Wednesday, September 21, 2016

Pevaryl Topical Lotion





1. Name Of The Medicinal Product



Pevaryl Topical Lotion


2. Qualitative And Quantitative Composition



Econazole nitrate PhEur 1% w/w.



3. Pharmaceutical Form



Lotion.



4. Clinical Particulars



4.1 Therapeutic Indications



For the treatment of fungal infections of the skin.



4.2 Posology And Method Of Administration



For topical administration.



The dosage regimen is the same for all patients. Apply twice daily to the affected part and rub gently into the skin. Continue the application until all skin lesions are healed. In the treatment of fungal infections of the nail, the lotion should be applied once a day and covered with an occlusive dressing.



4.3 Contraindications



Avoid areas of eczematous dermatitis.



4.4 Special Warnings And Precautions For Use



Hypersensitivity has rarely been recorded; if it should occur, administration of the product should be discontinued.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None stated.



4.6 Pregnancy And Lactation



Only small amounts of the drug are absorbed through the skin and no teratogenic effects have been observed in animals. Hence the product may be used with caution during pregnancy.



4.7 Effects On Ability To Drive And Use Machines



None stated.



4.8 Undesirable Effects



Rarely, transient local irritation may occur after immediate application, if this persists, please contact your doctor for advice.



4.9 Overdose



This product is for topical application only. If large amounts have been taken by mouth or swallowed, gastric emptying may be considered desirable.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Econazole nitrate is a broad spectrum antimycotic with activity against dermatophytes, yeasts and moulds. A clinically relevant action against Gram positive bacteria has also been found.



5.2 Pharmacokinetic Properties



Econazole nitrate is only slightly absorbed from the skin. No active drug has been detected in the serum. Radio labelling shows that less than 0.1% of an oral dose is absorbed. Peak serum levels are achieved after 2 hours and 90% binds to plasma proteins. Metabolism is limited but occurs primarily in the liver with excretion of metabolites in the urine.



5.3 Preclinical Safety Data



No relevant information other than that contained elsewhere in the Summary of Product Characteristics.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Colloidal silicon dioxide



Tefose 63



Labrafil Ml944 CS



Mineral oil



Butylated hydroxyanisole



Benzoic acid



Perfume no 4074



Purified water



6.2 Incompatibilities



None stated.



6.3 Shelf Life



3 years.



6.4 Special Precautions For Storage



Store at room temperature (not exceeding 25°C).



6.5 Nature And Contents Of Container



Polyethylene bottle and drop insert, and screw cap of polystyrene. Each bottle contains 30 ml lotion.



6.6 Special Precautions For Disposal And Other Handling



None.



7. Marketing Authorisation Holder



Janssen-Cilag Limited



Saunderton



High Wycombe



Buckinghamshire



HP14 4HJ



UK



8. Marketing Authorisation Number(S)



PL 0242/0260



9. Date Of First Authorisation/Renewal Of The Authorisation



1 September 1995



10. Date Of Revision Of The Text



3 February 1999



Legal category P




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