Marcaine/ Epinephrine 0.5% Inj

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, leading to a failure to propagate the action potential. Epinephrine, an alpha- and beta-adrenergic agonist, causes vasoconstriction at the site of injection, which prolongs the duration of bupivacaine's action, reduces its systemic absorption, and provides local hemostasis.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of acidosis (too much acid in the blood):
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of methemoglobinemia (a rare but potentially life-threatening condition):
+ 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 severe side effects:
+ Feeling extremely hot or cold
+ Dizziness or fainting
+ Lightheadedness, sleepiness, confusion, or blurred vision
+ Balance problems
+ Restlessness
+ Anxiety
+ Changes in speech
+ Numbness or tingling in the mouth
+ Metallic taste
+ Ringing in the ears
+ Shakiness
+ Twitching
+ Seizures
+ Breathing difficulties, slow breathing, or shallow breathing
+ Abnormal burning, numbness, or tingling sensations
+ Feeling nervous and excitable
+ Headache
+ Severe stomach upset or vomiting
+ Abnormal heartbeat, chest pain, or pressure
+ Fever or chills
+ Sneezing
+ Excessive sweating
+ Skin reactions at the injection site, such as burning, color changes, pain, skin breakdown, or swelling
* Spinal-related side effects:
+ Urination difficulties
+ Loss of bladder or bowel control
+ Erectile dysfunction
+ Long-lasting burning, numbness, tingling, or paralysis in the lower half of the body
+ Back pain
+ Stiff neck
+ Sensitivity to bright lights

Other Possible Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you have any side effects that bother you or do not go away, contact your doctor for advice. This is not an exhaustive list of possible side effects. If you have questions or concerns, discuss them with your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and signs.
Certain health conditions, including:
+ Bleeding disorders
+ Abnormal heart rhythms
+ Blood infections or infections at the site where the medication will be administered
+ Low blood pressure (hypotension)
If you are taking specific medications, such as:
+ Antidepressants like isocarboxazid, phenelzine, or tranylcypromine
+ Medications for Parkinson's disease, including selegiline or rasagiline
+ Tricyclic antidepressants like amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, or trimipramine
+ Beta blockers like nadolol, propranolol, sotalol, or timolol
All your current medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to disclose all your medications and health conditions to your doctor.

To ensure your safety, consult your doctor and pharmacist about all your medications and health problems before taking this medication. Do not initiate, stop, or modify the dose of any medication without first consulting your doctor.

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.

If you have a sulfite allergy, consult your doctor, as some products contain sulfites. A rare but serious blood condition called methemoglobinemia has been associated with this type of medication. Your risk may be increased if you have glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart or lung problems, or are taking certain other medications. Infants under 6 months of age are also at higher risk. 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 your doctor before use.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks with your doctor to ensure the best outcome for you and your baby.

Specific Warnings

Mouth: Avoid eating while your mouth is numb, as you may accidentally bite your tongue.
Spinal: 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 other activities until normal feeling and movement have returned.

• Intravenous regional anesthesia (Bier block)
• Obstetric paracervical block (due to fetal bradycardia/death)
• Use in areas with end-arteries (e.g., fingers, toes, nose, penis, earlobe) due to risk of ischemia/necrosis.

• Monoamine Oxidase Inhibitors (MAOIs): Potentiate pressor effects of epinephrine, leading to hypertensive crisis.
• Tricyclic Antidepressants (TCAs): Potentiate pressor effects of epinephrine, leading to severe prolonged hypertension.
• Ergot-type Oxytocic Drugs (e.g., methylergonovine): May cause severe persistent hypertension or cerebrovascular accidents when used with vasoconstrictors like epinephrine.
• General Anesthetics (e.g., halothane, enflurane): May sensitize the myocardium to the effects of 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.

• Non-selective Beta-blockers (e.g., propranolol): May enhance the pressor response to epinephrine, leading to hypertension and bradycardia.
• Phenothiazines and Butyrophenones: May reverse the pressor effect of epinephrine, leading to hypotension.
• Alpha-adrenergic Blockers: May antagonize the vasoconstrictor effects of epinephrine.
• Digitalis Glycosides: Increased risk of cardiac arrhythmias with epinephrine.

• Not typically categorized for this drug combination, as most interactions are significant.

• Lightheadedness
• Dizziness
• Tinnitus (ringing in ears)
• Perioral numbness
• Metallic taste
• Visual disturbances (blurred vision, difficulty focusing)
• Tremors
• Muscle twitching
• Slurred speech
• Anxiety
• Restlessness
• Drowsiness
• Disorientation
• Seizures
• Loss of consciousness
• Hypotension
• Bradycardia
• Tachycardia
• Hypertension
• Arrhythmias (ventricular fibrillation, asystole)
• Respiratory depression
• Apnea
• Chest pain
• Palpitations
• Nausea
• Vomiting

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Bupivacaine crosses the placenta. Epinephrine can reduce uterine blood flow. Obstetric paracervical block is contraindicated due to risk of fetal bradycardia and death.

L3 (Moderately safe). Bupivacaine is excreted into breast milk in small amounts. The amount ingested by the infant is generally considered too low to cause adverse effects. Epinephrine has a very short half-life and is unlikely to be present in breast milk in significant amounts. Monitor infant for drowsiness or feeding difficulties.

Use with extreme caution. Dosing must be carefully calculated based on weight and age, using the lowest effective concentration and volume. Children may be more susceptible to systemic toxicity. Avoid in very young infants if possible. The 0.75% concentration is not recommended for children.

Use with caution. Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic function, reduced plasma protein binding, and altered body composition. Consider lower doses and slower injection rates. Monitor closely for CNS and cardiovascular effects.

• Always aspirate frequently and in multiple planes before and during injection to minimize the risk of accidental intravascular administration, which can lead to severe systemic toxicity.
• Use the lowest effective concentration and volume to achieve the desired block, especially in high-risk areas or patients.
• Epinephrine prolongs the duration of action and reduces systemic absorption of bupivacaine, but it also adds its own cardiovascular effects (tachycardia, hypertension, arrhythmias).
• Contraindicated for use in areas supplied by end-arteries (e.g., fingers, toes, nose, penis, earlobe) due to the risk of vasoconstriction-induced ischemia and necrosis.
• Be prepared to manage systemic toxicity (CNS and cardiovascular) with appropriate resuscitation equipment and medications (e.g., lipid emulsion therapy for bupivacaine toxicity).
• Monitor patients closely for signs of CNS toxicity (e.g., lightheadedness, tinnitus, perioral numbness, seizures) and cardiovascular toxicity (e.g., hypotension, bradycardia, arrhythmias).

• Other local anesthetics without epinephrine (e.g., plain bupivacaine, lidocaine, ropivacaine)
• Regional anesthesia techniques without local anesthetic/epinephrine combination (e.g., nerve blocks with plain local anesthetic)
• General anesthesia
• Systemic analgesics (e.g., opioids, NSAIDs)
• Non-pharmacological pain management techniques

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 otherwise, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, as they can provide guidance or 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. 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred, as this will aid in receiving appropriate care.