Sensorcaine-Mpf 0.25%/epi Inj, 10ml

Manufacturer FRESENIUS KABI USA Active Ingredient Bupivacaine and Epinephrine(byoo PIV a kane & ep i NEF rin) Pronunciation byoo-PIV-uh-kane & ep-i-NEF-rin
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.
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Drug Class
Local Anesthetic, Vasoconstrictor
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Pharmacologic Class
Amide-type Local Anesthetic; Alpha- and Beta-Adrenergic Agonist
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a local anesthetic, often called a 'numbing medicine,' that is injected to block pain in a specific area of your body. It contains two main ingredients: bupivacaine, which causes the numbing effect, and epinephrine, which helps the numbing last longer and reduces bleeding in the area. It's commonly used for minor surgeries, dental procedures, or to manage pain after surgery.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. 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.
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Lifestyle & Tips

  • Avoid touching or putting pressure on the numb area until sensation returns to prevent injury.
  • Follow post-procedure instructions carefully, especially regarding activity restrictions or wound care.
  • Report any unusual symptoms immediately to your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on procedure, site, and patient factors. Typical doses for infiltration: 5-75 mg bupivacaine (2-30 mL of 0.25% solution). For peripheral nerve block: 12.5-150 mg bupivacaine (5-60 mL of 0.25% solution). Single maximum dose should not exceed 225 mg bupivacaine (with epinephrine) or 2 mg/kg (up to 400 mg) in 24 hours.
Dose Range: 5 - 225 mg

Condition-Specific Dosing:

infiltration: 2-30 mL (5-75 mg bupivacaine)
peripheral_nerve_block: 5-60 mL (12.5-150 mg bupivacaine)
epidural_block: 10-20 mL (25-50 mg bupivacaine) for surgical anesthesia; lower concentrations for labor analgesia
caudal_block: 15-30 mL (37.5-75 mg bupivacaine)
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and reduced doses if used.
Infant: Not established for routine use; extreme caution and reduced doses if used. Max dose: 2.5 mg/kg bupivacaine (with epinephrine).
Child: Max dose: 2.5 mg/kg bupivacaine (with epinephrine), not to exceed 100 mg. Dosing is highly individualized based on weight, age, and procedure.
Adolescent: Similar to adult dosing, but consider weight and physiological maturity. Max dose: 2.5 mg/kg bupivacaine (with epinephrine), not to exceed 175 mg.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment generally required.
Moderate: Use with caution. Monitor for signs of systemic toxicity.
Severe: Use with caution. Reduced doses may be necessary due to potential accumulation of metabolites. Monitor closely for systemic toxicity.
Dialysis: Bupivacaine is not significantly removed by hemodialysis. Use with caution, monitor for toxicity.

Hepatic Impairment:

Mild: No specific dose adjustment generally required.
Moderate: Use with caution. Reduced doses may be necessary due to impaired metabolism of bupivacaine. Monitor for signs of systemic toxicity.
Severe: Contraindicated or use with extreme caution. Significant dose reduction is likely necessary due to impaired metabolism, leading to increased risk of systemic toxicity. Monitor closely.

Pharmacology

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Mechanism of Action

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 reducing its systemic absorption and helps to reduce local bleeding.
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Pharmacokinetics

Absorption:

Bioavailability: Variable, depends on site of injection, vascularity, and presence of epinephrine. Epinephrine reduces systemic absorption of bupivacaine.
Tmax: Variable, typically 30-45 minutes for peak plasma levels after peripheral nerve block, but can be faster with highly vascular sites.
FoodEffect: Not applicable (parenteral administration)

Distribution:

Vd: Approximately 0.7 L/kg for bupivacaine.
ProteinBinding: Approximately 95% for bupivacaine (primarily to alpha-1-acid glycoprotein).
CnssPenetration: Limited at therapeutic doses; however, significant systemic absorption can lead to CNS toxicity.

