AROTRIX Cream

Permethrin INN 5% w/w

Composition:

Each gram cream contains Permethrin INN 50 mg.

Indications:

Arotrix Cream is indicated for the treatment of scabies and lice infestations.

Administration:

Precise recommendations for administration of Arotrix Cream are not possible because of variation in body surface and skin type from patient to patient. However the approximate amount of cream to be used is given as follows:

Adults & children over 12 years: Up to 30 cream

Children of 6-12 years               : Up to 15 g cream

Children of 1-6 years                 : Up to 7.5 g cream

Children of 2 months - 1 year   : Up to 3.75 g cream

In some cases, adults may need more 30 g cream for whole body application. Up to 60 g cream can be used.

Before use, ensure that your skin is clean, dry and cool.

Directions for application for adults and Children :

Apply Arotrix Cream in the skin over the whole body, excluding the head, taking particular attention to the areas between the fingers & toes, wrists, axillae, external genitalia and buttocks. The whole body should be washed thoroughly 8-12 hours later. If any area of the body is subsequently washed with soap and water during the treatment, Arotrix Cream should be reapplied.

A single application is generally curative. If necessary Arotrix Cream may be reapplied after seven days of initial application.

Directions for application for elderly & Children of 2 months - 2 years:

Directions for application for such patients are the same as directed for adults and children over 2 years.

An adult must supervise a children for the treatment with Arotrix Cream.

Mode of Action:

The principal physiological action in insects exposed to Permethrin is induction of electrochemical abnormalities across the membrane of excitable cells, leading to sensory hyperexcitability, incoordination and prostration. It assumes that the mode of action against mites is similar.

Pharmacokinetics:

Topical route is the only approved route of administration of Permethrin. Some presystemic metabolism occurs in the skin after application. Less than 0.5% of applied Permethrin is absorbed during the first 48 hours. Absorbed Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine.

Contraindications:

Individuals with a known allergy to Permethrin, its inactive components, other pyrethroids or pyrethrins.

Precautions & Warnings:

For external use only. Avoid contact of Arotrix Cream with the eyes. In the event of inadvertent eye contamination, rinse with water, or normal saline if possible. When applying Arotrix cream to the faces in children, care should be taken when applying to areas close to the eyes and mouth, where it may be licked off. Nnursing staff who routinely come in contact with the cream wear gloves to avoid any possible irritation to the hands. If hypersensitivity occurs, discontinue use.

Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days of application indicate that retreatment is necessary.

Side-Effects:

Burning or stinging occurs in a few patients soon after application of Arotrix Cream. This symptom occurs more frequently in patients with severe scabies and is usually mild and transient. Other sings and symptoms include erythema, oedema, eczema, rash which are considered to be part of the natural history of scabies.

In some treated patients, itching may persist because of allergic reactions to the dead mites under the skin and does not necessarily signify a treatment failure.

Use in Pregnancy & Lactation:

There is limited data on the use of Arotrix Cream in pregnancy. However, there is no indication of any risk to the foetus. The amount of is minimal. Permethrin absorbed is extremely low, less than 0.5%. Any risk to the foetus following treatment with Arotrix is minimal.

It is not known whether Permethrin is excreted in human breast milk or not. As extremely small amounts are absorbed, it is unlikely to present any risk to the neonate/infant.

Drug Interactions:

There is no known drug interaction with Permethrin.

Treatment with corticosteroids in eczematous condition should be held, as there is the risk of exacerbating the scabies infestation by reducing the immune response to the mite.

Toxicity of Overdosage:

No instance of overdosage of Arotrix cream has been reported.

Application of 30 g cream to a 2 months- old – child would result in a dose of approximately 350 mg/kg body weight to the skin. It is unlikely that such a dose would cause overt signs of toxicity even if 100% of the Permethrin was absorbed. It is likely that massive overdosage of Permethrin would result in localized adverse reactions described above.

Treatment of Overdosage:

Symptomatic prescription is indicated. In case of accidental ingestion by a child, gastric lavage should be done within 2 hours of ingestion. 

Storage:

· Store in a cool and dry place

· Do not freeze.

· Use only in medical advice..

· Keep out of the reach of children.

Packing:

Tube containing 15 g & 30 g cream.