Permethrin 5% w/w Cream

Permethrin 5% w/w (cis:trans isomer 25:75)

For excipients, see 6.1.

Cream.

Permethrin 5% Cream is indicated for the treatment of scabies.

Permethrin 5% Cream is suitable for adults, children of 2 months of age and above, and the elderly.

Permethrin 5% Cream is for external use only and should not be applied to broken skin, mucous membranes or near the eyes.

Permethrin 5% Cream should be applied to skin which is clean dry and cool. It should not be used immediately after a hot bath.

Children under 2 years should only be treated under medical supervision.

Older children should be supervised when applying the cream.

Permethrin 5% Cream is intended for a single application over the whole body. In view of the great variability in body area and skin types, precise dosage recommendations are not possible.

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

Adults & children over 2 years:

Apply the cream over the whole body but NOT the head and face. Pay particular attention to the areas between fingers and toes, under nails, wrists, armpits, external genitalia, breasts and buttocks.

The elderly:

Apply the cream over the whole body INCLUDING the neck, face, ears and scalp. Pay particular attention to the areas between fingers and toes, under nails, wrists, armpits, external genitalia, breasts and buttocks. Avoid the area close to the eyes.

Children under 2 years:

Apply the cream over the whole body INCLUDING the neck, face, ears and scalp. Pay particular attention to the areas between fingers and toes, under nails, wrists, armpits, palms of hands and soles of feet, external genitals and buttocks. Avoid the area around the mouth where the cream could be licked off and the area around the eyes.

The cream should be left on for at least 8 hours.

Reapply the cream to the hands if they are washed within 8 hours of treatment.

The whole body should be washed thoroughly 8-12 hours after application.

Approximately 90% of individuals are cured after a single application. If there are no signs of the original lesions healing or if new lesions have appeared, a second application can be made not less than 7 days after the first application.

Hypersensitivity to permethrin, to other pyrethroids or pyrethrins, or to any other ingredients of the cream.

Permethrin 5% Cream should be kept out of the reach of children.

Permethrin 5% Cream is for external use only. Nursing staff who routinely apply Permethrin 5% Cream may wish to wear gloves to avoid any possible irritation to the hand.

Avoid contact with the eyes. The cream can cause eye irritation. If you do get cream in your eyes, rinse with water immediately.

The treatment of eczematous-like reactions with corticosteroids should be withheld prior to treatment with Permethrin 5% 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.

The limited data available on the use of Permethrin 5% Cream show no indication of any risk to the foetus. The amount of permethrin absorbed systemically following a whole body application is extremely low. However, some permethrin may pass the placental barrier. The negative mutagenicity tests and the very low mammalian toxicity suggest that there is minimal risk to the foetus following treatment with permethrin.

It has been shown that very low concentrations of permethrin are excreted in milk following oral administration of permethrin in cattle. It is not known whether permethrin is excreted in human breast milk. However, it is unlikely that the concentrations of permethrin in the milk will present any risk to the neonate/infant as only extremely small amounts of permethrin are absorbed systemically and in theory only a very small percentage of this will pass into the breast milk.

None known.

Occasional reports of

• Burning or stinging sensation which passes quickly. This is usually mild and occurs more frequently in patients with severe scabies.

• Transient signs and symptoms of skin irritation including rash or itching, erythema, oedema and eczema.

These are generally considered to be part of the natural history of scabies. Itching may persist for up to 4 weeks after treatment. This is an allergic reaction to the dead scabies mites. It is normal and is not a sign that treatment has failed.

There are no reports of overdosage of Permethrin 5% Cream.

Excessive application to the skin might result in local adverse reactions. Application of a full tube (30g) of cream to a 2-month old would result in a dose of approximately 350mg/kg bodyweight. Even if completely absorbed, this dose would be unlikely produce overt signs of systemic toxicity.

In the event of accidental ingestion by a child, gastric lavage should be considered if within 2 hours of ingestion.

Treatment of hypersensitivity reactions should be symptomatic.

The principal physiological action in susceptible parasites exposed to permethrin is induction of electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyper-excitability, inco-ordination and prostration.

Permethrin is rapidly metabolised in mammals by ester hydrolysis to inactive metabolites which are excreted principally via the kidneys. The principal metabolites are detectable in the urine within 7 hours of whole body application of the cream to healthy volunteers or scabies patients. The highest levels of excretion are detectable within 48 hours but very low levels of metabolite are still detectable in the urine of some individuals 28 days after treatment. The overall pattern of excretion indicates that approximately 0.5% of applied permethrin is absorbed in the first 48 hours.

Long-term studies in rats revealed no evidence of oncogenicity. 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 for two years (approximately 750 mg/kg bodyweight/day). These findings are not considered to indicate a significant oncogenic potential for permethrin in humans.

Cetylstearyl alcohol

Paraffin, hard

Cetomacrogol 1000

Isopropylmyristate

Benzyl alcohol

Purified water

None known

24 months

Do not store above 25°C. Do not freeze.

Aluminium tube with polypropylene cap. Contains 30g of cream.

None

Sandoz Ltd

Woolmer Way

Bordon

Hampshire

GU35 9QE

PL 4416/0456

9 September 2003

9 September 2003