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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