Sensorcaine Mpf 0.25% Inj, 10ml

Bupivacaine is an amide-type local anesthetic that 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 prevents depolarization, thereby blocking the propagation of the action potential.

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 notice 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
Other serious side effects, including:
+ Abnormal heartbeat (fast, slow, or irregular)
+ Chest pain or pressure
+ Dizziness or fainting
+ Lightheadedness, sleepiness, confusion, or blurred vision
+ Balance problems
+ Restlessness
+ Anxiety
+ Changes in speech
+ Shakiness or tremors
+ Twitching
+ Ringing in the ears
+ Breathing difficulties, slow breathing, or shallow breathing
+ Seizures
+ Numbness or tingling in the mouth
+ Metallic taste
+ Severe nausea or vomiting
+ Feeling extremely hot or cold
+ Nervousness or excitability
+ Sneezing
+ Excessive sweating
* Spinal-related side effects, including:
+ 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 Side Effects

As with any medication, you may experience side effects. While many people have no side effects or only minor ones, it's essential to contact your doctor if you have any symptoms that bother you or persist. Not all possible side effects are listed here. If you have questions or concerns, consult your doctor.

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. Your doctor can also provide guidance on managing side effects and offer medical advice.

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 and its symptoms.
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 disorder called methemoglobinemia, which may be increased in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. Additionally, the risk may be higher when taking certain other medications or in infants 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.

Not all formulations of this medication are suitable for children, so it is crucial to consult with your doctor before administering it to a child.

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

Mouth (Local Anesthesia)
Do not eat or drink until the numbness in your mouth has resolved, as you may inadvertently bite your tongue.

Spinal Administration
This medication may cause temporary loss of sensation and motor function in the lower half of your body. Wait until these effects have subsided and you have regained normal feeling and movement before attempting to get out of bed or engaging in other activities.

Injection (Non-Spinal)
This medication may cause temporary loss of sensation and motor function at the injection site. Be cautious and avoid activities that may put you at risk of injury until the effects have worn off.

• Intravenous regional anesthesia (Bier block) due to risk of cardiac arrest.
• Obstetrical paracervical block (due to risk of fetal bradycardia and death).

• Antiarrhythmics (Class I antiarrhythmics like lidocaine, mexiletine, tocainide): Increased risk of cardiac toxicity.
• Other local anesthetics: Additive systemic toxicity.
• CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin): May increase bupivacaine plasma levels and risk of toxicity.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): May increase bupivacaine plasma levels and risk of toxicity.

• Beta-blockers: May reduce hepatic blood flow, potentially increasing bupivacaine levels.
• Cimetidine: May inhibit bupivacaine metabolism, increasing plasma levels.
• Neuromuscular blocking agents: Bupivacaine may potentiate or prolong the effect of non-depolarizing neuromuscular blockers.
• Vasoconstrictors (e.g., epinephrine): While often co-administered to prolong duration, systemic absorption of epinephrine can lead to cardiovascular effects.

• Not available

• Lightheadedness
• Dizziness
• Tinnitus
• Perioral numbness
• Metallic taste
• Blurred vision
• Tremors
• Muscle twitching
• Confusion
• Drowsiness
• Seizures
• Bradycardia
• Hypotension
• Arrhythmias
• Respiratory depression
• Nausea
• Vomiting

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid for obstetrical paracervical block due to risk of fetal bradycardia and death.

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

Use with caution, especially in infants and young children, as they may be more susceptible to systemic toxicity due to differences in metabolism and distribution. Dosing must be carefully calculated on a mg/kg basis. Not recommended for epidural anesthesia in children under 12 years.

Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic function, reduced renal clearance, and altered body composition. Consider lower doses and monitor closely for adverse effects. Increased risk of hypotension.

• Sensorcaine MPF (Methylparaben Free) is crucial for epidural, spinal, or other neuraxial blocks to avoid neurotoxicity associated with preservatives.
• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to systemic toxicity.
• The 0.25% concentration provides a less dense motor block and is often preferred for continuous epidural infusions for labor analgesia or postoperative pain management.
• Local anesthetic systemic toxicity (LAST) is a rare but life-threatening complication. Be prepared to manage LAST with lipid emulsion therapy.
• Monitor patients closely for signs of CNS toxicity (e.g., perioral numbness, tinnitus, dizziness) and cardiovascular toxicity (e.g., bradycardia, hypotension, arrhythmias).
• The addition of epinephrine prolongs the duration of action and reduces systemic absorption, but it also adds the cardiovascular effects of epinephrine.

• Lidocaine (shorter acting)
• Ropivacaine (similar duration, less cardiotoxic profile)
• Levobupivacaine (single isomer of bupivacaine, potentially less cardiotoxic)
• Mepivacaine (intermediate acting)
• Chloroprocaine (ester-type, very short acting)

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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.