Xylocaine-Mpf 1% 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, preventing 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, such as slow, shallow, or troubled breathing
+ Feeling lightheaded, sleepy, confused, or experiencing blurred vision
+ Slow heartbeat
+ Feeling nervous or excitable
+ 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

Additional Side Effects

This medication can cause other side effects, which may be mild or severe. If you experience any side effects that bother you or do not go away, contact your doctor or seek medical attention.

Specific Side Effects with Spinal Injection

If you receive this medication via spinal injection, you may be at risk for additional side effects, including:

Erectile dysfunction
Loss of motor function
Loss of bladder or bowel control
Urinary retention

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. You can also contact your doctor for medical advice about 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 have 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

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 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, take necessary precautions to protect the treated area from injury until sensation has returned.

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 normal sensation and motor function have returned.

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

• Antiarrhythmics (Class I, e.g., mexiletine, tocainide): Increased risk of cardiac depression and CNS toxicity.
• Beta-blockers (e.g., propranolol, metoprolol): May decrease lidocaine clearance, increasing plasma levels and toxicity risk.
• Cimetidine: May decrease lidocaine clearance, increasing plasma levels and toxicity risk.

• 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): May prolong neuromuscular blockade.
• Phenytoin: May increase lidocaine metabolism, but also increased risk of cardiac depression.

• Other local anesthetics: Additive systemic toxicity.

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

Category B. Studies in animals have shown no evidence of harm to the fetus. Adequate and well-controlled studies in pregnant women are lacking, but human experience with lidocaine for local anesthesia during pregnancy (e.g., epidural for labor) suggests no adverse effects on fetal development. Use only if clearly needed.

Lidocaine is excreted into breast milk in small amounts. The amount ingested by the infant is generally considered too small to cause adverse effects. Compatible with breastfeeding (L2).

Dose must be carefully calculated based on weight and age to avoid systemic toxicity. Use the lowest effective dose. Neonates and infants may have reduced protein binding and hepatic metabolism, increasing risk of toxicity.

Reduced doses may be required due to age-related decreases in hepatic blood flow, hepatic metabolism, and renal function. Increased susceptibility to systemic toxicity. Monitor closely for adverse effects.

• Xylocaine-MPF (Methylparaben Free) is specifically formulated without methylparaben, making it suitable for epidural and spinal anesthesia where preservatives can cause neurotoxicity.
• 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, 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), followed by seizures, and then cardiovascular depression (bradycardia, hypotension, arrhythmias, cardiac arrest).
• Lipid emulsion therapy (Intralipid) is the antidote for severe local anesthetic systemic toxicity (LAST).

• Bupivacaine (longer acting)
• Ropivacaine (less cardiotoxic than bupivacaine)
• Mepivacaine
• Prilocaine
• Chloroprocaine (ester-type, very short acting)

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 use, never share your prescription medications with others, and do not take medications prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. 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 offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call 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 was taken to ensure prompt and effective treatment.