This lotion is indicated for the treatment of scabies and pruritus.
Local Antipruritic, Parasiticidal preparations
This is a combination of Permethrin which is a photostable synthetic pyrethroid that possesses a broad spectrum of insecticidal activity and low mammalian toxicity and Crotamiton which is used to treat scabies infection. It is also used to relieve the itching of certain skin conditions.
Mode of action: The insect rapidly absorbs Permethrin via mouth, respiratory tract or the intact cuticle. Although the primary target tissue is the nervous system, insects are not killed by dysfunction of a single organ but by a complex series of reactions in various organs, such as metabolic exhaustion and paralysis of the nervous system. Permethrin primarily affects sodium channels in the nerve membrane and causes prolongation of the transient increase in sodium permeability associated with membrane depolarization. After treatment with permethrin, the sodium current is evoked by a step depolarization of the membrane. This leads to sensory hyperexcitability, incoordination and prostration. It is assumed that mode of action against mites is similar.
Pharmacokinetics: The only approved route of administration is the topical route and there are few human data available on systemic exposure or kinetics following permethrin application to the skin. Some presystemic metabolism occurs in skin. Less than 0.5% of applied permethrin is absorbed during the first 48 hours. Absorbed permethrin is rapidly metabolized by ester hydrolysis, most likely in the liver and the products are excreted primarily in the urine. Crotamiton penetrates rapidly into human skin. Low but measurable concentrations of crotamiton are found in plasma, with a maximum level after 4-10 hours, declining rapidly thereafter.
Adult: Permethrin & Crotamiton lotion is suitable for adults, children of 2 months of age and above, and the elderly. It is for external use only and should not be applied to broken skin, mucous membranes or near the eyes. Permethrin & Crotamiton lotion should be applied to skin which is clean, dry and cool. It should not be used immediately after a hot bath. Permethrin & Crotamiton lotion is intended for a single application over the whole body. Permethrin & Crotamiton lotion should be left on for at least 8 hours. Reapply the lotion to the hands if they are washed within 8 hours of treatment. The whole body should be washed thoroughly 8-12 hours after application. Adults & children over 2 years: Apply the lotion 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 lotion 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: Children under 2 years should only be treated under medical supervision. Apply the lotion 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 lotion could be licked off and the area around the eyes
The treatment of eczematous-like reactions with corticosteroids should be withheld prior to treatment with Permethrin and Crotamiton lotion, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite.
Combination of permethrin 5% and crotamiton 10% is contra-indicated in patients with known hypersensitivity to permethrin or crotamiton. This lotion should be kept out of the reach of children. This lotion is for external use only. Nursing staff who routinely apply this lotion may wish to wear gloves to avoid any possible irritation to the hand. Avoid contact with the eyes. The lotion can cause eye irritation. If lotion goes to the eyes, rinse with water immediately.
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, edema and eczema. These are generally considered to be part of the natural history of scabies.
There is no experience to judge the safety of permethrin & crotamiton in pregnancy, therefore it is not recommended during pregnancy, especially in the first three months. It is not known whether the active substance passes into breast milk. Nursing mothers should avoid applying it in the area of the nipples.
There are no reports of over dosage with Permethrin and Crotamiton lotion. It is possible that excessive application of Permethrin and Crotamiton lotion might result in localized adverse reactions or more severe skin reactions.
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.
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