Friday, October 28, 2016

Quinoped Cream





1. Name Of The Medicinal Product

QUINOPED™ CREAM


2. Qualitative And Quantitative Composition








Benzoyl Peroxide BP




5.0%




Potassium Hydroxyquinoline Sulphate BP




0.5%



3. Pharmaceutical Form



Quinoped Cream is a cream-coloured astringent cream.


4. Clinical Particulars



4.1 Therapeutic Indications



Quinoped Cream is indicated in the treatment of tinea pedis (athlete's foot) and other related fungal infections.



4.2 Posology And Method Of Administration



Route of administration: For topical use only.



Adults, children and the elderly: Spread thinly over all the affected area and gently massage until no trace of the cream can be seen on the skin surface. Apply morning and night.



4.3 Contraindications



Known sensitivity to either of the active ingredients. Quinoped Cream is for topical use only.



4.4 Special Warnings And Precautions For Use



Care should be taken to avoid contact with dyed fabrics as this preparation may adversely affect dye fastness. In a few isolated cases overreaction to Quinoped Cream may occur. To avoid this possibility select a small area of skin on the feet, apply the cream and leave for twelve hours. If severe irritation or pronounced redness occurs do not proceed.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Benzoyl Peroxide is an oxidising agent. Hence Quinoped Cream should not be used at the same time as other topical agents which would react with an oxidising agent.



4.6 Pregnancy And Lactation



Quinoped Cream is not contra-indicated in pregnancy or lactation.



4.7 Effects on ability to drive and use machine



Not applicable.



4.8 Undesirable Effects



Not applicable.



4.9 Overdose



Not applicable.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Benzoyl Peroxide functions as a keratolytic and facilitates the removal of macerated tissue and associated debris. Potassium Hydroxyquinoline Sulphate has anti-fungal and deodorant properties. In addition Quinoped Cream is formulated in an astringent cream base which helps dry the infected toe clefts.



5.2 Pharmacokinetic Properties



Not applicable. Quinoped Cream is for topical use only.



5.3 Preclinical Safety Data



None stated.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Lactic Acid BP, White Soft Paraffin BP, Edetic Acid BP, Sodium Acid Phosphate BP, Maize Starch BP, cetyl stearyl alcohol, sodium cetyl stearyl sulphate, PEG 40 castor oil, Purified Water BP.



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



Three years.



6.4 Special Precautions For Storage



Quinoped Cream should be stored in a cool dry place avoiding extremes of temperature i.e. not less than 5°C and not more than 30°C.



6.5 Nature And Contents Of Container



Quinoped Cream is available in low density polyethylene tubes with flush fitting cap containing 25 g of product.



6.6 Special Precautions For Disposal And Other Handling



No special instructions.



8. Marketing Authorisation Number(S)



PL 0291/0002



10. Date Of Revision Of The Text



January 1998



Legal category


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