1. Name Of The Medicinal Product
Gyno-Pevaryl™ Cream.
2. Qualitative And Quantitative Composition
Each 100 g of cream contains 1 g econazole nitrate Ph.Eur. (1% w/w).
3. Pharmaceutical Form
Vaginal Cream.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of mycotic vulvovaginitis and mycotic balanitis.
4.2 Posology And Method Of Administration
Route of Administration
For vaginal/penile administration.
Females: One applicator full (approximately 5 g) intravaginally once daily at night for not less than 14 days. The cream should also be applied to the vulva. The full 14 days treatment should be carried out even if the symptoms of vaginal itching or discharge have disappeared.
Males: Apply the cream to the penis, including under the foreskin, once daily for not less than 14 days.
The sexual partner should also be treated.
4.3 Contraindications
Hypersensitivity to any imidazole preparation, other vaginal antifungal products or to any of the ingredients of Gyno-Pevaryl cream.
4.4 Special Warnings And Precautions For Use
Not for ophthalmic or oral use.
Hypersensitivity has rarely been recorded; if it should occur administration should be discontinued.
Contact between contraceptive diaphragms or condoms and this product must be avoided since the rubber may be damaged by the preparation.
Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive.
Gyno-Pevaryl Cream should not be used in conjunction with other internal or external treatment of the genitalia
Gyno-Pevaryl Cream is not indicated for use in children under the age of 16 years.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Although not studied, based on the chemical similarity of econazole with other imidazole compounds, a theoretical potential for competitive interaction with compounds metabolized by CYP3A4/2C9 exists. Due to the limited systemic availability after vaginal application (see 5.2. Pharmacokinetic Properties), clinically relevant interactions are unlikely to occur. In patients on oral anticoagulants, such as warfarin and acenocoumarol, caution should be exercised and the anticoagulant effect should be monitored more frequently considered.
Adjustment of the oral anticoagulant dosage may be necessary during and after the treatment with econazole.
4.6 Pregnancy And Lactation
Pregnancy
In animals, econazole nitrate has shown no teratogenic effects but is foetotoxic at high doses. The significance of this to man is unknown as there is no evidence of an increased risk when taken in human pregnancy. However, because there is vaginal absorption, as with other imidazoles, econazole should be used in pregnancy only if the practitioner considers it to be necessary.
Lactation
Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. It is not known whether econazole nitrate is excreted in human milk. Caution should be exercised when using Gyno-Pevaryl Cream if the patient is breast-feeding
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
The most frequently reported adverse events in clinical trials were application site reactions, such as burning and stinging sensations, pruritus, and erythema.
Including the above mentioned adverse drug reactions (ADRs), the following table displays ADRs that have been reported with the use of Gynaecological Formulation from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention:
Very common (
Adverse Drug Reactions
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4.9 Overdose
Overdose with econazole nitrate has not been reported to date. In the event of accidental ingestion, nausea, vomiting and diarrhoea may occur. If necessary treat symptomatically.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic classification: (Antiinfectives and antiseptics, excl. combinations with corticosteroids, imidazole derivatives)
ATC code: G01A F05
Econazole nitrate has no anti-inflammatory action, no effect on circulation, no central or autonomic nervous effects, no effects on respiration, no effect on α or β receptors, no anticholinergic or antiserotonergic reactions.
A broad spectrum of antimycotic activity has been demonstrated against dermatophytes, yeasts and moulds. A clinically relevant action against Gram positive bacteria has also been found.
Econazole acts by damaging cell membranes. The permeability of the fungal cell is increased. Sub-cellular membranes in the cytoplasm are damaged. The site of action is most probably the unsaturated fatty acid acyl moiety of membrane phospholipids.
5.2 Pharmacokinetic Properties
Econazole nitrate is poorly absorbed from the vagina and skin. If given orally, peak plasma levels occur six hours after dosing. About 90% of the absorbed dose is bound to plasma proteins. Metabolism is limited, but primarily occurs in the liver, the metabolites excreted in the urine.
Five major and two minor metabolites have been identified.
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
Tefose 63
Labrafil M 1944 CS
Mineral oil
Butylated hydroxyanisole
Benzoic acid
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
Aluminium lacquered tubes.
Pack sizes 78 g, 30g, 15g.
Gyno-Pevaryl Cream (PL 0242/0229) is also contained in:
Gyno-Pevaryl 150 Combined Vaginal Pessaries and Cream
(PL 0242/0227 & PL 0242/0229)
Gyno-Pevaryl 1 C.P. PACK Vaginal Pessary and Cream
(PL 0242/0226 & PL 0242/0229)
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
8. Marketing Authorisation Number(S)
PL 00242/0229
9. Date Of First Authorisation/Renewal Of The Authorisation
22 September 1995/June 2003
10. Date Of Revision Of The Text
23 March 2011
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