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

Active substanceOksiconazoleOksiconazole

Similar drugsTo uncover

cream externally

Dosage form: & nbspcream for external use

Composition:

Active substance:	on 30 g (tuba)	per 100 grams
Oksiconazole	0.300 grams	1,000 grams
(in the form of oxyconazole nitrate)	0.3441 g	1.147 g,
Excipients:
stearic alcohol	3,600 grams	12,000 grams
cetyl alcohol	1,350 g	4,500 g
paraffin soft white	4,500 g	15,000 grams
polysorbate 60	1,500 grams	5,000 grams
propylene glycol	3.450 g	11,500 grams
benzoic acid	0.060 g	0.200 g
purified water	15,1959 g	50.653 g

Description:

White or almost white, homogeneous hydrophilic cream type water-oil emulsion, almost odorless.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

D.01.A.C Imidazole derivatives

D.01.A.C.11 Oksiconazole

Pharmacodynamics:

Oxiconazole is a synthetic imidazole derivative that inhibits cytochromal lanosterol-14α -detylase, an enzyme necessary for the synthesis of ergosterol - the main element of the cell wall of the fungus and some bacteria, which increases its permeability and reduces its barrier functions.

Oksiconazole has a broad antifungal activity spectrum, is active against dermatophytes from the genus Trichophyton, Microsporum, Epidermophyton; yeast, including Malassezia furfur (the causative agent of a varicolored lichen); fibrous and dimorphic fungi (for example, Aspergillus, Candida).

Oksiconazol also has an antimicrobial effect, it acts on staphylococci, streptococci, Corynebacterium.

Pharmacokinetics:

With external application, absorption of oxyconazole by the skin is insignificant (less than 1% of the amount of oxyconazole applied to the skin is absorbed). After external application of a cream in a dose of 150 mg oxyconazole in serum is not determined. Most of the applied oxyconazole accumulates in the stratum corneum, which allows the use of Mifungar® cream for the treatment of fungal diseases of the skin. Five hours after application of the cream to the skin at a dose of 2.5 mg / cm, the concentration of oxyconazole in the epidermis is 16.2 μmol (in the surface stratum corneum - 3.64 μmol, in the deeper layers-1.29 μmol).

Absorbed through the skin oxyconazole is excreted by the kidneys - 0.3% of the dose for 5 days after a single skin application of the cream.

Indications:

All fungal and combined fungal and bacterial diseases of the skin and external genital organs caused by pathogens sensitive to oxyconazole:

- dermatomycosis (candidiasis skin infection, trunk dermatomycosis, inguinal dermatomycosis, epidermophytia of the feet, dermatomycosis of the scalp, pityriasis, combined fungal and bacterial skin infections;

- fungal and combined fungal and bacterial infections of the vulva (vulvitis, balanitis).

Contraindications:

- Hypersensitivity to derivatives of imidazole, other components of the drug;

- Children's age till 8 years.

Pregnancy and lactation:

Pregnancy

Controlled studies on the use of the drug during pregnancy have not been conducted. The use of the drug during pregnancy is possible only on the prescription of the doctor in the event that the expected benefit for the mother exceeds the potential risk to the fetus.

Breastfeeding period

Oxiconazole is excreted into breast milk. The use of the drug during breastfeeding is possible only if prescribed by the doctor in the event that the expected benefit for the mother exceeds the potential risk for the infant.

Dosing and Administration:

Cream Mifungar® is used externally. It is applied a thin layer on the affected areas 1 time per day, preferably at night.

Duration of treatment:

- with candidiasis skin infection, trunk dermatomycosis, inguinal dermatomycosis, dermatomycosis of the scalp, pityrious lichen, fungal infections of the external genitalia,combined fungal bacterial infections of the skin and external genitalia - 2 weeks;

- with epidermophytia stop - 1 month.

To prevent recurrence of the disease, it is recommended to continue treatment with the drug for 1-2 weeks after signs of complete recovery.

The maximum duration of treatment with the drug is 6 months.

Side effects:

Cream Mifungar® is usually well tolerated.

To indicate the frequency of unwanted adverse reactions (NDP), the classification of the World Health Organization's NDP is used: very frequent ≥10% frequent ≥1 and <10%, infrequent ≥ 0,1 and <1%, rare≥ 0.01 and <0.1%, very rare <0.01%, unknown frequency (when it is not possible to estimate the frequency of development of CPD according to available data).

Disturbances from the skin and subcutaneous tissues

Frequent: moderate burning, itching.

Infrequent: erythema (especially with eczema - therefore it is recommended to treat eczema before applying Mifungar® cream).

Unknown frequency: pain, irritation, allergic dermatitis, folliculitis, cracks, maceration, skin rash.

If there are signs of hypersensitivity or irritation of the skin, the drug should be stopped and informed of this to the doctor.

Overdose:

Cases of overdose are not described.If the drug is taken orally, nausea and vomiting may occur. It is necessary to wash the stomach or induce vomiting and call a doctor, if necessary, perform symptomatic treatment. Interaction with other drugs

There are no reports of the interaction of Mifungar® with other medications.

Special instructions:

Without consulting a doctor, do not use it with other medicines for topical use.

In the treatment of fungal diseases of the external genital organs caused by drug-susceptible pathogens, simultaneous treatment of sexual partners is necessary. The drug is not intended for vaginal use.

Avoid contact with the eyes.

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

The drug does not break attention and does not affect the ability to drive vehicles and engage in other potentially hazardous activities.

Form release / dosage:

Cream for external use, 1%.

Packaging:

30 grams of cream in an aluminum tube.

Each tube is placed in a cardboard box together with instructions for use.

Storage conditions:

3 years.

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

Shelf life:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Terms of leave from pharmacies:Without recipe

Registration number:П N016153 / 01

Date of registration:26.02.2010

Expiration Date:Unlimited

The owner of the registration certificate:Zentiva c.s.Zentiva c.s. Czech Republic

Manufacturer: & nbsp

ZENTIVA, k.s. Czech Republic

Representation: & nbspZENTIVA PHARMA, LLCZENTIVA PHARMA, LLC

Information update date: & nbsp16.05.2018

Illustrated instructions

Instructions

Mifungar® (Myfungar®)