Crotam Plus 5%+10%

INDICATIONS

This combination lotion is indicated for the treatment of scabies and pruritus. Moreover, it is used for the relief of itching and skin irritation like as sunburn, dry eczema, itchy dermatitis, allergic rashes, hives, nettle rash, chickenpox, insect bite and stings, heat rashes and personal itching.

PHARMACOLOGY

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.

DOSAGE

Adults (including the elderly): After the patient has taken a warm bath, the skin should be well dried and Crotam Plus rubbed into the entire body surface (excluding the face and scalp) until no traces of the preparation remain visible on the surface. The application should be repeated once daily, preferably in the evening, for a total of 3-5 days. Depending on the response, special attention should be paid to sites that are particularly susceptibly to infestation by the mites (e.g. interdigital spaces, wrists, axillae and genitalia). Areas where there is pus formation should be covered with a dressing impregnated with this lotion.  While the treatment is in progress the patient may take a bath shortly before the next application. After completion of the treatment, a cleansing bath should be taken followed by a change of bed linen and underclothing.Children: Application as described for adults but in children under 2 years of age this lotion should not be applied more than once a day.
 
Treatment procedure: Before application of this lotion the skin should clean, cool and dry. For adults and children over 2 years: Apply the lotion to the whole body from the neck down, rubbing lightly into the skin until the lotion disappears. It is important to include all skin surfaces, such as between the fingers and toes, under the nails and on the soles of the feet. For babies under 2 years: Apply to the face, neck, ears and scalp as well, only avoiding the area immediately around the eyes and mouth. Leave lotion on for at least 8 hours, before washing off. Reapply to any area that may be washed during the 8 hours treatment time (such as after washing the hands).

INTERACTION

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.

SIDE EFFECTS

In scabies patients, skin discomfort, usually described as burning, stinging or tingling occurs in a few individuals soon after the lotion is applied. Other transient signs and symptoms of irritation including erythema, edema, eczema and rash which may follow the treatment of scabies with Permethrin and Crotamiton lotion are generally considered to be the part of the natural history of scabies.

PREGNANCY & LACTATION

There is no experience to judge the safety of Permethrin and 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.

PRECAUTIONS & WARNINGS

Nursing staff, who routinely apply Permethrin and Crotamiton lotion, may wear gloves to avoid any possible irritation to the hands. Avoid contact with the eyes. The lotion can cause eye irritation. If lotion goes to the eye, rinse with water immediately.

THERAPEUTIC CLASS

Local Antipruritic, Parasiticidal preparations

STORAGE CONDITIONS

Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.