1. Name Of The Medicinal Product
Pevaryl 1% Topical Cream.
2. Qualitative And Quantitative Composition
Econazole nitrate . 1.0% w/w.
Each gram of cream contains 10 mg econazole nitrate
Excipients: each gram of cream contains 2 mg benzoic acid and 52 micrograms butylated hydroxyanisole
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Cream.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of fungal infections of the skin.
4.2 Posology And Method Of Administration
For cutaneous administration.
Dosage
The dosage regimen is the same for all patients.
Apply twice daily to the affected part and rub into the skin gently with the finger. Continue the application until all skin lesions are healed.
In the treatment of fungal infections of the nail, the cream should be applied once a day and covered with an occlusive dressing.
4.3 Contraindications
Pevaryl Topical Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
4.4 Special Warnings And Precautions For Use
For external use only. Care should be taken not to get Pevaryl Topical Cream in the eyes or mouth. If the product is accidently applied to the eyes the patient should wash with clean water or saline and seek medical attention if symptoms persist.
If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.
Care should be taken in the presence of eczematous dermatitis.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Econazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, and acenocoumarol caution should be exercised and anticoagulant effect should be monitored more frequently.
Adjustment of the oral anticoagulant dosage may be necessary during the treatment with econazole and after its termination
4.6 Pregnancy And Lactation
.
Pregnancy
Systemic absorption of econazole is low (< 10%) after topical application to the intact skin in humans. There are no adequate and well-controlled studies on adverse effects from the use of Pevaryl Topical cream in pregnant women, and no other relevant epidemiological data are available. No adverse effects of Pevaryl Topical cream on pregnancy or on the health of the foetus/newborn child have been identified from a limited number of post-marketing reports.
In animal studies, econazole nitrate has shown no teratogenic effects but was foetotoxic in rodents. The significance of this in humans is unknown. (See section 5.3)
Because there is systemic absorption, use of Pevaryl Topical Cream is not recommended during pregnancy.
Lactation
It is not known whether cutaneous administration of Pevaryl Topical cream results in sufficient systemic absorption of econazole nitrate to produce detectable quantities in breast milk in humans. (see section 5.3)
A risk to the breast-fed child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Pevaryl Topical Cream therapy taking into account the benefit of breast feeding for the child and benefit of therapy for the woman.
If Pevaryl Topical Cream is used while breast feeding care should be taken to ensure the cream is not applied to the nipple or surrounding area.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
.
The safety of econazole nitrate cream (1%) and econazole nitrate emulsion (1%) was evaluated in 470 subjects who participated in 12 clinical trials and received at least one administration of either formulation. Based on pooled safety data from these clinical trials, the most commonly reported (
Including the above-mentioned ADRs, the following table displays ADRs that have been reported with the use of PEVARYL Dermatological Formulations from either clinical trial or post-marketing experiences. The displayed frequency categories use the following convention:
Very common (
In the PEVARYL Dermatological Formulations ADR table below, all ADRs with a known incidence (common or uncommon) are from clinical trial data and all ADRs with an unknown incidence are from post-marketing data.
Table 1: Adverse Drug Reactions
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4.9 Overdose
.
Pevaryl Topical Cream is for cutaneous application only. In the event of accidental ingestion, treat symptomatically
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 additional to that contained elsewhere in the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Pegoxyl-7-stearate
Peglicol-5-oleate
Liquid paraffin
Butylated hydroxyanisole (E320)
Benzoic acid (E210)
Flower Perfume 4074
Purified water
6.2 Incompatibilities
None stated.
6.3 Shelf Life
24 months.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
Resin lined, aluminium tubes containing 15 g or 30 g of cream.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements
7. Marketing Authorisation Holder
Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
8. Marketing Authorisation Number(S)
PL 00242/0259
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 01/07/95
Renewal of authorisation 18th March 2009
10. Date Of Revision Of The Text
03rd February 2011
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