Sensorcaine-Mpf 0.5% Inj,10ml
WARNING: Seizures, sudden loss of heart function, and death have been reported when this drug was used as an epidural during childbirth. Most of the time, this happened with a certain strength of this drug that is not meant for use during labor. If you have questions, talk with the doctor. @ COMMON USES: It is used to numb an area before a procedure.
Drug Class
Local Anesthetic
Pharmacologic Class
Amide-type Local Anesthetic
Pregnancy Category
Category C
FDA Approved
Jun 1972
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bupivacaine is a medicine used to numb a part of your body. It works by temporarily blocking nerve signals, so you don't feel pain during a medical procedure or surgery. It's often used for local numbing, nerve blocks, or epidurals.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered via injection.
Storage and Disposal
This medication will be administered in a hospital or doctor's office, so you will not need to store it at home.
Missed Dose
Since this medication is given as needed in a healthcare setting, you will not need to worry about missing a dose. The healthcare provider will administer the medication according to your medical needs.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is administered via injection.
Storage and Disposal
This medication will be administered in a hospital or doctor's office, so you will not need to store it at home.
Missed Dose
Since this medication is given as needed in a healthcare setting, you will not need to worry about missing a dose. The healthcare provider will administer the medication according to your medical needs.
Lifestyle & Tips
- Report any unusual sensations (e.g., dizziness, ringing in ears, numbness around mouth, muscle twitching) immediately to your healthcare provider during or after the injection.
- Avoid driving or operating machinery until the effects of the anesthetic have completely worn off and you feel normal.
- Follow post-procedure instructions carefully, especially regarding movement and sensation in the numbed area, to prevent injury.
Available Forms & Alternatives
Available Strengths:
- Sensorcaine Mpf 0.25% Inj, 10ml
- Sensorcaine-Mpf 0.5% Inj, 10ml
- Sensorcaine-Mpf 0.5% Inj, 30ml
- Sensorcaine Mpf 0.25% Inj, 30ml
- Sensorcaine-Mpf 0.5% Inj,10ml
- Sensorcaine Mpf 0.75% Inj, 30ml
- Sensorcaine Mpf 0.75% Inj, 10ml
- Sensorcaine-Mpf 0.25%/epi Inj, 30ml
- Sensorcaine-Mpf/epi 0.75% Inj, 30ml
- Sensorcaine-Mpf 0.25%/epi Inj, 10ml
- Sensorcaine -Mpf/epi 0.5%inj, 30ml
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by procedure and site of injection. Refer to specific guidelines for infiltration, nerve block, epidural, or spinal anesthesia.
Condition-Specific Dosing:
single_dose_max_infiltration:
Up to 175 mg (e.g., 35 mL of 0.5% solution)
single_dose_max_epidural:
Up to 200 mg (e.g., 40 mL of 0.5% solution)
single_dose_max_spinal:
6-20 mg (e.g., 1.2-4 mL of 0.5% solution)
total_24hr_max:
400 mg
Pediatric Dosing
Neonatal:
Not established for routine use; extreme caution due to immature hepatic function and higher risk of systemic toxicity. Dosing is highly individualized and typically lower than older children.
Infant:
Dosing is weight-based (e.g., 1-2 mg/kg for caudal block, max 2.5 mg/kg for single dose). Use lowest effective concentration and volume. Max 2.5 mg/kg/dose, not to exceed 400 mg/24 hours.
Child:
Dosing is weight-based (e.g., 1-2 mg/kg for caudal block, max 2.5 mg/kg for single dose). Use lowest effective concentration and volume. Max 2.5 mg/kg/dose, not to exceed 400 mg/24 hours.
Adolescent:
Similar to adult dosing, but consider weight and body surface area. Max 2.5 mg/kg/dose, not to exceed 400 mg/24 hours.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
No specific dose adjustment generally required, but monitor for signs of toxicity.
Severe:
No specific dose adjustment generally required, but monitor for signs of toxicity as metabolites may accumulate.
Dialysis:
Bupivacaine is not significantly removed by hemodialysis. No specific dose adjustment, but monitor closely.
Hepatic Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
Use with caution. Consider reduced doses and monitor for signs of toxicity due to impaired metabolism.
