Composition
Conatrim Cream: Each gram cream contains Econazole Nitrate BP 10 mg and Triamcinolone Acetonide BP 1 mg..
Pharmacology
Conatrim cream is a broad spectrum antimycotic with anti-inflammatory, anti-pruritic and anti-allergic effects. This cream is composed of Econazole Nitrate, a powerful antifungal and Triamcinolone Acetonide to enforce its antimicrobial effect and the effect of subduing comprehensive inflammations, therefore, it provides remarkable effects on mixed infections of gram-positive and fungus, eczema and recurrent inflammations and shows special effects on bacterial inflammations of skin folds. The range of action of econazole covers all dermatomycoses caused by the following pathogens:- Dermatophytes, such as Trichophyton, Epidermophyton, Microsporum, Cladosporium, Yeasts, such as Candida, Cryptococcus neoformans, Torulopsis, Rhodotorula, Moulds, Fungi, such as Scopulariopsis brevicaulis, Aspergillus flavus, Histoplasma capsulatum, Blastomycosis 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, versicolor and balanitis. On the other hand Triamcinolone Acetonide is a synthetic steroid which inhibits not only the early phenomena of the inflammatory process but also the later manifestations.
Pharmacological Properties:
Econazole Nitrate is only slightly (< 0.1%) absorbed from the skin. So no active drug has been detected in the serum. But Triamcinolone Acetonide is well absorbed from sites of local application.
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.
It is indicated for the treatment of steroid-responsive inflammatory dermatoses with econazole-sensitive mycotic and/or bacterial superinfections like:
– Eczematous mycosis,
– Eczema marginatum hebecae,
– Herpes circinatum,
– Folliculitistrichophytica,
– Mycosis barbae
Onychomycoses- for the treatment of onychomycoses, local therapy with Econazole/Triamcinolone cream, combined with an oral antimycotic, is recommended.
Dosage & Administration
For topical administration only.
Adults: Apply twice daily to the affected area and rub on the skin gently with the finger. Continue the applications for 14 days or as directed by the doctor.
Children: Suitable for topical application to children.
Route of Administration:
For topical administration only.
Contraindication
Econazole is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
Precautions & Warnings
* For external use only. This Cream is not for ophthalmic or oral use.
* If a reaction suggesting hypersensitivity or chemical irritation should occur, use of the medication should be discontinued.
* Corticosteroids applied to the skin can be absorbed in sufficient amounts to produce systemic effects, including adrenal suppression. Systemic absorption may be increased by various factors such as application over a large skin surface area, application to damaged skin, application under occlusive skin dressings and prolonged duration of therapy.
* Topical corticosteroids are associated with skin thinning and atrophy, striae, telangiectasis and purpura.
* Topical corticosteroids may lead to increased risk of dermatological superinfection or opportunistic infection.
Children: Increased caution is required when treating children. Compared to adults, the nature of a child’s skin and the larger skin surface area relative to body weight may lead to an increased absorption of the corticosteroid via the child’s skin. This cream should be used in children only for short periods of time (less than 2 weeks) and on small areas (less than 10% of body surface area).
Visual disturbance may be associated with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).
Side Effects
Rarely, transient local mild irritation, itching & redness may occur immediately after application. Econazole has minimal allergenic effect and is well tolerated, even by delicate skin. Adrenal suppression on long term continuous topical steroid therapy may occur, particularly in infants or children, or when occlusive dressings are applied. It should be noted that an infant’s napkin may act as an occlusive dressing.
Use in Pregnancy & Lactation
Pregnancy: Not the Econazole but the Triamcinolone Acetonide crosses the placenta and topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids in large amounts or for prolonged periods should not be used in pregnancy.
Lactation: Negligible amount of econazole and to some extent Triamcinolone may be excreted in small amounts in breast milk. So, this cream should not be prescribed to the lactating mother or if prescribed lactation should be withheld during treatment.
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.
Overdose
Zolecon cream is intended for topical 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
Conatrim Cream : Tube containing 10 gm of Econazole Nitrate and Triamcinolone Acetonide cream
