Outwardly: dermatomycosis of smooth skin; prevention and treatment of fungal infections of skin of a pilar part of the head; inguinal epidermophitia; skin candidiasis; epidermophitia of feet and brushes;
Locally: treatment of chronic and acute recurrent vaginal candidiasis; prevention of fungal infections of a vagina at the lowered body resistance and at the antibacterial therapy by other means and drugs leading to disturbance of normal microflora of a vagina;
Inside (in case of unavailability and intolerance of other methods of treatment): paracoccidioidomycosis, coccidioidomycosis, zymonematosis, chromomycosis, histoplasmosis.

Contraindications

Chronic and acute forms of diseases of a liver;
The expressed renal failures;
Period of pregnancy and breastfeeding;
Age up to 3 years;
Concomitant use with the following substrates of an isoenzyme CYP3A4: various groups of cardiovascular drugs (ранолазин, ивабрадин); antiarrhytmic means (quinidine, Disopyramidum, дронедарон, дофетилид); blockers of calcium channels (нисолдипин, фелодипин, bepridit, лерканидипин); analgetics (methadone, левацетилметадол); anthelmintic and anti-protozoan means (галофантрин); gastrointestinal drugs (цизаприд, домперидон); antihistaminic drugs (мизоластин, астемизол, терфенадин); antineoplastic means (иринотекан); drugs for treatment of migraine (methylergometrine, ergometrine, dihydroergotamine, ergotamine); anxiolytics, antipsychotic and somnolent drugs (сертиндол, луразидон, Pimozidum, to triazoles, at oral administration midazolam); diuretics (эплеренон); hypolipidemic drugs (ловастатин, симвастатин); immunodepressants (эверолимус); other (colchicine). The combination of the listed drugs with ketokonazoly leads to increase in their concentration in a blood plasma that can lead to extension or increase in therapeutic and/or side effects, including to emergence of potentially dangerous effects, such as development of ventricular arrhythmia like "pirouette" and lengthening of an interval of QT (an electrical systole of heart);
Hypersensitivity to a ketokonazol.

Route of administration and dosage

The dosing mode for external and topical administration depends on clinical indications and the used dosage form.

At purpose of drug inside, cream is accepted during food of 1 times days.

The recommended dose for intake:

To adults and children weighing more than 30 kg – on 200-400 mg a day;
To children weighing up to 30 kg – on 4-8 mg on 1 kg of body weight a day.

Side effects

From the alimentary system: an abdominal pain, nausea, vomiting, diarrhea, functional disturbances of a liver, abdominal distention, dyspepsia, dryness in a mouth, language discoloration, a lock, a dysgeusia, toxic hepatitis (increase in activity of hepatic transaminases or the alkaline phosphatase (AP), jaundice, a liver failure, a heavy hepatotoxic, including cholestatic hepatitis, гепатонекроз (biopsy), cirrhosis (including cases of transplantation and death));
From cardiovascular system: orthostatic hypotension;
From a nervous system: drowsiness, the general weakness, dizziness, a headache, paresthesias, a hyperexcitability, alarm, sleeplessness, fatigue, reversible increase in intracranial pressure (swelling of a fontanel at children of younger age, hypostasis of disks of optic nerves);
From a metabolism: increase in appetite, intolerance of alcohol, lipidemia, anorexia;
From a musculoskeletal system: arthralgia, mialgiya;
From skin and a hypodermic fatty tissue: itch, rash, alopecia, erythema, mnogoformny erythema, dermatitis, rushes of blood, xeroderma, photosensitization, acute generalized exanthematous пустулез;
From respiratory system: nasal bleeding;
From sense bodys: photophobia;
From immune system: pseudoanaphylactic shock;
From endocrine system: insufficiency of function of adrenal glands, a gynecomastia, disturbance of a menstrual cycle, decrease in level of concentration of testosterone in a blood plasma (in 24 h after reception it is normalized) is possible;
From a reproductive system: impotence, an azoospermism (at doses it is higher than 200-400 mg in days);
From laboratory indicators: decrease in number of thrombocytes in peripheral blood, thrombocytopenia;
Allergic reactions: urticaria, rash, anaphylactic reactions, Quincke's disease, acute anaphylaxis;
General reactions: fever, fever, peripheral hypostasis.

Special instructions

Dermazol's use at fungal meningitis as кетоконазол badly gets through a blood-brain barrier (GEB) is inexpedient.

Because of risk of a hepatotoxic, кетоконазол it is necessary to apply only if the expected potential advantage exceeds possible risk.

