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
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's a 'local anesthetic' that works by temporarily blocking nerve signals, so you don't feel pain during a medical procedure or surgery. It's often given as an injection near the area that needs to be numbed.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered via injection.
Storing and Disposing of Your Medication
This medication will be administered to you in a hospital or doctor's office, so you will not need to store it at home.
Missing a Dose
Since this medication is given as needed in a healthcare setting, you will not need to worry about missing a dose. The healthcare professionals will administer the medication according to your needs.
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. It is essential to follow the instructions carefully. This medication is administered via injection.
Storing and Disposing of Your Medication
This medication will be administered to you in a hospital or doctor's office, so you will not need to store it at home.
Missing a Dose
Since this medication is given as needed in a healthcare setting, you will not need to worry about missing a dose. The healthcare professionals will administer the medication according to your needs.
Lifestyle & Tips
- Report any unusual sensations or discomfort immediately during or after the injection.
- Avoid activities requiring full sensation or motor control until the effects of the anesthetic have completely worn off (e.g., driving, operating machinery, walking without assistance if lower limbs are affected).
- Protect the numb area from injury (e.g., burns, cuts) as you won't feel pain.
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:
Highly variable based on procedure, site, and concentration. For 0.5% solution: Infiltration: 2.5-50 mg (0.5-10 mL); Peripheral Nerve Block: 12.5-150 mg (2.5-30 mL); Epidural: 50-100 mg (10-20 mL); Caudal: 37.5-75 mg (7.5-15 mL). Max single dose: 225 mg (with epinephrine) or 175 mg (without epinephrine). Max 24-hour dose: 400 mg.
Dose Range:
2.5 - 225 mg
Condition-Specific Dosing:
infiltration:
0.5-10 mL of 0.5% solution
peripheralNerveBlock:
2.5-30 mL of 0.5% solution
epidural:
10-20 mL of 0.5% solution
caudal:
7.5-15 mL of 0.5% solution
maximumSingleDoseWithEpinephrine:
225 mg
maximumSingleDoseWithoutEpinephrine:
175 mg
maximum24HourDose:
400 mg
Pediatric Dosing
Neonatal:
Not established for routine use; extreme caution due to immature hepatic function and higher risk of systemic toxicity. Dosing should be individualized and significantly reduced.
Infant:
Not established for routine use; extreme caution. Dosing should be individualized and significantly reduced. Max dose: 2 mg/kg.
Child:
Max dose: 2.5 mg/kg (with epinephrine) or 2 mg/kg (without epinephrine). Dosing varies by procedure (e.g., caudal block: 1-3.7 mg/kg of 0.25% or 0.5% solution).
Adolescent:
Generally follow adult dosing guidelines, but consider lower end of dose range and weight.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required for single-dose administration.
Moderate:
No specific adjustment required for single-dose administration; monitor for signs of systemic toxicity with repeated doses.
Severe:
No specific adjustment required for single-dose administration; monitor closely for signs of systemic toxicity, especially with repeated doses or continuous infusions, due to potential accumulation of metabolites.
Dialysis:
Bupivacaine is not significantly removed by hemodialysis. No specific dose adjustment for single dose, but monitor for toxicity with repeated doses.
Hepatic Impairment:
Mild:
No specific adjustment required for single-dose administration.
Moderate:
Use with caution; consider lower doses and monitor for signs of systemic toxicity due to reduced 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 and resulting in local anesthesia.
Pharmacokinetics
Absorption:
Bioavailability:
Varies significantly based on site of administration (e.g., intercostal block > epidural > brachial plexus > subcutaneous infiltration).
Tmax:
Varies by route: Epidural (10-20 min), Caudal (10-20 min), Peripheral nerve block (10-30 min).
FoodEffect:
Not applicable (parenteral administration).
Distribution:
Vd:
0.7-1.7 L/kg (adults)
ProteinBinding:
Approximately 95% (primarily to alpha-1-acid glycoprotein and albumin).
CnssPenetration:
Limited at therapeutic doses, but can cross the blood-brain barrier and placenta, leading to CNS and fetal effects at higher concentrations.
Elimination:
HalfLife:
1.5-5.5 hours (adults), prolonged in neonates and patients with severe hepatic impairment.
Clearance:
0.4-0.9 L/min (adults).
ExcretionRoute:
Renal (primarily as metabolites, small amount as unchanged drug).
Unchanged:
Approximately 5% (renal excretion).
Pharmacodynamics
OnsetOfAction:
2-10 minutes (varies by concentration, dose, and site of injection).
PeakEffect:
30-45 minutes.
DurationOfAction:
2-8 hours (varies by concentration, dose, site of injection, and presence of epinephrine).
