Polocaine Mpf 2% Inj, 20ml

Manufacturer FRESENIUS KABI USA Active Ingredient Mepivacaine(me PIV a kane) Pronunciation me PIV a kane
It is used to numb an area before a procedure.
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Drug Class
Local Anesthetic
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Pharmacologic Class
Amide-type Local Anesthetic; Voltage-gated Sodium Channel Blocker
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Pregnancy Category
Category C
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FDA Approved
Jun 1960
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Mepivacaine is a numbing medicine (local anesthetic) used to block pain in a specific area of your body. It works by temporarily stopping nerve signals from reaching your brain, so you won't feel pain during a medical procedure or 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. It is essential to follow the instructions carefully. This medication is administered via injection.

Storing and Disposing of Your Medication

Since this injection is given in a healthcare setting, you will not need to store it at home. A healthcare professional will administer the medication, and you will not be responsible for storing or disposing of it.

Missing a Dose

This medication is given as needed in a healthcare setting, so you will not need to worry about missing a dose. The healthcare professional will administer the medication according to your specific needs.
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Lifestyle & Tips

  • Avoid touching or disturbing the numb area until sensation returns to prevent injury.
  • Follow post-procedure instructions carefully, especially regarding activity restrictions.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by procedure and site of injection. For infiltration, nerve block, or epidural, typical concentrations are 1% or 2%. Max single dose: 400 mg (or 6.6 mg/kg, whichever is less). Max total dose in 24 hours: 1000 mg.

Condition-Specific Dosing:

infiltration: 1% solution: 1-60 mL (10-600 mg); 2% solution: 1-30 mL (20-600 mg)
peripheralNerveBlock: 1% solution: 5-20 mL (50-200 mg); 2% solution: 5-10 mL (100-200 mg)
epiduralBlock: 1% solution: 15-20 mL (150-200 mg); 2% solution: 10-15 mL (200-300 mg)
caudalBlock: 1% solution: 15-20 mL (150-200 mg); 2% solution: 10-15 mL (200-300 mg)
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, reduced doses)
Infant: Not established (use with extreme caution, reduced doses)
Child: Maximum recommended dose is 5-6 mg/kg (0.25-0.3 mL/kg of 2% solution) not to exceed 400 mg. Administer smallest effective dose.
Adolescent: Same as adult dosing, but adhere to weight-based maximums.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment required.
Moderate: No specific adjustment required, but monitor for signs of toxicity.
Severe: Use with caution; monitor for signs of toxicity due to potential accumulation of metabolites. Consider reduced doses.
Dialysis: Not significantly removed by hemodialysis. Use with caution, monitor for toxicity.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: Use with caution; consider reduced doses and monitor for toxicity due to impaired metabolism.
Severe: Significant dose reduction required; use with extreme caution and close monitoring due to impaired metabolism and increased risk of systemic toxicity.

Pharmacology

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Mechanism of Action

Mepivacaine, 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 action stabilizes the membrane and prevents the propagation of the action potential, thereby producing local anesthesia.
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Pharmacokinetics

Absorption:

Bioavailability: Varies significantly based on site of administration, concentration, and presence of vasoconstrictor. Systemic absorption occurs from all sites of administration.
Tmax: Varies by site: Epidural (10-20 min), Intercostal (5-15 min), Brachial plexus (15-30 min).
FoodEffect: Not applicable (parenteral administration).

Distribution:

Vd: 1.1 L/kg (adults)
ProteinBinding: 60-78%
CnssPenetration: Yes (readily crosses blood-brain barrier, which is the basis for CNS toxicity)

Elimination:

HalfLife: 1.9 hours (adults); prolonged in neonates and patients with severe hepatic impairment.
Clearance: Not readily available as a single value, but hepatic metabolism is the primary route.
ExcretionRoute: Renal (less than 10% as unchanged drug, remainder as metabolites).
Unchanged: 5-10%
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Pharmacodynamics

OnsetOfAction: 3-5 minutes (rapid)
PeakEffect: Varies by site and concentration, generally within 15-30 minutes.
DurationOfAction: 2-3 hours (intermediate duration, longer than lidocaine, shorter than bupivacaine).

