Arotrix5% w/w

Arotrix 5% w/w cream is indicated for the treatment of scabies and crab lice infestations (Pediculosis). Scabies can affect everyone in the family. If one is infected, all family members must be treated together.

Parasiticidal preparations

Arotrix 5% w/w induces electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyperexcitability, in coordination and prostration. Arotrix 5% w/w is rapidly metabolized in mammals by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. The principal metabolites of Arotrix 5% w/w are detectable in the urine within hours of a whole body application of the cream to healthy volunteers or scabies patients. The highest levels of excretion are detectable within the first 48 hours, but very low levels of metabolites are still detectable in the urine of some individuals 28 days after treatment.

Recommended duration of Treatment: Adults and children over 12 years: a full tube Children aged 6-12 years: up to 1⁄2 of a tube Children aged 1-5 years: up to  ¼ of a tube Children aged 2 months to 1 year: up to ⅛ of a tube Children Less then 2 month: dose is not established

Before application of Arotrix 5% w/w cream the skin should be clean, cool and dry. Do not have a hot shower or bath before applying. For adults and children over 2 years: Apply the cream to the whole body from the neck down, rubbing lightly into the skin until the cream 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 cream on for at least 8 hours, before washing off. Reapply to any area that may be washed during the 8h treatment time (such as after washing the hands). If necessary, Arotrix 5% w/w cream should be used again after 7 days as per the advice of the doctor.

The treatment of eczemodous like reactions with corticosteroids should be withheld prior to treatment with Arotrix 5% w/w, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite.

Arotrix 5% w/w is contraindicated in patients with known hypersensitivity to any component of pyrethroids or Arotrix 5% w/w. Nursing staff who routinely apply Arotrix 5% w/w may wear globes to avoid any possible irritation to the hands.

In Scabies patients, skin discomfort, usually described as burning, stinging or tingling occurs in a few individuals soon after the cream is applied. Others transient signs and symptoms of irritation including enythema, edema, eczema, rash and puritis.

There are limited data on the use of Arotrix 5% w/w in pregnancy which provide no indication of any risk to the foetus. Furthermore, the amount of Arotrix 5% w/w absorbed systemically following a whole body application is extremely low. The negative mutagenicity tests and the very low mammalian toxicity would suggest that any risk to the foetus following treatment with Arotrix 5% w/w is minimal. Inspite of these, Arotrix 5% w/w is suggested not to useduring pregnancy.It is not known whether Arotrix 5% w/w is excreted in human breast milk. So, it should not be used in nursing mothers.

Scabies infestation is often accompanied by pruritus, edema & erythema. Treatment with Arotrix 5% w/w may temporarily exacerbate these conditions. Patients should be advised to avoid contact with eyes during application & to flash with water immediately if the cream gets in the eyes.

There are no reports of overdosage with Arotrix 5% w/w. It is possible that excessive application of Arotrix 5% w/w might result in localized adverse reactions or more severe skin reactions.

Store in a cool, dry place, away from light & keep out of the reach of children...

Parasiticidal preparations

Arotrix 5% w/w cream contains Arotrix 5% w/w, a pyrethroid, which is a topical scabicidal agent for the treatment of infestation with Sarcoptes Scabiei (scabies). It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization & paralysis of the pests are the consequences of this disturbance.Pharmacokinetics: The only approved route of administration is the topical route and there are few human data available on systemic exposure or kinetics following Arotrix 5% w/w application to the skin. Some presystemic metabolism occurs in skin. Less than 0.5% of applied Arotrix 5% w/w is absorbed during the first 48 hours. Absorbed Arotrix 5% w/w is rapidly metabolized by ester hydrolysis, most likely in the liver and the products are excreted primarily in the urine.

In the absence of specific studies in pregnant women, its use in pregnancy should only follow medical advice. It is not known whether Arotrix 5% w/w is excreted in human milk so it should not be used in nursing mothers.