Composition
Each gram cream contains Econazole Nitrate BP 10 mg.
Pharmacology
Econazole Nitrate is a broad-spectrum antifungal agent. The range of action of Econazole covers all dermatomycoses caused by the following pathogens :
Dermatophytes, such as Trichophyton, Epidermophyton, Microsporum, Cladosporium and others.
Yeasts, such as Candida, Cryptococcus neoformans, Torulopsis, Rhodotorula and others.
Moulds and other Fungi, such as Scopulariopsis brevicaulis, Aspergillus flavus, Histoplasma capsulatam, Blastomyces dermatitidis and others. As well as Malassezia furfur and Nocardia minutissima.
Moreover, it has antibacterial effect on Gram-positive cocci and bacilli, including Streptococcus pyogens and Staphylococcus aureus.
It is also effective against Trichomonus vaginalis
Indication
Zolecon Cream: All fungal skin infections due to dermatophytes, yeasts, moulds and other fungi. These include Vulvo-vaginal candidiasis, Candidial napkin rash, and other candidial infection, Ringworm (tinea) infections, Athlete’s foot, Paronychia, Pityriasis versicolor and Balanitis.
Dosage & Administration
Zolecon (Econazole Nitrate) cream is applied to the affected skin areas once or twice daily, in the morning and/or in the evening and gently rubbed in with the clean finger. For mycoses of the hands, application is recommended following each washing of the hands. For the treatment of onychomycosis, occlusive dressings are recommended.
Route of Administration:
By Local application
Contraindication
Econazole is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
Warning & Precaution
Hypersensitivity has rarely been recorded. If something like this occur, administration of the product should be discontinued. The infected area should be kept clean and dry during treatment.
Side Effects
Rarely, transient local mild irritation, itching & redness may occur immediately after application. Zolecon (Econazole Nitrate) has minimal allergic effect. It is well tolerated, even by delicate skin. Local irritations are not likely to occur, except in the rare cases, e.g. in eczematous skin areas.
Drug Interaction
Warfarin: Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. Most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econzole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.
Carcinogenicity Studies: Long-term animal studies to determine carcinogenic potential have not been performed.
Use in Pregnancy & Lactation
During Pregnancy: There is no information of any abnormality or adverse event in neonates while Zolecon (Econazole Nitrate) Cream had been used during pregnancy.
During Lactation: As the systemic absorption of Zolecon (Econazole Nitrate) cream is extremely low after topical/vaginal use, excretion in breast milk is likely to be negligible. So it can be used topically/vaginally during lactation if needed.
Overdose
Econazole Cream is intended for topical and vaginal use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered desirable.
Storage
Store at a cool & dry place, protect from light & moisture. Keep out of the reach of children.
Packing
Tube containing 10 gm cream.