Severe:
Use with extreme caution. Significant dose reduction may be necessary. Monitor closely for signs of systemic toxicity due to impaired metabolism and prolonged half-life.
Pharmacology
Mechanism of Action
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, thereby preventing the propagation of the action potential.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, dependent on site of injection, vascularity of tissue, and presence of vasoconstrictor (e.g., epinephrine). Systemic absorption is rapid from highly vascular areas (e.g., intercostal block) and slower from less vascular areas (e.g., subcutaneous infiltration).
Tmax:
Variable, typically 10-45 minutes depending on site of injection and dose.
FoodEffect:
Not applicable (parenteral administration).
Distribution:
Vd:
Approximately 73 L (adults), indicating extensive tissue distribution.
ProteinBinding:
High, approximately 95% (primarily to alpha-1-acid glycoprotein and albumin).
CnssPenetration:
Limited at therapeutic doses, but can penetrate CNS and cause toxicity at higher systemic concentrations.
Elimination:
HalfLife:
Approximately 2.7 hours (adults) after epidural administration; longer in neonates and patients with severe hepatic impairment.
Clearance:
Approximately 0.58 L/min (adults).
ExcretionRoute:
Primarily renal (approximately 5-10% as unchanged drug, remainder as metabolites).
Unchanged:
Approximately 5-10% (renal).
Pharmacodynamics
OnsetOfAction:
2-10 minutes (depending on concentration, dose, and site of injection).
PeakEffect:
30-45 minutes.
DurationOfAction:
2-8 hours (depending on concentration, dose, and site of injection; longer than lidocaine).
Safety & Warnings
BLACK BOX WARNING
There have been reports of cardiac arrest and death during the use of bupivacaine for epidural anesthesia in obstetrical patients. In most cases, this has followed the inadvertent intravascular injection of bupivacaine. Therefore, a test dose should be administered prior to the full dose. Bupivacaine is not recommended for intravenous regional anesthesia (Bier's block) due to the risk of systemic toxicity if the tourniquet fails. Bupivacaine 0.75% is contraindicated for obstetric epidural anesthesia due to the difficulty in resuscitating cardiac arrest in this population.
Side Effects
Urgent 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:
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, or swelling of the mouth, face, lips, tongue, or throat.
Acidosis (Too Much Acid in the Blood): Confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak.
Methemoglobinemia: A blue or gray discoloration of the lips, nails, or skin, irregular heartbeat, seizures, severe dizziness or fainting, severe headache, excessive sleepiness, feeling tired or weak, or shortness of breath. This rare condition can be life-threatening if left untreated.
Cardiovascular Issues: Fast, slow, or abnormal heartbeat, chest pain or pressure, dizziness or fainting, lightheadedness, sleepiness, confusion, or blurred vision.
Neurological Symptoms: Change in balance, restlessness, anxiety, speech changes, shakiness, twitching, ringing in the ears, trouble breathing, slow breathing, or shallow breathing, seizures, numbness or tingling in the mouth, or a metallic taste.
Gastrointestinal Issues: Severe stomach upset or vomiting, feeling hot or cold, nervousness, excitability, sneezing, or excessive sweating.
* Spinal-Related Symptoms: 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, chills, stiff neck, or sensitivity to bright lights.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you have any side effects that bother you or persist, contact your doctor for guidance. Not all possible side effects are listed here. If you have questions or concerns about side effects, consult 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 medical advice and guidance on managing side effects.
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:
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, or swelling of the mouth, face, lips, tongue, or throat.
Acidosis (Too Much Acid in the Blood): Confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak.
Methemoglobinemia: A blue or gray discoloration of the lips, nails, or skin, irregular heartbeat, seizures, severe dizziness or fainting, severe headache, excessive sleepiness, feeling tired or weak, or shortness of breath. This rare condition can be life-threatening if left untreated.
Cardiovascular Issues: Fast, slow, or abnormal heartbeat, chest pain or pressure, dizziness or fainting, lightheadedness, sleepiness, confusion, or blurred vision.
Neurological Symptoms: Change in balance, restlessness, anxiety, speech changes, shakiness, twitching, ringing in the ears, trouble breathing, slow breathing, or shallow breathing, seizures, numbness or tingling in the mouth, or a metallic taste.
