Currently, no cases of overdose of the drug Dafnejin have been reported.
hypersensitivity to the components of the drug,
the period of pregnancy and lactation,
children under 10 years of age.
Hypersensitivity to the components of the drug.
The effect of the cream is increased by systemic antimycotic agents.
The drug interaction of the drug Dafnejin is not described.
For all dosage forms
Rarely-itching or burning sensation. With prolonged external use of the drug, sensitization phenomena are possible.
Optional for for nail polish
Local reactions: rarely-skin irritation, hyperemia and peeling of the skin near the affected nail, allergic reactions.
Rarely: itching, burning at the site of application of the drug.
With prolonged external use of the drug, allergic reactions (hyperemia, edema, itching) may occur.
Cream for external use
Fungal skin lesions.
Nail Polish
Fungal nail diseases.
Local treatment and prevention of vaginal diseases (vulvovaginitis and vaginitis) caused by drug-sensitive fungi in adults.
Cream for external use. Ciclodan is a broad-spectrum antifungal agent with good penetrating power. The active substance cyclopyrox olamine is effective against dermatomycetes, yeast-like, mold-like and other types of fungi. It has an antibacterial effect against gram-positive strains of bacteria, most gram-negative pathogens.
Nail polish. A broad-spectrum antifungal drug. Active in relation to Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton tonsurans, Trichophyton quinckeanum, Trichophyton equinum, Trichophyton concentricum, Trichophyton epilans, Trichophyton ferrugineum, Trichophyton gallinae, Trichophyton schoenleinii, Trichophyton soudanense, Trichophyton terrestre, Trichophyton violaceum, Microsporum canis, Microsporum gypseum, Microsporum audouinii, Microsporum langeronii, Microsporum nanum, Epidermophyton floccosum, Candida (Candida albicans, Candida tropicalis, Candida krusei, Candida parapsilosis, Candida pseudotropicalis, Candida lipolytica, Candida guilliermondii, Candida brumpti, Candida utilis, Candida viswanathii), Cryptococcus neoformans, Histoplasma capsulatum, Sporotrichum schenckii, Torulopsis glabrata, Blastomyces dermatitidis, Paracoccidioides brasiliensis, Saccharomyces cerevisiae, Torula bergeri, Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger, Penicillium chrysogenum, Penicillium notatum, Absidia corymbifera, Mucor miehei, Paecilomyces variotii, Fusarium solani, Madurella grisea, Madurella mycetomatis, Allescheria boydii, Cladosporium carrionii, Cladosporium trichoides, Phialophora jeanselmei, Phialophora pedrosoi, Phialophora gougerotti, Hormodendrum dermatitidis, Pyrenochaeta romeroi, Leptosphaeria senegalensis. The antifungal effect of cyclopyrox is based on inhibiting the entry into the cell and inducing the removal of the components necessary for its vital activity from the cell. It has an antibacterial effect against gram-positive and most gram-negative pathogens. It suppresses the development of mycoplasmas and trichomonas.
Cyclopyroxolamine is a broad-spectrum antifungal agent. The drug acts bacterio - and fungistatically. Active in relation to Trichophyton rubrum, Epidermophyton floccosum, Candida albicans, Stopulariosus brevicaulusn and other types of fungi, as well as for some strains of gram-positive and gram-negative bacteria.
Cream for external use. When applying the cream on large surfaces (750 cm2) and for a long time (6 hours or more) it can be detected in the blood (1.3% of the dose), while 94-97% binds to plasma proteins, T1/2 it is 1.7 hours, is excreted by the kidneys.
Nail polish. The values of fungicidal concentrations with a one-day application of nail polish exceed the plasma Cmax 20-30 times (plasma Cmax for dermatophytes, fungi of the genus candida, mold and yeast-like fungi-0.98–3.9 micrograms / ml, for mycoplasma and Trichomonas vaginalis - 7.8-31.3 mcg / ml).
Studies of the pharmacokinetics of the drug Dafnejin have not been conducted.
Ciclodan
During pregnancy and lactation, the use of the drug is possible only in cases where the intended benefit to the mother exceeds the possible risk to the fetus or child. During pregnancy, the use of the drug is possible according to the indications and under the supervision of a doctor. During lactation, the issue of stopping breastfeeding should be resolved.
Ciclopirox
Ciclodan®Cream is not for ophthalmic use.
Keep out of reach of children.
PRECAUTIONSIf a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclodan®Cream, treatment should be discontinued and appropriate therapy instituted.
Carcinogenesis, Mutagenesis, Impairment Of FertilityA carcinogenicity study in female mice dosed cutaneously twice per week for 50 weeks followed by a 6-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application site.
The following in vitro and in vivo genotoxicity tests have been conducted with ciclopirox olamine: studies to evaluate gene mutation in the Ames Salmonella/Mammalian Microsome Assay (negative) and Yeast Saccharomyces Cerevisiae Assay (negative) and studies to evaluate chromosome aberrations in vivo in the Mouse Dominant Lethal Assay and in the Mouse Micronucleus Assay at 500 mg/kg (negative).
The following battery of in vitro genotoxicity tests were conducted with ciclopirox: a chromosome aberration assay in V79 Chinese Hamster Cells, with and without metabolic activation (positive); a gene mutation assay in the HGPRT - test with V79 Chinese Hamster Cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA Synthesis Assay in A549 Human Cells (negative)). An in vitro Cell Transformation Assay in BALB/C3T3 Cells was negative for cell transformation. In an in vivo Chinese Hamster Bone Marrow Cytogenetic Assay, ciclopirox was negative for chromosome aberrations at 5,000 mg/kg.
Pregnancy Category BReproduction studies have been performed in the mouse, rat, rabbit, and monkey (via various routes of administration) at doses 10 times or more the topical human dose and have revealed no significant evidence of impaired fertility or harm to the fetus due to ciclopirox. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing MothersIt is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ciclodan®Cream is administered to a nursing woman.
Pediatric UseSafety and effectiveness in pediatric patients below the age of 10 years have not been established.
Externally.
Cream for external use. The cream is applied to the affected areas of the skin 2 times a day, followed by drying. Treatment should continue until the symptoms of the disease disappear (usually 2 weeks). To prevent a relapse of the disease, it is recommended to use the drug for another 1-2 weeks after the disappearance of all clinical symptoms.
Nail polish. Before the first application of Ciclodan®, nail polish, should be removed with scissors as much as possible of the affected nail and nail file the remaining nail plate to create an uneven surface. The nail polish is applied in a thin layer on the affected nail 1 day a day during the first month, during the second-2 times a week, during the third-1 time a week. 1 time per week (for example, on Sunday) the varnish is removed with a conventional solvent or after a warm bath is scraped off, while the scissors should again remove the growing affected part of the nail plate. If the nail polish is damaged in the period between applying the varnish, then you should apply the varnish again only to those areas of the nail where the varnish coating is damaged
The duration of treatment depends on the severity of the nail plate fungus, but the treatment period should not exceed 6 months.
Cream: externally, intravaginally. Enter 1 time a day for 6 days with the help of an applicator, which is filled with cream (5 g) with light pressure on the tube. On the recommendation of a doctor, the duration of the course of treatment can be increased to 14 days.
intravaginal, 1 supp. (100 mg) once a day for 3-6 days, depending on the severity of the disease.
With recurrent candidiasis, in order to prevent repeated infection, you can treat the perianal and vaginal areas with a small amount of vaginal cream.
If necessary, the combined use of dosage forms of Dafnejin is possible.
In all controlled clinical studies with 514 patients using ciclopirox olamine cream and 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox olamine cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.
DRUG INTERACTIONSNo Information Provided
