Trosyd (Tioconazole)

TROSYD™ AF TROSYD™ J Pfizer Consumer Tioconazole Antifungal Agent

Action and Clinical

Tioconazole is a member of the imidazole class of antifungal agents. Although the mode of action of tioconazole has not as yet been determined, several studies have demonstrated that the imidazoles inhibit ergosterol synthesis in fungi by blocking C-14 demethylation. As a result, there is an accumulation of C-14 methyl sterol intermediates like langosterol, and a decrease in ergosterol. Langosterol cannot support yeast growth in the absence of ergosterol, and the inhibition of ergosterol synthesis or the accumulation of langosterol may be the primary antifungal mechanism of this class of drugs. At high drug concentrations the imidazoles have been postulated to exert a fungicidal effect by rapid membrane damage of the fungi.

Indications And Clinical Uses:

Trosyd AF: For the topical treatment of patients with tinea pedis and tinea corporis caused by T. rubrum, T. mentagrophytes, E. floccosum; cutaneous candidiasis due to C. albicans; tinea (pityriasis) versicolor caused by M. furfur (P. orbiculare).

Trosyd J: For the topical treatment of patients with tinea cruris caused by T. rubrum, T. mentagrophytes, E. floccosum; cutaneous candidiasis due to C. albicans; tinea (pityriasis) versicolor caused by M. furfur (P. orbiculare).

Children: Clinical experience with tioconazole cream in children is very limited.

Contra-Indications:

In those patients who have a history of sensitization to tioconazole or to any of the other components of the dermal cream, or to other imidazole antifungal agents.

Warnings in Clinical States:

Pregnancy: There are no adequate and well controlled studies which establish the safety of tioconazole cream in pregnant women.

In limited uncontrolled clinical use, tioconazole vaginal ointment and ovule applied as a single dose to about 20 patients during various stages of pregnancy did not appear to interfere with the normal progress of the pregnancy and at delivery.

However, local and systemic administration to rats indicate that adverse effects of parturition and/or fetal development were observed.

Accordingly, tioconazole cream should be used during pregnancy only if in the opinion of the physician the potential benefit outweighs the potential risk to the fetus.

Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, tioconazole cream should not be used by nursing women unless, in the judgment of a physician, the potential benefit outweighs the possible risk.

Precautions:

Skin and mucosal sensitization may occur. Use of tioconazole cream should be discontinued should such reaction occur, and appropriate therapy instituted.:

Tioconazole cream is not for ophthalmic use.

Adverse Reactions:

Tioconazole cream 1% w/w is well tolerated upon local application and no systemic adverse reactions have been observed with the dermal application of the drug.

Symptoms of local irritation have been reported by some patients (7.2%). They are usually seen during the first week of treatment and are most often transient. The most commonly observed symptoms of local irritation reported in clinical studies were burning sensation (3.2%), itching (2.8%), erythema (1.5%), rash (0.8%) and edema (0.2%).

Treatment was discontinued in 1.9% of the patients. The principal reason for termination of treatment was the development of eczematous reactions or dermatitis.

Symptoms and Treatment of Overdose:

Dosage And Administration:

Skin Infections: Trosyd AF or Trosyd J should be gently massaged into the affected and surrounding skin area twice a day, in the morning and evening. In intertriginous areas, the creams should be applied sparingly and smoothed in well to avoid macerating effects.

The duration of treatment and the success achieved will vary from patient to patient, depending on the infecting organism and the site of infection. On the basis of clinical studies the recommended length of treatment is: tinea versicolor, 7 to 28 days; tinea cruris, up to 14 days; tinea pedis, up to 6 weeks may be required in severe cases, especially the chronic hyperkeratotic type; dermatophyte infections and cutaneous candidiasis at other sites, 2 to 4 weeks.

Availability And Storage:

Trosyd AF: Each g of white homogeneous cream contains: tioconazole 10 mg (1% w/w) in a vanishing cream base. Nonmedicinal ingredients: benzyl alcohol (as preservative), ethoxylated cetostearyl alcohol, mineral oil, propylene glycol, purified water, stearic acid, stearyl alcohol and white petrolatum. Tubes of 30 g.

Trosyd J: Each g of white homogeneous cream contains: tioconazole 10 mg (1% w/w) in a vanishing cream base. Nonmedicinal ingredients: benzyl alcohol (as preservative), ethoxylated cetostearyl alcohol, mineral oil, propylene glycol, purified water, stearic acid, stearyl alcohol and white petrolatum. Tubes of 30 g.

Store at 15 to 30°C; avoid freezing.

TROSYD™ AF TROSYD™ J Pfizer Consumer Tioconazole Antifungal Agent

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