Gastrointestinal Issues: Severe stomach upset or vomiting, feeling hot or cold, nervousness, excitability, sneezing, or excessive sweating.
* Spinal-Related Symptoms: 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, chills, stiff neck, or sensitivity to bright lights.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you have any side effects that bother you or persist, contact your doctor for guidance. Not all possible side effects are listed here. If you have questions or concerns about side effects, consult 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 medical advice and guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Lightheadedness, dizziness, or feeling faint
- Ringing in the ears (tinnitus)
- Numbness or tingling around the mouth (perioral numbness)
- Metallic taste in the mouth
- Blurred vision or double vision
- Tremors or muscle twitching
- Feeling anxious, restless, or confused
- Difficulty breathing or shortness of breath
- Slow or irregular heartbeat
- Seizures
Before Using This Medicine
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 for guidance.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 for guidance.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
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, 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, notify 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 of this medication with your doctor to make an informed decision.
Mouth (Local Anesthesia)
Do not eat or drink until the numbness in your mouth has resolved, as you may inadvertently 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 motor function have returned.
Injection (Non-Spinal)
This medication may cause temporary loss of sensation and motor function at the injection site. Be cautious and avoid activities that may put you at risk of injury until normal sensation and motor function have returned.
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, 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, notify 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 of this medication with your doctor to make an informed decision.
Mouth (Local Anesthesia)
Do not eat or drink until the numbness in your mouth has resolved, as you may inadvertently 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 motor function have returned.
Injection (Non-Spinal)
This medication may cause temporary loss of sensation and motor function at the injection site. Be cautious and avoid activities that may put you at risk of injury until normal sensation and motor function have returned.
Overdose Information
Overdose Symptoms:
- Severe CNS toxicity (seizures, coma, respiratory arrest)
- Severe cardiovascular toxicity (profound hypotension, bradycardia, ventricular arrhythmias, cardiac arrest)
What to Do:
Immediate medical attention is required. Call 911 or your local emergency number. Management includes maintaining airway, breathing, and circulation, administering oxygen, managing seizures (e.g., with benzodiazepines), and treating cardiovascular collapse (e.g., with vasopressors, atropine, and intravenous lipid emulsion therapy). Call 1-800-222-1222 (Poison Control) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Intravenous regional anesthesia (Bier's block) - due to risk of systemic toxicity if tourniquet fails.
- Obstetric paracervical block - due to risk of fetal bradycardia and death.
Major Interactions
- Other local anesthetics (additive systemic toxicity)
- Class I antiarrhythmics (e.g., lidocaine, mexiletine, tocainide) - increased risk of cardiac depression and CNS toxicity.
- Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - may increase bupivacaine plasma levels and risk of toxicity.
- Potent CYP2C19 inhibitors (e.g., omeprazole, fluoxetine) - may increase bupivacaine plasma levels and risk of toxicity.
Moderate Interactions
- Beta-blockers (e.g., propranolol) - may reduce hepatic blood flow, potentially decreasing bupivacaine clearance.
- Cimetidine - may inhibit bupivacaine metabolism.
- Neuromuscular blocking agents - bupivacaine may potentiate or prolong the effect of non-depolarizing neuromuscular blockers.
Minor Interactions
- Not typically significant minor interactions.
Monitoring
Baseline Monitoring
Allergy history
Rationale: To identify hypersensitivity to amide-type local anesthetics.
Timing: Prior to administration.
Vital signs (HR, BP, RR, SpO2)
Rationale: To establish baseline and detect early signs of systemic toxicity or adverse reactions.
Timing: Prior to administration.
Patient's general condition and comorbidities
Rationale: To assess risk factors for adverse events (e.g., cardiac disease, hepatic impairment).
Timing: Prior to administration.
Routine Monitoring
Vital signs (HR, BP, RR, SpO2)
Frequency: Continuously or every 5-15 minutes during and immediately after administration, then as clinically indicated.
Target: Within patient's normal physiological range.
Action Threshold: Significant deviations (e.g., hypotension, bradycardia, desaturation) warrant immediate intervention.
Neurological status (level of consciousness, presence of dizziness, tinnitus, perioral numbness, visual disturbances)
Frequency: Continuously during and immediately after administration.
