Document: spc-doc_PL 00036-0097 change

• spc-doc_PL 00036-0097
• spc-doc_PL 44673-0052

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Permethrin Lotion 5% w/w

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Contains permethrin 5% w/w.

For excipients, see 6.1.

3 PHARMACEUTICAL FORM

Cutaneous emulsion.

White to off-white lotion.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Permethrin Lotion is indicated for the treatment of scabies.

4.2    Posology and Method of Administration

For topical administration.

Adults, elderly and children over 2 years of age:

Permethrin Lotion 5% w/w should be shaken before use.

Prior to application, the skin should be clean, dry and cool. A hot bath should not be taken prior to treatment. The lotion should be thoroughly massaged into the skin from the neck to the soles of the feet, paying particular attention to the areas between the fingers and toes, under the fingernails and toenails, wrists, armpits and genital area and buttocks. Permethrin Lotion 5% w/w disappears when rubbed gently into the skin; it is, therefore, not necessary for the patient to apply the medication until the lotion remains detectable on the skin. If the hands are washed with soap and water during the treatment period, Permethrin Lotion 5% w/w should be reapplied.

The following table indicates how much lotion would normally be used: Adults and children over 12 years: Up to one 50ml bottle Children:    5 to 12 years: Up to half of one 50ml bottle

1 to 5 years:    Up to a quarter of one 50ml bottle

2 months to 1 year:    Up to an eighth of one 50ml bottle.

The patient should put on clean clothes and leave the lotion in place for 12 to 14 hours. The lotion should then be washed off thoroughly during a shower or a bath. Patients should again change into clean clothes. One treatment is usually adequate to eliminate the scabies. However, if live mites are present, or new skin lesions appear, a second application can be given seven to ten days later.

Children 2 months to 2 years of age:

Prior to application, the skin should be clean, dry and cool. A hot bath should not be taken prior to treatment. The lotion should be thoroughly massaged into the child’s whole body, including their neck, face, ears and scalp. The area around the mouth and eyes should be avoided.

The child should put on clean clothes and leave the lotion in place for 12 to 14 hours. The lotion should then be washed off thoroughly during a shower or a bath. The child should be dressed in clean clothes. One treatment is usually adequate to eliminate the scabies. However, if live mites are present, or new skin lesions appear, a second application can be given seven to ten days later.

The safety and efficacy of Permethrin Lotion 5% w/w in children under 2 months of age have not been established. No data are available (see section 5.1).

4.3 Contraindications

The use of Permethrin Lotion 5% w/w is contraindicated in people with hypersensitivity to permethrin, any synthetic pyrethroid or pyrethrin, or to chrysanthemums.

4.4 Special Warnings and Precautions for Use

Keep out of the reach of children. For external use only. Gloves may be worn to avoid possible irritation to the hands of nursing staff who routinely use Permethrin Lotion 5% w/w.

Avoid contact with eyes. Permethrin is not an eye irritant but eye contact with Permethrin Lotion 5% w/w should be avoided because the lotion itself may cause irritation. In case of contact, rinse immediately with water. If a reaction occurs, discontinue use and consult your doctor.

Only limited experience is available with Permethrin Lotion 5% w/w in children aged 2 months to 23 months. Therefore treatement must be given only under close medical supervision in this age group.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

The treatment of eczematous-like reactions with corticosteroids should be withheld prior to treatment with, Permethrin Lotion 5% w/w as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite. However, the likelihood of interactions between the two treatments leading to potential adverse reactions or reduced efficacy is small.

4.6 Pregnancy and lactation

There is inadequate evidence of the safety in human pregnancy. Permethrin Lotion 5% w/w should only be used when the expected benefits outweigh the potential risks.    Nevertheless, the amount of permethrin absorbed systemically

following a whole body application is extremely low while the negative mutagenicity tests and the very low mammalian toxicity would suggest that any risk to the foetus following treatment    with Permethrin Lotion 5% w/w is

minimal.

There is no evidence of teratogenicity in reproduction studies in mice, rats and rabbits.

It is not known if permethrin is excreted in human milk, although it is unlikely that concentrations would present any risk to the infant. It is recommended that nursing be discontinued or treatment withheld if it is not possible to discontinue nursing. However, because only very small amounts of permethrin are absorbed systemically following treatment with Permethrin Lotion 5% w/w, it is unlikely that the concentration of permethrin in the milk will present any risk to the neonate/infant.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Localised reactions and erythema have been infrequently reported with topical use of permethrin, but they are usually mild and resolve rapidly after cessation of treatment.

In scabies patients, skin discomfort, usually described as burning, stinging or tingling, occurs in a few people soon after Permethrin Lotion 5% w/w is

applied. This occurs more frequently in patients with severe scabies and is usually mild and transient.

Other transient signs and symptoms of irritation, including oedema eczema and rash may occur, together with itching which may be temporarily exacerbated or may persist for several weeks after treatment, but does not indicate a treatment failure. Retreatment is only necessary if live mites appear or new lesions develop.

4.9 Overdose

There has been no incidence of ingestion of Permethrin Lotion 5% w/w. Overdose is unlikely to be caused by topical administration of Permethrin

Lotion

5% w/w.

Application of a full bottle of Permethrin Lotion 5% w/w to a two month old child would result in a dose of approximately 600mg/kg body weight to the skin. It is unlikely that such a dose would cause any overt signs of systemic toxicity, even if 100% of permethrin were absorbed.

It is possible that excessive application of Permethrin Lotion 5% w/w might result in localised adverse reactions or more severe skin reactions. Symptomatic treatment is indicated should hypersensitivity-type reactions occur.

In the event of accidental ingestion of the contents of a whole bottle of Permethrin Lotion 5% w/w by a child, gastric lavage could be considered if consultation is within 2 hours of ingestion, or vomiting can be induced.

5.1 Pharmacodynamic Properties

Permethrin is rapidly absorbed across the insect cuticle. The principle physiological lesion is the induction of electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyperexcitability, incoordination and prostration. When presented in an aqueous base, the ovicidal activity of permethrin is increased by the addition of an alcohol.

Newborns and infants:

The safety and efficacy of permethrin in newborns and infants under 2 months of age have not been established since no data are available from prospective trials or larger case series. A limited number of case reports in the treatment of children under 2 months of age presenting with scabies do not suggest specific safety concerns for the use of topical permethrin in this age group, but no definate conclusion can be drawn.

5.2 Pharmacokinetic properties

Permethrin is rapidly metabolised by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. The application of cream rinse to the hair of volunteers for the recommended application time resulted in extremely low or undetectable levels of permethrin metabolites in plasma and urine samples. In vitro studies have shown that permethrin levels on hair were not affected by chlorine in concentrations used in swimming pools.

5.3 Preclinical safety data

Permethrin has been shown to have very low acute toxicity in animals, likely due to its rapid metabolic degradation to inactive constituents and incomplete absorption from the gastrointestinal tract. Overall, there is little evidence of chronic toxicity with permethrin use. Pharmacological studies showed that topically applied 5% permethrin lotion was very minimally (<0.032% of dose) absorbed.

5% permethrin lotion caused minimal effects in animal dermal and eye irritation studies.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Purified water Polysorbate 20 Sorbitan laurate Imidurea Disodium edetate Propylene glycol Sodium hydroxide Propyl p-hydroxybenzoate Methyl p-hydroxybenzoate Carbomer

6.2 Incompatibilities

None known

6.3 Shelf life

36 months