ENNLA 5% CREAM 5×5GM

Indications

Off-Label Uses

Off-label: analgesia for cosmetic skin procedures (e.g., laser hair removal, tattoos/piercings) and premature ejaculation (topical genital use).

Dosage & Administration

Initial Dose

Apply 1.5-2g per 10cm² of skin under occlusive dressing

Maintenance Dose

Single application per procedure; reapplication not typically required

Maximum Dose

Adults (intact skin): up to 60 g over a maximum 600 cm² for up to 5 hours. Pediatrics: maximum depends on age/weight and area (e.g., 1-6 years >10 kg: max 10 g over 100 cm²; 7-12 years >20 kg: max 20 g over 200 cm²).

Children's Dosage

Dosing is based on age and weight. 0-3 months (<5 kg): Max 1g over 10 cm² for 1 hour. 3-12 months (>5 kg): Max 2g over 20 cm² for up to 4 hours. 1-6 years (>10 kg): Max 10g over 100 cm² for up to 4 hours. 7-12 years (>20 kg): Max 20g over 200 cm² for up to 4 hours.

Side Effects

Common Side Effects

Very common: application-site pallor, erythema, edema. Common: application-site burning/stinging, itching/pruritus, altered temperature sensation.

Safety & Warnings

Warnings & Precautions

Do not exceed recommended amount/area/time; avoid eyes and do not apply to broken/damaged/inflamed skin unless directed; occlusion increases absorption; monitor/avoid use in patients at risk of methemoglobinemia (infants, G6PD deficiency, congenital/idiopathic methemoglobinemia, and those on methemoglobin-inducing drugs); caution in severe hepatic disease and significant cardiac conduction disease/antiarrhythmic use; protect the numbed area from heat/cold/trauma until sensation returns.

Age Restriction

Do not use in preterm neonates (<37 weeks gestational age). Use with caution in infants <12 months, with highest caution in those <3 months (greater methemoglobinemia risk).

Special Populations

Children

Dosing is based on age and weight. 0-3 months (<5 kg): Max 1g over 10 cm² for 1 hour. 3-12 months (>5 kg): Max 2g over 20 cm² for up to 4 hours. 1-6 years (>10 kg): Max 10g over 100 cm² for up to 4 hours. 7-12 years (>20 kg): Max 20g over 200 cm² for up to 4 hours.

Storage & Patient Advice

Patient Counseling

Apply a thick layer to intact skin only and cover with an occlusive dressing for the time directed before the procedure (often ~60 minutes on intact skin; shorter on genital mucosa as directed). Avoid eyes, mouth, and inside the nose/ears; do not use on broken/irritated skin unless specifically instructed. Do not exceed the prescribed amount/area/time-especially in infants/young children-due to risk of systemic toxicity and methemoglobinemia; seek urgent care if bluish/gray skin or lips, unusual drowsiness, dizziness, shortness of breath, or palpitations occur. Protect the numbed area from heat/trauma until sensation returns. Store below 30°C and keep the tube tightly closed.

Monitoring Requirements

No routine laboratory monitoring for standard small-area use on intact skin; in high-risk patients (especially infants/young children, G6PD deficiency, or those on methemoglobin-inducing drugs, or with large-area/prolonged application), monitor clinically for methemoglobinemia and consider methemoglobin measurement if symptoms or high-risk exposure occurs.

Pharmacology

Mechanism of Action

A eutectic mixture of lidocaine and prilocaine that produces local anesthesia by reversibly blocking voltage-gated sodium channels in neuronal membranes, inhibiting initiation and conduction of nerve impulses.

Onset of Action

Intact skin: typically requires about 60 minutes under occlusion for adequate anesthesia (may be 45-60 minutes depending on site/age); genital mucosa: about 5-10 minutes.

Duration of Effect

On intact skin, anesthesia typically persists about 1-2 hours after removal (longer application can prolong effect).

Bioavailability

Systemic absorption after topical application is generally low from intact skin and is highly dependent on site, surface area, duration, and occlusion; typical systemic absorption is in the low single-digit range (often cited around ~3-5% from intact skin under usual conditions).

Excretion

Both lidocaine and prilocaine are extensively metabolized and their metabolites are primarily excreted in urine; only a small fraction of parent drug is excreted unchanged.

Product Information

Available Dosage Forms

Cream (this product: 5% cream in 5 g tube per SFDA); lidocaine/prilocaine is also available in some markets as a topical patch.

Composition per Dose

Each gram of cream: Lidocaine hydrochloride 25mg + Prilocaine 25mg (total anesthetic concentration 5%)

Skin Condition

Wound Care

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.