Elimination:

HalfLife: Approximately 2.7 hours for bupivacaine in adults (longer in neonates and pregnant women). Epinephrine has a very short half-life (minutes).
Clearance: Approximately 0.58 L/min for bupivacaine.
ExcretionRoute: Renal (bupivacaine and metabolites); metabolites of epinephrine are renally excreted.
Unchanged: Approximately 5-10% of bupivacaine is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: 2-10 minutes (infiltration, nerve block)
PeakEffect: 30-60 minutes
DurationOfAction: 3-7 hours (prolonged by epinephrine)

Safety & Warnings

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BLACK BOX WARNING

WARNING: ACCIDENTAL INTRAVASCULAR INJECTION. The 0.75% concentration of bupivacaine is not recommended for obstetrical paracervical block anesthesia. There have been reports of maternal convulsions with subsequent fetal bradycardia and death. There have been reports of cardiac arrest and death during the use of bupivacaine for epidural anesthesia and peripheral nerve blocks. Resuscitation has been difficult or impossible. The 0.75% concentration is contraindicated for epidural anesthesia in obstetrical patients. Despite the lower concentration (0.25%), accidental intravascular injection of any bupivacaine formulation can lead to systemic toxicity, including cardiac arrest.
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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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
+ Irregular heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia, a rare but potentially deadly condition, such as:
+ 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 serious side effects, such as:
+ 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, such as burning, numbness, or tingling
+ Feeling nervous and excitable
+ Headache
+ Severe nausea or vomiting
+ Abnormal heartbeat, chest pain, or pressure
+ Fever or chills
+ Sneezing
+ Excessive sweating
+ Skin reactions, such as burning, color changes, pain, skin breakdown, or swelling at the injection site
* Spinal-related side effects, such as:
+ Urination problems
+ 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, 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.
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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, restless, or confused
  • Unusual drowsiness
  • Slow or fast heartbeat
  • Feeling faint or dizzy when standing up
  • Difficulty breathing or shortness of breath
  • Seizures
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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 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
Medications you are currently taking, particularly:
+ 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 prescription and over-the-counter medications, natural products, and vitamins you are taking, as this is not an exhaustive list of potential interactions.

To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. Do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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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 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 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. Until these effects have worn off and you have regained normal feeling and movement, do not attempt to get out of bed or engage in any activities that require physical mobility.
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Overdose Information

Overdose Symptoms:

  • Severe CNS toxicity (e.g., seizures, unconsciousness, respiratory arrest)
  • Severe cardiovascular toxicity (e.g., profound hypotension, bradycardia, ventricular arrhythmias, asystole, cardiac arrest)

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. In the US, you can also call Poison Control at 1-800-222-1222. Management involves maintaining airway, breathing, and circulation, administering oxygen, managing seizures (e.g., with benzodiazepines), and treating cardiovascular collapse (e.g., with vasopressors, atropine, lipid emulsion therapy).

Drug Interactions

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Contraindicated Interactions

  • Intravenous regional anesthesia (IVRA) with bupivacaine (due to high risk of cardiac arrest)
  • Known hypersensitivity to amide-type local anesthetics or epinephrine
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Major Interactions

  • 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: May cause severe hypertension followed by bradycardia due to unopposed alpha-adrenergic effects of epinephrine.
  • General Anesthetics (e.g., Halogenated hydrocarbons like Halothane, Enflurane, Isoflurane): May sensitize the myocardium to epinephrine, increasing risk of arrhythmias.
  • Other Local Anesthetics: Additive systemic toxicity.
  • Antiarrhythmics (e.g., Class I antiarrhythmics like Lidocaine, Mexiletine): Additive cardiac effects, increased risk of toxicity.
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Moderate Interactions

  • Phenothiazines and Butyrophenones: May reverse the pressor effect of epinephrine, leading to hypotension.
  • Oxytocic Drugs (e.g., Ergot alkaloids): May cause severe persistent hypertension or cerebrovascular accidents when given with vasoconstrictors like epinephrine.
  • Alpha-adrenergic blocking agents: May diminish the pressor response to epinephrine.
  • Diuretics: May reduce arterial responsiveness to pressor agents like epinephrine.
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Minor Interactions

  • Cimetidine: May inhibit bupivacaine metabolism, potentially increasing plasma levels (clinical significance usually minor).

Monitoring

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Baseline Monitoring

Patient history and physical examination

Rationale: To identify contraindications, allergies, pre-existing conditions (cardiac, hepatic, renal disease, neurological disorders) that may affect drug metabolism or increase risk of adverse events.

Timing: Prior to administration

Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate)

Rationale: To establish baseline and detect early signs of systemic toxicity or adverse reactions to epinephrine.

Timing: Prior to administration

Allergy status

Rationale: To prevent hypersensitivity reactions.

Timing: Prior to administration

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Routine Monitoring

Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate)

Frequency: Every 5-15 minutes during and immediately after administration, then as clinically indicated.

