Sensorcaine Mpf 0.75% 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, leading to a failure of the propagation of action potentials and thus local anesthesia.

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
+ 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 severe 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
+ Speech changes
+ Shakiness
+ Twitching
+ Ringing in the ears
+ Breathing difficulties (trouble breathing, slow breathing, or shallow breathing)
+ Seizures
+ Numbness or tingling in the mouth
+ Metallic taste
+ Severe stomach upset or vomiting
+ Feeling extremely hot or cold
+ Feeling nervous and excitable
+ Sneezing
+ Excessive sweating
* Spinal-related side effects, including:
+ 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 Possible 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 or seek medical attention. This is not a comprehensive list of all possible side effects. If you have questions or concerns, discuss them with your doctor.

Reporting Side Effects

You can report side effects 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 answering any questions you may have.

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 existing treatments and health conditions. Never start, stop, or adjust 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. This risk may be increased in individuals with certain conditions, such as 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 to you and your baby with your doctor.

Specific Administration Warnings

Mouth: Do not eat or drink while your mouth is numb, as you may accidentally bite your tongue.
Spinal Administration: This medication may cause temporary loss of sensation and motor function in the lower half of your body. Do not attempt to get out of bed or perform any activities until normal sensation and movement have returned.
* Injection (Non-Spinal): This medication may cause temporary loss of sensation and motor function at the injection site.

• Antiarrhythmics (Class I, e.g., lidocaine, mexiletine): Increased risk of cardiac depression and CNS toxicity.
• Other local anesthetics: Additive systemic toxicity.

• CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin): May increase bupivacaine plasma levels.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): May increase bupivacaine plasma levels.
• Opioids: May enhance analgesic effect but also increase risk of respiratory depression when used intrathecally/epidurally.
• Sedatives/Hypnotics: Additive CNS depression.
• Neuromuscular blockers: May prolong or enhance neuromuscular blockade.

• Cholinergic agents: May antagonize effects of bupivacaine.

• Lightheadedness
• Dizziness
• Tinnitus
• Perioral numbness
• Metallic taste
• Blurred vision
• Tremors
• Muscle twitching
• Seizures
• Drowsiness
• Unconsciousness
• Respiratory depression/arrest
• Bradycardia
• Hypotension
• Cardiac arrest
• Nausea
• Vomiting
• Allergic reactions (rash, urticaria, anaphylaxis)

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects. The 0.75% concentration is contraindicated 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 extreme caution, especially in infants and young children, due to increased susceptibility to systemic toxicity and immature metabolic pathways. The 0.75% concentration is generally not recommended for pediatric use; lower concentrations and careful dose calculation based on weight are essential. Max dose typically 2.5 mg/kg.

Reduced doses may be required due to decreased hepatic function, reduced renal clearance, and decreased protein binding. Elderly patients may be more susceptible to systemic toxicity and cardiovascular effects. Monitor closely.

• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to severe systemic toxicity.
• The 0.75% concentration is potent and has a high risk of cardiotoxicity if accidentally injected intravascularly. It is specifically contraindicated for obstetrical paracervical block and intravenous regional anesthesia (Bier block).
• Bupivacaine has a slower onset but a significantly longer duration of action compared to lidocaine.
• Systemic toxicity typically manifests as CNS symptoms first (e.g., perioral numbness, tinnitus, dizziness, seizures), followed by cardiovascular depression (e.g., bradycardia, hypotension, arrhythmias, cardiac arrest).
• Lipid emulsion therapy (Intralipid) is the antidote for severe local anesthetic systemic toxicity (LAST) and should be readily available when administering large doses of bupivacaine.
• Epinephrine-containing formulations prolong the duration of action and reduce systemic absorption, but are contraindicated in certain areas (e.g., digits, penis, nose) due to risk of ischemia.

• Lidocaine (shorter acting)
• Ropivacaine (similar to bupivacaine, less cardiotoxic at equipotent doses)
• Levobupivacaine (S-enantiomer of bupivacaine, potentially less cardiotoxic)
• Mepivacaine
• Chloroprocaine (ester-type, very short acting)
• General anesthesia (for surgical procedures)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further 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. 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. 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.