Dermofix Сream 15 gm

Trade Name:

Dermofix 

Sertaconazole nitrate 2%

Topical cream

15 gm

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