SCABIANIL CREAM 60G 5%

SCABIANIL

active ingredients

Permethrin 5% (isomeri) cis:trans 25:75). For excipients see point 6.1

Excellent

Cetostearilic alcohol, paraffin, cetomacrogol 1000, isopropylmiristat, benzilic alcohol, purified water.

Therapeutic indications

Treatment of the scabies.

Contraindications

Hypersensitivity to the active ingredient, to any of the excipients or to other pyrethroids or pyretrins. Generally contraindicated during pregnancy and nursing.

Population

SCABIANIL should be applied on clean, dry and fresh skin. The product should not be applied immediately after making a hot bath. Treatment of children under two years of age should only be carried out under medical supervision. The application of the cream by older children should be carried out under the supervision of an adult. SCABIANIL 5% cream is available in 30 and 60 g tubes. SCABIANIL 5% cream in 30 g tube, it is usually sufficient for only one application on the whole body. For some adults there is a need for a greater quantity of cream; in this case you can use the 60 g packaging, always in one application on the whole body. Since the amount of cream required for treatment varies from the surface to be treated and the type of skin, it is not possible to recommend a precise dosage.

Adults, elders and children over 12 years:	30 g cream tube. Some adults may need an additional cream tube to cover the entire body, but you should never use more than 60 g for each individual application.
Children from 6 to 12 years:	Up to half 30 g (15 g) tube of cream.
Children from 1 to 5 years:	Up to a quarter of 30 g (7,5 g) tube of cream.
Children from 2 months to 1 year:	Up to an eighth tube of 30 g (3,75 g) of cream.

Adults and children over 2 years: Apply the cream on the whole body except the head and face, with particular care for the areas between the fingers of the hands and feet, under the nails and on wrists, armpits, external genitals, breasts and buttocks. Seniors: Apply the cream all over the body including neck, face, ears and scalp. Apply the cream with special care on the areas between the fingers and the feet, under the nails and on wrists, armpits, external genitals, breasts and buttocks. Avoid the area around the eyes. Children under 2 years: Apply the cream on the whole body including neck, face, ears and scalp, with particular care for the areas between the fingers of the hands and feet, under the nails and on wrists, armpits, palms, feet plants, external genitals and buttocks. Avoid the area around the mouth (to prevent the cream from being removed with the tongue) and the area around the eyes. The cream should be allowed to act for at least 8 hours. If you wash your hands before 8 hours have passed since the application of the cream, you must reapply it on them. Wash the body thoroughly after 8-12 hours from the application of the cream. In 90% of cases a single application SCABIANIL is enough to eliminate infestation. If lesions do not give a sign of healing or appear new injuries, a second application of cream can be used after 7 days.

Conservation

Do not keep above 30°C, do not freeze.

Warnings

SCABIANIL is only for external use. If you apply the cream on other people, use of gloves is recommended. Avoid contact of the product with the eyes; in case of accidental contact, rinse immediately with water. _.

Interactions

Treatment of eczematous type reactions with corticosteroids should be evaluated before treatment with permethrin 5% cream, since there is a risk of exacerbation of scabies infestation due to reduction of the immune response to the acaro. The probability of interaction between the two treatments that leads to the strengthening of adverse reactions or the reduction of effectiveness is however low.

Effects

Occasionally, some cases of burning or short-lived hives have been reported. This is usually in light form and happens more frequently in patients with severe scabies. Transient signs and symptoms of skin irritations such as rash or itching, erythema, edema, eczema. Itching can also continue for 4 weeks after treatment and is due to an allergic reaction to the mites of the dead scabies. It is a normal phenomenon and not a sign that treatment has not been effective.

Overdosing

There are no overdose reports of permethrin 5% cream. Excessive application of cream on the skin could result in local adverse reactions. The application of a whole tube (30 g) of cream on a two-month child would correspond to a dose of about 350 mg/kg body weight. It is unlikely that, even if completely absorbed, this dose may cause clear signs of systemic toxicity. In the case of accidental ingestion of the product by a child, gastric washing could be used, to be carried out within 2 hours of ingestion. Treatment of hypersensitivity reactions should be symptomatic.

The data available to date on the use of permethrin 5% cream did not show any risk to the fetus. The amount of permethrin absorbed by systemic way after application of the cream on the whole body surface is extremely low. However, permethrin can pass the placental barrier. The negativity of mutagenesis tests and low toxicity on mammals suggest that the treatment with permethrin involves minimal risks to the fetus. It is shown that, following oral administration, very low concentrations of permethrin are excrete in cow milk. It is not known if permethrin is excreted in human milk. However, it is unlikely that permethrin concentrations in milk represent a risk for the newborn as only extremely small amounts of permethrin are systematically absorbed and in theory only a very small percentage can pass into human milk. During pregnancy and breastfeeding, the medicinal product must be used in cases of actual need and under direct medical control.

Source: Farmadati