Myk-1

Overdose

No information provided.

Contraindications

Myk-1 (sulconazole nitrate) SOLUTION, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.

Undesirable effects

There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with sulconazole nitrate solution in controlled clinical trials. Approximately 1% of these patients reported itching and 1% burning or stinging. These complaints did not usually interfere with treatment.

Therapeutic indications

Myk-1 (sulconazole nitrate) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot).

Symptomatic relief usually occurs within a few days after starting Myk-1 (sulconazole) SOLUTION and clinical improvement usually occurs within one week.

Name of the medicinal product

Qualitative and quantitative composition

Special warnings and precautions for use

No information provided.

Myk-1 (sulconazole nitrate) SOLUTION, 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the solution should be discontinued and appropriate therapy instituted.

Long-term animal studies to determine carcinogenic potential have not been performed. In vitro studies have shown no mutagenic activity.

Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses 125 times the human dose (in mg/kg). The drug at this dose given orally to rats also resulted in prolonged gestation and dystocia. Several females died during the perinatal period, most likely due to labor complications. Sulconazole nitrate was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day.

There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sulconazole nitrate is administered to a nursing woman.

Safety and effectiveness in children have not been established.

Clinical studies of Myk-1 (sulconazole) SOLUTION, 1.0%, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

Dosage (Posology) and method of administration

A small amount of the solution should be gently massaged into the affected and surrounding skin areas once or twice daily.

Symptomatic relief usually occurs within a few days after starting Myk-1 (sulconazole nitrate) SOLUTION, 1.0%, and clinical improvement usually occurs within one week. To reduce the possibility of recurrence, tinea cruris, tinea corporis, and tinea versicolor should be treated for 3 weeks.

If significant clinical improvement is not seen after 4 weeks of treatment, an alternate diagnosis should be considered.