Lyclear Dermal Cream

/ GSK

The cream suitable for use by adults and children of 2 months of age and above, also suitable for use by the elderly. Should be applied to clean, dry, cool skin. If the patient has taken a warm bath prior to treatment the skin should be allowed to cool before the cream is applied. The cream is a vanishing cream and when rubbed gently into the skin it will disappear. Therefore, there is no need to continue to apply cream to the skin until it remains detectable on the surface. Older children should be supervised by an adult when applying the cream to ensure that a thorough treatment is administered. For adults and children over 12 years of age, up to one 30g tube may be used as a single application. A few adults may need to use more than one tube to ensure total body coverage, but not more than two tubes (60g in total) should be used for a single application. For children 12 years and under, the following table indicates the approximate amount of cream to be used as a single application. These drug recommendations are only approximate and are intended to serve as a guide. (Recommendations are based on the use of a 30g tube).
Children aged:
2 months to 1 year – up to ⅛ of a tube.
1-5 years – up to ¼ of a tube.
6-12 years – up to ½ of a tube.
The safety and efficacy of the drug in children under 2 months of age have not been established. No data are available.
Method of Administration: For cutaneous use only. The medicinal product must not be swallowed. Carefully apply a thin layer of cream to the skin (cutaneous use). Adults should apply the cream uniformly to the whole body including the neck, palms of the hands and soles of the feet. The head and face can be spared unless scabies efflorescences are present in this region. On application, the areas between the fingers and toes (also under the finger and toe-nails), the wrists, elbows, armpits, external genitalia and the buttocks should be especially carefully treated. In cases where the head, neck, scalp and ears are treated (see below) the dosage may be increased to ensure total body coverage. In women, the whole body application should include the breasts. The whole body should be washed thoroughly 8-12 hours after treatment. During the treatment period, the  Cream should be re-applied to the hands if they are washed with soap and water. Approximately 90% of individuals are cured with a single application of cream. If necessary, a second application may be given, not less than 7 days after the initial application, if there are no signs of the original lesions healing or if new lesions are present.
Paediatric population: Children should apply the cream uniformly to the whole body, including the palms of the hands, soles of the feet, neck, face, ears and scalp.  Parts of the skin around the mouth (because the cream could be licked off) and the eyes should be spared.  Children should be kept from licking the cream from the hands. If necessary, children should wear gloves.

Treatment of scabies.

Hypersensitivity to the active substance permethrin, other substances of the pyrethrin group, any of the excipients, or to chrysanthemums. In such cases treatment should be switched to a chemically different antiscabies agent.

In the case of hypersensitivity to chrysanthemums or other compositae, treatment should only be given if strictly indicated. When using the Cream, care should be taken not to allow the cream to get into the eyes or come into contact with mucous membranes (e.g. nasopharyngeal space, genital area) or open wounds.
Paediatric population: Only limited experience is available in children aged 2 months to 23 months. Therefore treatment must be given only under close medical supervision in this age group. For cutaneous use only. The cream is for external use only and should be kept out of the sight and reach of children. Permethrin is not an eye irritant, but contact of the  cream with the eyes should be avoided because other components of the product can cause marked irritation. In the event of inadvertent eye contamination, the affected area should be rinsed immediately with plenty of water or, if readily available, normal saline. In the event of accidental ingestion of permethrin, please seek immediate medical attention. It is important to ensure that the course of treatment is followed as directed because treatment failure has been reported when this has not occurred. Nursing staff who routinely apply the cream may wish to wear gloves to avoid any possible irritation to the hands. Direct contacts should be treated. If no improvement occurs consult the doctor. Pyrethrins are used as an agricultural and horticultural insecticide, the potential for sensitisation through this route should be kept in mind.
Elderly patients: There is an increasing body of data specifically relating to the use of the cream for the treatment of scabies in the elderly, and in view of these data it is considered that there is no need for any special precautions for use in this age group.

Paresthesia, skin burning, sensation, Pruritus, erythematous rash, dry skin.
See prescribing information for full details.

No interactions are known.
See prescribing information for full details.

Pregnancy: There are limited data on the use of the cream in pregnancy which provide no indication of any risk to the foetus. Furthermore, the amount of permethrin absorbed systemically following a whole body application is extremely low, less than 0.5% of the applied dose is absorbed. These data together with the negative mutagenicity tests and the very low mammalian toxicity would suggest that any risk to the foetus following treatment with the drug is minimal. Women who are pregnant should use permethrin only after prior consultation with a healthcare professional.
Lactation: Studies, following oral administration of permethrin in cattle have indicated that very low concentrations of permethrin are excreted in milk. It is not known whether permethrin is excreted in human breast milk.
See prescribing information for full details.   

On the basis of animal and human volunteer studies, it is unlikely, even with misuse or excessive topical application that the amount of permethrin required to produce clinically relevant toxic effects would be reached. In the event of accidental ingestion of permethrin, please seek immediate medical attention.
Symptoms: Symptoms of overdose are generally likely to occur primarily because after accidental or deliberate oral ingestion due to swallowing and in rare cases because of skin absorption following excessive topical application and may include dizziness, loss of appetite, nausea, vomiting, headache, weakness, seizures, and loss of consciousness. It is possible that excessive application of the cream cream might result in localised adverse reactions as described in the side-and adverse effects section or more severe skin reactions.
Managment: Symptomatic treatment is indicated should hypersensitivity-type reactions occur. In the event of overdose or accidental ingestion of the contents of a tube of the cream by a child, gastric lavage should be considered if consultation is within 2 hours of ingestion.

Storage: Do not store above 25ºC. Do not freeze.