Marcaine 0.75% Spinal Inj, 2ml

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 action stabilizes the membrane and inhibits depolarization, thereby preventing the propagation of the action potential and resulting in 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 medical attention immediately:

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
+ Abnormal heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling very 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
+ Abnormal heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling tired or weak
+ Shortness of breath
Other severe side effects, including:
+ Abnormal heartbeat (fast, slow, or irregular)
+ Chest pain or pressure
+ Dizziness or fainting
+ Feeling lightheaded, sleepy, confused, or experiencing blurred vision
+ Balance problems
+ Restlessness
+ Anxiety
+ Changes in speech
+ Shakiness
+ Twitching
+ Ringing in the ears
+ Breathing difficulties, slow breathing, or shallow breathing
+ Seizures
+ Numbness or tingling in the mouth
+ Metallic taste
+ Severe stomach upset or vomiting
+ Feeling hot or cold
+ Feeling nervous and excitable
+ Sneezing
+ Excessive sweating
* Spinal-related side effects, including:
+ Difficulty urinating
+ 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 Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any 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

You can report side effects 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, such as foods or drugs. Describe the allergic reaction you experienced, including the 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
* 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 other medications and health conditions. Never start, stop, or change 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.

Risk of Methemoglobinemia

This medication can cause a severe blood disorder called methemoglobinemia. Your risk may be higher if you have glucose-6-phosphate dehydrogenase (G6PD) deficiency, heart problems, or lung problems. Additionally, the risk may increase when taking certain other medications or in infants under 6 months of age. If you have a history of methemoglobinemia, notify 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 with your doctor before use. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor to ensure the best outcome for you and your baby.

Mouth and Throat Precautions

When using this medication for mouth procedures, do not eat until the numbness has worn off, as you may accidentally bite your tongue.

Spinal Administration Precautions

After spinal administration of this medication, you may experience temporary loss of feeling and motor function in the lower half of your body. Do not attempt to get out of bed or perform other activities until normal sensation and movement have returned.

Injection Precautions (Non-Spinal)

When this medication is administered via injection (other than spinal), you may experience temporary loss of feeling and motor function at the injection site.

• Other local anesthetics (additive systemic toxicity)
• Class I antiarrhythmics (e.g., lidocaine, mexiletine, tocainide - additive cardiac effects, increased risk of cardiotoxicity)
• Cholinesterase inhibitors (e.g., neostigmine, pyridostigmine - may prolong neuromuscular blockade if used concurrently with neuromuscular blockers)

• Opioids (additive CNS depression, respiratory depression when used intrathecally)
• Sedatives/Hypnotics (additive CNS depression)
• General anesthetics (additive CNS and cardiovascular depression)
• Alpha-adrenergic agonists (e.g., phenylephrine, epinephrine - used as vasoconstrictors, may prolong duration of block but also increase systemic absorption and toxicity risk)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin - theoretical increase in bupivacaine levels, though clinical significance for single-dose spinal is low)

• Anticoagulants/Antiplatelets (increased risk of spinal hematoma with neuraxial blockade, though not a direct drug-drug interaction with bupivacaine itself)

• Lightheadedness
• Dizziness
• Tinnitus
• Blurred vision
• Numbness of the tongue or lips
• Metallic taste
• Tremors
• Muscle twitching
• Seizures
• Drowsiness
• Unconsciousness
• Respiratory depression
• Hypotension
• Bradycardia
• Arrhythmias
• Cardiac arrest

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Bupivacaine crosses the placenta. The 0.75% concentration is specifically contraindicated for obstetrical epidural anesthesia due to risk of cardiac arrest. For spinal anesthesia in obstetrics, lower concentrations and doses are typically preferred, and careful monitoring is essential.

L3 (Moderately Safe). Bupivacaine is excreted into breast milk in small amounts. The amount ingested by the infant is generally very 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. The 0.75% concentration may be too potent for routine use in very young children for spinal anesthesia, requiring precise volume measurement. Not recommended for neonates or infants for spinal anesthesia due to limited data and potential for higher systemic absorption and toxicity.

Use with caution. Elderly patients may be more susceptible to the systemic toxic effects of bupivacaine due to decreased hepatic metabolism, reduced renal clearance of metabolites, and age-related physiological changes. Consider reduced doses and slower injection rates. Monitor closely for hypotension and CNS effects.

• The 0.75% bupivacaine solution is hyperbaric (contains dextrose), which influences its spread in the CSF. Patient position during and immediately after injection is critical for controlling the level of block.
• Always have resuscitation equipment, oxygen, and lipid emulsion therapy readily available when administering bupivacaine, especially for spinal anesthesia, due to the risk of systemic toxicity.
• A test dose is not typically used for single-shot spinal anesthesia, but careful aspiration before injection is crucial to avoid intravascular injection.
• Post-dural puncture headache (PDPH) is a known complication of spinal anesthesia; use of smaller gauge needles and proper technique can reduce incidence.
• The onset of action for spinal bupivacaine is rapid, and the duration is prolonged, making it suitable for longer surgical procedures.

• Lidocaine (for shorter duration spinal anesthesia)
• Ropivacaine (another amide-type local anesthetic, often preferred for epidural due to lower cardiotoxicity profile)
• Tetracaine (ester-type local anesthetic, used for spinal anesthesia)
• General anesthesia
• Epidural anesthesia
• Peripheral nerve blocks

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities have drug take-back programs that provide a safe and responsible way to dispose of unwanted medications.

Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance and support.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was taken, to ensure prompt and effective treatment.