Ginedermofix
Ginedermofix Uses, Dosage, Side Effects, Food Interaction and all others data.
Ginedermofix 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. Ginedermofix 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.
Ginedermofix is an imidazole/triazole type antifungal agent. Ginedermofix is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14 α-demethylation via the inhibition of the enzyme cytochrome P450 14α-demethylase. This enzyme converts lanosterol to ergosterol, and is required in fungal cell wall synthesis. The subsequent loss of normal sterols correlates with the accumulation of 14 α-methyl sterols in fungi and may be partly responsible for the fungistatic activity of fluconazole. Mammalian cell demethylation is much less sensitive to fluconazole inhibition. Ginedermofix exhibits in vitro activity against Cryptococcus neoformans and Candida spp. Fungistatic activity has also been demonstrated in normal and immunocompromised animal models for systemic and intracranial fungal infections due to Cryptococcus neoformans and for systemic infections due to Candida albicans.
| Trade Name | Ginedermofix |
| Availability | Prescription only |
| Generic | Sertaconazole |
| Sertaconazole Other Names | Sertaconazol, Sertaconazole, Sertaconazolum |
| Related Drugs | clotrimazole topical, ketoconazole topical, terbinafine, miconazole topical, Lamisil |
| Type | |
| Formula | C20H15Cl3N2OS |
| Weight | Average: 437.77 Monoisotopic: 435.997066923 |
| Protein binding | >99% to plasma |
| Groups | Approved, Investigational |
| Therapeutic Class | Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations |
| Manufacturer | |
| Available Country | Spain |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Ginedermofix 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.
Ginedermofix is also used to associated treatment for these conditions: Interdigital Tinea Pedis, Skin Mycoses, Vulvovaginal Candidiasis
How Ginedermofix works
Ginedermofix 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. Ginedermofix 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
Ginedermofix dosage
In the treatment of interdigital tinea pedis, Ginedermofix cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of Ginedermofix 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 Ginedermofix 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 Ginedermofix 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 Ginedermofix cream, 2%, to patients known to be sensitive to azole antifungals, since crossreactivity may occur.
Food Interaction
No interactions found.Elimination Route
Bioavailability is negligible.
Pregnancy & Breastfeeding use
Pregnancy Category C. There are no adequate and well-controlled studies conducted with Ginedermofix cream in pregnant women. Ginedermofix 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 ERGinedermofix TACZO cream, 2%, to a nursing woman.
Contraindication
None
Special Warning
Pediatric Use: The efficacy and safety of Ginedermofix cream, 2%, have not been established in pediatric patients below the age of 12 years.
Geriatric Use: Clinical trials of Ginedermofix 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
You find simplified version here Ginedermofix
Ginedermofix contains Sertaconazole see full prescribing information from innovator Ginedermofix Monograph, Ginedermofix MSDS, Ginedermofix FDA label
FAQ
What is Ginedermofix used for?
Ginedermofix is used to treat tinea pedis.Ginedermofix is in a class of medications called imidazoles. It works by slowing the growth of fungi that cause infection.
Is Ginedermofix safe?
Ginedermofix is a broad-spectrum third-generation imidazole derivative that is effective and safe for the treatment for superficial mycoses, such as tineas, candidiasis, and pityriasis versicolor.
What are the common side effects of Ginedermofix?
Common side effects may include:dryness of treated skin;skin tenderness; or mild rash or skin irritation where the medicine was applied.
How do you use Ginedermofix?
Apply Ginedermofix to the affected skin twice daily or as directed by your doctor.Apply enough medication to cover the affected skin and some of the surrounding skin. After applying this medication, wash your hands.
Is Ginedermofix safe during pregnancy?
Ginedermofix should be used during pregnancy only if the benefit outweighs the risk to the fetus.
Is Ginedermofix safe during breastfeeding?
It is not known whether Ginedermofix topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
What is the indication of Ginedermofix?
Ginedermofix is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Who should not take Ginedermofix?
Do not use Ginedermofix topical on anyone under 12 years old without medical advice.
How should I use Ginedermofix topical?
Do not take by mouth.Ginedermofix topical is for use only on the skin.Clean and dry the affected area.
Apply the medicine to the affected areas between the toes and nearby skin 2 times per day for 1 month.
What happens if I miss Ginedermofix?
Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.
What should I avoid while using Ginedermofix topical?
Avoid getting Ginedermofix topical in your eyes.Avoid getting this medicine in your nose, mouth, rectum, or vagina.
Can I drive after taking Ginedermofix?
No influence on ability to drive.
Can I drink alcohol with Ginedermofix?
No known interaction with alcohol. Consult with doctor.
Can I overdose on Ginedermofix?
Overdose with Ginedermofix topical cream is unlikely. There are no symptoms of Ginedermofix overdose reported. If you suspect overdose with this medicine, immediately seek emergency medical attention.
Can I take Ginedermofix long time?
Do not use more or less of it or use it more often than prescribed by your doctor. Your symptoms should improve in the first two weeks of your treatment. Continue to use Ginedermofix cream even if your condition improve.
