Xylocaine-Mpf 2% Inj, 5ml

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 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 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
+ Feeling tired or weak
+ 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
+ Feeling tired or weak
Other severe side effects, including:
+ Breathing difficulties, slow breathing, or shallow breathing
+ Feeling lightheaded, sleepy, confused, or experiencing blurred vision
+ Slow heartbeat
+ Feeling nervous or excitable
+ Speech difficulties
+ Abnormal burning, numbness, or tingling sensations
+ 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

Additional Side Effects to Discuss with Your Doctor

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

Erectile dysfunction
Loss of mobility
Loss of bowel or bladder control
Urination difficulties

Other Possible Side Effects

As with any medication, you may experience side effects that are not severe but still bothersome. If you notice any of the following symptoms or have concerns about side effects, contact your doctor:

Mild side effects that do not go away or bother you
Any new or worsening symptoms

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 is also available to provide guidance and support regarding side effects.

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

This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products
Vitamins
Health problems

Verify with your doctor that it is safe to take this medication in combination with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor first.

Important Warnings and Cautions

Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.

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 before using this medication, as some products may contain sulfites.

Post-Administration Precautions
Avoid driving and other activities that require alertness until the effects of this medication have worn off and you feel fully awake. If you are discharged before the numbness has resolved, protect the treated area from injury until sensation returns.

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.

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 normal sensation and motor function have returned.

Mouth and Dental Procedures
Do not eat while your mouth feels 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): 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.

• Succinylcholine: Lidocaine may prolong the neuromuscular blockade of succinylcholine.
• Phenytoin: May increase lidocaine metabolism; also, both can cause cardiac depression.
• Muscle relaxants: Lidocaine may enhance or prolong the effect of non-depolarizing muscle relaxants.
• MAO inhibitors, tricyclic antidepressants, phenothiazines (if lidocaine contains epinephrine): Increased risk of hypertension and arrhythmias.

• Digoxin: Potential for additive cardiac effects, though less common with local anesthetic doses.

• 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 (Category B). It crosses the placenta but has not been shown to increase the risk of fetal abnormalities. Use the lowest effective dose.

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).

Children, especially infants and neonates, are more susceptible to systemic toxicity due to differences in metabolism, distribution, and a higher ratio of surface area to body weight. Dosing must be carefully calculated on a mg/kg basis, and the lowest effective concentration and volume should be used. Monitor closely for signs of toxicity.

Elderly patients may have reduced hepatic function, decreased plasma protein binding, and reduced renal clearance, leading to increased plasma concentrations and a higher risk of systemic toxicity. A reduced dose may be necessary, and careful monitoring is essential. They may also be more sensitive to the CNS and cardiovascular effects.

• Always aspirate prior to injection to ensure the needle is not in a blood vessel, which can lead to rapid systemic absorption and 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, earlobe) due to risk of ischemia.
• Systemic toxicity typically manifests as CNS symptoms first (e.g., perioral numbness, tinnitus, dizziness, seizures), followed by cardiovascular depression (e.g., bradycardia, hypotension, arrhythmias).
• Management of severe lidocaine toxicity involves airway management, oxygenation, seizure control (e.g., benzodiazepines), and lipid emulsion therapy (Intralipid) for severe cardiovascular collapse.
• Ensure the correct concentration and formulation (e.g., MPF - methylparaben-free for epidural/intrathecal use) are used for the intended procedure.

• Bupivacaine (longer duration of action)
• Ropivacaine (similar to bupivacaine, less cardiotoxic)
• Mepivacaine (similar onset and duration to lidocaine, less vasodilation)
• Procaine (ester-type local anesthetic, shorter duration)
• Chloroprocaine (ester-type, very short duration, rapid metabolism)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. 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 the 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 or pharmacist, 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, as they can provide guidance on the best approach. Additionally, you may want to inquire about potential drug take-back programs in your area.

Some medications may come with a separate patient information leaflet, so it is a good idea to check with your pharmacist to see if this is the case. 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 clarification.

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 was taken, as this will be crucial in determining the best course of action.