Prescription Required
In stock
Manufacturer
IGI LABS, INC./
SKU
52565002285

econazole nitrate 1% cream

Generic
$53.98 / tube
$434.70 / tube
$380.72 / tube
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1,000 tubes Available
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Uses

Dermatophytoses

Econazole nitrate 1% topical cream is used for the treatment of certain dermatophytoses, including tinea corporis (body ringworm), tinea cruris (jock itch), and tinea pedis (athlete's foot) caused by Epidermophyton floccosum, Microsporum audouinii, M. canis, M. gypseum, Trichophyton mentagrophytes, T. rubrum, or T. tonsurans.

Clinical studies to date indicate that econazole nitrate 1% cream is effective for the topical treatment of dermatophytoses and appears to be equivalent in efficacy and safety to topical clotrimazole 1% cream, miconazole nitrate 1% cream, or tioconazole 1 or 2% cream (not commercially available in the US).

Like other imidazole derivatives (e.g., clotrimazole, ketoconazole, miconazole, oxiconazole, sulconazole) and ciclopirox olamine, econazole nitrate has an advantage over some other topical antifungal agents (e.g., nystatin, tolnaftate) in the treatment of mixed infections or for empiric treatment pending identification of the causative organism, since the drug is active against both dermatophytes and Candida.

Tinea Corporis and Tinea Cruris

Tinea corporis and tinea cruris generally can be effectively treated using a topical antifungal; however, an oral antifungal may be necessary if the disease is extensive, dermatophyte folliculitis is present, the infection is chronic or does not respond to topical therapy, or the patient is immunocompromised because of coexisting disease or concomitant therapy.

Many clinicians consider topical imidazole-derivative azole antifungals (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole) or topical allylamine antifungals (e.g., naftifine, terbinafine) the drugs of first choice for the topical treatment of tinea corporis or tinea cruris, although other antifungals (e.g., ciclopirox olamine, butenafine hydrochloride, tolnafate, undecylenic acid) also can be effective in the treatment of these infections.

Tinea Pedis

While topical antifungals usually are effective for the treatment of uncomplicated tinea pedis, an oral antifungal usually is necessary for the treatment of hyperkeratotic areas on the palms and soles, for chronic moccasin-type (dry-type) tinea pedis, and for the treatment of tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).

Pityriasis (Tinea) Versicolor

Econazole nitrate 1% topical cream is used for the treatment of pityriasis (tinea) versicolor, a superficial infection caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).

Pityriasis versicolor generally can be treated topically with an imidazole-derivative azole antifungal (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole), an allylamine antifungal (e.g., terbinafine), ciclopirox olamine, or certain other topical therapies (e.g., selenium sulfide 2.5%). However, an oral antifungal (e.g., itraconazole, ketoconazole) may be indicated, with or without a topical antifungal, in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.

Cutaneous Candidiasis

Econazole 1% topical cream is used for the treatment of cutaneous candidiasis caused by Candida albicans.

Other Uses

Econazole nitrate has been used effectively as a 1% vaginal cream or 150-mg vaginal suppositories for the treatment of vulvovaginal candidiasis. In a few comparative studies, these vaginal preparations produced cure rates similar to those produced by clotrimazole or nystatin vaginal tablets. Econazole nitrate has also been used with some success as a 1% otic solution for the treatment of otomycoses. The vaginal cream and suppositories and otic solution currently are not commercially available in the US.

Dosage and Administration

Administration

Econazole nitrate is applied topically to the skin as a 1% cream.

The cream should not be applied to the eye and should not be administered intravaginally.

A sufficient amount of the cream should be applied to cover the affected areas of skin and rubbed in gently.

Dosage

Dermatophytoses

For the treatment of tinea corporis (body ringworm), tinea cruris (jock itch), or tinea pedis (athlete's foot), econazole nitrate topical cream should be applied once daily.

The usual duration of treatment to reduce the possibility of recurrence is 2 weeks for tinea corporis and tinea cruris or 1 month for tinea pedis. Occasionally, treatment periods up to 6 weeks or longer may be required for these infections.

Clinical improvement and relief of symptoms usually occur within the first 1-2 weeks of treatment. If clinical improvement does not occur after the treatment period, the diagnosis should be reevaluated.

Pityriasis (Tinea) Versicolor

For the treatment of pityriasis (tinea) versicolor, econazole nitrate topical cream should be applied once daily.

Patients with tinea versicolor usually exhibit clinical and mycologic clearing after 2 weeks of treatment, at which time therapy may be discontinued if response is considered sufficient. If clinical improvement does not occur after the treatment period, the diagnosis should be reevaluated.

Cutaneous Candidiasis

For the treatment of cutaneous candidiasis, econazole nitrate topical cream should be applied twice daily (morning and evening).

The usual duration of treatment is 2 weeks. Occasionally, treatment periods up to 6 weeks or longer may be required for these infections. If clinical improvement does not occur after the treatment period, the diagnosis should be reevaluated.

Cautions

Adverse Effects

Topically applied econazole nitrate appears to have a low order of toxicity. Adverse effects reported during clinical studies occurred in about 3% of patients and consisted principally of burning and stinging sensations, pruritus, and erythema. These adverse effects usually occurred after 2-4 days of treatment, were associated mainly with application of the drug to the inguinal area, were transient, and only rarely required discontinuance of therapy.

Contact dermatitis has been reported rarely in patients receiving topical econazole. Contact dermatitis also has been reported following topical application of other imidazole-derivative azole antifungals (e.g., clotrimazole, miconazole, oxiconazole, sulconazole, tioconazole). Cross-sensitization appears to occur among the imidazole derivatives; however, cross-sensitivity appears to be unpredictable.

