Naropin 7.5mg/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 nerve cell membrane to sodium ions. This action stabilizes the neuronal 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood):
+ 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):
+ 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 severe side effects:
+ 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
+ Extreme nervousness or excitability
+ Depression
+ Seizures
+ Breathing difficulties (trouble breathing, slow breathing, or shallow breathing)
+ Sneezing
+ Excessive sweating
Epidural-specific side effects:
+ Urination problems
+ 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 concerned about any of the following side effects or if they persist, contact your doctor:

Headache
Upset stomach or vomiting
Back pain

This is not an exhaustive list of potential side effects. If you have questions or concerns, 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This will help your doctor identify potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is crucial to:

Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dosage of any medication without first consulting your doctor. This will help prevent potential interactions and ensure the safe use of this 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
- Pre-existing heart problems
- Pre-existing lung problems
- Concurrent use of certain other medications
- Infancy, particularly in children under 6 months of age

If you have a history of methemoglobinemia, inform your doctor.

Special Considerations

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 function have returned to normal, do not attempt to get out of bed or engage in any activities that require physical mobility.

• Other local anesthetics (increased risk of systemic toxicity)
• Antiarrhythmics (e.g., Class I antiarrhythmics like mexiletine, lidocaine, tocainide; Class III antiarrhythmics like amiodarone): Increased risk of cardiac toxicity due to additive effects on cardiac conduction.

• 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.
• Opioids (e.g., fentanyl, sufentanil): Used in combination for epidural analgesia; may enhance analgesic effect but also increase risk of respiratory depression.
• Sedatives/Hypnotics (e.g., benzodiazepines): May potentiate CNS depressant effects.

• CYP1A2 inducers (e.g., omeprazole, rifampin): May decrease ropivacaine plasma concentrations.
• CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin): May decrease ropivacaine plasma concentrations.

• Lightheadedness
• Dizziness
• Tinnitus
• Perioral numbness
• Metallic taste
• Blurred vision
• Tremors
• Muscle twitching
• Seizures
• Drowsiness
• Unconsciousness
• Respiratory depression
• Hypotension
• Bradycardia
• Arrhythmias (e.g., ventricular fibrillation, asystole)

Category B. Animal studies have not shown evidence of harm to the fetus. Ropivacaine is commonly used for epidural anesthesia during labor and delivery. However, careful monitoring of both mother and fetus is essential, especially to detect signs of systemic toxicity or fetal bradycardia.

L3 (Moderately Safe). Ropivacaine is excreted into breast milk in very small amounts. The amount ingested by the infant is considered clinically insignificant and unlikely to cause adverse effects. Breastfeeding can generally continue after a single dose.

Use with extreme caution, especially in neonates and infants, due to immature hepatic metabolism and higher risk of systemic toxicity. Dosing must be carefully calculated based on weight and type of block. 7.5 mg/mL concentration is generally not recommended for pediatric use due to high concentration and increased risk of toxicity.

Caution advised. Elderly patients may be more susceptible to the systemic toxic effects of ropivacaine due to decreased hepatic and renal function, reduced plasma protein binding, and altered body composition. Consider lower doses and slower administration rates. Monitor closely for signs of toxicity.

• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to rapid systemic toxicity.
• Administer in incremental doses, especially for large volumes or highly vascular areas, to minimize the risk of systemic toxicity.
• The 7.5 mg/mL concentration is primarily for surgical anesthesia where a dense motor block is desired, not typically for continuous pain management infusions.
• Be prepared to manage systemic toxicity (LAST - Local Anesthetic Systemic Toxicity) with lipid emulsion therapy (Intralipid) readily available.
• Monitor for both CNS (e.g., seizures) and cardiovascular (e.g., bradycardia, hypotension, arrhythmias) signs of toxicity, as cardiovascular collapse can occur rapidly after CNS symptoms or even without preceding CNS signs in severe cases.

• 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 guidance. To ensure your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. Instead, consult with your pharmacist to determine the best disposal method, as some communities have drug take-back programs in place.

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 reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was ingested, to ensure prompt and effective treatment.