Safety & Warnings

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BLACK BOX WARNING

Local anesthetics are not recommended for obstetrical paracervical block anesthesia. The use of mepivacaine in this procedure has been associated with fetal bradycardia and death.
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Side Effects

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, or 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, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak.
Signs of methemoglobinemia: 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.
Abnormal heartbeat, including fast, slow, or irregular rhythms.
Restlessness or anxiety.
Changes in speech.
Feeling lightheaded, sleepy, confused, or experiencing blurred vision.
Numbness or tingling in the mouth.
Metallic taste.
Dizziness or fainting.
Ringing in the ears.
Shakiness or twitching.
Seizures.
Depression.
Breathing difficulties, including slow or shallow breathing.
Feeling nervous or excitable.
Severe stomach upset or vomiting.
Feeling extremely hot or cold.
Sneezing.
Excessive sweating.

Additional Side Effects (Epidural Use)

If you are using this medication via epidural administration, you may also experience:

Erectile dysfunction.
Long-lasting burning, numbness, tingling, or paralysis in the lower half of the body.
Loss of bladder or bowel control.
Urination difficulties.
Headache.
Backache.
Fever or chills.
Stiff neck.
* Sensitivity to bright lights.

Other Possible Side Effects

As with any medication, you may experience side effects that are not listed here. If you have any symptoms that concern you or do not go away, contact your doctor for advice. Not all side effects require medical attention, but it is essential to discuss any concerns with your doctor.

Reporting Side Effects

You can report any 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 answering any questions you may have.
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Seek Immediate Medical Attention If You Experience:

  • Feeling lightheaded or dizzy
  • Ringing in your ears (tinnitus)
  • Numbness or tingling around your mouth
  • Blurred vision
  • Tremors or muscle twitching
  • Feeling unusually anxious or restless
  • Difficulty breathing
  • Slow or irregular heartbeat
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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 symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or worsen certain health problems.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems

Carefully review your medications and health conditions to confirm it is safe to take this medication. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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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.

Risk of Methemoglobinemia
A severe blood disorder called methemoglobinemia has been associated with medications like this one. Your risk may be increased if you have:
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Heart problems
- Lung problems
- Are taking certain other medications
- Are an infant younger than 6 months of age
If you have a history of methemoglobinemia, notify your doctor.

Special Considerations
- Children: This medication should be used with caution in children, as the risk of side effects may be higher in some pediatric patients.
- Older Adults (65 and older): Use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.

Mouth and Numbing Effects
- Eating: Avoid eating until the numbness in your mouth has worn off to prevent accidentally biting your tongue.
- Numbness: Until the numbing effect has subsided and you feel fully alert, refrain from driving or engaging in activities that require your full attention.
- If you are discharged before the numbness has resolved, take precautions to protect the treated area from injury until sensation returns.

Epidural Administration
This medication may cause temporary loss of sensation and motor function in the lower part of your body. Do not attempt to get out of bed or perform any tasks until your feeling and motor skills have returned to normal.
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Overdose Information

Overdose Symptoms:

  • Severe dizziness or lightheadedness
  • Seizures
  • Unconsciousness
  • Slow or irregular heartbeat
  • Very low blood pressure
  • Respiratory arrest
  • Cardiac arrest

What to Do:

Immediate medical attention is required. Call 911 or your local emergency number. For suspected poisoning, call Poison Control at 1-800-222-1222.

Drug Interactions

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Major Interactions

  • Other local anesthetics (additive systemic toxicity)
  • Antiarrhythmics (e.g., Class I antiarrhythmics like tocainide, mexiletine; increased risk of cardiac effects)
  • CNS depressants (additive CNS depression)
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Moderate Interactions

  • Beta-blockers (may reduce hepatic blood flow, potentially increasing mepivacaine levels)
  • Cimetidine (may inhibit mepivacaine metabolism, increasing levels)
  • Opioids (additive CNS depression, respiratory depression)
  • Skeletal muscle relaxants (prolonged neuromuscular blockade)

Monitoring

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Baseline Monitoring

Allergy history

Rationale: To identify potential hypersensitivity reactions to amide-type local anesthetics.

