Marcaine/epinephrine 0.5% Inj, 10ml

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 acts as a vasoconstrictor, primarily through alpha-adrenergic receptor stimulation, which localizes the bupivacaine at the injection site, prolongs its duration of action, and reduces systemic absorption, thereby decreasing systemic toxicity.

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 effect can be life-threatening if it occurs)
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 (fast, slow, or irregular)
Chest pain or pressure
Fever or chills
Sneezing
Excessive sweating
Burning, color changes, pain, skin breakdown, or swelling at the injection site
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 many people may not experience any or may only have mild side effects. If you have any side effects that bother you or do not go away, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor.

To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website 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, 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
If you are taking any of the following medications:
+ 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 your medications, including prescription and over-the-counter drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to discuss all your medications and health conditions with your doctor to ensure safe use.

Remember to consult your doctor and pharmacist before starting, stopping, or changing the dose of any medication to guarantee safe use and minimize potential interactions.

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, as some products may contain sulfites.

There is a risk of developing a severe blood condition called methemoglobinemia with this medication. This risk 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. Not all products are suitable for children, so consult your doctor to discuss the appropriate use.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to weigh the benefits and risks to you and your baby.

Mouth and Throat Precautions

Do not eat while your mouth feels numb, as you may accidentally bite your tongue.

Spinal Precautions

This medication may cause temporary loss of sensation and motor function in the lower half of your body. Until feeling and motor function return to normal, do not attempt to get out of bed or engage in any activities that require physical mobility.

• Not for intravenous regional anesthesia (Bier's block) due to risk of systemic toxicity.
• Not for obstetric paracervical block (0.5% concentration) due to risk of fetal bradycardia and death.

• Antiarrhythmics (e.g., lidocaine, mexiletine, amiodarone): Increased risk of cardiac depression and CNS toxicity.
• MAO inhibitors (MAOIs): Potentiation of epinephrine's pressor effects, leading to hypertensive crisis.
• Tricyclic antidepressants (TCAs): Potentiation of epinephrine's pressor effects, leading to hypertensive crisis.
• Non-selective beta-blockers (e.g., propranolol): May cause severe hypertension followed by bradycardia due to unopposed alpha-adrenergic effects of epinephrine.
• Ergot-type oxytocic drugs (e.g., ergonovine, methylergonovine): May cause severe, persistent hypertension or cerebrovascular accidents when used with vasoconstrictors like epinephrine.

• Inhalational anesthetics (e.g., halothane, isoflurane): May sensitize the myocardium to the arrhythmogenic effects of epinephrine.
• Phenothiazines and butyrophenones: May reverse the pressor effect of epinephrine, leading to hypotension.
• Alpha-adrenergic blocking agents (e.g., phentolamine): May antagonize the vasoconstrictor effect of epinephrine.
• Other local anesthetics: Additive systemic toxicity.

• Not available

• Lightheadedness
• Dizziness
• Tinnitus
• Perioral numbness
• Metallic taste
• Blurred vision
• Tremors
• Muscle twitching
• Seizures
• Drowsiness
• Unconsciousness
• Respiratory depression/arrest
• Bradycardia
• Hypotension
• Hypertension
• Tachycardia
• Arrhythmias
• Cardiac arrest

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Bupivacaine crosses the placenta. Epinephrine may reduce uterine blood flow. Not recommended for obstetric paracervical block due to risk of fetal bradycardia and death.

Bupivacaine is excreted into breast milk in small amounts, but the relative infant dose is low (L2). Epinephrine is rapidly metabolized and unlikely to be present in breast milk in significant amounts. Generally considered compatible with breastfeeding, but caution is advised.

Use with extreme caution. Dosing must be individualized and based on weight (mg/kg). Higher risk of systemic toxicity in younger children due to differences in pharmacokinetics and smaller body mass. Avoid in neonates and infants due to lack of established safety and efficacy.

Reduced doses may be necessary due to decreased hepatic function, reduced renal clearance, and altered body composition. Elderly patients may be more susceptible to systemic toxicity and cardiovascular effects of both bupivacaine and epinephrine. Monitor closely for adverse reactions.

• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to severe systemic toxicity.
• The addition of epinephrine prolongs the duration of action and reduces systemic absorption of bupivacaine, but also adds the cardiovascular effects of epinephrine.
• Bupivacaine is known for its potential for severe cardiac toxicity, especially at higher concentrations or with rapid systemic absorption. Resuscitation equipment and medications (e.g., lipid emulsion therapy) should be immediately available.
• Not for intravenous regional anesthesia (Bier's block) due to the high risk of systemic toxicity if the tourniquet fails or is released prematurely.
• Careful patient selection and dose individualization are crucial, especially in patients with pre-existing cardiac disease, liver impairment, or in pediatric and elderly populations.

• Plain Bupivacaine (without epinephrine)
• Lidocaine (plain)
• Ropivacaine (plain or with epinephrine)
• Levobupivacaine (plain)
• Other regional anesthetic techniques (e.g., spinal anesthesia, general anesthesia)
• 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 to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct 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 amount, and the time of ingestion.