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emla™ cream 5% (prilocaine, lidocaine).

Consult Summary of Product Characteristics before prescribing.

Use
Local anaesthetic for topical use to produce surface anaesthesia of the skin and on the genital mucosa to facilitate the removal of warts in adults.

Presentation
White cream containing lidocaine 25mg/g and prilocaine 25mg/g

Dosage and administration
Adults (including elderly) and children > 1 year Skin (apply a thick layer of cream under an occlusive dressing). For minor dermatological procedures e.g. needle insertion and surgical treatment of localised lesions. Approximately 2g emla applied for a minimum of 60 minutes, maximum 5 hours. For dermal procedures on larger areas e.g. split skin grafting. Approximately 1.5-2g/10 cm2 emla applied for a minimum of 2 hours, maximum 5 hours.

Male genital skin
(apply a thick layer of cream under an occlusive dressing). Prior to injection of local anaesthetic. Approximately 1g/10 cm2 emla applied for 15 minutes

Genital mucosa (adults) (no occlusive dressing required).
For surgical treatment of localised lesions. Approximately 5-10g emla for 5-10 minutes. Commence procedure immediately thereafter.

Analgesic efficacy may decline if the skin application time is more than 5 hours. Procedures on intact skin should begin soon after the occlusive dressing is removed.
On the genital mucosa analgesic efficacy declines after 10-15 minutes and therefore the procedure should be commenced immediately.

Contraindications
Known hypersensitivity to anaesthetics of the amide type or to any other component of the product.

Precautions
Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to drug induced methaemoglobinaemia. Do not apply to wounds, mucous membranes or in areas of atopic dermatitis or to genital mucosa in children. Care should be taken not to allow emla to come in contact with the eyes as it may cause eye irritation. Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If contact with the eye occurs, immediately rinse the eye with water or sodium chloride solution and protect it until sensation returns. emla may be ototoxic and should not be instilled in the middle ear nor should it be used for procedures which might allow penetration into the middle ear. Caution should be exercised in patients with anaemia, congenital or acquired methaemoglobinaemia or patients on concomitant therapy known to produce such conditions. Patients treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. Lidocaine and prilocaine have bacteriocidal and antiviral properties in concentrations above 0.5 - 2%. For this reason, the results of intracutaneous injections of live vaccines should be monitored. Methaemoglobinaemia may be accentuated in patients already taking drugs known to induce the condition e.g. sulphonamides. The risk of additional systemic toxicity should be considered when large doses of emla are applied to patients already using other local anaesthetics or structurally related drugs e.g. mexiletine. Specific interaction studies with lidocaine/prilocaine and anti-arrhythmic drugs class III (e.g. amiodarone) have not been performed, but caution is advised. Use with caution in women who are pregnant or breastfeeding.

Undesirable events
Transient paleness, redness and oedema have been reported. Prilocaine has been known to cause methaemoglobinaemia when given parenterally. In rare cases local anaesthetics have been associated with allergic reaction including anaphylactic shock. Rare cases of discrete local lesions at the application site, described as purpuric or petechial, have been reported, especially after longer application times in children with atopic dermatitis or mollusca contagiosa. Corneal irritation after accidental eye exposure. An initial mild burning or itching sensation at the site of application. Uncommonly, local paraesthesia such as tingling at the site of application.

Legal category
P

Marketing authorisation number
PL 17901/0120.

Basic NHS cost
"Pre-medication pack" containing 5 x 5 g tubes emla and 12 occlusive dressings £9.75, 1 x 30 g tube £10.25, 1 x 5 g tube £1.73

Further information is available from the Marketing Authorisation holder
AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK.

emla is a trademark of the AstraZeneca group of companies.

AZ 01/08

 

C14499 March 2008