Care should be taken when applying RACSER Cream to patients with atopic dermatitis. The application time should be reduced to 15-30 minutes. RACSER Cream should not be applied to the genital mucosa of children and open sores.
RACSER Cream should not be used on a damaged tympanic membrane or in other situations when penetration to the middle ear may occur.
RACSER Cream can cause irritation in the eyes. Therefore RACSER Cream must be used with care near the eyes.
The loss of protective reflexes may allow the occurrence of corneal irritation and potential abrasion. lf RACSER comes in contact with the eyes, the eye should be rinsed immediately with water or sodium chloride solution, and protected until sensation returns.
The results of intracutaneous injections of live vaccine (e.g. BCG) should be carefully monitored as lidocaine and prilocaine have bactericidal and antiviral properties in concentrations above 0.5-2%.
When RACSER Cream is used as recommended for adults, the formation of methaemoglobin as a result of metabolites of prilocaine is not normally a clinical problem. However, some patients are more susceptible to drug-induced methaemoglobinaemia, such as patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia.
As the cardiac effects of lidocaine and class III antiarrhythmic drugs can be additive, patients treated with class III antiarrhythmic drugs (e.g. amiodarone) should be closely observed and ECG monitoring should be considered.
Effects on ability to drive and use machines: Reaction capacity is not affected by treatment with RACSER Cream.
Use in Children: Studies have not been able to show that RACSER Cream gives pain relief during the heel lancing of neonates.
In children aged under 3 months, safety and efficacy have only been studied with administration of a single dose. A transient increase in the methaemoglobin level is often seen for up to 13 hours after RACSER Cream has been applied in these children. However, the increases observed are probably of no clinical significance. Until further clinical experience has been obtained, RACSER Cream should not be used on children aged 0-12 months who are being treated concomitantly with methaemoglobin-inducing drugs.