For the use only of Registered Medical Practitioners or a Hospital or a Laboratory NEDAX -5 LOTION. Permethrin Lotion 5% w/w

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1 For the use only of Registered Medical Practitioners or a Hospital or a Laboratory NEDAX -5 LOTION Permethrin Lotion 5% w/w QUALITATIVE AND QUANTITATIVE COMPOSITION Permethrin 5% w/w in a aqueous base q.s. PHARMACEUTICAL FORM Lotion. CLINICAL PARTICULARS Therapeutic Indications NEDAX-5 LOTION is indicated for treatment of scabies. Posology and Method of Administration For external use only. Do not apply to mucous membranes, or near the eyes. Keep out of sight and reach of children. For all applicable age groups, approximately 90% of individuals are cured with a single application of product. A second application may be required 7-10 days after first treatment if the original lesions have not healed or new skin lesions appear. Considering the large variability in body area and skin types in the different age groups using 5% w/w permethrin formulation, precise dosage recommendations are not possible. As such, dosage information provided is for guidance purposes only. 1

2 Table: Guidance for dosage of 5% w/w permethrin lotion formulation in different age groups Age group Adults, the elderly and children over 12 years Children 6 to 12 years Children 2 to 5 years Guidance for dosage sufficient for full body coverage in a single application Up to 30 ml of lotion. If more than 30 ml is required for full body coverage, not more than 60 ml should be used during a single application. Up to 15 ml of lotion. Up to 7.5 ml of lotion. Adults (not including the elderly) The product should be applied to clean, dry, cool skin. If the patient has taken a warm bath prior to treatment the skin should be allowed to cool before the lotion is applied. The product should be applied to the skin over the whole body, excluding the head, from the neck to the soles of the feet, paying particular attention to the areas between the fingers and toes and under fingernails and toenails, wrists, armpits, buttocks and external genitalia. In women, the whole body application should include the breasts. The product should not be applied to the head and face. After application, clean clothes should be put on. The product should be left on for at least 8 hours. The product should be washed off with a mild soap and water. Following application of the product hands should be washed before eating. The product should be re-applied to the hands if they are washed within 8 hours of treatment. After washing, clean clothes should be put on. The product rubs easily into the skin. It is not necessary to apply more lotion until it can be seen on the skin surface. Children 2 years and over Children should be supervised by an adult when applying the product to ensure thorough treatment is administered. Use as directed for adults. 2

3 Under 2 years Do not use the product without medical supervision. Elderly Use as directed for adults but apply the product to the whole body including the neck, face, ears and scalp. Avoid the area close to the eyes. Patients over 70 years should be treated under medical supervision. Renal impairment No change in dosing is required in patients with renal impairment. Hepatic impairment No change in dosing is required in patients with hepatic impairment. Contraindications Permethrin is contraindicated in patients with a previous history of hypersensitivity reactions to permethrin, any components of the product, other pyrethroids, or pyrethrins or to chrysanthemums. Special Warnings and Special Precautions for Use Excipient warning statements Parahydroxybenzoates: May cause allergic reactions (possibly delayed). Cetyl alcohol: May cause local skin reactions (e.g. contact dermatitis). Permethrin is not an eye irritant, but contact with the eyes should be avoided because other components of the products may cause marked irritation. In the event of inadvertent eye contamination, the affected area should be rinsed immediately with plenty of water or, if readily available, normal saline. Carers who routinely apply permethrin may wish to wear gloves to avoid any possible irritation to the hands. In the event of accidental ingestion of permethrin, please seek immediate medical attention. 3

4 If skin irritation occurs and does not improve, consult a doctor. Pyrethrins are used as an agricultural and horticultural insecticide the potential for sensitisation through this route should be kept in mind. Keep out of reach of children. For external use only. It is important to ensure that the course of treatment is followed as directed because treatment failure has been reported when this has not occurred. Interaction with Other Medicaments and Other Forms of Interaction No interactions are known. The treatment of eczematous-like reactions with corticosteroids should be withheld prior to treatment with permethrin 5% lotion, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite. The likelihood of interactions between the two treatments leading to potentiated adverse reactions or reduced efficacy is, however small. Pregnancy and Lactation Limited data on the use of a permethrin-containing scabicide in pregnancy provide no indication of any risk to the foetus. This, together with poor systemic absorption of permethrin and in vivo genotoxicity tests which demonstrate that permethrin has no adverse effects on reproductive function or upon embryo-foetal development, would suggest that the risk to the foetus following treatment with permethrin is minimal; however women who are pregnant should use permethrin only after prior consultation with a healthcare professional. It is not known whether permethrin is excreted in human breast milk but studies in cattle have indicated that very low concentrations of permethrin are excreted in milk after oral administration. Poor systemic absorption of permethrin following topical application, together with very limited data which suggest that suckling infants are unaffected following maternal use of permethrin containing products, would make it unlikely that the concentrations of permethrin in the milk will present any risk to the neonate/infant. The amount of permethrin absorbed systemically in humans following a whole body application is extremely low (less than 0.5% of the applied dose). These data, together with the negative mutagenicity tests and the very low mammalian toxicity, would suggest that any risk to the foetus following treatment with permethrin is minimal. However, women who are breastfeeding should only use permethrin containing products after consultation with a healthcare professional. 4

