Sensorcaine -Mpf/epi 0.5%inj, 30ml

Bupivacaine is an amide-type local anesthetic that reversibly blocks the initiation and conduction of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions. This action stabilizes the neuronal membrane and inhibits depolarization, resulting in a failure to propagate the action potential. Epinephrine acts as a vasoconstrictor (alpha-adrenergic agonist) which prolongs the duration of bupivacaine's action by slowing its systemic absorption, and also reduces systemic toxicity.

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 too much acid in the blood (acidosis):
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Abnormal heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling very tired or weak
Signs of methemoglobinemia (a rare but potentially life-threatening condition):
+ Blue or gray discoloration of the lips, nails, or skin
+ Abnormal heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling 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 burning, numbness, or tingling sensations
+ Feeling nervous and excitable
+ Headache
+ Severe stomach upset or vomiting
+ Abnormal heartbeat, fast or slow heart rate, or chest pain
+ Fever or chills
+ Sneezing
+ Excessive sweating
+ Skin reactions at the injection site, such as burning, color changes, pain, skin breakdown, or swelling
+ 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 for advice. 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.

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. 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)
Concurrent use of specific medications, such as:
+ Monoamine oxidase inhibitors (MAOIs) like isocarboxazid, phenelzine, or tranylcypromine, which are used to treat depression
+ Drugs for Parkinson's disease, including selegiline or rasagiline
+ Tricyclic antidepressants like amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, or trimipramine
+ Beta blockers, such as nadolol, propranolol, sotalol, or timolol
All your current medications, including prescription and over-the-counter (OTC) 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 treatment, consult your doctor and pharmacist about all your medications and health problems before taking this medication. Do not initiate, discontinue, or modify 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.

If you have a sulfite allergy, consult your doctor, as some products contain sulfites.

There is a risk of developing a severe blood disorder 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 possible outcome for you and your baby.

Mouth (Local Anesthesia)
Do not eat until the numbness in your mouth has subsided, 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. Until feeling and motor function have returned to normal, do not attempt to get out of bed or engage in any activities that require mobility.

• Intravenous regional anesthesia (Bupivacaine without epinephrine is contraindicated for this use; caution with any bupivacaine formulation)
• Patients with known hypersensitivity to amide-type local anesthetics or epinephrine.

• Monoamine Oxidase 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 dueivacaine to unopposed alpha-adrenergic effects of epinephrine.
• Ergot-type Oxytocic Drugs (e.g., Ergonovine): May cause severe, persistent hypertension or cerebrovascular accidents when used with vasoconstrictors like epinephrine.
• Halogenated General Anesthetics (e.g., Halothane, Isoflurane): May sensitize the myocardium to the effects of epinephrine, increasing risk of arrhythmias.
• Class I Antiarrhythmics (e.g., Lidocaine, Mexiletine): Additive cardiac effects with bupivacaine, increasing risk of cardiotoxicity.

• Other Local Anesthetics: Additive systemic toxicity.
• Antiarrhythmics (e.g., Amiodarone): Increased risk of cardiac depression.
• Phenothiazines and Butyrophenones: May reverse the pressor effect of epinephrine, leading to hypotension.
• Alpha-adrenergic Blocking Agents (e.g., Phentolamine): May diminish the pressor effect of epinephrine.
• Vasopressors (e.g., Norepinephrine): Additive pressor effects.
• CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin): May increase bupivacaine plasma levels, increasing risk of toxicity.

• Not available

• Lightheadedness
• Dizziness
• Tinnitus
• Metallic taste
• Numbness of tongue and circumoral region
• Blurred vision
• Tremors
• Muscle twitching
• Seizures
• Drowsiness
• Unconsciousness
• Respiratory depression or arrest
• Bradycardia
• Hypotension
• Hypertension
• Tachycardia
• Arrhythmias (ventricular fibrillation, asystole)
• Nausea
• Vomiting
• Urticaria
• Pruritus
• Angioedema
• Bronchospasm
• Anaphylaxis

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Bupivacaine crosses the placenta. Epinephrine may reduce uterine blood flow and inhibit uterine contractions. Close monitoring of maternal and fetal status is essential.

Bupivacaine is excreted into 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 sedation or feeding difficulties. The amount transferred is typically too small to cause adverse effects in a healthy, full-term infant.

Use with extreme caution in pediatric patients, especially those under 12 years of age. Dosing must be carefully calculated on a mg/kg basis, and the lowest effective dose should be used. Children may be more susceptible to systemic toxicity. Avoid rapid injection and monitor closely for signs of toxicity.

Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic function, reduced renal clearance, and altered body composition. Lower doses and slower administration rates may be required. Monitor vital signs and neurological status closely.

• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to severe systemic toxicity.
• The addition of epinephrine prolongs the duration of action of bupivacaine and reduces systemic absorption, but also carries risks related to its vasoconstrictive effects (e.g., ischemia in areas with limited collateral circulation like digits, ears, nose, penis).
• Systemic toxicity of bupivacaine primarily affects the CNS and cardiovascular system. CNS toxicity often precedes cardiovascular toxicity, but cardiovascular collapse can occur rapidly, especially with high doses or inadvertent intravascular injection.
• Lipid emulsion therapy (Intralipid) is the antidote for severe local anesthetic systemic toxicity (LAST) and should be readily available when administering large volumes or high concentrations of bupivacaine.
• Monitor patients closely for at least 30 minutes after administration for signs of systemic toxicity.
• The 'MPF' in Sensorcaine-MPF stands for 'Methylparaben Free', which is important for patients with sulfite or paraben allergies, as some multi-dose vials may contain these preservatives.

• Lidocaine (shorter duration)
• Ropivacaine (less cardiotoxic than bupivacaine, similar duration)
• Levobupivacaine (less cardiotoxic isomer of bupivacaine)
• Procaine (ester-type, shorter duration)
• Chloroprocaine (ester-type, very short duration)
• General anesthesia (for extensive procedures or patient intolerance to local anesthesia)
• Regional anesthesia techniques using other agents or without epinephrine (e.g., plain bupivacaine)

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 can be an alternative disposal option. Some medications may come with an additional patient information leaflet, so it is a good idea 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.