Mycozoral is an antifungal drug.
Release form and composition
- Tablets for ingestion: flat-cylindrical, white or white with a grayish or creamy shade of color (marbling is possible), with risk and chamfer (10 pcs. In blisters, 1, 2 or 3 packs in a cardboard box);
- Ointment for external use 2%: white or white with a pinkish or cream color, with a slight specific odor (15, 20, 30, 40 or 50 g each in aluminum tubes, 1 tube per carton pack);
- Shampoo 5%: transparent, viscous, from yellow-orange to orange in color, with a slight specific smell (60 g in polymeric bottles, 1 bottle in a carton pack).
The active ingredient of the drug is ketoconazole. Its content is:
- 1 tablet - 200 mg;
- 1 g of cream - 20 mg;
- 1 g of shampoo - 20 mg.
- Tablets: potato starch, lactose monohydrate, colloidal silicon dioxide, povidone, talc and magnesium stearate;
- Ointment: carmellose sodium, distilled monoglycerides, propylene glycol, nipagin (methyl parahydroxybenzoate), emulsifying wax, dibunol (butylhydroxytoluene), castor oil, purified water;
- Shampoo: sodium laureth sulfate, hydroxypropyl methyl cellulose, sodium metabisulfite, propylene glycol, macrogol glyceryl cocoate, hydrochloric acid, diluted, imido urea, purified water, yellow-orange dye.
Indications for use
For pills - systemic infections:
For tablets, infections of the scalp or smooth skin caused by yeast fungi and / or dermatophytes in cases of significant lesion depth, large lesions, when local treatment is not applicable, as well as in the absence of effect from previous local treatment:
- Licolor versicolor;
- Chronic recurrent vaginal candidiasis;
- Folliculitis caused by fungi of the genus Pityrosporum;
- Chronic candidiasis of the skin and mucous membranes (including oral cavity, pharynx, esophagus).
For ointment - local treatment of mycoses:
- Groin athlete's disease;
- Tinea versicolor;
- Ringworm smooth skin;
- Seborrheic dermatitis caused by Pityrosporum ovale;
- Skin candidiasis;
- Epidermofitiya hands and feet.
For shampoo - treatment and prevention:
- Tinea versicolor;
- Seborrheic dermatitis;
A general contraindication to Mycozoral in all dosage forms is hypersensitivity to its components.
Additionally for tablets:
- Acute and chronic liver diseases;
- Glucose-galactose malabsorption, lactase deficiency, lactose intolerance;
- Children's age up to 3 years;
- Acceptance of some drugs (more details - in the drug interaction).
Additionally for ointment:
- Violation of the integrity of the skin in places of application of the drug.
In the form of tablets Mykozoral should be used with caution in the following cases:
- Insufficiency of the adrenal cortex and pituitary;
- Liver failure;
- The simultaneous use of potentially hepatotoxic drugs;
- Age over 50 years in women;
Dosing and Administration
In the form of tablets Mycozoral should be taken orally, preferably with meals.
Adults are prescribed 1 tablet per day. If necessary, the daily dose may be increased to 2 tablets in 1 reception.
The dose for vaginal candidiasis is 2 tablets 1 time per day.
Recommended doses for children older than 3 years depending on body weight:
- More than 30 kg: as for adults;
- 15-30 kg: 1/2 tablet 1 time per day.
The average duration of treatment depending on the diagnosis:
- Histoplasmosis, paracoccidioidosis, blastomycosis, coccidioidosis - 6 months;
- Fungal lesions of the scalp - 1-2 months;
- Chronic candidiasis of the skin and mucous membranes - 2-3 weeks;
- Dermatophytosis - 4 weeks;
- Licolor versicolor - 10 days;
- Vaginal candidiasis - 7 days.
Ointment Mycozoral is applied externally: it is applied to the affected and / or surrounding areas 1-2 times a day.
The average duration of treatment:
- Infections caused by yeast-like fungi - 2-3 weeks;
- Pityriasis versicolor - 2-3 weeks;
- Seborrheic dermatitis - 2-4 weeks;
- Groin athlete - 2-4 weeks;
- Dermatomycosis of smooth skin - 3-4 weeks;
- Epidermofitiya stop - 4-6 weeks.
Treatment should continue for at least several days after the symptoms of the disease disappear. If after 4 weeks of use, the improvement does not occur, it is necessary to consult a doctor to clarify the diagnosis.
Mycozoal shampoo is applied to the scalp or affected skin for 3-5 minutes, then washed off with water.
Frequency of use:
- Seborrheic dermatitis of the scalp and dandruff: 2 times a week for 3-4 weeks;
- Pityriasis versicolor: daily for 5-7 days.
