Xylocaine 1% Inj, 50ml

Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby exerting a 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, this medication can cause severe and potentially life-threatening side effects. If you experience 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 methemoglobinemia, a rare but potentially deadly condition, such as:
+ Blue or gray discoloration of the lips, nails, or skin
+ Abnormal heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Fatigue or weakness
+ Shortness of breath
Signs of acidosis (too much acid in the blood), such as:
+ Confusion
+ Rapid breathing
+ Rapid heartbeat
+ Abnormal heartbeat
+ Severe stomach pain, nausea, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Fatigue or weakness
Other severe side effects, including:
+ Breathing difficulties, slow breathing, or shallow breathing
+ Lightheadedness, drowsiness, confusion, or blurred vision
+ Slow heartbeat
+ Nervousness or excitability
+ Speech difficulties
+ Abnormal sensations, such as burning, numbness, or tingling
+ Restlessness
+ Anxiety
+ Changes in vision
+ Ringing in the ears
+ Dizziness or fainting
+ Severe headache
+ Twitching
+ Shakiness
+ Seizures
+ Feeling excessively hot or cold
+ Metallic taste
+ Chest pain
+ Mood changes

If you receive this medication via spinal injection, you may also experience:

Erectile dysfunction
Loss of motor function
Loss of bladder or bowel control
Urination difficulties

Other Possible Side Effects

As with any medication, you may experience side effects. While many people do not experience significant side effects, some may have mild or moderate reactions. If you experience any side effects that bother you or persist, contact your doctor for guidance.

Remember, this is not an exhaustive list of potential side effects. If you have concerns or questions, consult your doctor. You can also 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 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, 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 medications. 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 condition 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 before taking this medication, 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.
- If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor.

Injection into the Spine
This medication 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 sensation 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.

• Antiarrhythmics (Class I, e.g., mexiletine, tocainide): Increased risk of cardiac depression and toxicity.
• Beta-blockers (e.g., propranolol, metoprolol): May decrease hepatic metabolism of lidocaine, leading to increased lidocaine plasma levels and toxicity.
• Cimetidine: Inhibits hepatic metabolism of lidocaine, increasing plasma levels and risk of toxicity.
• Other local anesthetics: Additive systemic toxicity.

• Phenytoin: May increase lidocaine metabolism; also, phenytoin itself has antiarrhythmic properties.
• Skeletal muscle relaxants (e.g., succinylcholine): Prolonged neuromuscular blockade.
• Amide-type local anesthetics (e.g., bupivacaine, ropivacaine): Increased risk of systemic toxicity if administered concurrently or sequentially in large doses.
• CYP1A2/3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors): May increase lidocaine levels.

• Not available

• Lightheadedness
• Dizziness
• Tinnitus
• Perioral numbness
• Metallic taste
• Slurred speech
• Nystagmus
• Blurred vision
• Tremors
• Muscle twitching
• Convulsions (seizures)
• Drowsiness
• Unconsciousness
• Hypotension
• Bradycardia
• Cardiac arrest
• Respiratory depression
• Apnea

Lidocaine is generally considered safe for use during 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. It is considered compatible with breastfeeding (L2 - Safer). The amount ingested by the infant is typically very low and rapidly metabolized.

Children, especially younger ones, are more susceptible to systemic toxicity due to differences in metabolism and higher relative doses per body weight. Use the lowest effective concentration and dose. Max dose: 2-4 mg/kg (without epinephrine). Careful monitoring for signs of toxicity is crucial.

Elderly patients may have reduced hepatic function, decreased protein binding, and reduced renal clearance, leading to higher plasma concentrations and increased risk of toxicity. Use lower doses and monitor closely. Consider age-related changes in body composition and organ function.

• Always aspirate prior to injection to avoid inadvertent intravascular administration, which can lead to rapid systemic toxicity.
• The addition of epinephrine prolongs the duration of action and reduces systemic absorption, allowing for higher total doses, but should be avoided in areas with end-arterial circulation (e.g., fingers, toes, nose, ears, penis) due to risk of ischemia.
• Systemic toxicity typically manifests as CNS symptoms first (e.g., circumoral numbness, tinnitus, lightheadedness, seizures), followed by cardiovascular depression (e.g., hypotension, bradycardia, arrhythmias).
• Manage systemic toxicity by stopping the injection, ensuring airway patency, administering oxygen, and if severe, managing seizures (e.g., benzodiazepines) and cardiovascular collapse (e.g., IV fluids, vasopressors, lipid emulsion therapy for severe cases).
• The 1% solution means 10 mg of lidocaine per mL. A 50 mL vial contains 500 mg of lidocaine.
• Be aware of the maximum recommended doses per kg body weight to prevent toxicity.

• Bupivacaine (longer-acting local anesthetic)
• Ropivacaine (longer-acting local anesthetic, less cardiotoxic than bupivacaine)
• Mepivacaine (intermediate-acting local anesthetic)
• Chloroprocaine (short-acting ester-type local anesthetic)
• Procaine (short-acting ester-type 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, 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 correct 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 quantity, and the time of the incident.