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Pharmacodynamics: Lidocaine and prilocaine are local anaesthetics of the amide type. On penetration into the epidermis and dermis these substances produced anaesthesia of the skin. The degree of anaesthesia depends on the dose and application time.
Intact skin: With an application time of 1-2 hours, the effect lasts for approximately 2 hours after the occlusive dressing has been removed.
No differences with regard to safety or efficacy including time to anaesthesia could be seen between geriatric patients (65-96 years) and younger patients.
The superficial vascular bed is affected by RACSER Cream. This can cause transient paleness or redness. This reaction happens more rapidly in patients with atopic dermatitis, after only 30 to 60 minutes, indicating more rapid absorption through the skin.
A study in healthy volunteers with intact skin indicates that in 90% the anaesthesia is enough for use of biopsy punches (Diameter: 4 mm) to a depth of 2 mm after 60 minutes application time and to a depth of 3 mm after 120 minutes application time.
RACSER Cream can be used before vaccination with subcutaneous or intramuscular vaccine.
Refer to Precautions for intracutaneous vaccination with live vaccine, e.g. BCG.
RACSER Cream is equally effective, irrespective of the skin pigmentation/colour (skin types I-VI).
Genital mucosa: As the absorption takes place more rapidly than in cases of application to intact skin, the time to onset of action for necessary anaesthesia is shorter.
After 5-10 minutes application of RACSER Cream to genital mucosa in women, the local anaesthesia for argon laser-induced pain lasted for 15-20 minutes (interindividual variation from 5 to 45 minutes).
Leg ulcers: For cleaning leg ulcers, RACSER Cream gives pain relief for up to 4 hours after application.
No negative effect on ulcer healing or bacterial flora has been observed.
Pharmacokinetics: The systemic absorption of RACSER Cream depends on the following: the amount of cream; the application time; the thickness of the skin (this varies between different areas of the body); the condition of the skin in other respects.
Intact skin: The systemic absorption has been measured as being 3% for lidocaine and 5% for prilocaine after application of RACSER Cream 60 g/400 cm2 (1.5 g/10 cm2) for 3 hours to intact skin (thigh) in adults. Absorption takes place slowly.
With the previously mentioned dose, maximum plasma concentrations for lidocaine (mean 0.12 μg/ml) and prilocaine (mean 0.07 μg/ml) were reached within approximately 4 hours after application. There is a risk of toxic symptoms only at levels of 5-10 μg/ml.
Genital mucosa: After application of 10 g RACSER Cream to the vaginal mucosa for 10 minutes, maximum plasma concentrations (means: lidocaine 0.18 μg/ml; prilocaine 0.15 μg/ml) were measured after approximately 35 minutes.
Leg ulcers: Maximum plasma levels of lidocaine and prilocaine were reached after approximately 1-2.5 hours (for lidocaine within the range 0.05 -0.84 μg/ml and for prilocaine 0.02-0.08 μg/ml) after application of 5-10 g RACSER Cream for 30 minutes to leg ulcers.
No relevant accumulation in plasma of lidocaine, prilocaine or their metabolites was observed after repeated application of RACSER Cream to leg ulcers. 2-10 g RACSER Cream was applied for 30 to 60 minutes to a maximum area of 62 cm2 for a total of 15 times in 1 month, 3-7 treatment occasions per week.
