Sensorcaine Mpf 0.75% Inj, 10ml

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 prevents the propagation of the action potential, thereby producing local anesthesia.

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 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 too much acid in the blood (acidosis), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Feeling extremely sleepy
+ Shortness of breath
+ Feeling very 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
+ Feeling extremely sleepy
+ Feeling 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
Changes in balance
Restlessness
Anxiety
Changes in speech
Shakiness
Twitching
Ringing in the ears
Trouble breathing, slow breathing, or shallow breathing
Seizures
Numbness or tingling in the mouth
Metallic taste
Severe stomach upset or vomiting
Feeling hot or cold
Feeling nervous and excitable
Sneezing
Excessive sweating
Spinal-related symptoms, such as:
+ Trouble 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 may cause side effects. Many people experience no side effects or only minor ones. If you experience any side effects that bother you or do not go away, contact your doctor for advice.

Not all possible side effects are listed here. If you have questions or concerns about side effects, contact 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 allergic reaction you experienced, including any symptoms that occurred.
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 currently 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 adjust 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 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 Warnings for Different Administration Routes

Mouth: Do not eat or drink while your mouth is numb, 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. Do not attempt to get out of bed or perform any 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.

• Intravenous regional anesthesia (Bier's block) due to risk of systemic toxicity.
• Obstetrical paracervical block (due to risk of fetal bradycardia and death).

• Other local anesthetics (additive systemic toxicity, especially cardiac and CNS).
• Class I antiarrhythmics (e.g., lidocaine, mexiletine, tocainide) - increased risk of cardiac depression and CNS toxicity.
• CYP1A2 inhibitors (e.g., cimetidine, fluvoxamine, ciprofloxacin) - may increase bupivacaine plasma levels.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may increase bupivacaine plasma levels.

• Beta-blockers (e.g., propranolol) - may reduce hepatic blood flow, potentially increasing bupivacaine levels.
• Alpha-adrenergic agonists (e.g., phenylephrine, norepinephrine) - may prolong duration of action when co-administered with epinephrine-containing bupivacaine formulations (not applicable to MPF).
• Neuromuscular blocking agents - bupivacaine may potentiate or prolong the effect of non-depolarizing neuromuscular blockers.

• Not specifically identified for minor interactions with significant clinical impact.

• Lightheadedness
• Dizziness
• Tinnitus
• Circumoral numbness
• Metallic taste
• Visual disturbances (blurred vision, diplopia)
• Muscle twitching
• Tremors
• Shivering
• Seizures
• Drowsiness
• Unconsciousness
• Bradycardia
• Hypotension
• Cardiac arrhythmias
• Cardiac arrest
• Respiratory depression
• Apnea

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Bupivacaine crosses the placenta. The 0.75% concentration is contraindicated for obstetrical epidural and paracervical block due to severe risks.

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

Use with extreme caution, especially in infants and young children, due to increased susceptibility to systemic toxicity and difficulty in assessing early signs of toxicity. Dosing must be carefully calculated on a mg/kg basis. The 0.75% concentration is generally not recommended for pediatric use due to higher risk of toxicity.

Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic function, reduced renal clearance of metabolites, and altered body composition. Lower doses and careful titration are recommended. Monitor closely for signs of CNS and cardiovascular toxicity.

• Sensorcaine MPF (Methylparaben Free) is crucial for epidural and intrathecal administration to avoid neurotoxicity associated with preservatives.
• The 0.75% concentration of bupivacaine carries a higher risk of systemic toxicity, especially cardiotoxicity, compared to lower concentrations. It is specifically contraindicated for obstetrical epidural and paracervical blocks.
• Always aspirate carefully before injection to avoid inadvertent intravascular administration, which can lead to rapid systemic toxicity.
• Administer in incremental doses, especially for epidural or large nerve blocks, to detect early signs of toxicity.
• Have resuscitation equipment, oxygen, and lipid emulsion therapy (Intralipid) readily available when administering bupivacaine, especially high concentrations.
• Bupivacaine-induced cardiac arrest can be resistant to conventional resuscitation efforts; lipid emulsion therapy is a critical intervention.

• Lidocaine (shorter acting, less cardiotoxic)
• Ropivacaine (similar to bupivacaine, but less cardiotoxic)
• Levobupivacaine (S-enantiomer of bupivacaine, potentially less cardiotoxic)
• Mepivacaine
• Chloroprocaine (ester-type, very short acting)

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. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper 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 of ingestion.