Sensorcaine-Mpf/epi 0.75% Inj, 30ml

Bupivacaine, an amide-type local anesthetic, reversibly blocks the initiation and conduction of nerve impulses by decreasing the permeability of the nerve cell membrane to sodium ions. This stabilizes the membrane and inhibits depolarization, preventing the propagation of the action potential. Epinephrine, an alpha- and beta-adrenergic agonist, causes local vasoconstriction, which prolongs the duration of bupivacaine's action by slowing its systemic absorption and reduces systemic toxicity.

Serious 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
+ 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
+ Abnormal heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Feeling extremely sleepy
+ Feeling tired or weak
+ Shortness of breath
Other serious side effects, such as:
+ Feeling hot or cold
+ Dizziness or fainting
+ Lightheadedness, sleepiness, confusion, or blurred vision
+ Balance problems
+ Restlessness
+ Anxiety
+ Changes in speech
+ Numbness or tingling in the mouth
+ Metallic taste
+ Ringing in the ears
+ Shakiness
+ Twitching
+ Seizures
+ Breathing difficulties, slow breathing, or shallow breathing
+ Abnormal burning, numbness, or tingling sensations
+ Feeling nervous and excitable
+ Headache
+ Severe stomach upset or vomiting
+ Abnormal heartbeat, chest pain, or pressure
+ Fever or chills
+ Sneezing
+ Excessive sweating
+ Skin problems, such as burning, color changes, pain, skin breakdown, or swelling at the injection site
+ Spinal problems, such as:
- Urination difficulties
- Loss of bladder or bowel control
- Erectile dysfunction
- Long-lasting burning, numbness, tingling, or paralysis in the lower half of the body
- Back pain
- Stiff neck
- Sensitivity to light

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. This is not a comprehensive list of all possible side effects. If you have questions or concerns, talk to 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 (hypotension)
If you are taking medications for depression, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline (used for Parkinson's disease)
+ Rasagiline (used for Parkinson's disease)
If you are taking any of the following medications:
+ Amitriptyline
+ Amoxapine
+ Clomipramine
+ Desipramine
+ Doxepin
+ Imipramine
+ Nortriptyline
+ Protriptyline
+ Trimipramine
If you are taking any of the following medications:
+ Nadolol
+ Propranolol
+ Sotalol
+ Timolol

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Any health problems you are experiencing

Do not start, stop, or change the dosage of any medication without consulting your doctor first. It is essential to verify that it is safe to take this medication with all your other medications and health conditions.

Important Warnings and Cautions

When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.

To ensure your safety, avoid driving and engaging in activities that require alertness until the effects of the medication have worn off and you feel fully awake.

If you have a sulfite allergy, consult your doctor before taking this medication, as some products may contain sulfites.

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, 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 products are suitable for children, so it is crucial to consult with your doctor before administering this medication to a child.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

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

Spinal (Regional Anesthesia)
This medication may cause temporary loss of sensation and motor function in the lower half of your body. To avoid injury, do not attempt to get out of bed or engage in any activities until your feeling and motor function have returned to normal.

• Intravenous regional anesthesia (IVRA) - due to high risk of systemic toxicity.
• Obstetrical paracervical block - due to risk of fetal bradycardia/death (especially with 0.75% concentration).
• Patients with known hypersensitivity to amide-type local anesthetics or epinephrine.

• MAO Inhibitors (MAOIs): Potentiate pressor effects of epinephrine, leading to hypertensive crisis.
• Tricyclic Antidepressants (TCAs): Potentiate pressor effects of epinephrine, leading to severe hypertension and arrhythmias.
• Non-selective Beta-blockers (e.g., Propranolol): May cause severe hypertension followed by bradycardia due to unopposed alpha-adrenergic effects of epinephrine.
• Class I Antiarrhythmics (e.g., Lidocaine, Tocainide, Mexiletine): Additive cardiac effects, increased risk of CNS and cardiovascular toxicity.
• Class III Antiarrhythmics (e.g., Amiodarone): Increased risk of cardiac toxicity.
• General Anesthetics (e.g., Halothane, Enflurane): May sensitize the myocardium to the effects of epinephrine, increasing risk of arrhythmias.

• Phenothiazines and Butyrophenones: May reverse the pressor effect of epinephrine, leading to hypotension.
• Ergot-type Oxytocic Drugs (e.g., Ergonovine): May cause severe, persistent hypertension or cerebrovascular accidents when used with vasoconstrictors like epinephrine.
• Other Local Anesthetics: Additive systemic toxicity.

• Not typically listed as minor for this combination, as most interactions are significant.

• Lightheadedness
• Dizziness
• Tinnitus
• Metallic taste
• Numbness of tongue/lips (circumoral numbness)
• Visual disturbances (blurred vision, diplopia)
• Muscle twitching
• Tremors
• Shivering
• Anxiety
• Restlessness
• Drowsiness
• Disorientation
• Seizures
• Loss of consciousness
• Bradycardia
• Hypotension
• Hypertension
• Palpitations
• Arrhythmias
• Respiratory depression
• Apnea
• Nausea
• Vomiting
• Urticaria
• Pruritus
• Angioedema
• Bronchospasm
• Anaphylaxis

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Bupivacaine crosses the placenta. Epinephrine can reduce uterine blood flow and cause fetal bradycardia. The 0.75% concentration is specifically not recommended for obstetrical epidural anesthesia due to higher risk of cardiac arrest, and contraindicated for paracervical block due to fetal risk.

Bupivacaine is excreted in breast milk in small amounts (L2). Epinephrine is rapidly metabolized and unlikely to be present in significant amounts (L3). Generally considered compatible with caution, especially after a single dose for a procedure. Monitor infant for sedation or feeding difficulties.

Higher risk of systemic toxicity due to lower body weight, immature hepatic metabolism, and potential for relative overdose. Dosing must be carefully calculated on a mg/kg basis. The 0.75% concentration is generally not recommended for pediatric use due to the high concentration and increased risk of toxicity; lower concentrations are preferred.

Increased risk of systemic toxicity due to decreased hepatic function, reduced renal clearance of metabolites, and potential for altered drug distribution. Start with lower doses and titrate slowly. More susceptible to cardiovascular effects of epinephrine.

• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to severe systemic toxicity.
• The 0.75% concentration of bupivacaine with epinephrine is potent and carries a higher risk of cardiotoxicity; it is NOT recommended for obstetrical epidural anesthesia or IV regional anesthesia.
• Epinephrine prolongs the duration of action and reduces systemic absorption of bupivacaine, but also adds its own systemic effects (e.g., tachycardia, hypertension, anxiety).
• Monitor patients closely for signs of systemic toxicity (CNS and cardiovascular) during and after administration, especially with larger doses or highly vascular injection sites.
• Lipid emulsion therapy (Intralipid) should be readily available for the treatment of severe bupivacaine-induced systemic toxicity.
• Use methylparaben-free (MPF) formulations for epidural or intrathecal administration to avoid neurotoxicity.

• Other local anesthetics (e.g., Lidocaine, Ropivacaine, Mepivacaine, Chloroprocaine)
• Regional anesthesia techniques without epinephrine (e.g., plain bupivacaine)
• General anesthesia
• Opioid analgesics (for pain management)

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 your pharmacist or healthcare provider. For guidance on the best disposal method, consult your pharmacist, who may also be aware of local drug take-back programs. 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 was taken to ensure prompt and effective treatment.