Dermofix Cream 15 g
Sigmatec
Sigmatec
Composition
Sertaconazole nitrate 20 mg
Inactive ingredients
Ethylene glycol, polyethylene glycol, palmito stearate, lauroyl macrogol-6 glycerides, glycerol-mono, di-isostearate, vaseline oil, methyl p-hydroxybenzoate, sorbic acid, distilled water
Properties
Dermofix (sertaconazole nitrate) cream, 2% is for topical application. It contains the azole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers. Sertaconazole, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzymes. This enzyme functions to convert lanosterol to ergosterol. Ergosterol is a key component of fungal cell membranes and lack of this component leads to fungal cell injury by leakage of key constituents in the cytoplasm from the cell.
Indications
Dermofix (sertaconazole nitrate) cream, 2%, is indicated 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.
Directions for use
-In the treatment of interdigital tinea pedis
Dermofix cream 2%, should be applied twice daily for 4 weeks. Sufficient amount 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
Local Adverse Reactions
-If irritation develops, treatment should be discontinued and appropriate therapy instituted.
-Physicians should exercise caution when prescribing Dermofix cream 2% to patients known to be sensitive to azole antifungals, since cross- reactivity may occur.
-Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation and hyperpigmentation.
Warnings and precautions
Pregnancy
Dermofix cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Breastfeeding
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 Dermofix cream 2%, to a nursing woman.
Pediatric Use
The efficacy and safety of Dermofix cream 2%, have not been established in pediatric patients below the age of 12 years.
Use Dermofix cream, 2%, as directed by the physician. The hands should be washed after applying the medication to the affected area(s).
Avoid contact with the eyes, mouth, vagina and other mucous membranes. Dermofix cream, 2% is for external use only.
Inform the physician if the area of application shows signs of increased irritation, redness, itching, burning, blistering, swelling or oozing.
Keep out of reach of children.
Storage
Store at a temperature not exceeding 30°C
Package
Carton box holds a tube 15 gm cream and an insert leaflet