Confidence:
Medium
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. The 0.75% concentration of bupivacaine is not recommended for obstetrical epidural anesthesia. In addition, bupivacaine is contraindicated for intravenous regional anesthesia (Bier block) due to the risk of systemic toxicity if the tourniquet fails.
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 notice any of the following signs or 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: Bluish or grayish 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: 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, breathing difficulties, slow breathing, or shallow breathing.
Seizures: Sudden, uncontrolled muscle contractions.
Other Symptoms: Numbness or tingling in the mouth, metallic taste, severe stomach upset or vomiting, feeling extremely hot or cold, nervousness, excitability, sneezing, excessive sweating.
Spinal-Related Symptoms: 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, fever, chills, stiff neck, or sensitivity to bright lights.
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions or concerns about side effects, consult your doctor for medical advice.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or 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: Bluish or grayish 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: 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, breathing difficulties, slow breathing, or shallow breathing.
Seizures: Sudden, uncontrolled muscle contractions.
Other Symptoms: Numbness or tingling in the mouth, metallic taste, severe stomach upset or vomiting, feeling extremely hot or cold, nervousness, excitability, sneezing, excessive sweating.
Spinal-Related Symptoms: 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, fever, chills, stiff neck, or sensitivity to bright lights.
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any side effects that bother you or persist, contact your doctor for guidance.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. If you have questions or concerns about side effects, consult your doctor for medical advice.
Seek Immediate Medical Attention If You Experience:
- Dizziness or lightheadedness
- 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 or restless
- Confusion or drowsiness
- Slow or fast heartbeat
- Feeling faint or dizzy when standing up
- Difficulty breathing or shortness of breath
- 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
General Precautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until the effects of this drug have worn off and you feel fully alert, avoid driving and other activities that require your full attention.
Risk of Methemoglobinemia
A severe blood disorder called methemoglobinemia has been associated with drugs like this one. Your risk may be increased if you have 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.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Not all products are suitable for children, so consult with your doctor before use. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor to ensure the best outcome for you and your baby.
Specific Warnings
Mouth: Avoid eating while your mouth feels numb, as you may accidentally bite your tongue.
Spinal: This medication may cause temporary loss of feeling and motor function in the lower half of your body. Do not attempt to get out of bed or perform other activities until normal sensation and movement have returned.
* Injection (non-spinal): This medication may cause temporary loss of feeling and motor function at the injection site.
General Precautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until the effects of this drug have worn off and you feel fully alert, avoid driving and other activities that require your full attention.
Risk of Methemoglobinemia
A severe blood disorder called methemoglobinemia has been associated with drugs like this one. Your risk may be increased if you have 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.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Not all products are suitable for children, so consult with your doctor before use. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor to ensure the best outcome for you and your baby.
Specific Warnings
Mouth: Avoid eating while your mouth feels numb, as you may accidentally bite your tongue.
Spinal: This medication may cause temporary loss of feeling and motor function in the lower half of your body. Do not attempt to get out of bed or perform other activities until normal sensation and movement have returned.
* Injection (non-spinal): This medication may cause temporary loss of feeling and motor function at the injection site.
Overdose Information
Overdose Symptoms:
- Severe CNS effects (seizures, unconsciousness, respiratory arrest)
- Severe cardiovascular effects (bradycardia, hypotension, arrhythmias, cardiac arrest)
What to Do:
Immediate medical attention is required. Call 911 or emergency services. Management includes airway management, oxygenation, ventilatory support, circulatory support (IV fluids, vasopressors), and treatment of seizures (e.g., benzodiazepines). Lipid emulsion therapy (Intralipid) is a specific antidote for severe local anesthetic systemic toxicity (LAST). Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Contraindicated Interactions
- Intravenous regional anesthesia (Bier block) due to risk of systemic toxicity if tourniquet fails.
- Obstetric paracervical block (0.75% formulation) due to risk of fetal bradycardia/death.
Major Interactions
- Other local anesthetics (additive systemic toxicity, especially CNS and cardiovascular).
- Antiarrhythmics (e.g., Class I antiarrhythmics like lidocaine, mexiletine, tocainide) - additive cardiac effects, increased risk of cardiotoxicity.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may increase bupivacaine plasma levels, increasing toxicity risk.
- CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine) - may increase bupivacaine plasma levels.
- Vasoconstrictors (e.g., epinephrine) - while often co-administered to prolong duration, caution is needed as systemic absorption of epinephrine can cause cardiovascular effects.
Moderate Interactions
- Opioids (additive CNS depression if systemic absorption occurs).
- Sedatives/Hypnotics (additive CNS depression).
- Neuromuscular blockers (may prolong or enhance block, though not a direct interaction, related to muscle relaxation).
