EXELDERM Cream, 1.0% (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Journey Medical Corporation

Λέξεις κλειδιά

69489-711

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1. Description

EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in EXELDERM CREAM, is an imidazole ...

2. Clinical Pharmacology

Sulconazole nitrate is an imidazole derivative with broad-spectrum antifungal activity that inhibits the growth in vitro of the common pathogenic dermatophytes including Trichophyton rubrum, ...

3. Indications and Usage

EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is an antifungal agent indicated for the treatment of tinea pedis (athletes foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton ...

4. Contraindications

EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of its ingredients.

6.1. General

EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the cream should be discontinued and appropriate therapy instituted.

6.2. Information for Patients

Patients should be told to use EXELDERM CREAM as directed by the physician, to use it externally only, and to avoid contact with the eyes.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

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

6.7. Pregnancy

(Category C) There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if clearly needed. Sulconazole nitrate has been shown to be embryotoxic ...

6.9. Nursing Mothers

It is not known whether sulconazole nitrate is excreted in human milk. Caution should be exercised when sulconazole nitrate is administered to a nursing woman.

6.10. Pediatric Use

Safety and effectiveness in children have not been established.

6.11. Geriatric Use

Clinical studies of EXELDERM CREAM, 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 ...

7. Adverse Reactions

There were no systemic effects and only infrequent cutaneous adverse reactions in 1185 patients treated with sulconazole nitrate cream in controlled clinical trials. Approximately 3% of these patients ...

10. Dosage and Administration

A small amount of cream should be gently massaged into the affected and surrounding skin areas once or twice daily, except in tinea pedis, where administration should be twice daily. Early relief of symptoms ...

11. How Supplied

EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is a smooth, glossy white to off-white cream having a slight characteristic odor. It is supplied as follows: 60 g tube – NDC 69489-711-60

12. Storage and Handling

Avoid excessive heat, above 40°C (104°F).

13. Clinical Studies

In a vehicle-controlled study for the treatment of tinea pedis (moccasin type) due to T. rubrum, after 4 to 6 weeks of treatment 69% of patients on the active drug and 19% of patients on the drug ...