Sensorcaine-Mpf 0.25%/epi Inj, 30ml

Bupivacaine, an amide-type local anesthetic, reversibly blocks the initiation and conduction of nerve impulses by decreasing the permeability of the neuronal membrane to sodium ions. This stabilizes the membrane and inhibits depolarization, leading to a reversible loss of sensation and motor activity. Epinephrine, an alpha- and beta-adrenergic agonist, causes local vasoconstriction, which prolongs the duration of action of bupivacaine, reduces systemic absorption, and decreases local bleeding.

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:
+ 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):
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular 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):
+ 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 severe side effects:
+ Feeling extremely 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 sensations (burning, numbness, or tingling)
+ Feeling nervous and excitable
+ Headache
+ Severe stomach upset or vomiting
+ Abnormal heartbeat (fast, slow, or irregular)
+ Chest pain or pressure
+ Fever or chills
+ Sneezing
+ Excessive sweating
+ Skin reactions (burning, color changes, pain, skin breakdown, or swelling) at the injection site
* Spinal-related side effects:
+ 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 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. This is not an exhaustive list of 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 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 taking any of the following medications:
+ Antidepressants like isocarboxazid, phenelzine, or tranylcypromine
+ Medications for Parkinson's disease, such as selegiline or rasagiline
+ Tricyclic antidepressants, including amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, or trimipramine
+ Beta blockers like nadolol, propranolol, sotalol, or timolol
All your medications, including prescription and over-the-counter drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to discuss all your medications and health conditions with your doctor to ensure safe use.

Remember to consult your doctor and pharmacist before starting, stopping, or changing the dose of any medication to guarantee safe use and minimize potential interactions.

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 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. Note that not all products are suitable for children, so consult 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 outcome for you and your baby.

Mouth and Throat Precautions

Do not eat or drink while your mouth is numb, as you may accidentally bite your tongue.

Spinal Precautions

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 feeling and motor function have returned to normal.

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

• Other local anesthetics (additive systemic toxicity)
• Antiarrhythmics (e.g., lidocaine, mexiletine, amiodarone - increased risk of cardiac depression/arrhythmias)
• Monoamine Oxidase Inhibitors (MAOIs) - (with epinephrine: hypertensive crisis)
• Tricyclic Antidepressants (TCAs) - (with epinephrine: severe prolonged hypertension, arrhythmias)
• Ergot-type oxytocic drugs (e.g., methylergonovine) - (with epinephrine: severe persistent hypertension, stroke)
• Non-selective Beta-blockers (e.g., propranolol) - (with epinephrine: hypertension followed by bradycardia)

• Alpha-adrenergic blockers (e.g., phentolamine) - (may reduce vasoconstrictive effect of epinephrine)
• Phenothiazines (e.g., chlorpromazine) - (may reverse epinephrine's pressor effect)
• Inhalation anesthetics (e.g., halothane, isoflurane) - (may sensitize myocardium to epinephrine, increasing arrhythmia risk)
• Digitalis glycosides (e.g., digoxin) - (increased risk of arrhythmias with epinephrine)

• Not available

• Lightheadedness
• Dizziness
• Tinnitus
• Metallic taste
• Numbness of tongue or circumoral region
• Blurred vision
• Tremors
• Muscle twitching
• Shivering
• Confusion
• Drowsiness
• Seizures
• Unconsciousness
• Bradycardia
• Hypotension
• Hypertension (initial, due to epinephrine)
• Palpitations
• 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. Epinephrine can affect uterine blood flow and contractility. Not recommended for obstetrical paracervical block due to risk of fetal bradycardia and death.

Bupivacaine is excreted in breast milk in small amounts. Epinephrine is rapidly metabolized and unlikely to be present in significant amounts. Generally considered compatible with breastfeeding, but monitor infant for drowsiness or feeding difficulties.

Use with extreme caution. Dosing must be precisely calculated based on weight (mg/kg) and not exceed recommended maximums. Children may be more susceptible to systemic toxicity. Monitor closely for signs of CNS and cardiovascular toxicity.

Use with caution. Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic and renal function, reduced plasma protein binding, and altered body composition. Consider reduced doses and monitor closely for adverse effects.

• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to severe systemic toxicity.
• The presence of epinephrine causes vasoconstriction, which prolongs the duration of action and reduces systemic absorption of bupivacaine, but also carries risks related to epinephrine (e.g., hypertension, tachycardia, arrhythmias, tissue ischemia in end-artery areas).
• Do not use solutions containing epinephrine in areas with end-artery blood supply (e.g., fingers, toes, nose, ears, penis) due to risk of ischemia and necrosis.
• Methylparaben-free (MPF) formulations are essential for epidural or intrathecal administration to prevent neurotoxicity associated with methylparaben.
• Systemic toxicity (CNS and cardiovascular) can occur even with appropriate dosing, especially if inadvertently injected intravascularly. Be prepared to manage toxicity with lipid emulsion therapy.
• The onset and duration of action are highly dependent on the concentration, volume, site of injection, and individual patient factors.

• Plain Bupivacaine (without epinephrine)
• Lidocaine (plain)
• Ropivacaine (plain or with epinephrine)
• Levobupivacaine (plain or with epinephrine)
• General anesthesia
• Other regional anesthetic techniques (e.g., spinal anesthesia, peripheral nerve blocks with other agents)
• Non-pharmacological pain management techniques

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, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs, which your pharmacist can help you locate.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to 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 was taken, as this will aid in prompt and effective treatment.