Mycosorrhal - instructions for use, reviews, analogs and form of release (shampoo 2%, ointment or cream, 200 mg tablets) drug for the treatment of mycosis or fungus skin and nails, candidiasis in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Mycosorrhal. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Mycosorol in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Mycosoril in the presence of existing structural analogues.Use to treat mycosis or fungus skin and nails, candidiasis in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Mycosorrhal - has a fungicidal or fungistatic action against dermatophytes, yeast-like (Candida (Candida), Pityrosporum, Torulopsis, Cryptococcus), dimorphic fungi and higher fungi (eumycetes).

Less sensitive to the action of Ketoconazole (active ingredient of Mikozoral) Aspergillus spp., Sporothrix schenckii, other Dermatiaceae, Mucor spp. and other fikomycetes, with the exception of Enomophthorales.

It is also active against staphylococci and streptococci.

Mycosoril inhibits the biosynthesis of ergosterol in fungi, which leads to a change in the composition of lipid components in membranes.

Reduces the formation of androgens.

Composition

Ketoconazole + auxiliary substances.

Pharmacokinetics

Absorption is high (especially in the acidic environment of the stomach). Bioavailability is directly dependent on the value of the dose taken. Connection with blood plasma proteins - 99%. Well distributed in tissues and body fluids. In small amounts, it penetrates into the spinal fluid and testicles (does not create therapeutic concentrations), penetrates the placenta and into breast milk. Metabolized in the liver in a large number of inactive metabolites.The main ways of metabolism are oxidation and cleavage of imidazole and Piperazine rings, oxidative o-dealkylation and aromatic hydroxylation. It is an inhibitor of the isoenzymes CYP2C19 and CYP3A4, CYP3A5, CYP3A7. Output unchanged in the form of inactive metabolites: within 4 days 70% of the dose received (57% - with bile and 13% - kidney) is excreted. The pharmacokinetic characteristics of ketoconazole generally differ slightly in patients with hepatic or renal insufficiency and in patients without such.

Indications

Smooth skin infections of the scalp caused by dermatophytes and / or yeast fungi in cases where local treatment is not applicable due to the large size of the affected areas, significant lesion depth, and also in the absence of the effect of previous local treatment:

• dermatophytosis;
• colored lichen;
• Folliculitis caused by fungi of the genus Pityrosporum;
• smooth skin dermatomycosis;
• epidermophytia of hands and feet, candidiasis of the skin;
• chronic candidiasis of the skin and mucous membranes (including the oral cavity, pharynx and esophagus);
• chronic recurrent vaginal candidiasis in the absence of the effect of local therapy;
• treatment and prevention of dandruff, seborrheic dermatitis and pityriasis lichen (shampoo).

Systemic fungal infections:

• paracoccidioidosis;
• histoplasmosis;
• coccidioidosis;
• blastomycosis.

Forms of release

Tablets 200 mg.

Shampoo 2%.

Ointment for external use 2% (sometimes mistakenly called cream).

Instructions for use and how to use them

Pills

Mycosorrhal should be taken orally, to improve the absorption of the drug - while eating.

Adults

1 tablet (200 mg) once a day. If no improvement occurs after taking this dose, you should increase the dose to 2 tablets (400 mg) once a day.

Vaginal candidiasis - 2 tablets (400 mg) once a day.

Children over 3 years old

With a body weight of 15 to 30 kg - 1/2 tablet (100 mg) once a day.

With a body weight of more than 30 kg - the doses indicated for adults.

Average duration of treatment:

• vaginal candidiasis - 7 days;
• dermatophytosis - about 4 weeks;
• multi-colored lichen-10 days;
• chronic candidiasis of skin and mucous membranes (including the oral cavity, pharynx and esophagus) - 2-3 weeks;
• fungal lesions of the scalp - 1-2 months;
• paracoccidioidosis, histoplasmosis, coccidioidosis, blastomycosis - usually the duration of treatment is 6 months.

Shampoo

Outwardly. Apply Mikozoral shampoo to the affected skin or scalp for 3-5 minutes, then rinse with water.

Treatment:

• various types of dandruff and seborrheic dermatitis of the scalp: 2 times a week for 3-4 weeks;
• pityriasis lichen: daily for 5 days, and in the absence of effect, prolongation of the course to 7 days.

