Monoshield
Monoshield Uses, Dosage, Side Effects, Food Interaction and all others data.
Monoshield 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. Monoshield 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.
Monoshield is an imidazole/triazole type antifungal agent. Monoshield 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. Monoshield 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 | Monoshield |
| Availability | Prescription only |
| Generic | Sertaconazole |
| Sertaconazole Other Names | Sertaconazol, Sertaconazole, Sertaconazolum |
| Related Drugs | clotrimazole topical, ketoconazole topical, terbinafine, miconazole topical, Lamisil |
| Type | Cream |
| 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 | Kreit Pharma Pvt Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Monoshield 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.
Monoshield is also used to associated treatment for these conditions: Interdigital Tinea Pedis, Skin Mycoses, Vulvovaginal Candidiasis
How Monoshield works
Monoshield 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. Monoshield 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
Monoshield dosage
In the treatment of interdigital tinea pedis, Monoshield cream, 2%, should be applied twice daily for 4 weeks. Sufficient amount of Monoshield 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 Monoshield 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 Monoshield 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 Monoshield 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 Monoshield cream in pregnant women. Monoshield 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 ERMonoshield TACZO cream, 2%, to a nursing woman.
Contraindication
None
Special Warning
Pediatric Use: The efficacy and safety of Monoshield cream, 2%, have not been established in pediatric patients below the age of 12 years.
Geriatric Use: Clinical trials of Monoshield 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 Monoshield
Monoshield contains Sertaconazole see full prescribing information from innovator Monoshield Monograph, Monoshield MSDS, Monoshield FDA label
FAQ
What is Monoshield used for?
Monoshield is used to treat tinea pedis.Monoshield is in a class of medications called imidazoles. It works by slowing the growth of fungi that cause infection.
Is Monoshield safe?
Monoshield 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 Monoshield?
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 Monoshield?
Apply Monoshield 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 Monoshield safe during pregnancy?
Monoshield should be used during pregnancy only if the benefit outweighs the risk to the fetus.
Is Monoshield safe during breastfeeding?
It is not known whether Monoshield 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 Monoshield?
Monoshield 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 Monoshield?
Do not use Monoshield topical on anyone under 12 years old without medical advice.
How should I use Monoshield topical?
Do not take by mouth.Monoshield 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 Monoshield?
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 Monoshield topical?
Avoid getting Monoshield topical in your eyes.Avoid getting this medicine in your nose, mouth, rectum, or vagina.
Can I drive after taking Monoshield?
No influence on ability to drive.
Can I drink alcohol with Monoshield?
No known interaction with alcohol. Consult with doctor.
Can I overdose on Monoshield?
Overdose with Monoshield topical cream is unlikely. There are no symptoms of Monoshield overdose reported. If you suspect overdose with this medicine, immediately seek emergency medical attention.
Can I take Monoshield 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 Monoshield cream even if your condition improve.
