pharmacopeia
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/api/v1/drug/sulconazole

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: 14-alpha Demethylase Inhibitors.

14-alpha Demethylase

Indications

Sourced from openFDA
  • EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is an antifungal agent indicated for the treatment of tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagro-phytes, Epidermophyton floccosum, and Microsporum canis,* and for the treatment of tinea versicolor. *Efficacy for this organism in the organ system was studied in fewer than ten infections.ICD-10: B35.3

Contraindications

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

Dosage & administration

Sourced from openFDA

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 is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, tinea corporis/cruris and tinea versicolor should be treated for 3 weeks and tinea pedis for 4 weeks to reduce the possibility of recurrence. If significant clinical improvement is not seen after 4 to 6 weeks of treatment, an alternate diagnosis should be considered.

Adverse reactions

Sourced from openFDA

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 reported itching, 3% burning or stinging, and 1% redness. These complaints did not usually interfere with treatment.

Use in specific populations

Sourced from openFDA

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

Approval history

Sourced from openFDA
  • Aug 30, 1985NDANDA018738Journey
  • Feb 28, 1989NDANDA018737Journey

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
22 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective314%
  2. 2Fatigue29.1%
  3. 3Herpes Zoster29.1%
  4. 4Hypotension29.1%
  5. 5Nausea29.1%
  6. 6Pruritus29.1%
  7. 7Abnormal Dreams14.5%
  8. 8Acute Kidney Injury14.5%
  9. 9Altered State Of Consciousness14.5%
  10. 10Anxiety14.5%
  11. 11Asthenia14.5%
  12. 12Atrial Fibrillation14.5%
  13. 13Basal Cell Carcinoma14.5%
  14. 14Bradycardia14.5%
  15. 15Cardioactive Drug Level Increased14.5%

Frequently asked questions

How does Sulconazole work?
Mechanism-of-action class: 14-alpha Demethylase Inhibitors.
What is Sulconazole used for?
According to FDA labeling, Sulconazole carries indications including: EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is an antifungal agent indicated for the treatment of tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagro-phytes, Epidermophyton floccosum, and Microsporum canis,* and for the treatment of tinea versicolor. *Efficacy for this organism in the organ system was studied in fewer than ten infections.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sulconazole?
Sulconazole is classified as Imidazole and triazole derivatives, Azole Antifungal, 14-alpha Demethylase Inhibitors, Decreased Cell Wall Integrity.
What are the brand names for Sulconazole?
Sulconazole is marketed under brand names including Exelderm.
What are the contraindications for Sulconazole?
Sulconazole labeling lists contraindications including: EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of its ingredients.. Always consult the full prescribing information and a clinician.
Note. Data for sulconazole is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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