Sensorcaine Mpf 0.25% Inj, 30ml

Bupivacaine 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, thereby preventing the propagation of the action potential.

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, 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
+ Irregular 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
+ Irregular heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling extremely tired or weak
+ Shortness of breath
Abnormal heart rhythms, including fast, slow, or irregular heartbeat
Chest pain or pressure
Dizziness or fainting
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Balance problems
Restlessness
Anxiety
Changes in speech
Shakiness or tremors
Twitching
Ringing in the ears
Breathing difficulties, including slow or shallow breathing
Seizures
Numbness or tingling in the mouth
Metallic taste
Severe nausea or vomiting
Feeling extremely hot or cold
Feeling nervous and excitable
Sneezing
Excessive sweating
Spinal-related side effects, such as:
+ 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 Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you have any side effects that bother you or do not go away, contact your doctor for advice. Some additional side effects may include:

Mild side effects, such as headache or fatigue
Other side effects not listed here

Reporting Side Effects

If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. You can also contact your doctor for medical advice about side effects.

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.
Certain health conditions, including:
+ Bleeding disorders
+ Abnormal heart rhythms
+ Blood infections or infections at the site where the medication will be administered
+ Low blood pressure
* If you are using or plan to use another medication similar to this one. If you are unsure, consult your doctor or pharmacist.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never 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 condition 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 certain other medications
- Age, particularly in infants under 6 months old
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.

Special Considerations

Not all formulations of this medication are suitable for children. Consult with your doctor to determine the appropriate use.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of using this medication with your doctor to make an informed decision.

Administration-Specific Warnings

- Mouth: Do not eat until the numbness in your mouth has resolved, as you may inadvertently bite your tongue.
- Spinal: This medication may cause temporary loss of sensation and motor function in the lower half of your body. Avoid attempting to get out of bed or performing other activities until normal sensation and motor function have returned.
- Injection (non-spinal): This medication may cause temporary loss of sensation and motor function at the injection site.

• Other local anesthetics (additive systemic toxicity)
• Class I antiarrhythmics (e.g., mexiletine, lidocaine, tocainide - additive cardiac effects)
• Class III antiarrhythmics (e.g., amiodarone - increased risk of cardiac toxicity)
• CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin - increased bupivacaine levels)

• Opioids (additive CNS depression, respiratory depression)
• Sedatives/hypnotics (additive CNS depression)
• Neuromuscular blocking agents (prolonged block)
• Cholinesterase inhibitors (may antagonize effects of bupivacaine)
• Vasoconstrictors (e.g., epinephrine - may increase systemic absorption of bupivacaine if not used appropriately, but typically used to prolong local effect)

• Lightheadedness
• Dizziness
• Tinnitus (ringing in ears)
• Perioral numbness
• Metallic taste
• Slurred speech
• Confusion
• Muscle twitching
• Tremors
• Seizures
• Bradycardia
• Hypotension
• Arrhythmias
• Respiratory depression
• Cardiac arrest

Category C. Bupivacaine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fetal bradycardia and death have been reported with the use of bupivacaine for obstetric paracervical block.

L3 (Moderately safe). Bupivacaine is excreted into breast milk in small amounts. The amount ingested by the infant is generally considered to be low and unlikely to cause adverse effects. Monitor infant for sedation or feeding difficulties.

Use with caution. Pediatric patients, especially neonates and infants, may be more susceptible to systemic toxicity due to immature metabolic pathways and higher relative doses. Dosing must be carefully calculated on a mg/kg basis and individualized.

Use with caution. Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic and renal function, reduced protein binding, and increased sensitivity to the drug's effects. Consider reduced doses and careful monitoring.

• Bupivacaine provides a longer duration of action compared to lidocaine, making it suitable for prolonged pain relief.
• It has a higher potential for cardiotoxicity than lidocaine, especially at higher concentrations (e.g., 0.75%).
• Methylparaben-free (MPF) formulations (like Sensorcaine MPF) are essential for epidural and intrathecal administration to prevent neurotoxicity associated with preservatives.
• Intravenous lipid emulsion therapy is the primary antidote for severe systemic local anesthetic toxicity (LAST).
• Not indicated for intravenous regional anesthesia (Bier block) due to high risk of systemic toxicity upon tourniquet release.
• Careful aspiration before injection is crucial to avoid inadvertent intravascular administration, which can lead to rapid systemic toxicity.

• Lidocaine (shorter acting, less cardiotoxic)
• Ropivacaine (similar to bupivacaine, but less cardiotoxic)
• Mepivacaine (intermediate duration)
• Chloroprocaine (very short acting, rapid onset)

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 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. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call 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.