Lidocaine/prilocaine Cream 30gm

Lidocaine and prilocaine are amide-type local anesthetics that stabilize the neuronal membrane by inhibiting the ionic fluxes (primarily sodium influx) required for the initiation and conduction of nerve impulses. This action results in local anesthetic effect.

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, including:
+ 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
Slow heartbeat
Dizziness or fainting
Feeling lightheaded, sleepy, confused, or experiencing blurred vision
Feeling anxious, nervous, excitable, shaky, or restless
Seizures or twitching
Changes in balance or coordination
Changes in speech
Ringing in the ears (tinnitus)
Depression
Breathing difficulties, slow breathing, or shallow breathing
Numbness or tingling in the mouth
Changes in temperature sensation (feeling hot or cold)
Vomiting

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:

Local irritation at the application site, such as burning, redness, swelling, or other skin reactions
* Pale skin

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with methemoglobinemia, a condition characterized by an abnormal amount of methemoglobin in the blood.
* If you are using this medication in your ear and have a ruptured eardrum. Do not use this medication in your ear if you have a ruptured eardrum, as it may exacerbate the condition.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any existing health problems. Your healthcare team will help you determine whether it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety and the effectiveness of your treatment.

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

If this medication is accidentally swallowed, seek immediate medical attention by calling a doctor or a poison control center.

There is a risk of a severe blood disorder called methemoglobinemia associated with this type of medication. This risk may be increased in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, pre-existing heart or lung problems, or when taking certain other medications. Additionally, infants under 6 months of age may also be at a higher risk. If you have a history of methemoglobinemia, notify your doctor.

To ensure safe use, avoid applying this medication to open wounds, cuts, or irritated skin. When applying it to a large skin area or near open wounds, exercise caution and consult your doctor.

Use this medication only for the duration prescribed by your doctor. Avoid scratching or rubbing the skin while it is numb, and protect it from extreme temperatures.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

When using this medication in children, exercise caution, as they may have a higher risk of experiencing certain side effects.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.

• Drugs known to induce methemoglobinemia (e.g., sulfonamides, antimalarials, nitrites, dapsone, phenobarbital, phenytoin, nitroprusside, nitroglycerin) - increased risk of methemoglobinemia.
• Class I antiarrhythmics (e.g., tocainide, mexiletine) - additive cardiac effects, increased risk of toxicity.

• Other local anesthetics - additive systemic toxicity.
• Phenytoin, Phenobarbital - may increase lidocaine metabolism.
• Cimetidine, Beta-blockers (e.g., propranolol) - may decrease lidocaine clearance, increasing systemic levels.
• Antiarrhythmics (e.g., amiodarone) - increased risk of cardiac effects.

• Dizziness
• Lightheadedness
• Confusion
• Tremors
• Seizures
• Ringing in ears (tinnitus)
• Unusual tiredness or weakness
• Pale or bluish skin (especially lips, nail beds)
• Shortness of breath
• Fast or slow heart rate
• Low blood pressure

Category B. Generally considered safe for topical use during pregnancy when used as directed, as systemic absorption is low. Animal studies have not shown harm to the fetus.

L2 (Lidocaine and Prilocaine). Considered safe. Both lidocaine and prilocaine are excreted into breast milk in very small amounts, which are unlikely to cause adverse effects in a breastfed infant when used topically as directed.

Increased risk of methemoglobinemia, especially in infants <3 months of age or those with G6PD deficiency. Strict adherence to age- and weight-based dosing limits and application areas is crucial. Not recommended for premature infants. Monitor closely for signs of systemic toxicity and methemoglobinemia.

No specific dose adjustments are typically needed. However, use with caution in frail elderly patients or those with significant hepatic, renal, or cardiac impairment, as they may be more susceptible to systemic adverse effects if significant absorption occurs. Monitor for signs of toxicity.

• Always apply with an occlusive dressing (e.g., Tegaderm, plastic wrap) for optimal anesthetic effect and to prevent accidental removal.
• The onset of action is slower than injectable local anesthetics; allow adequate time (at least 60 minutes for intact skin) for full effect.
• The risk of methemoglobinemia is higher in infants, patients with G6PD deficiency, or those concurrently taking other methemoglobin-inducing drugs. Be vigilant for signs of cyanosis.
• Do not apply to mucous membranes (except specifically indicated for genital use) or broken/damaged skin for prolonged periods, as this significantly increases systemic absorption and risk of toxicity.
• Ensure complete removal of the cream before the procedure to prevent interference with surgical fields or equipment.
• Educate patients not to scratch, rub, or injure the numbed area, as they may not feel pain and could cause tissue damage.
• Store at room temperature and keep out of reach of children.

• Cryoanesthesia (ice packs)
• Distraction techniques (especially for pediatric patients)
• Inhaled nitrous oxide (for procedural sedation)
• Injectable local anesthetics (e.g., lidocaine, bupivacaine)
• Non-pharmacological pain management strategies

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them 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. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.