Lidocaine 2.5% w/w (25mg/g), Prilocaine 2.5% w/w (25mg/g)

What Lidocaine/Prilocaine is used for:

Lidocaine/Prilocaine topical cream is indicated for:

• Topical anaesthesia of the skin 
• Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia; in adults and adolescents ≥ 12 years
• Topical anaesthesia of leg ulcers to facilitate mechanical cleansing/debridement in adults only.

Do not take Lidocaine/Prilocaine:

If you know you are allergic to lidocaine and/or prilocaine or local anesthetics of the amide type.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Lidocaine/Prilocaine if you:

• or your child have a rare inherited illness that affects the blood called ‘glucose-6-phosphate dehydrogenase deficiency’.
• or your child have a problem with blood pigment levels called “methemoglobinaemia”.
• or your child have an itchy skin condition called ‘atopic dermatitis’, a shorter application time may be sufficient.
• take particular products for heart rhythm disorders (class III antiarrhythmics, such as amiodarone). 

Lidocaine/Prilocaine should not be used:

• in newborn infants/infants up to 12 months of age receiving concomitant treatment with methemoglobin-inducing agents.
• in preterm newborn infants with a gestational age less than 37 weeks as they are at risk of developing increased methemoglobin levels.

Possible side effects :

These include transient local skin reactions (paleness, redness, swelling) in the treated area during treatment of skin, genital mucosa or leg ulcers, an initially mild sensation of burning, itching or warmth at the treated area during treatment of genital mucosa or leg ulcers.

Pediatric population:

Frequency, type and severity of adverse reactions are similar in the pediatric and adult age groups, except for methemoglobinemia, which is more frequently observed, often in connection with overdose, in newborn infants and infants aged 0 to 12 months.

Other medicines and Lidocaine/Prilocaine:

Tell your doctor or pharmacist if you are taking: 

• Medicines used to treat infections, called ‘sulphonamides’ and nitrofurantoin.
• Medicines used to treat epilepsy, called phenytoin and phenobarbital.
• Other local anaesthetics.
• Medicines to treat an uneven heartbeat, such as amiodarone.
• Cimetidine or beta-blockers, which may cause an increase in the blood levels of lidocaine. 

How to use Lidocaine/Prilocaine:

Adults and adolescents 12 years of age and above:

Skin

• Minor procedures, e.g. needle insertion and surgical treatment of localised lesions: 2 g (approx half a 5 g tube) or approx. 1.5 g/10 cm2 for 1 to 5 hours.
• Dermal procedures on newly shaven skin of large body areas, e.g. laser hair removal (self-application by patient): Maximum recommended dose: 60 g. Maximum recommended treated area; 600 cm2 for a minimum of 1 hour, maximum 5 hours.
• Dermal surgical procedures on larger areas in a hospital setting, e.g. split-skin grafting: Approx 1.5-2 g/10 cm2 for 2 to 5 hours.
• Skin of male genital organs-Prior to injection of local anaesthetics: 1 g/10 cm2 for 15 minutes.
• Skin of female genital organs-Prior to injection of local anaesthetics: 1-2 g/10 cm2 for 60 minutes.

Genital mucosa

• Surgical treatment of localised lesions, e.g. removal of genital warts (condylomata acuminata) and prior to injection of local anaesthetics: approx 5-10 g of cream for 5-10 minutes.
• Prior to cervical curettage: 10 g of cream should be administered in the lateral vaginal fornices for 10 minutes.

Leg ulcer(s)

Mechanical cleansing/debridement: approx 1-2 g/10 cm2 up to a total of 10 g to the leg ulcer(s). Application time: 30-60 minutes.

Pediatric patients 0-11 years of age :

• Newborn infants and infants 0-2 months: up to 1 g and 10 cm2 for one hour
• Infants 3-11 months: up to 2 g and 20 cm2 for one hour
• Toddlers and children 1-5 years: up to 10 g and 100 cm2 for 1-5 hours
• Children 6-11 years: up to 20 g and 200 cm2 for 1-5 hours
• Pediatric patients with atopic dermatitis: application time: 30 minutes.

How to store Lidocaine Prilocaine:

• Keep this medicine out of the sight and reach of children.
• Do not store above 30°C and do not freeze.
• Do not use this medicine after the expiry date which is stated on the package and tube after ‘EXP:’. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.