risk Category L2 - Safer).

Use with caution, especially in infants and young children, due to increased susceptibility to systemic toxicity and variability in pharmacokinetic parameters. Dosing must be carefully calculated based on weight and age, and the lowest effective concentration and volume should be used. Close monitoring for signs of toxicity is essential.

Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic function, reduced plasma protein binding, and altered body composition. Lower doses and slower administration rates may be required. Monitor closely for signs of CNS and cardiovascular toxicity.

• Ropivacaine is less cardiotoxic than bupivacaine, making it a preferred choice for large volume blocks or where there is a higher risk of systemic absorption.
• The 0.5% (5 mg/mL) concentration is primarily used for surgical anesthesia, while lower concentrations (e.g., 0.2%, 0.1%) are often used for continuous infusions for postoperative pain management.
• Always aspirate prior to injection to minimize the risk of accidental intravascular administration, which can lead to severe systemic toxicity.
• Have lipid emulsion (Intralipid) readily available when administering large volumes or high concentrations of ropivacaine, as it is the primary antidote for severe local anesthetic systemic toxicity (LAST).
• Monitor patients closely for signs of CNS toxicity (e.g., lightheadedness, tinnitus, perioral numbness, seizures) and cardiovascular toxicity (e.g., bradycardia, hypotension, arrhythmias).

• Bupivacaine (another amide-type local anesthetic, often used for similar indications, but with higher cardiotoxicity risk)
• Lidocaine (amide-type local anesthetic, shorter duration of action)
• Levobupivacaine (S-enantiomer of bupivacaine, similar efficacy to bupivacaine with potentially lower cardiotoxicity)
• Chloroprocaine (ester-type local anesthetic, very short duration of action, rapid metabolism)

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, do not share your medication with others, and never take someone else's medication. 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 flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs that provide a safe and environmentally friendly way to dispose of medications.

Some medications may have additional patient information leaflets available. Your pharmacist can provide more information on this. If you have any questions or concerns about your medication, it is best 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 treatment.