Xylocaine 2% Inj, 20ml

Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. It blocks voltage-gated sodium channels in the neuronal cell membrane, preventing depolarization and propagation of action potentials.

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 signs or symptoms, contact your doctor or seek medical attention immediately:

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.
Methemoglobinemia: 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, or shortness of breath. This rare condition can be life-threatening if left untreated.
Acidosis (Too Much Acid in the Blood): Confusion, rapid breathing, rapid heartbeat, abnormal heartbeat, severe stomach pain, nausea, vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak.
Respiratory Problems: Trouble breathing, slow breathing, or shallow breathing.
Neurological Symptoms: Feeling lightheaded, sleepy, confused, or experiencing blurred vision.
Cardiovascular Issues: Slow heartbeat.
Nervous System Symptoms: Feeling nervous and excitable, trouble speaking, burning, numbness, or tingling sensations, restlessness, anxiety, changes in vision, ringing in the ears, dizziness or fainting, severe headache, twitching, shakiness, seizures, feeling hot or cold, metallic taste, or chest pain.
Mood Changes: Changes in mood or emotional state.

Additional Side Effects of Spinal Injection:

Sexual Dysfunction: Difficulty getting or maintaining an erection.
Motor Function: Loss of movement or control over stools and urine.
* Urinary Problems: Trouble passing urine.

Other Side Effects:

Not all side effects are severe, and many people may experience no side effects or only minor ones. However, if you notice any side effects that bother you or persist, contact your doctor for guidance. 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 medical advice and guidance on managing side effects.

Before Taking This Medication: Important Information to Share with Your Doctor

To ensure safe treatment, inform your doctor of the following:

Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reactions you experienced.
If you are scheduled to receive this medication via spinal injection, notify your doctor if you have:
+ Heart block
+ Severe bleeding
+ Severe infection
+ An infection at the injection site

This list is not exhaustive. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Risk of Methemoglobinemia
A severe blood disorder called methemoglobinemia has been associated with drugs like this one. Your risk may be increased if you have:
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Heart problems
- Lung problems
- Are taking certain other medications
- Are an infant younger than 6 months of age
If you have a history of methemoglobinemia, notify your doctor.

Sulfite Allergy
If you are allergic to sulfites, consult with your doctor, as some products may contain sulfites.

Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until the effects of this medication have worn off and you feel fully awake.

Post-Treatment Precautions
If you are discharged before the numbness has resolved, protect the treated area from injury until you have regained sensation.

Special Considerations
- If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
- If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the potential benefits and risks to you and your baby.

Spinal Injection
If this medication is administered into the spine, it may cause 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 feeling and motor function have returned to normal.

Mouth and Dental Procedures
Do not eat while your mouth is numb, as you may accidentally bite your tongue.

• Antiarrhythmics (e.g., amiodarone, mexiletine, procainamide, quinidine): Increased risk of cardiac depression and arrhythmias.
• Beta-blockers (e.g., propranolol, metoprolol): Decreased hepatic metabolism of lidocaine, leading to increased lidocaine levels and toxicity.
• Cimetidine: Decreased hepatic metabolism of lidocaine, leading to increased lidocaine levels and toxicity.
• Other local anesthetics: Additive systemic toxicity.

• CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin): May increase lidocaine levels.
• CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors): May increase lidocaine levels.
• Skeletal muscle relaxants (e.g., succinylcholine): Prolonged neuromuscular blockade.
• Phenytoin: May increase lidocaine metabolism (decreased lidocaine levels) or increase risk of cardiac depression.

• Cholinergic drugs: May antagonize effects.

• Lightheadedness
• Dizziness
• Tinnitus
• Perioral numbness
• Metallic taste
• Blurred vision
• Tremors
• Muscle twitching
• Seizures
• Drowsiness
• Confusion
• Respiratory depression
• Bradycardia
• Hypotension
• Cardiac arrest

Lidocaine is generally considered safe for use during pregnancy when clinically indicated and administered at appropriate doses. It crosses the placenta. Category B.

Lidocaine is excreted into breast milk in small amounts. The amount ingested by the infant is typically very low and unlikely to cause adverse effects. Considered compatible with breastfeeding (L2).

Use with caution, especially in neonates and infants, due to immature hepatic metabolism and higher susceptibility to systemic toxicity. Dosing must be carefully calculated based on weight and age. Avoid formulations with preservatives (e.g., benzyl alcohol) in neonates.

Use with caution. Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic function, reduced protein binding, and altered body composition. Consider lower doses and monitor closely.

• Always aspirate prior to injection to avoid intravascular administration, which can lead to rapid systemic toxicity.
• The addition of epinephrine prolongs the duration of action and reduces systemic absorption, but should be avoided in areas with end-arterial circulation (e.g., fingers, toes, nose, penis, ears) due to risk of ischemia.
• Monitor for signs of CNS toxicity (e.g., perioral numbness, tinnitus, dizziness, tremors) as these often precede more severe cardiovascular toxicity.
• Lipid emulsion therapy (Intralipid) is the antidote for severe local anesthetic systemic toxicity (LAST).
• The 2% concentration (20 mg/mL) is potent; ensure correct dilution and volume for the intended procedure and patient weight.

• Bupivacaine (longer acting local anesthetic)
• Ropivacaine (longer acting local anesthetic, less cardiotoxic than bupivacaine)
• Mepivacaine (intermediate acting local anesthetic)
• Prilocaine (intermediate acting local anesthetic)
• Chloroprocaine (short acting local anesthetic)

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 or take someone else's medication. 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 your pharmacist or healthcare provider. For guidance on the best disposal method, consult your pharmacist, who may also be aware of local drug take-back programs. 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.