Econazole Nitrate + Triamcinolone Acetonide
Indications
This preparation cream is indicated for the treatment of:
- Eczematous Mycoses
- Psoriasis
- Tinea Pedis (Athlete’s foot)
- Tinea Corporis (Ring worm)
- Tinea Cruris (Jock itch)
- Inflammatory Intertrigo
- Diaper Dermatitis
Description
This 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.
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.
Dosage & Administration
Adults: This cream should be applied sparingly to the skin lesion no more than 2 times daily, preferably once in the morning and once in the evening. This cream should not be applied with an occlusive dressing, or to large areas of skin on the body. The duration of treatment with this cream should continue until the inflammatory symptoms subside but not longer than 2 weeks; after 2 weeks of therapy with this cream, continue therapy as needed with a preparation containing econazole or econazole nitrate alone.
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight. Caution should be exercised.
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight. Caution should be exercised.
Interaction
Econazole: compound metabolized by CYP3A4/2C9 oral anticoagulants (warfarin & acenocoumarol).
Triamcinolone: lowering of plasma salicylates levels. Increased risk of Gl bleeding and ulceration with NSAIDs. Antagonised blood glucose-lowering effects of the antidiabetics. Increased risk of Hyperkalemia with amphotericin B, beta-blockers, potassium-depleting diuretics, theophylline. Increased clearance of the triamcinolone with ciclosporin, carbamazepine, phenytoin, barbiturate, rifampicin.
Triamcinolone: lowering of plasma salicylates levels. Increased risk of Gl bleeding and ulceration with NSAIDs. Antagonised blood glucose-lowering effects of the antidiabetics. Increased risk of Hyperkalemia with amphotericin B, beta-blockers, potassium-depleting diuretics, theophylline. Increased clearance of the triamcinolone with ciclosporin, carbamazepine, phenytoin, barbiturate, rifampicin.
Contraindications
This Cream is contraindicated-
- In individuals who have shown hypersensitivity to any of its ingredients.
- Like any other dermatological preparation containing corticosteroids, this Cream is contraindicated in specific skin conditions such as tuberculous, varicella, herpes simplex or other viral infections of the skin, or fresh vaccination sites.
- Decubitus ulcers: Viral, bacterial or fungal skin infections (e.g. tuberculosis of the skin, syphilis of the skin, herpes simplex, herpes zoster, chickenpox).
- Rosacea and rosacea-like dermatitis.
Side Effects
Rarely, transient local mild irritation, itching & redness may occur immediately after application. Econazole has the 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.
Pregnancy & Lactation
Pregnancy: Not the Econazole but the Triamcinolone Acetonide crosses the placenta and topical administration of corticosteroids during pregnancy 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.
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.
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.
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).
Overdose Effects
This Cream is for cutaneous application only. Corticosteroids applied to the skin, including triamcinolone, can be absorbed in sufficient amounts to produce systemic effects. In the event of accidental ingestion, treat symptomatically. If this cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.
Therapeutic Class
Triamcinolone & Combined preparations
Storage Conditions
Store in a cool (below 30°C) and dry place, away from light. Keep out of the reach of children.
