Marcaine/epinephrine 0.5% Inj, 50ml

Bupivacaine, 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 stabilizes the membrane and inhibits depolarization, preventing the propagation of the action potential. Epinephrine acts as a vasoconstrictor, primarily via alpha-1 adrenergic receptor stimulation, which localizes the bupivacaine, prolongs its duration of action, and reduces systemic absorption, thereby decreasing systemic toxicity and local bleeding.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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, nausea, 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 nausea or vomiting
+ Abnormal heartbeat, 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

As with any medication, you may experience side effects. While many people do not have any side effects or only have mild ones, it is essential to contact your doctor if you have any symptoms that bother you or do not go away. This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor.

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 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 (hypotension)
If you are taking medications for depression, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline (used for Parkinson's disease)
+ Rasagiline (used for Parkinson's disease)
If you are taking any of the following medications:
+ Amitriptyline
+ Amoxapine
+ Clomipramine
+ Desipramine
+ Doxepin
+ Imipramine
+ Nortriptyline
+ Protriptyline
+ Trimipramine
* If you are taking any of the following medications:
+ Nadolol
+ Propranolol
+ Sotalol
+ Timolol

Please note that this is not an exhaustive list of all potential interactions. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.

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.

Not all products are suitable for children, so it is crucial to consult with 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)
When your mouth feels 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 physical mobility.

• Intravenous regional anesthesia (IVRA) with bupivacaine 0.75% (though this formulation is 0.5%, IVRA is generally contraindicated for bupivacaine due to high risk of cardiac arrest)
• Concomitant use with MAO inhibitors (MAOIs) or tricyclic antidepressants (TCAs) due to enhanced pressor effects of epinephrine, leading to severe, prolonged hypertension and possible arrhythmias.

• Non-selective beta-blockers (e.g., propranolol): May cause severe hypertension and reflex bradycardia due to unopposed alpha-adrenergic effects of epinephrine.
• General anesthetics (e.g., halothane, cyclopropane): May sensitize the myocardium to epinephrine, increasing risk of arrhythmias.
• Other local anesthetics or structurally related antiarrhythmics (e.g., lidocaine, mexiletine, tocainide): Additive systemic toxicity, especially cardiac and CNS effects.
• Phenothiazines and butyrophenones: May reverse the pressor effect of epinephrine, leading to hypotension.

• Ergot-type oxytocic drugs (e.g., ergonovine, methylergonovine): May cause severe, persistent hypertension or cerebrovascular accidents when used with vasoconstrictors like epinephrine.
• Alpha-adrenergic blocking agents (e.g., phentolamine): May diminish the pressor effect of epinephrine.
• Cardiac glycosides (e.g., digoxin): Increased risk of arrhythmias with epinephrine.

• Not available

• Lightheadedness
• Dizziness
• Tinnitus
• Metallic taste
• Numbness of the tongue and lips (circumoral numbness)
• Restlessness
• Anxiety
• Tremors
• Muscle twitching
• Seizures
• Drowsiness
• Unconsciousness
• Respiratory depression or arrest
• Bradycardia
• Hypotension
• Hypertension
• Arrhythmias (e.g., ventricular fibrillation, asystole)
• 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 may reduce uterine blood flow and inhibit uterine contractions.

Bupivacaine is excreted into breast milk in small amounts. Epinephrine is rapidly metabolized. Generally considered compatible with breastfeeding, but monitor infant for sedation or feeding difficulties.

Use with extreme caution, especially in neonates and infants, due to increased susceptibility to systemic toxicity and immature metabolic pathways. Dosing must be carefully calculated on a mg/kg basis and not exceed recommended maximums. Monitor closely for signs of toxicity.

Reduced doses may be required due to decreased hepatic function, renal function, and/or reduced plasma protein binding. Elderly patients may be more susceptible to systemic toxicity. Monitor closely for adverse effects.

• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to severe systemic toxicity.
• The presence of epinephrine prolongs the duration of action and reduces systemic absorption, but also carries risks related to its vasoconstrictive and cardiac stimulant effects.
• Not for intravenous regional anesthesia (Bier block) due to high risk of cardiac arrest.
• Monitor patients closely for signs of CNS toxicity (e.g., circumoral numbness, tinnitus, seizures) and cardiovascular toxicity (e.g., hypotension, bradycardia, arrhythmias).
• Lipid emulsion therapy (Intralipid) is the antidote for severe bupivacaine systemic toxicity and should be readily available in settings where large volumes or high concentrations are used.

• Lidocaine (shorter acting)
• Ropivacaine (less cardiotoxic than bupivacaine, but less potent)
• Levobupivacaine (less cardiotoxic isomer of bupivacaine)
• Chloroprocaine (ester-type, very short acting)
• General anesthesia (for procedures requiring complete unconsciousness)
• Regional nerve blocks with other local anesthetics (e.g., plain bupivacaine, lidocaine)

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. 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 for advice. Many communities have drug take-back programs, which your pharmacist can help you locate. 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, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.