Studies conducted to date have not revealed evidence of phototoxicity, changes in pigmentation, or photocontact sensitization following topical application of econazole nitrate.

Although hepatocellular dysfunction has occurred during systemic treatment with imidazole-derivative antifungal agents (i.e., ketoconazole), this adverse effect has not been reported to date following topical econazole nitrate therapy.

Precautions and Contraindications

Topical econazole nitrate 1% cream is contraindicated in patients who have shown hypersensitivity to the drug or any ingredient in the formulation.

Patients receiving topical econazole nitrate therapy should be instructed to use the medication for the full, prescribed treatment period, even if symptoms improve, and to contact their physician if their skin condition does not improve after a full course of therapy.

Patients should be instructed to contact their physician if signs of increased irritation occur. If a reaction suggesting sensitivity or chemical irritation occurs during treatment with econazole nitrate 1% cream, the drug should be discontinued and appropriate therapy initiated.

The fact that patients with contact sensitivity to one imidazole-derivative azole antifungal may be sensitive to other similar drugs should be considered.

Commercially available econazole nitrate 1% cream is intended for topical application to the skin only and should not be applied to the eye and should not be administered intravaginally.

Pediatric Precautions

Topical econazole nitrate 1% cream has been used with good results and without unusual adverse effects for the treatment of cutaneous fungal infections in some children 3 months of age and older.

Mutagenicity and Carcinogenicity

In vitro tests have not shown econazole nitrate to be mutagenic. Long-term animal studies to determine carcinogenic potential of the drug have not been performed to date.

Pregnancy, Fertility, and Lactation

Pregnancy

Reproduction studies in mice, rabbits, and rats using orally administered econazole nitrate have not revealed evidence of teratogenicity; however, gestation has been reported to be prolonged in rats following oral administration of the drug. Prolonged gestation has not been reported following intravaginal administration of econazole nitrate in humans. Fetotoxic or embryotoxic effects were observed in reproduction studies in rats receiving oral econazole nitrate dosages 10-40 times the topical human dosage, and similar effects occurred in mice, rabbits, and/or rats receiving oral dosages 40 or 80 times the topical human dosage. Econazole nitrate 1% cream should be used during the first trimester of pregnancy only when considered essential to the welfare of the patient and during the second or third trimester of pregnancy only when clearly needed.

Fertility

Reproduction studies in rats using orally administered econazole nitrate have not revealed evidence of impaired fertility. No adverse reproductive effects have been reported following intravaginal administration of the drug in humans.

Lactation

Following oral administration of econazole nitrate to lactating rats, econazole and/or its metabolites are distributed into milk and have been detected in nursing pups. In addition, in lactating rats receiving oral econazole nitrate dosages 40 or 80 times the topical human dosage, postpartum viability of pups and survival to weaning were reduced; however, at these dosages, maternal toxicity was present and may have been a contributing factor. Since it is not known whether econazole nitrate is distributed into human milk following topical application, econazole nitrate 1% cream should be used with caution in nursing women.

Drug Interactions

Corticosteroids

In vitro studies indicate that corticosteroids (i.e., hydrocortisone, triamcinolone acetonide) inhibit the antifungal activity of econazole nitrate against Saccharomyces cerevisiae and Candida albicans in a concentration-dependent manner, but have no effect on the antibacterial activity of econazole nitrate against Staphylococcus. When the concentration of the corticosteroid was equal to or greater than that of econazole nitrate on a weight basis, the antifungal activity was substantially inhibited; when the corticosteroid concentration was only one-tenth that of econazole nitrate, the antifungal activity was unaffected.

Studies on healthy skin in humans showed that the presence of econazole nitrate in 10-fold higher molar concentrations did not substantially alter the blanching phenomenon elicited by topical application of triamcinolone acetonide, suggesting that the antifungal agent does not alter the activity of the corticosteroid.

Pharmacokinetics

Absorption

Percutaneous absorption of econazole nitrate appears to be rapid but minimal following topical application of the drug to intact skin.

In one patient in which 70-100 mg of econazole nitrate 1% cream was applied to a 28-cm skin area of the thigh and covered with an occlusive dressing for about 16 hours, less than 1% of the dose was recovered in urine. In another study in healthy individuals in which 1 g of econazole nitrate 2% cream was applied to intact skin and to skin stripped of the stratum corneum, peak plasma drug concentrations were less than 1 ng/mL and 20 ng/mL, respectively, and approximately 0.1 and 3.7% of the applied doses, respectively, were recovered in urine and feces.

Distribution

Following topical application of econazole nitrate 1% cream to healthy human skin in vivo in one study, about 7.6-9.6% of the applied dose was present in the stratum corneum 0.5-5 hours after application. Although the highest drug concentrations, ranging from 1070-1410 mcg/cm, were present in the stratum corneum, concentrations present in the epidermis ranged from 0.95-20.6 mcg/cm, which exceeded the usual MIC for most susceptible fungi; inhibitory concentrations of the drug were also attained as deep as the middle region of the dermis. Occlusive dressings appear to only slightly increase the extent of dermal penetration of the drug.

It is not known if econazole nitrate is distributed into human milk following topical application; the drug and/or its metabolites are distributed into milk in rats following oral administration.

Elimination

The metabolic and excretory fate of econazole nitrate has not been fully elucidated. Following topical application of econazole nitrate cream to intact skin, less than 1% of the applied dose is excreted in urine and feces; most of the systemically absorbed fraction of the dose appears to be excreted in urine within 24 hours.

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