- Anticoagulants/Antiplatelets (increased risk of hematoma with neuraxial blocks).
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Patient assessment (medical history, allergies, current medications)
Rationale: To identify contraindications, potential drug interactions, and risk factors for adverse events.
Timing: Prior to administration
Vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation)
Rationale: To establish baseline and detect early signs of systemic toxicity or adverse reactions.
Timing: Prior to administration
Site of injection assessment
Rationale: To ensure appropriate site, identify infection or inflammation, and prevent complications.
Timing: Prior to administration
Routine Monitoring
Vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation)
Frequency: Every 5-15 minutes during and immediately after injection, then as clinically indicated.
Target: Within patient's normal range; deviations should prompt investigation.
Action Threshold: Significant changes (e.g., bradycardia, hypotension, desaturation, tachypnea) or signs of systemic toxicity.
Neurological status (level of consciousness, signs of CNS toxicity)
Frequency: Continuously during and immediately after injection, then periodically.
Target: Alert and oriented; no signs of dizziness, tinnitus, perioral numbness, confusion, or seizures.
Action Threshold: Any new or worsening neurological symptoms.
Pain assessment
Frequency: As needed to assess efficacy.
Target: Adequate pain control.
Action Threshold: Inadequate pain relief or return of sensation.
Motor and sensory block assessment (for regional anesthesia)
Frequency: As needed to assess efficacy and spread of block.
Target: Desired level of motor and sensory blockade.
Action Threshold: Inadequate or excessive block.
Symptom Monitoring
- Lightheadedness
- Dizziness
- Tinnitus
- Perioral numbness
- Metallic taste
- Blurred vision
- Tremors
- Muscle twitching
- Seizures
- Drowsiness
- Confusion
- Bradycardia
- Hypotension
- Arrhythmias
- Cardiac arrest
- Respiratory depression
- Apnea
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Bupivacaine crosses the placenta. Fetal bradycardia and death have been reported, particularly with paracervical block. The 0.75% concentration is contraindicated for obstetric epidural anesthesia.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally avoided unless clearly necessary due to potential for systemic toxicity.
Second Trimester:
Generally considered safer than first trimester if clinically indicated, but still with caution.
Third Trimester:
Used for labor and delivery (epidural, spinal), but specific risks (e.g., fetal bradycardia with paracervical block) must be considered. The 0.75% concentration is contraindicated for obstetric epidural anesthesia.
Lactation
L3 (Moderate Risk). Bupivacaine is excreted into breast milk in small amounts. The amount ingested by the infant is generally low and unlikely to cause adverse effects. Monitor the infant for drowsiness or feeding difficulties.
Infant Risk:
Low risk of adverse effects to the breastfed infant with typical single-dose administration. Caution with repeated doses or high systemic absorption.
Pediatric Use
Use with extreme caution, especially in neonates and infants, due to immature hepatic function, higher risk of systemic toxicity, and potential for dose-related adverse effects. Dosing must be carefully calculated based on weight and age, and the lowest effective dose should be used. Max dose limits are crucial. Monitor closely for signs of systemic toxicity.
Geriatric Use
Elderly patients may be more susceptible to systemic toxicity due to reduced hepatic function, decreased plasma protein binding, and altered body composition. Consider lower doses and slower administration rates. 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 rapid systemic toxicity.
- Use the lowest effective concentration and volume to achieve the desired effect and minimize systemic exposure.
- Epinephrine is often added to bupivacaine to prolong the duration of action and reduce systemic absorption, but it also adds cardiovascular effects.
- Bupivacaine has a higher cardiotoxicity profile compared to other local anesthetics like lidocaine, especially the 0.75% concentration. Resuscitation from bupivacaine-induced cardiac arrest can be more challenging.
- Lipid emulsion therapy (Intralipid) is the recommended treatment for severe local anesthetic systemic toxicity (LAST) and should be readily available where bupivacaine is used.
- Monitor patients closely for signs of systemic toxicity (CNS and cardiovascular) during and after administration, especially within the first 30 minutes.
Alternative Therapies
- Lidocaine (shorter duration, less cardiotoxic)
- Ropivacaine (similar to bupivacaine but with a better safety profile regarding cardiotoxicity)
- Levobupivacaine (S-enantiomer of bupivacaine, potentially less cardiotoxic)
- Mepivacaine
- Chloroprocaine (ester-type, very short duration)
- Tetracaine (ester-type, long duration, topical/spinal)
Cost & Coverage
Average Cost:
Varies widely by concentration, volume, and supplier. Typically ranges from $5 - $50 per vial/ampule. per 10mL vial of 0.5%
Generic Available:
Yes
Insurance Coverage:
Generally covered by most insurance plans as it is a commonly used hospital/clinic administered medication.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. 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 emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.