Prescribing Details
Description
Permisol ® cream is indicated for the treatment of scabies and crab lice infestations.
Uses
No Data
Indications
No Data
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:
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.
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.
Use in pregnancy & 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.
Geriatric use
No Data
Precautions
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.
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.
Contraindications
It is contraindicated in individuals with a known allergy to Permethrin, its components, other pyrethroids or pyrethrins
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.
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.
Overdose
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.
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.
Preparation
No Data
Pharmaceutical precautions
Store in a cool & dry place. Protect from light.
Presentation
Permisol ® cream:
White, smooth cream containing permethrin INN 5% w/w.
Package quantities
Permisol ® cream:
Tube of 15g & 30g
