INSTRUCTION for Usage of Pharmaceutical Preparation for Medical

for Usage of Pharmaceutical Preparation for Medical Application
Registration number
Trade name: Mycocet®
International non-proprietary name: ketoconazole
Dosage form: ointment for external application
Composition for 100 g of ointment.
Active substance: ketoconazole 2 g
Adjuvants: methyl parahydroxybenzoate (methyl paraben or nipagin) - 0.2 g, propylene glycol 10.0 g, glycerol (distilled glycerin) - 10.0 g, vaseline (white petrolatum) - 15.0 g, emulsifier No. 1 8.0 g, water (purified water) up to 100 g.
Ointment of white or off-white or whitish pink colour.
Pharmacotherapeutic Group:
Antifungal agent.
ATX Code: [D01АС08]
Pharmacologic Properties
Ketoconazole is a broad-spectrum antifungal agent, a synthetic derivative of imidazoledioxolan.
Displays fungicidal and fungistatic activity.
The preparation is active in relation to dermatophytes Trichophyton spp. (including Trichophyton
rubrum, Trichophyton mentagrophytes), Microsporum spp. (including Microsporum canis), Epidermophyton floccosum, yeastlike fungi of genus Candida spp. (including Candida albicans), Pityrosporum spp. (including Pityrosporum ovale, Pityrosporum orbiculare, Malassezia furfur). Ketoconazole is also active in relation to bacteria Staphylococcus spp. and Streptococcus spp. The mechanism of action of ketoconazole consists in inhibiting the biosynthesis of ergosterine, triglycerides
and phospholipids required for the fungi cellular wall synthesis, resulting in the fungi cellular wall
permeability disorder and loss of an ability to form filaments and colonies.
Mycocet® ointment alleviates itching very quickly at dermatophytic and yeast infections, including
skin lesions caused by Pityrosporum spp. At that, sympthomatic improvement is observed before the
first signs of recovery. 1
At external use, ketoconazole is not absorbed into the systemic blood flow; at prolonged application
of the ointment the ketoconazole concentration in blood is not defined.
Indications for usage
Treatment of dermatomycosises caused by fungi sensitive to the preparation:
- dermatomycosis of the body;
- epidermophytosis inguinalis;
- athlete’s foot and epidermophytosis of hands;
- candidosis of the body;
- chromophytosis;
- seborrheic dermatitis caused by Pityrosporum ovale.
Hypersensitivity to ketoconazole or any other adjutant of the preparation.
Usage of the preparation during pregnancy and breast feeding
The use of the preparation during pregnancy and breast feeding is not contra-indicated as at external
use ketoconazole is not absorbed into the systemic blood flow.
Method of application and doses
Dermatomycosis of the body, epidermophytosis inguinalis, athlete’s foot and epidermophytosis of
hands, candidosis of the body, and chromophytosis: Apply the ointment one time a day to the affected skin and to directly adjacent area.
Seborrheic dermatitis: Apply the ointment to the affected area one or two times a day depending on
the severity of lesion.
The treatment should be persisted during a sufficiently long period of time at least several days after
all the symptoms of the disease vanish.
The diagnosis should be reconsidered if there is no clinical improvement after 4 weeks of treatment.
Usual duration of the treatment is as follows: 3 to 4 weeks for dermatomycosis of the body, 4 to 6
weeks for athlete’s foot, 2 to 4 weeks for epidermophytosis inguinalis, 2 to 3 weeks for candidosis of
the body, and 2 to 3 weeks for chromophytosis.
Total duration of the seborrheic dermatitis treatment is 2 to 4 weeks.
For the supportive treatment at seborrheic dermatitis the ointment is to be applied 1 or 2 times a
Side effects
Rarely: 1/10000 administrations (> 0.01% and < 0.1%)
Cutaneous covering response: rarely - irritation and burning sensation; local skin manifestations of
allergic nature, such as contact dermatitis, caused by the ointment active component, ketoconazole,
or one of the adjuvants – propylene glycol.
Usage of the ointment in excessive quantities may result in erythema, edema and burning sensation
that vanish after the treatment cessation. In case of an accidental ingestion of the ointment, a gastric
lavage should be done. Symptomatic therapy is to be conducted.
Interaction with other medicinal preparations
Drug interaction of ketoconazole has not been described.
Specific instructions
For external usage only.
Do not use the ointment in ophthalmological practice.
Do not let the ointment get into eyes.
Observe common measures of hygiene to control the sources of infection and reinfection.
Effect on the ability to drive motor transport or operate mechanisms
The preparation does not affect the ability to drive transport vehicles, to control mechanisms and to
be occupied by other dangerous activities that require special attention and rapid response.
Form of issue
Ointment for external usage 2%.
15 g in aluminum tubes. Each tube with an instruction for usage is placed in a cardboard box.
Storage conditions
In a place protected from light, at a temperature of 15°С up to 20°С.
Keep out of reach of children.
Effective Life:
2 years
Do not use after the expiration of effective life.
Dispensing conditions
Available without prescription.
Manufacturer/organization that accepts claims:
Open Joint Stock “Kurgan Joint Stock Company of Medical Preparations and Articles “Sintez” (Sintez Joint Stock Company);
#7, Prospect Konstitutsii, city of Kurgan, Russian Federation, 640008;
Tel. /fax: (3522)481689