Gyno-Zalain

Uses

Gyno-Zalain cream 2% is an azole antifungal used for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by: Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

Gyno-Zalain is also used to associated treatment for these conditions: Interdigital Tinea Pedis, Skin Mycoses, Vulvovaginal Candidiasis

How Gyno-Zalain works

Gyno-Zalain interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Gyno-Zalain may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis.

Dosage

Gyno-Zalain dosage

In the treatment of interdigital tinea pedis, Gyno-Zalain cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of Gyno-Zalain cream, 2%, should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin of patients with interdigital tinea pedis. Not for ophthalmic, oral, or intravaginal use.

Side Effects

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.

In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving Gyno-Zalain cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site skin tenderness.

In a dermal sensitization trial, 8 of 202 evaluable subjects tested with Gyno-Zalain cream, 2%, and 4 of 202 evaluable subjects tested with vehicle, exhibited a slight erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers.

Precaution

If irritation develops, treatment should be discontinued and appropriate therapy instituted. Physicians should exercise caution when prescribing Gyno-Zalain cream, 2%, to patients known to be sensitive to azole antifungals, since crossreactivity may occur.

Food Interaction

Elimination Route

Bioavailability is negligible.

Pregnancy & Breastfeeding use

Pregnancy Category C. There are no adequate and well-controlled studies conducted with Gyno-Zalain cream in pregnant women. Gyno-Zalain cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known if sertaconazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when prescribing ERGyno-Zalain TACZO cream, 2%, to a nursing woman.

Contraindication

None

Special Warning

Pediatric Use: The efficacy and safety of Gyno-Zalain cream, 2%, have not been established in pediatric patients below the age of 12 years.

Geriatric Use: Clinical trials of Gyno-Zalain cream, 2%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Storage Condition

Store at 20°C - 25°C; excursions permitted to 15°- 30°C

Innovators Monograph

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