SUMARY OF PRODUCT CHARACTERISTICS
NAME OF PRODUCT: Sertaconazole® Cream: Acute and subacute lesions, moist areas, mucous membranes. Solution: Areas with hair, very moist, large areas. Prevents maceration. Skins that are sensitive to oily excipients. Powder: Folds of the skin, areas between the fingers or toes, strong absorbent and drying action. Gel: Affectations of large skin areas and / or hair.
Pharmacological action: Sertaconazole is a new topical antimycotic with fungicidal activity, a wide activity spectrum which includes the pathogenic yeasts (Candida albicans, C. tropicalis, C. spp. Pityrosporum orbiculare), dermatophytes (Trichophyton, Epidermophyton and Microsporum), and other agents causing and accompanying infections of the skin and mucous membranes such as Gram-positive germs (Staphylococci and Streptococci).
Composition: per gram of cream: Sertaconazole nitrate 20 mg Excipients q.s.
Indications: Topical treatment of mycosis of the surface of the skin such as dermatophytosis. Tinea pedis (athlete’s foot), Tinea cruris (Hebra’s eczema), Tinea corporis (herpes circinatus), Tinea barbae (beard mycosis) and Tinea manus, Candidiasis (moniliasis) and Pityriasis versicolor (Pityrosporum orbiculare). Dosage: Apply the cream once or twice a day (preferably at night or in the morning and at night), spreading gently and evenly over the lesion and covering at least 1 cm. of healthy skin (approximately) surrounding the affected area. The duration of treatment to obtain a complete cure varies from patient to patient depending on the causal agent and the location of the infection. In general, four weeks of treatment is recommended to ensure a complete clinical and micro-biological cure and prevent the appearance of relapses. In many cases this clinical and microbiological cure appears much earlier, after between two and four weeks of treatment. Contraindications: Do not administer in the event of any known allergy to the substance or to any of the constituents of the excipient. Precautions: Not to be used for ophthalmic treatments. Drugs interactions: No interactions have been reported. Undesired effects: Safety in local treatment is excellent; no toxic or photosensitive effects have been observed. Reports been received of some slight cases of a local transitory erythematous reaction during the first few days of treatment; it was not necessary to discontinuation treatment in any of these cases. Use during pregnancy: No levels were detected in plasma even the topical application of large amounts; nevertheless, its harmlessness has not been demonstrated in pregnant women; therefore possible risks and benefits should be evaluated before use during pregnancy and for breast-feeding mothers. Overdose and treatment: Considering the concentration of active substance and the route of administration intoxication is impossible; nevertheless, in the event of accidental ingestion, appropriate symptomatic treatment should be applied.
Not all dosage forms are available.