5 Effects on Ability to Drive and Use Machines Permethrin is unlikely to have any effects on the ability to drive and use machines. Undesirable Effects Nervous system disorders Paraesthesia. Skin and subcutaneous tissue disorders Eczema, skin oedema, rash, erythema, pruritus, burning sensation, skin irritation, skin discomfort, smarting, pain of skin. Skin discomfort occurs in patients with severe scabies, is not usually severe and is of short duration. Other symptoms of irritation are part of the natural development of the infection. In patients being treated for scabies, the pruritus may persist for up to 4 weeks after treatment. This is generally considered to be an allergic reaction to the dead mites present under the skin and is not necessarily a sign that the treatment has failed. Overdose On the basis of animal and human volunteer studies, it is unlikely, even with misuse or excessive topical application, that the amount of permethrin required to produce clinically relevant toxic effects would be reached. Symptoms and Signs Symptoms of overdose are generally likely to occur after accidental or deliberate oral ingestion due to swallowing and in rare cases because of skin absorption following excessive topical application and may include dizziness, loss of appetite, nausea, vomiting, headache, weakness, seizures, and loss of consciousness. Treatment In the event of overdose or accidental ingestion, please seek immediate medical attention. 5

6 PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties Pharmacotherapeutic group: Delousing agent Pyrethroid; ATC Code: P03AC04. Pharmacodynamic Effects The principal physiological action in insects (lice) exposed to permethrin is induction of electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyperexcitability, in-coordination and prostration. It is assumed that the mode of action against arachnids (mites) is similar. Pharmacokinetic Properties Absorption Less than 0.5% of applied permethrin is absorbed during the first 48 hours. Toxicity is therefore not commonly seen since a 70 kg adult would have to consume a total of 2640 g of 5% w/w permethrin product to have an LD 50 dose. Distribution The distribution of topically applied permethrin is primarily limited to the skin, since very little permethrin is systemically absorbed. Metabolism In mammals, permethrin is metabolised by ester hydrolysis in the skin and liver to produce inactive metabolites that are excreted primarily in the urine. Elimination The principal metabolites of permethrin are detectable in the urine within hours of a whole body application of the lotion to healthy volunteers or scabies patients. The highest levels of excretion are detected within the first 48 hours, but very low levels of metabolites are still detectable in the urine of some individuals 21 days after treatment. Special Patient Populations There are no reported clinical studies of permethrin in special patient populations and this is not considered relevant to the safe and effective clinical use of permethrin. 6

7 Clinical Studies The clinical safety and efficacy of permethrin for the stated indication is well established and supported by the studies described in the literature. Preclinical Safety Data Preclinical safety data on permethrin in the literature have not revealed findings which are of relevance to the recommended dosage and use of the product. Although in vitro genotoxicity studies with permethrin have shown contradictory results, no evidence of genotoxicity was demonstrated in in vivo genotoxicity studies. Furthermore, long term bioassays in rodents have demonstrated no evidence of carcinogenic potential. Overall, permethrin is not considered to represent a genotoxic or carcinogenic hazard to humans. PHARMACEUTICAL PARTICULARS List of Excipients Stearic acid, Cetyl alcohol, Xanthum gum, Methyl paraben, Propyl paraben, Glyceryl monostearate, Triethanolamine, Fragrance herbal fresh and Cyclomethicone Dimethicone. Incompatibilities There are no relevant data available. Shelf Life 36 months. The expiry date is indicated on the label and packaging. Special Precautions For Storage Store below 25 o C. Keep out of reach of children. Nature and Specification of Container 40 g Lami tube with screw cap. 7

8 Instructions for Use / Handling For application to the skin. For external use only. Avoid contact with eyes. There are no other special requirements for use or handling of this product. For further information please contact: Stiefel India Private Limited. Registered Office: 401& 402, A Wing, 4 th Floor, Floral Deck Plaza, Opp. Rolta Bhavan, Central MIDC Road, Andheri (E), Mumbai NEDAX is a Registered Trademark under Licence from Stiefel Laboratories Inc., USA. Version: NED/PI/IN/2015/01 dated 10 Nov Adapted from Permethrin GDS 02 dated 13 Jul

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