Prevention:

• various types of dandruff and seborrheic dermatitis of the scalp: weekly or 1 time in two weeks;
• pityriasis lichen: daily for 3-5 days (one-time course) in the spring before the onset of summer.

Ointment

With smooth skin dermatomycosis (inguinal epidermophytosis, epidermophytosis of hands and feet, skin candidiasis and pityriasis), the ointment is applied to the affected area immediately adjacent to it 1 time per day.

With 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: for dermatomycosis smooth skin - 3-4 weeks, with inguinal epidermophytosis - 2-4 weeks, with epidermophytosis stop - 4-6 weeks, with infections caused by yeast-like fungi - 2-3 weeks, with pityriasis - 2 -3 weeks, with seborrheic dermatitis - 2-4 weeks.

It should continue treatment for at least several days after the disappearance of the symptoms of the disease. If clinical improvement is not observed after 4 weeks of treatment, then the diagnosis should be clarified.

Side effect

• decreased appetite;
• nausea, vomiting;
• abdominal pain;
• diarrhea;
• toxic hepatitis;
• headache;
• dizziness;
• drowsiness;
• paresthesia;
• reversible increase in intracranial pressure;
• photophobia;
• thrombocytopenia, leukopenia, hemolytic anemia;
• hives;
• skin rash;
• fever;
• anaphylactic shock;
• anaphylactoid and anaphylactic reactions;
• angioedema;
• decreased libido in men;
• oligospermia;
• impotence;
• menstrual cycle disorders;
• alopecia;
• gynecomastia (reversible);
• a temporary decrease in testosterone in the blood plasma (normalized less than 24 hours after admission);
• local irritation and itching (when using shampoo).

Contraindications

• hypersensitivity to ketoconazole or other components of the drug;
• acute or chronic liver disease;
• lactation period;
• children up to 3 years;
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Application in pregnancy and lactation

The drug Mikozoral should not be prescribed to pregnant women, except when the intended benefit to the mother exceeds the potential risk to the fetus.Since ketoconazole penetrates into breast milk, it is recommended to stop breastfeeding while taking the drug.

Use in children

It is used in children from 3 years of age according to the indications.

Application in elderly patients

Use with caution in women older than 50 years.

special instructions

Before the treatment, it is necessary to evaluate the liver function in order to avoid acute or chronic diseases, during the treatment it is necessary to regularly and regularly monitor liver function in all patients in order not to miss the first signs of hepatotoxicity. The total dose of ketoconazole (for treatment) is a risk factor for severe hepatotoxicity.

In women older than 50 years, with liver disease in history, with drug intolerance, the use of hepatotoxic drugs, and if the duration of treatment with the drug exceeds 2 weeks, it is necessary to monitor liver function before treatment, after 2 weeks of treatment and then monthly, so as in these categories of patients the risk of the toxic effect of the drug on the liver increases.

It is very important to acquaint patients who need long-term treatment with the drug,with symptoms of liver disease (fatigue, loss of strength, increased body temperature, darkening of urine, discoloration of feces, jaundice).

In case of symptoms of hepatitis or if functional liver tests confirm liver disease, treatment should be stopped immediately. If the treatment of skin lesions was carried out by glucocorticosteroids, then ketoconazole is prescribed not earlier than 2 weeks after their withdrawal.

Patients taking antacid preparations (for example, aluminum hydroxide) should take them no earlier than 2 hours after taking the drug.

In patients with achlorhydria or hypochlorhydria due to an unpredictable decrease in the degree of absorption, mycorrhagal may be ineffective when taken orally. The use of acidic drinks increases the absorption of ketoconazole.

When applied at a dose of 400 mg or more, a decrease in the "cortisol response" with stimulation of the adrenal glands by adrenocorticotropic hormone (ACTH) is observed, therefore, during the treatment it is necessary to monitor the adrenal function in patients with adrenal insufficiency, as well as in patients undergoing significant stress effects (incl. h.extensive surgical interventions).

When using shampoo, avoid contact with eyes. If shampoo comes into the eyes, rinse with water.

Ointment Mycosorrhal is not used in ophthalmic practice. Avoid contact with ointment in the eyes.

Impact on the ability to drive vehicles and manage mechanisms

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Drug Interactions

Drugs that affect the metabolism of ketoconazole

Microsomal oxidation inductors such as rifampicin, rifabutin, carbamazepine, isoniazid, nevirapine, and phenytoin significantly reduce the bioavailability of ketoconazole. The use of ketoconazole with such drugs is not recommended.

