Racser

Lidocaine, prilocaine.

White smooth cream, free from foreign particle.
1 g of RACSER Cream contains Lidocaine 25 mg, Prilocaine 25 mg.

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.

Surface anaesthesia of the skin in connection with needle insertion and for superficial surgical procedures.
Surface anaesthesia of leg ulcers prior to cleaning and superficial surgical procedures, e.g. removal of fibrin, pus and necroses. Surface anaesthesia of the genital mucosa.

Recommended Dose: Adults: Intact skin: For needle insertion e.g. insertion of intravenous cannula, taking of blood samples - ¹/₂ tube (approximately 2g) per 10 cm² for 1 hour, maximum 5 hours. Apply thick layer of cream to the skin and cover with an occlusive dressing.
For minor superficial surgical, e.g. removal of warts - 1.5 to 2g per 10 cm2 for 1 hour, maximum 5 hours. Apply thick layer of cream to the skin and cover with an occlusive dressing.
For more extensive superficial surgical procedures, e.g. split skin grafting - 1.5 to 2g per 10 cm² for 2 hours, maximum 5 hours. Apply thick layer of cream to the skin and cover with an occlusive dressing.
Leg ulcers: For cleaning of leg ulcers: Approximately 1-2 g per 10 cm². Apply thick layer of cream to the surface of the skin ulcer, but not more than 10 g per treatment occasion. Cover the surface of the ulcer with an occlusive dressing.
Application time: at least 30 minutes.
An opened tube is intended for single use, and left-over cream should therefore be discarded after each treatment occasion.
For leg ulcers with tissue that is particularly difficult to penetrate, the application time may be extended to 60 minutes.
Cleaning of the ulcer should begin within 10 minutes after the cream has been removed.
Genital mucosa: For removal of condylomata or prior to injection of local anaesthetics: Approximately 5-10 g, depending on the area to be treated. The whole surface, including the mucous membrane folds must be covered. Occlusion is not necessary.
Application time: 5-10 minutes. The surgery may be begun immediately after removal of the cream.
Children: For needle insertion, removal of mollusca and other minor superficial surgical procedures: 1 g per 10 cm².
A thick layer of cream should be applied to the skin and covered with an occlusive dressing.
The dose should not exceed 1 gram per 10 cm² and must be adjusted according to the application area: See table.

Click on icon to see table/diagram/image

Children with atopic dermatitis: reduce application time to 30 minutes.
Route of administration: Topical.

Rare cases of clinically significant methaemoglobinaemia have been reported in children. Prilocaine in high doses may cause an increase in the methaemoglobin level. Topical administration of 125 mg prilocaine for 5 hours caused moderate methaemoglobinaemia in a 3-month-old child. Topical administration of 8.6-17.2 mg/kg lidocaine caused very severe intoxication in babies.
Should other symptoms of systemic toxicity occur, the signs are anticipated to be similar in nature to those following the administration of other local anaesthetic treatment, i.e. excitatory CNS symptoms and in severe cases CNS depression and myocardial depression.
Severe neurological symptoms (convulsions, CNS depression) must be treated symptomatically by assisted ventilation and the administration of anticonvulsive drugs. The antidote for methemoglobinemia is methyl thionine. A patient with symptoms of toxicity should be observed for several hours after treatment of these symptoms due to slow systemic absorption.

Hypersensitivity to local anaesthetics of the amide type or to any other component of the product. RACSER Cream must not be used on premature infants (born before 37 completed weeks of pregnancy).

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.

Pregnancy/Reproduction: No specific disturbances to the reproductive process have been reported so far. However, caution should be exercised when treating pregnant women.
Breastfeeding: Lidocaine, and in all probability, Prilocaine are excreted in breast milk, but in such small quantities that there is generally no risk of the child being affected at therapeutic dose levels.

Adverse reactions to local anaesthetics in the true sense of the term, occur in <1/1000 of those treated.
Common (>1/100): Skin: Transient local skin reactions at the application site e.g. local paleness, redness, oedema.
Uncommon (1/100-1/1000): Skin: Initially slight smarting, itching (at the application site).
Rare (<1/1000): General: Allergic reactions, in the most severe cases, anaphylactic shock.
Methaemoglobin in children.
Rare cases of discrete actions at the application site (e.g. purpura or pethechiae), have been reported, especially after prolonged application times in children with atopic dermatitis or warts.
In cases of accidental contact with the eye, corneal irritation can occur.

RACSER Cream may cause an increase in the formation of methaemoglobin in patients treated with methaemoglobin-inducing drugs (e.g. sulphonamides).
With large doses RACSER Cream, consideration should be given to the risk of additional systemic toxicity in patients receiving other local anesthetics or agents structurally related to local anaesthetics (e.g. tocainide), since the toxic effects are additive.
There are no specific interaction studies with local anaesthetics and class III antiarrhythmic drugs (e.g. amiodarone) carried out, but caution is recommended.

Store at a temperature below 30°C and protected from light.
Shelf Life: 36 Months from the date of manufacture.

Anaesthetics - Local & General

N01BB20 - combinations ; Belongs to the class of amides. Used as local anesthetics.

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