Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Permethrin
Dowelhurst Ltd
P03AC04
Permethrin
50mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100400
Permethrin Cream is used to treat infestations of scabies on the body. It contains the ingredient permethrin which belongs to a group of medicines called pyrethroids which kill mites such as scabies. DO NOT USE PERMETHRIN CREAM IF YOU ARE: • Allergic (hypersensitive) to permethrin, to other pyrethroids or pyrethrins, or to any of the other ingredients of Permethrin Cream (see section 6). WARNING AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING PER- METHRIN CREAM: • If you are known to be allergic to chrysanthemums or other compositae - you should only use Permethrin Cream after speaking to your doctor. TAKE SPECIAL CARE If this product comes into contact with dressings, clothing and bedding the fabric can be easily ignited with a naked flame. You should keep away from fire when using this product. TAKING OTHER MEDICINES Corticosteroids (steroids) should not be used to treat skin conditions like eczema when Permethrin Cream is being used because they may make the infestation of scabies worse by interfering with the body's natural defence to scabies. Permethrin Cream is not known to interact with any medicines. PREGNANCY AND BREAST-FEEDING As with all medicines, if you are pregnant or breast feeding, consult your doctor before using Permethrin Cream during pregnancy or while breast feeding. CHILDREN UP TO 23 MONTHS OF AGE Do not use Permethrin Cream in newborns and infants less than 2 months of age, unless your doctor tells you so. There is no adequate experience in infants and toddlers. Treatment to children up to 23 months of age should only be given under close medical supervision. EXCIPIENTS Permethrin creams contains 0.45g benzyl alcohol per tube. Benzyl alcohol may cause allergic reactions. Not to be swallowed. For external use only. Avoid contact with the eyes. Rinse with plenty of cold water immediately should the cream accidentally get into the eyes. To pierce tube, remove the cap and reverse it over the nozzle, push firmly and turn. Apply the cream to clean, dry, cool skin. Do not apply Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Permethrin 5% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Permethrin Medical Grade 5% w/w (_cis:trans_ isomer 25:75) For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream for topical application. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Permethrin 5% w/w Cream is indicated for the treatment of scabies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Permethrin 5% w/w Cream is suitable for adults, children of 2 months of age and above, and the elderly. Permethrin 5% w/w Cream is for external use only and should not be applied to broken skin, mucous membranes or near the eyes. Permethrin 5% w/w Cream should be applied to skin which is clean dry and cool. It should not be used immediately after a hot bath. Permethrin 5% w/w Cream is a vanishing cream and when rubbed gently into the skin it will disappear. Therefore, there is no need to continue to apply cream to the skin until it remains detectable on the surface. Reapply the cream to the hands if they are washed within 8 hours of treatment. The whole body should be washed thoroughly 8-12 hours after application. Children under 2 years should only be treated under medical supervision. Older children should be supervised when applying the cream to ensure that a thorough treatment is administered. In view of the great variability in body area and skin types, precise dosage recommendations are not possible. In cases where the head, neck, scalp and ears are treated (see below), the dosage may be increased to ensure total body coverage. Adults, the elderly & children over 12 years Normally, up to one tube (30g). A few adults may need to use an additional tube for full body coverage but should not use more than 2 tubes (60g in total) at each application. Children 6 to 12 years Up to half a tube (15g). Children 1 to 5 years Up to a quarter of a tube (7.5g). Children 2 months to 1 year Up to an eighth of a tube (3.75g). _Adults & children over 2 years: _ Apply the cream over the whole body but NO Baca dokumen lengkap