Timing: Prior to administration

Vital signs (HR, BP, RR)

Rationale: To establish baseline and identify pre-existing cardiovascular instability.

Timing: Prior to administration

Site of injection assessment

Rationale: To ensure appropriate site selection and identify any contraindications (e.g., infection).

Timing: Prior to administration

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Routine Monitoring

Vital signs (HR, BP, RR)

Frequency: 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., bradycardia, hypotension, hypertension, tachypnea) warrant intervention.

Neurological status (CNS toxicity)

Frequency: Continuously during and for several hours post-administration.

Target: Absence of symptoms.

Action Threshold: Presence of lightheadedness, dizziness, tinnitus, perioral numbness, metallic taste, blurred vision, tremors, muscle twitching, seizures.

Cardiovascular status (cardiac toxicity)

Frequency: Continuously during and for several hours post-administration.

Target: Stable cardiac rhythm and function.

Action Threshold: Presence of bradycardia, hypotension, arrhythmias, cardiac arrest.

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Symptom Monitoring

  • Lightheadedness
  • Dizziness
  • Tinnitus
  • Perioral numbness
  • Metallic taste
  • Blurred vision
  • Tremors
  • Muscle twitching
  • Nausea
  • Vomiting
  • Anxiety
  • Restlessness
  • Drowsiness
  • Slurred speech
  • Seizures
  • Bradycardia
  • Hypotension
  • Arrhythmias
  • 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. Mepivacaine crosses the placenta. Not recommended for obstetrical paracervical block due to risk of fetal bradycardia and death.

Trimester-Specific Risks:

First Trimester: Potential for fetal exposure, but data are limited. Avoid if possible.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Increased risk of fetal bradycardia and death if used for paracervical block. Monitor fetus closely if used for other indications.
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Lactation

Mepivacaine is excreted into breast milk in small amounts. Generally considered compatible with breastfeeding, but monitor infant for drowsiness or feeding difficulties. L3 (Moderately Safe).

Infant Risk: Low risk of adverse effects in breastfed infants. Monitor for sedation or poor feeding.
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Pediatric Use

Children, especially younger ones, are more susceptible to systemic toxicity. Dosing must be carefully calculated based on weight (mg/kg) and the lowest effective dose should be used. Close monitoring for signs of toxicity is crucial.

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Geriatric Use

Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic function, reduced renal clearance of metabolites, and altered body composition. Reduced doses and careful monitoring are recommended.

Clinical Information

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Clinical Pearls

  • Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to rapid systemic toxicity.
  • The addition of epinephrine is generally not recommended with mepivacaine as it offers minimal prolongation of action and may increase the risk of systemic toxicity, especially in patients with cardiovascular disease.
  • Mepivacaine is an intermediate-acting local anesthetic, providing a good balance between rapid onset and moderate duration.
  • Monitor patients closely for signs of CNS toxicity (e.g., lightheadedness, tinnitus, perioral numbness, seizures) and cardiovascular toxicity (e.g., bradycardia, hypotension, arrhythmias).
  • Lipid emulsion therapy (Intralipid) should be readily available for the treatment of severe local anesthetic systemic toxicity (LAST).
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Alternative Therapies

  • Lidocaine (shorter duration, faster onset)
  • Bupivacaine (longer duration, slower onset)
  • Ropivacaine (similar to bupivacaine, less cardiotoxic)
  • Prilocaine (similar duration, risk of methemoglobinemia at high doses)
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Cost & Coverage

Average Cost: Varies, typically $10-$50 per 20ml vial (2% solution)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 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 by a healthcare professional or pharmacist. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet. If you have any questions or concerns about your medication, it is recommended that you consult 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 critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.