Target: Within patient's normal range, or as per clinical protocol.

Action Threshold: Significant deviations (e.g., hypotension, bradycardia, tachycardia, hypertension, respiratory depression) warrant immediate intervention.

Level of Consciousness/Neurological Status

Frequency: Continuously during and immediately after administration.

Target: Alert and oriented, no signs of CNS toxicity.

Action Threshold: Signs of CNS toxicity (e.g., dizziness, tinnitus, perioral numbness, metallic taste, confusion, tremors, seizures) require immediate cessation of administration and supportive care.

ECG monitoring (if high dose or high-risk patient)

Frequency: Continuous during administration and recovery.

Target: Normal sinus rhythm, no significant arrhythmias.

Action Threshold: Arrhythmias (e.g., ventricular tachycardia, fibrillation, severe bradycardia) require immediate intervention.

Pain assessment

Frequency: As needed to assess efficacy and determine need for additional analgesia.

Target: Acceptable pain level for the procedure.

Action Threshold: Inadequate pain control may indicate need for re-dosing or alternative analgesia.

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Symptom Monitoring

  • Lightheadedness
  • Dizziness
  • Tinnitus
  • Perioral numbness
  • Metallic taste
  • Blurred vision
  • Tremors
  • Muscle twitching
  • Confusion
  • Drowsiness
  • Seizures
  • Bradycardia
  • Hypotension
  • Hypertension
  • Tachycardia
  • Arrhythmias
  • Nausea
  • Vomiting
  • Anxiety
  • Restlessness
  • Respiratory depression
  • Cardiac arrest

Special Patient Groups

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Pregnancy

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.

Trimester-Specific Risks:

First Trimester: Potential for fetal exposure, but data on teratogenicity are limited. Use with caution.
Second Trimester: Generally considered safer than first trimester, but still use with caution and lowest effective dose.
Third Trimester: Can cause maternal hypotension, fetal bradycardia, and other adverse effects if used for obstetrical paracervical block (especially 0.75% concentration). Epinephrine can cause uterine vasoconstriction and reduce uterine blood flow. Monitor fetal heart rate closely if used.
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Lactation

L2 (Bupivacaine). 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 when used as a local anesthetic, but observe infant for drowsiness or feeding difficulties.

Infant Risk: Low risk of adverse effects to the breastfed infant. Monitor for unusual drowsiness or changes in feeding patterns.
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Pediatric Use

Use with extreme caution, especially in infants and young children, due to increased susceptibility to systemic toxicity and immature metabolic pathways. Dosing must be carefully calculated on a mg/kg basis, and the lowest effective dose should be used. Accidental intravascular injection is a higher risk in this population.

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Geriatric Use

Use with caution. Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic and renal function, reduced protein binding, and altered body composition. Start with lower doses and titrate slowly. Monitor closely for adverse effects, especially CNS and cardiovascular toxicity.

Clinical Information

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Clinical Pearls

  • Always aspirate prior to injection to avoid accidental intravascular administration, which can lead to severe systemic toxicity, including cardiac arrest.
  • The presence of epinephrine prolongs the duration of action and reduces systemic absorption of bupivacaine, but also adds the risk of epinephrine-related side effects (e.g., tachycardia, hypertension, anxiety).
  • Bupivacaine has a higher potential for cardiotoxicity compared to lidocaine, especially with accidental intravascular injection. Resuscitation can be difficult.
  • Lipid emulsion therapy (Intralipid) is the antidote for severe local anesthetic systemic toxicity (LAST) and should be readily available when administering bupivacaine.
  • Do not use bupivacaine with epinephrine for areas with end-arterial supply (e.g., fingers, toes, nose, penis, earlobe) due to the risk of ischemia and necrosis from vasoconstriction.
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Alternative Therapies

  • Lidocaine (without epinephrine)
  • Ropivacaine
  • Levobupivacaine
  • Chloroprocaine
  • General anesthesia
  • Regional anesthesia (e.g., spinal anesthesia)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
  • Opioid analgesics
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Cost & Coverage

Average Cost: Price varies widely by supplier and contract. Typically $5-$20 per 10mL vial. per 10mL vial
Generic Available: Yes
Insurance Coverage: Usually covered by medical insurance for in-office procedures or hospital use. Coverage tier varies by plan.
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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 reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs that provide a safe and environmentally friendly way to dispose of unwanted medications.

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 quantity, and the time it was taken, as this will aid in providing appropriate treatment.