Emla Cream 30gm

Lidocaine and Prilocaine are amide-type local anesthetics. They stabilize the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, thereby producing local anesthetic action. This is primarily achieved by blocking voltage-gated sodium channels.

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
Other severe side effects, such as:
+ 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
+ Depression
+ Trouble breathing, 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Burning, redness, swelling, or irritation at the site of application
* Pale skin

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 symptoms you experienced.
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 cause further complications.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions.

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

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 developing a severe blood disorder called methemoglobinemia associated with this 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. Infants under 6 months of age are also 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 the risk of certain side effects may be higher in this population.

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

• Methemoglobinemia-inducing agents (e.g., sulfonamides, nitrates, antimalarials, phenobarbital, phenytoin, acetaminophen, nitroprusside, dapsone, local anesthetics other than lidocaine/prilocaine): Increased risk of methemoglobinemia.
• Class I antiarrhythmics (e.g., tocainide, mexiletine): Additive systemic toxicity if significant absorption occurs.

• Other local anesthetics: Increased risk of systemic toxicity.
• Antiarrhythmics (e.g., amiodarone, beta-blockers): Potential for additive cardiac effects if significant systemic absorption occurs.
• Cimetidine, Beta-blockers (e.g., propranolol): May reduce hepatic clearance of lidocaine, increasing systemic levels.

• Local: Erythema, pallor, edema, itching, burning, rash, urticaria, purpura, petechiae, blistering.
• Systemic (CNS): Lightheadedness, dizziness, blurred vision, tinnitus, disorientation, drowsiness, tremors, twitching, convulsions, unconsciousness.
• Systemic (Cardiovascular): Bradycardia, hypotension, myocardial depression, cardiac arrest.
• Methemoglobinemia: Cyanosis (bluish or grayish skin/lips/nail beds), dyspnea, fatigue, weakness, headache, dizziness, tachycardia.

Category B. Animal studies have not shown harm, but human studies are limited. Use only if clearly needed and potential benefits outweigh risks. Minimal systemic absorption with proper topical use reduces risk.

Lidocaine and prilocaine are excreted in breast milk in small amounts. Due to low systemic absorption from topical application, the amount transferred to breast milk is generally considered too small to cause harm to a healthy, full-term infant. Use with caution, especially with large application areas or broken skin.

Not recommended for infants under 3 months of age due to increased risk of methemoglobinemia. Not recommended for infants under 12 months of age who are receiving treatment with methemoglobinemia-inducing agents. Dosing must be carefully calculated based on age, weight, and surface area to avoid systemic toxicity and methemoglobinemia. Close monitoring is essential.

Use with caution. Elderly patients may be more susceptible to systemic toxicity due to decreased hepatic/renal function, reduced protein binding, or underlying cardiovascular disease. Consider lower doses or smaller application areas.

• Always apply EMLA cream under an occlusive dressing (e.g., Tegaderm, plastic wrap) to ensure proper absorption and prevent accidental removal or transfer.
• Ensure the skin is intact before application; do not apply to open wounds, broken skin, or mucous membranes unless specifically indicated (e.g., leg ulcers, genital mucosa).
• The duration of application is critical for efficacy; typically 1 hour for minor procedures, up to 2-4 hours for deeper anesthesia.
• Wipe off the cream completely before the procedure to prevent interference with antiseptic solutions or surgical fields.
• Be vigilant for signs of methemoglobinemia, especially in infants, patients with G6PD deficiency, or those on concomitant methemoglobinemia-inducing drugs. Pulse oximetry may be unreliable in methemoglobinemia.
• Educate patients on the importance of not exceeding recommended dose, application area, or duration to minimize systemic absorption and toxicity risk.

• Topical Lidocaine (e.g., Lidoderm patch, Lidocaine cream/gel)
• Topical Benzocaine
• Topical Tetracaine
• Cryoanesthesia (e.g., ethyl chloride spray)
• Infiltrative local anesthetics (e.g., lidocaine injection)
• Non-pharmacological pain management techniques (e.g., distraction, cold packs)

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.