Mikoket - instructions for use, dose, side effects, contraindications

Excipients: (methylparaben or nipagin) 0.2 g, propylene glycol 10.0 g, glycerol (glycerin distilled) 10.0 g, petroleum jelly (petroleum jelly) 15,0 g, emulsifier No. 1 8.0 g, water (purified water) up to 100 g.

Description:Ointment is white or white with a cream or pinkish hue of color.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

J.02.A.B.02 Ketoconazole

D.01.A.C.08 Ketoconazole

Pharmacodynamics:

Ketoconazole is a broad-spectrum antifungal agent, a synthetic derivative of imidazolidioxole. Has a fungicidal or fungistatic effect.

The drug is active against dermatophytes Trichophyton spp. (in t.h. Trichophyton rubrum, Trichophyton mentagrophytes), Microsporum spp. (in t.h. Microsporum canis), Epidermophyton floccosum, yeast-like fungi of the genus Candida spp. (in t.h. Candida albicans), Pityrosporum spp. (in t.h. Pityrosporum ovale, Pityrosporum orbiculare, Malassezia furfur). Ketoconazole is also active against bacteria Staphylococcus spp. and Streptococcus spp. The mechanism of action of ketoconazole is the inhibition of the biosynthesis of ergosterol, triglycerides and phospholipids necessary for the synthesis of the cell wall of fungi,which leads to a violation of the permeability of the cell wall of fungi, to the loss of the ability of fungi to form filaments and colonies.

Ointment MycoKet® very quickly affects the itching with dermatophyte and yeast infections, including. with skin lesions caused by Pityrosporum spp.. In this symptomatic improvement is observed even before the appearance of the first signs of recovery.

Pharmacokinetics:With external application ketoconazole is not absorbed into the systemic circulation, with prolonged use of the ointment, the concentration of ketoconazole in the blood is not determined.

Indications:

Treatment of skin mycoses caused by drug-sensitive fungi:

- smooth skin dermatomycosis;

- inguinal epidermophytia;

- epidermophytia of feet and brushes;

- candidiasis of the skin;

- pityriasis (multicolored) deprive;

- seborrheic dermatitis caused by Pityrosporum ovale.

Contraindications:

Hypersensitivity to ketoconazole or to any of the auxiliary components of the drug.

Pregnancy and lactation:

The use of the drug during pregnancy and during breastfeeding is not contraindicated, since with external application ketoconazole is not absorbed into the systemic circulation.

Dosing and Administration:

Tinea smooth skin, jock itch, athlete's hands and feet, skin candidosis, pityriasis (multicolored) Zoster: apply ointment 1 time per day to the affected skin and immediately adjacent areas.

Seborrheic dermatitis: an ointment applied to the affected area 1-2 times a day depending on the severity of lesions.

Continue treatment for a sufficient period of time, at least for several days after the disappearance of all symptoms of the disease.

The diagnosis should be reviewed if there is no clinical improvement after 4 weeks of treatment.

Typical duration of treatment Next: ringworm smooth skin - 3-4 weeks, athlete's foot - 4-6 weeks, jock itch - 2-4 weeks, skin candidiasis - 2-3 weeks, pityriasis versicolor - 2-3 weeks.

The total duration of treatment for seborrheic dermatitis is 2-4 weeks.

For maintenance therapy with seborrheic dermatitis ointment applied 1 or 2 times a week.

Side effects:

Rarely - 1/10000 appointments (> 0.01% and <0.1%)

From the skin: rarely - irritation and burning sensation; local cutaneous allergic manifestations such as contact dermatitis caused by active ingredient ointments - ketoconazole or one of the auxiliary components - propylene glycol.

Overdose:

The use of ointment in excessive amounts can lead to erythema, edema and burning sensation, which usually disappear after discontinuation of therapy.

In case of accidental ingestion of ointment, gastric lavage should be performed. Conduct symptomatic therapy.

Interaction:

The drug interaction of ketoconazole is not described.

Special instructions:

For external use only.

Ointment can not be used in ophthalmic practice. Avoid contact with eyes.

General hygiene measures should be observed to control sources of infection and reinfection.

Effect on the ability to drive transp. cf. and fur:

The drug has no effect on the ability to drive vehicles, mechanisms and engage in other hazardous activities requiring special attention and quick reactions.

Form release / dosage:

Ointment for external use 2%.

Packaging:

For 15 g in tubes of aluminum or tubes laminated.

Each tube together with the instructions for application is placed in a pack of cardboard.

Storage conditions:

In the dark place at temperature from 10 to 20 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date. term on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-002463

Date of registration:14.02.2011

Expiration Date:Unlimited

The owner of the registration certificate:SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia

Information update date: & nbsp07.06.2018

Illustrated instructions

Instructions

MycoKet® (Mycocet®)