Xylocaine 1% 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 the influx of sodium ions and thus inhibiting 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: A blue or gray color 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.
Central Nervous System Effects: Feeling lightheaded, sleepy, confused, or experiencing blurred vision.
Cardiovascular Effects: Slow heartbeat.
Neurological Effects: 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, or metallic taste.
Cardiac Effects: Chest pain.
Mood Changes: Changes in mood.

Additional Side Effects (Injection into the Spine):

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 everyone experiences side effects, and many people have only minor side effects. However, if you notice 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, 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.

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

To ensure safe treatment, inform your doctor about 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, tell your doctor if you have:
+ Heart block
+ Severe bleeding
+ Severe infection
+ An infection at the injection site

It is crucial to disclose all your health conditions and medications to your doctor and pharmacist, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

This will help determine if it is safe to take this medication with your existing health conditions and other drugs. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

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 your doctor, as some products may contain sulfites.

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

Protecting the Treated Area
If you are discharged before the numbness has resolved, take precautions to 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.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor.

Injection (Spinal Administration)
This medication may cause temporary loss of sensation and motor function in the lower half of your body. Do not attempt to get out of bed or perform tasks until feeling and motor function have returned to normal.

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

• Known hypersensitivity to amide-type local anesthetics
• Stokes-Adams syndrome
• Severe degrees of heart block (e.g., second or third-degree AV block) without a pacemaker (when used as antiarrhythmic, but caution for local use if systemic absorption is high)

• Antiarrhythmics (Class I, e.g., mexiletine, procainamide): Additive cardiac effects, increased risk of toxicity.
• Beta-blockers (e.g., propranolol, metoprolol): May decrease hepatic clearance of lidocaine, increasing plasma levels and risk of toxicity.
• Cimetidine: May inhibit lidocaine metabolism, increasing plasma levels and risk of toxicity.

• Succinylcholine: May prolong neuromuscular blockade.
• Phenytoin: May increase lidocaine metabolism (less common interaction).
• MAOIs, TCAs, phenothiazines (if lidocaine contains epinephrine): May cause severe prolonged hypertension or arrhythmias.

• Not available

• Lightheadedness
• Dizziness
• Tinnitus (ringing in ears)
• Perioral numbness or tingling
• Metallic taste
• Blurred vision
• Tremors or muscle twitching
• Nervousness or anxiety
• Drowsiness or sedation
• Slurred speech
• Seizures
• Bradycardia
• Hypotension
• Cardiac arrest

Lidocaine is generally considered safe for use as a local anesthetic during pregnancy (Pregnancy Category B). It crosses the placenta but is rapidly metabolized. Use the lowest effective dose.

Lidocaine is excreted into breast milk in small amounts. The amount transferred to the infant is generally considered too small to cause adverse effects. It is rated L2 (likely compatible) by LactMed. Use the lowest effective dose.

Pediatric patients, especially infants and young children, are more susceptible to systemic toxicity due to differences in metabolism, distribution, and higher relative doses per body weight. Dosing must be carefully calculated based on weight (mg/kg) and the lowest effective concentration and volume should be used. Close monitoring for signs of systemic toxicity is crucial.

Elderly patients may have reduced hepatic blood flow and metabolism, leading to higher plasma concentrations and increased risk of systemic toxicity. Lower doses may be required, and careful monitoring for adverse effects is recommended. Co-morbidities (e.g., cardiac, renal impairment) should be considered.

• Always aspirate prior to injection to ensure the needle is not in a blood vessel, which can lead to rapid systemic absorption and toxicity.
• Use the lowest effective concentration and volume to achieve the desired anesthetic effect.
• The addition of epinephrine (vasoconstrictor) 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.
• Be vigilant for signs of Local Anesthetic Systemic Toxicity (LAST), which can manifest as CNS symptoms (e.g., circumoral numbness, tinnitus, seizures) or cardiovascular symptoms (e.g., bradycardia, hypotension, arrhythmias). Lipid emulsion therapy is the antidote for severe LAST.
• Patients with cardiac conduction abnormalities (e.g., sick sinus syndrome, severe AV block) are at higher risk for cardiac adverse effects if systemic absorption occurs.

• Bupivacaine (longer duration of action)
• Ropivacaine (less cardiotoxic than bupivacaine)
• Mepivacaine (similar to lidocaine, slightly longer duration)
• Prilocaine (less cardiotoxic, but risk of methemoglobinemia with high doses)
• Chloroprocaine (ester-type, very short duration, rapid metabolism)
• Topical anesthetics (e.g., benzocaine, tetracaine)
• Cryoanalgesia
• 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. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred.