Lyclear Dermal Cream

Permethrin, Medical Grade 5.0% w/w (Cis/Trans Isomer 25/75)

For excipients, see 6.1

Cream for topical application.

Lyclear Dermal Cream is indicated for the treatment of scabies and crab lice.

Treatment of scabies

Lyclear Dermal Cream is suitable for use by adults and children of 2 months of age and above.

Lyclear Dermal Cream is also suitable for use by the elderly.

Lyclear Dermal Cream 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.

Lyclear Dermal 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 to ensure that a thorough treatment is administered.

The whole body should be washed thoroughly 8 – 12 hours after treatment.

Use in adults and children over 2 months

In view of the great individual variability in body area and skin types precise recommendations are not possible.

For adults and children over 12 years of age, up to a 30 g 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 (60 g 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 based on the use of a 30 g tube.

Children aged:

2 months to 1 year - Up to 1/8 of a tube

1-5 years - Up to ¼ of a tube

6-12 years - Up to ½ of a tube

In cases where the head, neck, scalp and ears are treated (see below) the dosage may be increased to ensure total body coverage.

In adults and children over 2 years of age Lyclear Dermal Cream should be applied to the whole body excluding the head paying particular attention to the areas between the fingers and toes, wrists, axillae, external genitalia, buttocks and under finger and toe nails. In women, the whole body application should include the breasts.

During the treatment period, Lyclear Dermal Cream should be re-applied to the hands if they are washed with soap and water.

Children between 2 months and 2 years should be treated under medical supervision. Lyclear Dermal Cream should be applied over the whole body as directed for adults and children over 2 years, but should include the palms, soles, face, neck, scalp and ears. Care must be taken to avoid the vicinity of the mouth where it could be licked off, and areas close to the eyes.

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.

Use in the Elderly

In the elderly Lyclear Dermal Cream should be used as directed for adults and children over 12 years but should also include the head, neck, scalp and ears. Care must be taken to avoid applying Lyclear Dermal Cream to areas close to the eyes.

Treatment of crab lice

The elderly

The elderly should be treated only on the advice of a doctor or a health professional.

Adults 18 years and over

Sufficient cream should be applied to cover the pubic region, peri-anal (around the anus), inner thighs down to the knees and any hair that grows up from the pubic area to the chest/stomach.

One (30 g) tube is more than sufficient to treat one hairy adult. It is recommended that up to a third of a tube is used to treat the pubic region, peri-anal region, thighs, stomach and chest. Not more than two thirds of the tube should be needed for complete treatment.

For relatively hair-free individuals proportionately less cream will be required.

The cream should be left on the skin for 24 hours. The treatment areas should then be thoroughly washed.

Any facial hair (beards, moustaches) and eyelashes should be checked for the presence of live lice and eggs. Cream should be applied to any facial hair, carefully avoiding eyes. If live lice or eggs are found on the eyelashes they should be removed carefully using tweezers. Cream should not be applied to the eyelashes because the cream can cause moderate eye irritation.

Lyclear Dermal Cream is contraindicated in subjects with known hypersensitivity to the product, its components, other pyrethroids or pyrethrins.

Lyclear Dermal Cream is for external use only and should be kept out of reach of children.

Permethrin is not an eye irritant but contact of Lyclear Dermal Cream with the eyes should be avoided because the cream itself may 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.

Nursing staff who routinely apply Lyclear Dermal Cream may wish to wear gloves to avoid any possible irritation to the hands.

There is an increasing body of data specifically relating to the use of Lyclear Dermal 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.

No interactions are known.

The treatment of eczematous-like reactions with corticosteroids should be withheld prior to treatment with Lyclear Dermal Cream, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite. The likelihood of interactions between the two treatments leading to potentiated adverse reactions or reduced efficacy is, however, small.

There are limited data on the use of Lyclear Dermal 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. Some permethrin may cross the placental barrier. The negative mutagenicity tests and the very low mammalian toxicity would suggest that any risk to the foetus following treatment with Lyclear Dermal Cream is minimal.