Target: Alert and oriented, absence of CNS symptoms.
Action Threshold: Onset of CNS symptoms (e.g., agitation, confusion, seizures) requires immediate cessation of infusion and supportive care.
ECG monitoring (especially with large doses or in patients with cardiac disease)
Frequency: Continuous during and immediately after administration.
Target: Normal sinus rhythm, absence of arrhythmias.
Action Threshold: Arrhythmias (e.g., wide QRS, ventricular tachycardia/fibrillation) require immediate intervention, including lipid emulsion therapy.
Symptom Monitoring
- Lightheadedness
- Dizziness
- Tinnitus
- Perioral numbness
- Metallic taste
- Blurred vision
- Tremors
- Muscle twitching
- Seizures
- Drowsiness
- Unconsciousness
- Respiratory depression/arrest
- Bradycardia
- Hypotension
- Cardiac arrhythmias
- Cardiac arrest
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Bupivacaine crosses the placenta. Avoid obstetric paracervical block due to high risk of fetal bradycardia and death.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally avoided unless absolutely necessary due to potential for fetal exposure during organogenesis.
Second Trimester:
Generally considered safer than first trimester if clinically indicated, but still Category C.
Third Trimester:
Commonly used for labor and delivery (epidural, spinal), but specific risks (e.g., fetal bradycardia with paracervical block) must be considered. Monitor fetal heart rate closely.
Lactation
L2 - Likely compatible. Bupivacaine is excreted into breast milk in very small amounts. The amount ingested by the infant is typically very low and unlikely to cause adverse effects.
Infant Risk:
Low risk. Monitor infant for unusual drowsiness or feeding difficulties, though unlikely.
Pediatric Use
Increased susceptibility to systemic toxicity due to higher relative doses per body weight, immature hepatic metabolism (especially in neonates and young infants), and potential for rapid absorption. Careful dose calculation based on weight and age is crucial. Use the lowest effective concentration and volume. Monitor closely for signs of CNS and cardiovascular toxicity.
Geriatric Use
Increased risk of systemic toxicity due to age-related physiological changes, including decreased hepatic blood flow, reduced plasma protein binding, and decreased renal function, which can alter drug distribution and elimination. Start with lower doses and titrate slowly. Monitor closely for signs of CNS and cardiovascular toxicity.
Clinical Information
Clinical Pearls
- Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to severe systemic toxicity.
- Administer a test dose (e.g., 3-5 mL of a local anesthetic with epinephrine) prior to epidural or large nerve block to detect intravascular or intrathecal injection.
- Bupivacaine has a relatively long duration of action compared to other local anesthetics like lidocaine.
- The 0.75% concentration of bupivacaine is contraindicated for obstetric epidural anesthesia due to increased risk of cardiac arrest.
- Intravenous lipid emulsion (ILE) therapy is the antidote for severe local anesthetic systemic toxicity (LAST), particularly for bupivacaine-induced cardiac arrest.
- Monitor patients closely for signs of local anesthetic systemic toxicity (LAST), which can manifest as CNS symptoms (e.g., perioral numbness, tinnitus, seizures) or cardiovascular symptoms (e.g., hypotension, bradycardia, arrhythmias).
Alternative Therapies
- Lidocaine (shorter acting, faster onset)
- Ropivacaine (similar to bupivacaine, potentially lower cardiotoxicity profile)
- Levobupivacaine (S-enantiomer of bupivacaine, potentially lower cardiotoxicity)
- Mepivacaine
- Chloroprocaine (ester-type, very short acting)
Cost & Coverage
Average Cost:
Varies widely by concentration, volume, and supplier. Typically $5 - $50 per vial/ampule. per 10 mL vial of 0.5%
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic), Tier 3 (Brand) - typically covered by medical benefit for in-office procedures or hospital stays.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, 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 to someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications. Unless instructed to do so by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, as they can provide guidance on safe disposal practices and inform you about potential drug take-back programs in your area.
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, 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 help healthcare professionals provide appropriate care.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications. Unless instructed to do so by a healthcare professional or pharmacist, do not dispose of medications by flushing them down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, as they can provide guidance on safe disposal practices and inform you about potential drug take-back programs in your area.
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, 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 help healthcare professionals provide appropriate care.