Naropin 5mg/ml Inj, 30ml

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 reversible loss of sensation and motor activity in the area of injection.

Serious 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, 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 too much acid in the blood (acidosis), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Abnormal heartbeat
+ Severe stomach pain, upset stomach, 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, including:
+ 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
Epidural-specific side effects:
+ 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

Most medications can cause side effects, but many people experience none or only mild symptoms. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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, 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.

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 assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, 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 current medications and health conditions. Do not initiate, discontinue, or modify the dosage 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 associated with this type of medication. Certain factors may increase this risk, including:
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Pre-existing heart problems
- Pre-existing lung problems
- Concurrent use of certain other medications
- Age, particularly in infants under 6 months old

If you have a history of methemoglobinemia, it is crucial to discuss this with your doctor.

For individuals 65 years or older, caution is advised when using this medication, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.

Specific Considerations for Epidural Use

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 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)
• Antiarrhythmics (e.g., Class I antiarrhythmics like lidocaine, mexiletine, tocainide; Class III antiarrhythmics like amiodarone, sotalol) - increased risk of cardiac toxicity.
• Strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) - increased ropivacaine plasma levels and potential for toxicity.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - potential for increased ropivacaine plasma levels.

• Moderate CYP1A2 inhibitors (e.g., cimetidine, oral contraceptives) - may increase ropivacaine plasma levels.
• Opioids (e.g., fentanyl, sufentanil) - synergistic effect on analgesia, but also increased risk of respiratory depression when used epidurally.
• Sedatives/Hypnotics (e.g., benzodiazepines) - additive CNS depression.
• Neuromuscular blockers - may prolong or enhance neuromuscular blockade.

• Perioral numbness
• Tingling
• Tinnitus
• Dizziness
• Blurred vision
• Tremors
• Muscle twitching
• Seizures
• Lightheadedness
• Nausea
• Vomiting
• Bradycardia
• Hypotension
• Arrhythmias
• Respiratory depression
• Anxiety
• Restlessness
• Somnolence
• Loss of consciousness

Category B. Studies in animals have shown no evidence of harm to the fetus. Controlled studies in pregnant women are lacking, but ropivacaine has been widely used for obstetric analgesia and anesthesia with no evidence of adverse effects on the fetus when used appropriately. Use during early pregnancy should be with caution and only if clearly needed. It is commonly used for epidural anesthesia during labor and delivery.

L3 (Moderately Safe). Ropivacaine is excreted into breast milk in very small amounts. The amount ingested by the infant is very low and unlikely to cause adverse effects. Short-term use for procedures is generally considered compatible with breastfeeding. Monitor the infant for unusual drowsiness or feeding difficulties.

Dosing must be carefully calculated based on weight and age, and the specific procedure. Lower concentrations and volumes are generally used. Neonates and infants may have reduced protein binding and immature metabolic pathways, potentially leading to higher free drug concentrations and increased risk of toxicity. Close monitoring for systemic toxicity is crucial.

Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic function, reduced protein binding, and/or decreased renal clearance of metabolites. Consider lower doses and slower administration rates. Monitor closely for signs of CNS and cardiovascular toxicity. Reduced lean body mass and cardiac output may also influence drug distribution and elimination.

• Always aspirate frequently before and during injection to avoid accidental intravascular administration, which can lead to severe systemic toxicity.
• Use the lowest effective concentration and volume to achieve the desired block, especially in pediatric and elderly patients.
• Be prepared to manage systemic toxicity (LAST) with lipid emulsion therapy (Intralipid) readily available when administering large volumes or high concentrations.
• Ropivacaine has a favorable safety profile compared to bupivacaine due to its lower cardiotoxicity, particularly at higher concentrations.
• Monitor for signs of both CNS excitation (e.g., tremors, seizures) and depression (e.g., somnolence, respiratory depression) as toxicity can manifest in various ways.
• The 5 mg/ml (0.5%) concentration is commonly used for major nerve blocks and surgical epidurals, while lower concentrations (e.g., 2 mg/ml or 0.2%) are often used for continuous epidural infusions for labor analgesia or postoperative pain.

• Bupivacaine (another amide-type local anesthetic, higher cardiotoxicity risk)
• Lidocaine (amide-type local anesthetic, shorter duration of action)
• Levobupivacaine (S-enantiomer of bupivacaine, similar to ropivacaine in cardiotoxicity profile)
• Chloroprocaine (ester-type local anesthetic, very short duration of action, rapid metabolism)
• Tetracaine (ester-type local anesthetic, long duration of action, often topical or spinal)

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 or take someone else's medication. 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 with your pharmacist, who can also inform you about potential drug take-back programs in your area. Additionally, some medications may come with a separate 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 amount, and the time it occurred.