Sensorcaine-Mpf 0.5% 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 and resulting in local anesthesia.

Urgent 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 signs or symptoms, contact your doctor or seek immediate medical attention:

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.
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.
Methemoglobinemia: A 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 condition can be life-threatening if left untreated.
Cardiovascular Issues: Abnormal heartbeat, fast or slow heartbeat, chest pain or pressure, dizziness or fainting, lightheadedness, sleepiness, confusion, or blurred vision.
Neurological Symptoms: Change in balance, restlessness, anxiety, speech changes, shakiness, twitching, ringing in the ears, trouble breathing, slow breathing, or shallow breathing, seizures, numbness or tingling in the mouth, or a metallic taste.
Gastrointestinal Issues: Severe stomach upset or vomiting, feeling hot or cold, nervousness, excitability, sneezing, or excessive sweating.
* Spinal-Related Symptoms: Difficulty urinating, loss of bladder or bowel control, erectile dysfunction, long-lasting burning, numbness, tingling, or paralysis in the lower half of the body, backache, fever, chills, stiff neck, or sensitivity to bright lights.

Other Possible 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 discuss any concerns with your doctor. If you experience any side effects that bother you or persist, contact your doctor for guidance.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions or concerns about side effects, consult your doctor for 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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ 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 existing medications and health conditions. Never start, stop, or change 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 condition called methemoglobinemia, which may be increased in individuals with:
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Heart problems
- Lung problems
- When taking certain other medications
- In infants under 6 months of age
If you have a history of methemoglobinemia, notify 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. 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 this medication with your doctor to make an informed decision.

Specific Administration Warnings

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

• Class I Antiarrhythmics (e.g., lidocaine, mexiletine, tocainide): Additive cardiac effects, increased risk of myocardial depression and arrhythmias.
• Other Local Anesthetics: Additive systemic toxicity, especially CNS and cardiovascular effects.

• CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): May increase bupivacaine plasma concentrations, increasing risk of toxicity.
• CYP2C19 Inhibitors (e.g., fluoxetine, fluvoxamine, omeprazole): May increase bupivacaine plasma concentrations.
• Sedatives/Hypnotics/Opioids: Additive CNS depression.
• Neuromuscular Blocking Agents: May prolong or enhance the effect of neuromuscular blockers.

• Beta-blockers: May reduce hepatic blood flow, potentially decreasing bupivacaine clearance, though clinical significance is usually low for single doses.

• Lightheadedness
• Dizziness
• Tinnitus
• Metallic taste
• Circumoral numbness
• Visual disturbances (blurred vision, diplopia)
• Tremors
• Muscle twitching
• Seizures
• Drowsiness
• Unconsciousness
• Bradycardia
• Hypotension
• Arrhythmias (ventricular tachycardia, ventricular fibrillation)
• Respiratory depression
• Nausea/Vomiting

Category C. Bupivacaine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It crosses the placenta. Not recommended 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. However, caution is advised, especially with repeated doses or in premature/sick infants.

Use with extreme caution. Pediatric patients, especially neonates and infants, have a higher risk of systemic toxicity due to immature hepatic metabolism, higher volume of distribution, and potentially higher peak plasma concentrations. Dosing must be carefully calculated on a mg/kg basis, and the lowest effective concentration and dose should be used. Continuous monitoring for signs of toxicity is essential.

Geriatric patients may be more susceptible to the systemic toxic effects of bupivacaine due to decreased hepatic function, reduced renal clearance of metabolites, and altered body composition. Lower doses and slower administration rates may be necessary. Careful monitoring for CNS and cardiovascular toxicity is crucial.

• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to severe systemic toxicity including cardiac arrest.
• Administer the dose slowly, in increments, while continuously monitoring the patient's vital signs and neurological status.
• The 'MPF' (Methylparaben-Free) designation is crucial for epidural and intrathecal use to prevent neurotoxic effects associated with preservatives.
• For severe systemic toxicity (especially cardiovascular collapse), intravenous lipid emulsion therapy (Intralipid) is the antidote and should be administered promptly.
• Bupivacaine provides prolonged anesthesia, which can be beneficial for post-operative pain control but also requires careful patient education regarding the duration of numbness and motor weakness.

• Lidocaine (shorter duration, faster onset)
• Ropivacaine (similar duration to bupivacaine, but with a lower potential for cardiac toxicity)
• Mepivacaine (intermediate duration)
• Chloroprocaine (very short duration, ester-type)

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, 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. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult 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 help healthcare providers deliver appropriate care.