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Trade name of the drug: Mycozoral ®

International non-proprietary name: Ketoconazole

Dosage Form: ointment for external use.

Composition: 1 g ointment contains:
active substance - ketoconazole 20 mg;
Excipients: propylene glycol, carmellose sodium, castor oil, distilled monoglycerides, emulsifying wax, nipagin (methyl parahydroxybenzoate), dibunol (butylhydroxytoluene), purified water.

Description: ointment from white to white with a creamy or pinkish shade of color, with a slight specific smell.

Pharmacotherapeutic group: antifungal agent

Pharmacological properties
Ketoconazole is a synthetic imidazoldiaxolane derivative, which has a fungicidal or mycostatic effect. Active against dermatophytes: Trichophyton sp., Microsporum sp., Epidermophyton floccosum, Candida fungi, as well as against staphylococci and streptococci. Especially effective against Pityrosporum sp. The mechanism of action is to inhibit the biosynthesis of ergosterol and change the lipid composition of the membrane of fungi.
Symptomatic improvement is observed very quickly, even before signs of recovery appear.
With prolonged topical use of ointment ketoconazole is not detected in the blood.

Indications for use
Topical treatment of mycoses caused by mushrooms susceptible to the preparation: ringworm, smooth skin, athlete's groin, athlete's foot and hand infections, candidosis of the skin, pityriasis versicolor, seborrheic dermatitis caused by Pityrosporum ovale.

Mycozoral® should not be used in case of hypersensitivity to ketoconazole, in violation of the integrity of the skin in places of the intended application of ointment.

Dosage and administration
In case of dermatomycosis of smooth skin (inguinal athlete's disease, athlete's hand and foot, candidiasis of the skin and pityriasis), ointment is applied to the affected and immediately adjacent area once a day.
When seborrheic dermatitis ointment is applied to the affected area 1-2 times a day, depending on the severity of the lesion. The average duration of treatment is: with dermatomycosis of smooth skin - 3-4 weeks, with inguinal athlete - 2-4 weeks, with athlete's foot - 4-6 weeks, with infections caused by yeast-like fungi - 2-3 weeks, with chromophytosis - 2 -3 weeks, with seborrheic dermatitis — 2-4 weeks. Treatment should continue for at least a few days after the symptoms of the disease disappear. If clinical improvement is noted after 4 weeks of treatment, the diagnosis needs to be clarified.

Side effect
With the local application of ointment Mykozoral® local allergic reactions are possible in the form of burning, urticaria and skin rash. In rare cases, contact dermatitis occurs.

Since the drug is intended only for external use and is practically not absorbed into the systemic circulation, the development of symptoms of overdose is unlikely. In case of accidental use of the ointment inside the special measures are not required.
Drug interaction
Drug interaction drug Mykozoral® when applied externally not described.

Use during pregnancy and lactation
Given that ketoconazole is practically not absorbed into the systemic circulation when used externally, it is possible to use it during pregnancy and lactation.
However, before applying the ointment Mycozoral® in these cases, you should consult with your doctor.

special instructions
The drug is intended for external use only. Ointment is not used in ophthalmic practice. Avoid getting ointment in the eyes. During treatment should follow the general rules of hygiene.

Storage conditions
In a dry place, at a temperature not higher than 15 ° C. Keep out of the reach of children.

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