Only for the use of Medical Professionals
Permisol®
Presentation:
Permisol® cream: White, smooth cream containing permethrin INN 5% w/w.
Uses: Permisol® cream is indicated for the treatment of scabies and crab lice infestations.
Dosage and administration:
ln view of the great individual variability in body surface area and skin type, precise
recommendations are not possible.
The following table indicates the approximate amount of cream to be used as single
application:
Adults and children over 12 years : Up to 1 tube
Children 6-12 years : Up to ½ of a tube
1-5 years : Up to ¼ of a tube
2 months-1 year : Up to 1/8 of a tube
A few adults may need more than one tube (30gm or cream) for whole body application,
however the maximum amount of Permisol® cream used in one application should be
limited up to two tubes (60gm of cream)
Ensure that the skin is clean, dry and cool prior to treatment.
Contraindications, warnings, etc.
Contraindications : It is contraindicated in individuals with a known allergy to Permethrin,
its components, other pyrethroids or pyrethrins.
Precautions and warnings : For external use only. Avoid contact of Permisol® cream
with eyes. ln the event of inadvertent eye contamination, rinse with water, or normal saline
if possible. When applying Permisol® cream in the face of the children, care should be
taken when applying to areas close to the eyes and mouth, where it may be licked off.
Nursing staff who routinely come in contact with the cream may wear gloves to avoid any
possible irritation to the hands.
Side effects: Skin discomfort, usually described as burning or stinging occurs in a few
individuals soon after Permisol® cream is applied. This symptom occurs more frequently in
patients with severe scabies and is usually mild and transient.
Other signs and symptoms of irritation, including erythema, oedema, eczema, rash and
pruritus 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.
Mutagenicity/ Carcinogenicity/ teratogenicity: Permethrin does not have the potential
to induce mutagenic changes.
Permethrin has no significant oncogenic potential in humans.
No evidence of teratogenicity has been found in mice, rats, or rabbits.
Pregnancy and lactation:
There is limited data on the use of Permisol® cream in pregnancy, however, there is no
indication of any risk to the foetus. The amount of Permethrin absorbed is extreamly low,
less than 0.5%. Any risk to the foetus following treatment with Permisol® is minimal.
It is not known whether Permethrin is excreted in human breast milk. As extremely small
amounts are absorbed, it is unlikely , to present any risk to the neonate/infant.
Drug interactions:
There are no known drug interactions with permethrin.
Treatment with corticosteroids in eczematous conditions should be withheld, as there is the
risk of exacerbating the scabies infestation by reducing the immune response to the mite.
Toxicity and treatment of over dosage:
No instance of over dosage or Permisol® cream has been reported.
Application of a full tube of cream to a 2 month-old-child would result in a dose of
approximately 350mg/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 over dosage of Permethrin would result in localized adverse reactions described
above.
Treatment of over dosage:
Symptomatic prescription is indicated. In case of accidental ingestion by a child, gastric
lavage should be done within 2 hours of ingestion.
Directions for use:
Treatment procedures for adults ( excluding the elderly and the children over 2 years):
Apply Permisol® cream over the whole body, excluding the head, paying particular
attention to the areas between the fingers and 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 period, Permisol®
cream should be reapplied.
Nature of the cream is such that it disappears when rubbed gently into the skin. It is,
therefore not necessary to apply the cream until it remains detectable on the majority of
individuals, scabies infection is cleared with a single application. If necessary, however,
Permisol® cream may be reapplied after seven days of initial application.
Use in the elderly and children between 2 months to 2 years of age:
Prescription procedure for these patient groups is the same as directed for adults and
children above 2 years. However, as scabies lesions on the face, neck, scalp, and ears are
more widespread in these patients, Permisol® cream should also be applied to these areas,
where affected. Avoid areas close to the eyes.
Pharmaceutical precautions :
Store in a cool & dry place. Protect from light.
Package quantities :
Permisol® cream: Tube of 15g & 30g
® Registered Trade Mark
ACI Limited
Narayanganj, Bangladesh
Brand: ACI Limited
