Oflomikol cream 2%, 20g

Superficial mycoses of the skin:

• dermatophytosis;

• mycoses of the legs, feet and hands;

• mycoses of the trunk;

• mycosis of the beard;

• candidiasis;

• multicolored (pityriasis) versicolor;

• seborrheic dermatitis.

Topically applied 1-2 times / day for 2-4 weeks.

Cream for external use, white, homogeneous.

1 g

sertaconazole nitrate 0.02 g

Excipients: cetyl alcohol - 0.035 g, stearyl alcohol - 0.035 g, myristyl alcohol (Sepeziol c 14) - 0.02 g, glyceryl monostearate (NSE) - 0.02 g, sorbitan stearate - 0.01 g, polysorbate 60 (Tween 60) - 0.035 g , octyldodecanol - 0.04 g, liquid paraffin - 0.04 g, benzyl alcohol - 0.01 g, purified water - 0.735 g.

Hypersensitivity to sertaconazole, an imidazole derivative.

pharmachologic effect

Antifungal agent for external and local use. Sertaconazole is a derivative of imidazole and benzothiophene with a broad spectrum of action against pathogenic fungi Candida spp. (including Candida albicans, Candida tropicalis), other pathogenic fungi (Pityrosporum orbiculare, Malassezia spp.), dermatophytes (Trichophyton and Microsporum), gram-positive bacteria (Streptococcus spp., Staphylococcus spp.), as well as Gardnerella vagococcus vaginal spp. faecalis, Bacteroides spp., Trichomonas vaginalis. Sertaconazole does not suppress the viability of Lactobacillus spp. in vitro. In therapeutic doses, it has a fungicidal and fungistatic effect. The mechanism of action of sertaconazole is to suppress the synthesis of ergosterol,the main component of the membranes of fungal cells and in competitive antagonism with another component of the cell wall - tryptophan. This leads to disorganization and increased permeability of the cell membrane, destruction and destruction of the pathogenic microorganism.

Pharmacokinetics

The therapeutic concentration of sertaconazole in the stratum corneum after application to the skin is reached within 30 minutes and lasts for more than 48 hours. With daily use for 14 days in increasing amounts, sertaconazole is not detected in blood and urine. After intravaginal administration, high concentrations of sertaconazole in the vaginal lumen persist for a long time and significantly exceed both the minimum inhibitory concentrations and fungicidal concentrations against C. albicans, C. glabrata and other fungi not belonging to the genus Candida. There is no systemic absorption after intravaginal use. Unchanged sertaconazole is not detected in either blood plasma or urine.

Side effect

When applied externally: a rapidly passing local erythematous reaction.

Application during pregnancy and lactation

Use during pregnancy is possible if the expected benefit of therapy to the mother outweighs the potential risk to the fetus or infant. During lactation, intravaginal use is possible if the intended benefit of therapy to the mother outweighs the potential risk to the infant; if necessary, external use should decide on the termination of breastfeeding.

special instructions

It is not recommended to use sertaconazole in ophthalmic practice. In the absence of characteristic clinical symptoms, the mere detection of fungi of the genus Candida on the vaginal mucosa cannot be an indication for the use of sertaconazole. When confirming the diagnosis of candidiasis, it is recommended to identify and eliminate household and hygienic factors that contribute to the development and persistence of infection. It is recommended to use neutral soap for the hygiene of the genitals, use cotton underwear instead of synthetic clothing. The use of acidic detergents is not recommended (an acidic environment promotes the multiplication of Candida fungi). During the period of treatment, it is recommended to refrain from sexual intercourse. To prevent urogenital reinfection, it is recommended to carry out simultaneous treatment of the sexual partner.

Drug interactions

Simultaneous intravaginal administration of sertaconazole and topical spermicidal contraceptives is not recommended, because weakening of the spermicidal effect is possible.