Marcaine/epinephrine 0.5% Inj, 30ml

Bupivacaine is an amide-type local anesthetic that reversibly blocks the initiation and conduction of nerve impulses by decreasing the permeability of the neuronal membrane to sodium ions. This stabilizes the membrane and inhibits depolarization, preventing the propagation of the action potential. Epinephrine is a sympathomimetic amine that acts on alpha- and beta-adrenergic receptors, causing vasoconstriction at the site of injection. This vasoconstriction prolongs the duration of bupivacaine's action by slowing its systemic absorption, reduces systemic toxicity, and decreases local bleeding.

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 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 light

Other Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you have any side effects that bother you or persist, 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, 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 (hypotension)
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, such as nadolol, propranolol, sotalol, or timolol
All your medications, including prescription and over-the-counter (OTC) 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 taking this medication to verify that it is safe to use with your existing medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.

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 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 before administering this medication to a child.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to make an informed decision.

Mouth (Local Anesthesia)

While your mouth is numb, avoid eating to prevent accidentally biting your tongue.

Spinal (Regional Anesthesia)

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

• Not for intravenous regional anesthesia (Bier block) due to risk of cardiac arrest.
• 0.75% Bupivacaine is contraindicated for obstetrical epidural anesthesia due to risk of intractable cardiac arrest.

• Other local anesthetics (additive systemic toxicity)
• Antiarrhythmics (e.g., Class I antiarrhythmics like lidocaine, mexiletine, tocainide - additive cardiac effects)
• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine - potentiate pressor effects of epinephrine, leading to hypertensive crisis)
• Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, imipramine - potentiate pressor effects of epinephrine, leading to hypertensive crisis)
• Non-selective Beta-blockers (e.g., propranolol, nadolol - can lead to severe hypertension followed by bradycardia due to unopposed alpha-adrenergic effects of epinephrine)
• Ergot-type oxytocic drugs (e.g., ergonovine, methylergonovine - severe persistent hypertension or cerebrovascular accidents when used with vasoconstrictors like epinephrine)
• Inhalation anesthetics (e.g., halothane, isoflurane - sensitize myocardium to epinephrine, increasing risk of arrhythmias)

• Alpha-adrenergic blocking agents (e.g., prazosin, tamsulosin - may reduce vasoconstrictive effect of epinephrine)
• Phenothiazines and other antipsychotics (e.g., chlorpromazine - may reverse pressor effect of epinephrine)
• Thyroid hormones (may increase sensitivity to catecholamines like epinephrine)
• Digitalis glycosides (increased risk of arrhythmias with epinephrine)

• Not available

• Lightheadedness
• Dizziness
• Tinnitus
• Perioral numbness
• Metallic taste
• Blurred vision
• Tremors
• Muscle twitching
• Seizures
• Drowsiness
• Unconsciousness
• Respiratory depression/arrest
• Bradycardia
• Hypotension
• Hypertension
• Tachycardia
• Palpitations
• Arrhythmias
• Chest pain
• Anxiety
• Restlessness
• Nausea/vomiting

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.

Bupivacaine is excreted into breast milk in small amounts (L2 - probably compatible). Epinephrine is rapidly metabolized and unlikely to be present in breast milk in significant amounts (L1 - compatible). Generally considered safe for breastfeeding mothers when used appropriately.

Use with extreme caution, especially in infants and young children, due to higher risk of systemic toxicity from lower body weight, immature hepatic metabolism, and potential for relative overdose. Dosing must be carefully calculated on a mg/kg basis. Avoid in neonates and infants unless absolutely necessary and with expert supervision.

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

• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to severe systemic toxicity (LAST).
• The presence of epinephrine prolongs the duration of action and reduces systemic absorption, but also adds the risk of epinephrine-related side effects (e.g., tachycardia, hypertension, anxiety, myocardial ischemia, especially in patients with cardiovascular disease).
• Bupivacaine has a higher potential for cardiotoxicity compared to other local anesthetics like lidocaine. Resuscitation from bupivacaine-induced cardiac arrest can be challenging and may require lipid emulsion therapy.
• Do not use formulations containing epinephrine in areas with end-arterial supply (e.g., fingers, toes, nose, penis, earlobe) due to risk of ischemia and necrosis.
• Carefully consider the total dose of both bupivacaine and epinephrine, especially in smaller patients or those with comorbidities.
• Always have resuscitation equipment and medications (e.g., lipid emulsion, vasopressors, benzodiazepines) readily available when administering bupivacaine.

• Lidocaine (shorter duration, less cardiotoxic)
• Ropivacaine (less cardiotoxic than bupivacaine, similar duration)
• Levobupivacaine (S-enantiomer of bupivacaine, potentially less cardiotoxic)
• Tetracaine (ester-type, longer duration, topical/spinal use)
• Chloroprocaine (ester-type, very short duration)
• General anesthesia
• Regional nerve blocks without vasoconstrictor (shorter duration)
• Non-pharmacological pain management techniques

If your symptoms or health problems persist or worsen, 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 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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. 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 have additional patient information leaflets, so it is a good idea to check with your pharmacist for more information. 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 was taken to ensure prompt and effective treatment.