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. However, because only extremely small amounts of permethrin are absorbed systemically following treatment with Lyclear Dermal Cream and in theory only a very small percentage of this systemic permethrin may pass into the breast milk, it is unlikely that the concentrations of permethrin in the milk will present any risk to the neonate/infant.

Reproduction studies in mice, rats and rabbits given oral dosage of 200 to 400 mg/kg bodyweight/day, revealed no evidence of impaired fertility. In addition, permethrin did not show any adverse effects on the reproductive function of rats given an oral dosage of 180 mg/kg bodyweight/day, in a three generation study.

There was no evidence of teratogenicity in reproduction studies in mice, rats and rabbits.

None known.

In scabies patients, skin discomfort, usually described as burning, stinging or tingling, occurs in a few individuals soon after Lyclear Dermal Cream is applied. This occurs more frequently in patients with severe scabies and is usually mild and transient.

Other transient signs and symptoms of irritation, including erythema, oedema, eczema, rash and pruritus which may follow treatment of scabies with Lyclear Dermal Cream are generally considered to be part of the natural history of scabies.

In patients treated for scabies, itching may persist for up to 4 weeks post-treatment. This is generally regarded as due to an allergic reaction to the dead mites under the skin and is not necessarily indicative of a treatment failure.

There are no reports of overdosage with Lyclear Dermal Cream.

Application of a full tube of cream to a 2 month old would result in a dose of approximately 350 mg/kg bodyweight to skin. It is unlikely that such a dose would cause overt signs of systemic toxicity even if 100% of the permethrin were absorbed.

It is possible that excessive application of Lyclear Dermal Cream might result in localised adverse reactions or more severe skin reactions.

Symptomatic treatment is indicated should hypersensitivity-type reactions occur.

In the event of accidental ingestion of the contents of a tube of Lyclear Dermal Cream by a child, gastric lavage should be considered if consultation is within 2 hours of ingestion.

The principal physiological action in insects (lice) exposed to permethrin is induction of electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyperexcitability, inco-ordination and prostration. It is assumed that the mode of action against arachnids (mites) is similar.

Permethrin is rapidly metabolised in mammals by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. The principal metabolites of permethrin are detectable in the urine within hours of a whole body application of the cream to healthy volunteers or scabies patients. The highest levels of metabolite are still detectable in the urine of some individuals 28 days after treatment. The overall pattern of excretion indicates a mean of approximately 0.5% of applied permethrin is absorbed during the first 48 hours.

In vitro and in vivo genetic toxicity studies were all negative, revealing no potential for permethrin to induce mutagenic changes.

In repeated long-term bioassays for carcinogenic potential performed in rats, no evidence of oncogenicity was observed. Similar studies in mice have shown species specific increases in pulmonary adenomas, a common benign tumour of mice of high spontaneous background incidence. In one of these studies, there was an increased incidence of benign liver adenomas and of pulmonary alveolar cell carcinomas only in female mice when permethrin was given in their food at 1:5000 parts per million (approximately 750 mg/kg bodyweight/day) for two years. It is considered that these findings do not indicate a significant oncogenic potential for permethrin in humans.

Fractionated coconut oil

Glyceryl monostearate

Macrogol (2) cetyl ether

Cetomacrogol 1000

Isopropyl myristate

Lanolin alcohols/liquid paraffin

Mixture (amerchol 1-101)

Butylated hydroxytoluene

Glycerol

Formaldehyde solution

Carbomer

Sodium hydroxide

Purified water

None known

60 months

Do not store above 25°C.

Do not freeze.

Plastic foil laminate ointment tubes (30g) with Polyolefin screw caps.

Or

Internally lacquered membrane sealed collapsible aluminium tubes (30g) with high density polyethylene caps.

Not applicable.

Chefaro UK Ltd,

4^th Floor, Hamilton House,

Mabledon Place, Bloomsbury,

LONDON, WC1H 9BB

United Kingdom

PL 02855/0014

17th January 2005

14th November 2010