Scheme of use for the purpose of prevention:
- Seborrheic dermatitis of the scalp and dandruff: 1 time in 7 or 14 days;
- Pityriasis versicolor: daily for 3-5 days in spring before the onset of summer.
When taking pills:
- Digestive system: abdominal pain, nausea, loss of appetite, diarrhea, vomiting, toxic hepatitis;
- Central nervous system: drowsiness, dizziness, paresthesias, headache, reversible increase in intracranial pressure;
- The urogenital system: menstrual disorders, oligospermia, impotence, decreased libido in men;
- Organs of blood formation: leukopenia, thrombocytopenia, hemolytic anemia;
- Sense organs: photophobia;
- Allergic reactions: fever, skin rash, urticaria, very rarely - anaphylactoid and anaphylactic reactions, anaphylactic shock, angioedema;
- Other: reversible gynecomastia, alopecia, temporary decrease in plasma testosterone concentration.
The local application of the ointment may cause allergic reactions in the form of a skin rash, urticaria, burning sensation; rarely, contact dermatitis.
When applying the shampoo in rare cases, itching and local irritation. Hair may become dry or greasy.
Before prescribing Mycozoral in the form of tablets, liver function should be evaluated in order to exclude acute and chronic diseases, and during treatment, the functional state of the liver should be regularly monitored so as not to miss the first signs of hepatotoxicity.
It is very important to familiarize patients with long-term treatment with symptoms of liver disease, such as loss of strength, fatigue, fever, fecal discoloration, dark urine, jaundice.
In the case of concomitant administration of antacid preparations, they should be taken not earlier than 2 hours after taking Mykozoral.
Acidic drinks increase the absorption of ketoconazole.
During the period of treatment, caution is recommended when driving and taking on potentially hazardous activities that require responsiveness and concentration.
When using ointment and shampoo Mycozoral, it is important not to allow their contact with eyes.
At external use medicinal interaction of Mycozoral was not described.
Inside the drug is prohibited to take simultaneously with the following means:
- Triazolam and midazolam (oral forms), ergot alkaloids (ergometrine, dihydroergotamine, methylergometrine, ergotamine), lovastatin, simvastatin, irinotecan, eplerenone, nisoldipine, everolimus, because their effects are enhanced, including side effects;
- Halofantrine, disopyramide, levometadil, dofetilide, cisapride, quinidine, mizolastine, astemizole, pimozide, terfenadine, bepridil, sertindol, domperidone, because increases the risk of severe ventricular tachycardia, including the type of pirouette.
It is not recommended to combine Mycozoral with the following drugs: microsomal oxidation inducers, such as carbamazepine, rifabutin, isoniazid, rifampicin, phenytoin, nevirapine.
Ritonavir increases the bioavailability of ketoconazole, so the dose of the latter should be reduced.
With the simultaneous use of ethanol and other hepatotoxic drugs increases the risk of damage to the hepatic parenchyma. With the use of alcoholic beverages, in addition, the development of disulfiram-like reactions is possible.
Blockers of H2-histamine receptors, anticholinergics, antacids and other drugs that reduce the acidity of gastric juice, reduce the absorption of ketoconazole.
It should be borne in mind that ketoconazole:
- Strengthens or prolongs the action of agents metabolized with cytochrome P450 (especially from the CYP3A group);
- Enhances the toxicity of phenytoin;
- Weakens the effect of amphotericin B;
- Reduces the stimulating effect of corticotropin on the adrenal glands;
- Increases the risk of breakthrough bleeding in the case of simultaneous use with oral contraceptives with a low content of hormones.
When prescribing the following drugs should reduce their dose, monitor plasma concentration, severity of therapeutic and side effects:
- Some glucocorticosteroids are: fluticasone, budesonide, dexamethasone, and methylprednisolone;
- HIV protease inhibitors: indinavir and saquinavir;
- Oral anticoagulants;
- Some immunosuppressive agents: tacrolimus, cyclosporine, sirolimus;
- Tolterodine, sildenafil;
- Some HMG-CoA reductase inhibitors, including atorvastatin;
- Blockers of slow calcium channels of the dihydropyridine series, metabolized by the CYP3A4 isoenzyme, verapamil;
- Some anticancer drugs: Vinca pink alkaloids, docetaxel, busulfan, imatinib, erlotinib;
- Other drugs: alfentanil, buspirone, alprazolam, carbamazepine, brotizolam, ebastine, trimetrexate, reboxetine, rifabutin, quetiapine, cilostazol, solifenacin, eletriptan, repaglinide, digoxin, fentanyl.
Terms and conditions of storage
Store in a place inaccessible to children, protected from light and moisture, at temperature: tablets - up to 25 ºС, ointment - not higher than 15 ºС, shampoo - 15-25 ºС.
Shelf life of tablets and ointment - 3 years, shampoo - 2 years.