Marcaine 0.5% Inj, 30ml

Bupivacaine is an amide-type local anesthetic. It reversibly blocks the initiation and conduction of nerve impulses by decreasing the permeability of the nerve cell membrane to sodium ions. This action stabilizes the neuronal membrane, preventing the propagation of the action potential and thus producing local anesthesia.

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 immediate medical attention:

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 life-threatening 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 severe side effects, including:
+ Abnormal heartbeat (fast, slow, or irregular)
+ Chest pain or pressure
+ Dizziness or fainting
+ Lightheadedness, sleepiness, confusion, or blurred vision
+ Balance problems
+ Restlessness
+ Anxiety
+ Changes in speech
+ Shakiness or tremors
+ Twitching
+ Ringing in the ears
+ Breathing difficulties (trouble breathing, slow breathing, or shallow breathing)
+ Seizures
+ Numbness or tingling in the mouth
+ Metallic taste
+ Severe nausea or vomiting
+ Feeling extremely hot or cold
+ Feeling nervous and excitable
+ Sneezing
+ Excessive sweating
* Spinal-related side effects, including:
+ Urination problems
+ Loss of bladder or bowel control
+ Erectile dysfunction
+ Long-lasting burning, numbness, tingling, or paralysis in the lower half of the body
+ Back pain
+ Fever or chills
+ Stiff neck
+ Sensitivity to bright lights

Other Possible Side Effects

As with any medication, you may experience side effects. While many people have no side effects or only minor ones, it's essential to contact your doctor if you notice any symptoms that bother you or persist. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.

Reporting Side Effects

If you experience any side effects, you can report them 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 offer medical advice.

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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Bleeding disorders
+ Abnormal heart rhythms
+ Blood infections or infections at the site where the medication will be administered
+ Low blood pressure
* If you are using or plan to use another medication similar to this one. If you are unsure, consult your doctor or pharmacist.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change 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 this medication have worn off and you feel fully awake.

There is a risk of developing a severe blood condition called methemoglobinemia associated with this type of medication. This risk may be increased in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, pre-existing heart or lung problems, or when taking certain other medications. Additionally, infants under 6 months of age may also be at a higher risk. 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 formulations of this medication are suitable for children, so it is crucial to consult with your doctor before administering it to a child.

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

Specific Administration-Related Warnings

Mouth: Do not eat or drink while your mouth is numb, as you may accidentally bite your tongue.
Spinal Administration: This medication may cause temporary loss of sensation and motor function in the lower half of your body. Avoid getting out of bed or performing any activities until normal sensation and movement have returned.
* Injection (Non-Spinal): This medication may cause temporary loss of sensation and motor function at the injection site. Be cautious and avoid activities that may put you at risk of injury until normal sensation and movement have returned.

• Intravenous regional anesthesia (Bier block)

• Other local anesthetics (additive systemic toxicity)
• Antiarrhythmics (e.g., Class I antiarrhythmics like lidocaine, mexiletine, tocainide - additive cardiac effects)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir - increased bupivacaine levels)
• CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine - increased bupivacaine levels)

• Opioids (additive CNS depression, respiratory depression when used intrathecally/epidurally)
• Sedatives/Hypnotics (additive CNS depression)
• Neuromuscular blockers (prolongation of block, especially with large doses)
• Vasopressors (e.g., epinephrine - when co-administered, can affect absorption and systemic levels of bupivacaine, also additive cardiovascular effects)

• Not available

• Lightheadedness
• Dizziness
• Tinnitus
• Perioral numbness
• Metallic taste
• Blurred vision
• Tremors
• Muscle twitching
• Seizures
• Drowsiness
• Confusion
• Bradycardia
• Hypotension
• Arrhythmias
• Respiratory depression
• Nausea/vomiting

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Bupivacaine crosses the placenta. Fetal bradycardia and other adverse effects have been reported.

L3 (Moderately Safe). Bupivacaine is excreted into breast milk in small amounts. The amount ingested by the infant is generally low and unlikely to cause adverse effects. Monitor infant for drowsiness or feeding difficulties.

Use with caution. Dosing must be carefully calculated based on weight and age to avoid systemic toxicity. Neonates and young infants have immature hepatic metabolism, leading to prolonged half-life and increased risk of accumulation and toxicity. Not recommended for routine use in children under 12 years for some procedures. Close monitoring for CNS and cardiovascular toxicity is essential.

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. Consider lower doses and slower administration rates. Monitor closely for CNS and cardiovascular effects.

• 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, but should not be used in areas with end-arterial supply (e.g., fingers, toes, nose, penis, ears) due to risk of ischemia.
• Bupivacaine is known for its cardiotoxicity, especially at higher concentrations or with rapid IV injection. Lipid emulsion therapy (Intralipid) is the recommended treatment for severe local anesthetic systemic toxicity (LAST).
• Different concentrations (0.25%, 0.5%, 0.75%) and formulations (plain, with epinephrine, isobaric, hyperbaric) are available for specific uses. Ensure the correct formulation is used for the intended procedure.
• The 0.75% concentration is contraindicated for obstetric epidural anesthesia due to reports of refractory cardiac arrest in pregnant patients.

• Lidocaine (shorter duration, less cardiotoxic)
• Ropivacaine (similar to bupivacaine but less cardiotoxic, often preferred for epidurals)
• Levobupivacaine (S-enantiomer of bupivacaine, potentially less cardiotoxic)
• Mepivacaine
• Chloroprocaine (ester-type, very short duration)
• Tetracaine (ester-type, long duration, primarily for spinal anesthesia)

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 to ensure prompt and effective treatment.