Ritonavir increases the bioavailability of ketoconazole, and as a result of this, a dose of ketoconazole should be reduced when taken together.

Effect of ketoconazole on the metabolism of other drugs

Mycosorhal may enhance or prolong the action of drugs metabolized with cytochrome P450, especially from the CYP3A group.

It is not possible to prescribe during the course of treatment with ketoconazole:

• terfenadine, astemizole, misolastine, cisapride, dofetilide, quinidine, pimozide, bepridil, disopyramide, halofantrine, levometadil, domperidone and sertindole. The risk of severe ventricular tachycardia increases, incl. type "pirouette";
• midazolam and triazolam (oral forms) metabolized by the isoenzyme CYP3A4 HMG-CoA reductase inhibitors such as simvastatin and lovastatin, ergot alkaloids (dihydroergotamine, ergometrine, ergotamine, methylergometrine), nisoldipine, eplerenone, irinotecan, everolimus. Effects, including side effects, of these drugs are increasing.

Drugs, in the appointment of which it is necessary to monitor their concentration in blood plasma, the severity of therapeutic effects and side effects (their dosage when combined with Mikozoral if necessary should be reduced):

• oral anticoagulants;
• HIV protease inhibitors, such as indinavir, saquinavir;
• Some antineoplastic agents, such as Pink Roseberry alkaloids, busulfan, docetaxel, erlotinib, imatinib;
• metabolized by the isoenzyme CYP3A4 blockers of the "slow" calcium channels dihydropyridine series and, possibly, verapamil;
• Some immunosuppressive agents: cyclosporine, tacrolimus, sirolimus;
• sildenafil, tolterodine;
• some HMG-CoA reductase inhibitors, for example, atorvastatin;
• Some glucocorticosteroids, such as budesonide, fluticasone, dexamethasone and methylprednisolone;
• other drugs: digoxin, carbamazepine, buspirone, alfentanil, alprazolam, brotisolam, rifabutin, trimetrexate, ebastin, reboxetine, quetiapine, solifenacin, cilostazol, eletriptan, fentanyl, repaglinide.

Ethanol (alcohol) and other hepatotoxic drugs increase the risk of damage to the liver parenchyma. With the joint use of ethanol, disulfiram-like reactions may occur.

Weaken the effect of amphotericin B.

Reduces the stimulating effect of corticotropin on the adrenal glands.

Increases the risk of developing breakthrough bleeding when using oral contraceptives with a low content of hormones.

Increases the toxicity of phenytoin.

Antatsidnye and anticholinergic drugs, blockers of H2-histamine receptors and other drugs that reduce the acidity of gastric juice, reduce the absorption of ketoconazole.

Analogues of the drug Mikozoral

Structural analogs for the active substance:

• Dermazol;
• Ketoconazole;
• Livarol;
• Mikanisal;
• Mikoket;
• Nizoral;
• Oronazole;
• Perch;
• Sebosol;
• Fungavis;
• Fungin.

Analogues on the curative effect (antifungal drugs):

• Amphotericin B;
• Antifungole;
• Batrafen;
• Binafin;
• Bifonazole;
• Butoconazole nitrate;
• Vagiphereon;
• Vfend;
• Voriconazole;
• Ginezole 7;
• Griseofulvin;
• Daphnejin;
• Diflason;
• Diflucan;
• Zalain;
• Irunin;
• Itraconazole;
• Itramikol;
• Candide;
• Kanesten;
• Canison;
• Ketoconazole;
• Clindacine B prolong;
• Clion D 100;
• Clotrimazole;
• Lamisyl;
• Levorin;
• Livarol;
• Loceril;
• Metronikon Neo;
• Mikoderil;
• Mikozolone;
• Myconorm;
• Mycospores;
• Natamycin;
• Neo Penotran;
• Neo Piotrand Forte;
• Nizoral;
• Nystatin;
• Nitrofungin;
• Orungal;
• Offlomil Luck;
• Pimafucin;
• Primafungin;
• Rumikoz;
• Safotsid;
• Sebosol;
• Sertaconazole;
• Sertamicol;
• Terbisyl;
• Terbinafine;
• Fluconazole;
• Flucostat;
• Fukortsin;
• Fungizon;
• Fungoterbine;
• Exifin;
• Exoderyl;
• Ecofuqin;
• Eraksis.

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