Before purpose of drug it is necessary to estimate a functional condition of a liver for an exception of chronic and acute diseases.

The patients who transferred toxic damage of a liver owing to use of other medicines or with a superactivity of liver enzymes should not accept кетоконазол, except those cases when the expected effect justifies risk of damage of a liver.

The total dose of drug is risk factor of a heavy hepatotoxic at patients which development cannot be excluded, since first week of treatment. Therefore not to pass the first symptoms of a hepatotoxic, use of drug needs to be accompanied with regular control of a picture of peripheral blood, a functional condition of kidneys and a liver.

At researches кетоконазол in a daily dose of 400 mg and more caused decrease in "the kortizolovy response" to stimulation of adrenocorticotropic hormone (AKTG) in volunteers. Therefore during use of drug it is necessary to control function of adrenal glands at patients with the diagnosed adrenal insufficiency or borderline cases owing to stressful influence, including conditions of an intensive care, extensive surgeries or patients with the long period have treatments at suspicion on adrenal insufficiency.

Dermazol appoint not earlier than a two-week break after cancellation of the previous therapy of skin diseases of glucocorticosteroids (GKS).

Absorbability of a ketokonazol increases the use of acid drinks.

Medicinal interaction

Simultaneous use with antiacid drugs (blockers of histamine H2 receptors, aluminum hydroxide, inhibitors of the protonew pump) reduces bioavailability of a ketokonazol. Decrease in absorption of drug in combination with powerful inductors of an isoenzyme CYP3A4, such as рифабутин, an isoniazid, rifampicin, эфавиренз, carbamazepine, Phenytoinum, not Virapinum is possible. These combinations demand regular control of antifungal activity of Dermazol, and in case of decrease in its efficiency – carrying out correction of its dose towards increase.

Antiviral drugs, CYP3A4 isoenzyme inhibitors, including ритонавир, strengthened ritonaviry фосампренавир and дарунавир, can increase drug absorption. In this case it is recommended to control a condition of the patient for definition of signs of increase in activity and duration of effect of drug, if necessary to carry out decrease in its dose on the basis of data on concentration of a ketokonazol to blood.

Ketokonazol is capable to slow down the mediated metabolism of inhibitors of an isoenzyme of CYP3A4 and the movement of active agents caused by a P-glycoprotein. It can cause increase in level of concentration of these drugs and/or their active metabolites in a blood plasma and to become the reason of increase in duration and intensity of therapeutic or side effects of the medicines used in a combination.

It is not recommended to apply кетоконазол along with fentanyl, tamsuloziny, rifabutiny, carbamazepine, rivaroksabany, trabektediny, dazatiniby, nilotiniby, salmeteroly. At impossibility to avoid these combinations, it is necessary to provide clinical control of a condition of the patient, level of concentration of the corresponding drug in plasma, and if necessary to reduce a dose or to cancel its reception.

With care it is recommended to combine use of a ketokonazol with the following medicines: аторвастатин, periwinkle alkaloids, alfentanil, алитретиноин (for intake), алискирен, to alprazola, the aprepitant, арипипразол, buprenorphine (intravenously (in/in) and it is sublingual), brotiozolam, бортезомиб, буспирон, бусульфан, будесонид, verapamil, a haloperidol, dexamethasone, digoxin, dotsetakset, иматиниб, индинавир, иксабепилон, имидафенацин, coumarins, кветиапин, лапатиниб, a maravirok, midazolam (in/in), Methylprednisolonum, мозаваптан, Nadololum, oxycodone, a praziquantel, пероспирон, рамелтерон, ребоксетин, репаглинид, рисперидон, саксаглиптин, sildenafit, солифенацин, саквинавир, сиролимус, триметрексат, такролимус, tadalfit, темсиролимус, толтеродин, толваптан, эрлотиниб, tsinakaltst, циклесонид, цилостазол, cyclosporine, флутиказон, фезотеродин, эбастин, элетриптан. At a concomitant use it is regularly necessary to monitor a clinical condition of the patient, in case of need to control concentration of drug in a blood plasma and if it is required – to lower its dose.

Alcohol intake during treatment ketokonazoly in isolated cases can cause disulfiramopodobny reaction.

Terms and storage conditions

To store in the dry, protected from light place at a temperature up to 25 °C. To protect from children.

Period of validity – 3 years.

Whether you know that:

Having fallen from a donkey, you more likely will kill yourself, than having fallen from a horse. Only do not try to disprove this statement.

10 delusions about care of face skin

To look healthy and means well-groomed not only to be pleasant to people around, but also to feel strong, sure and taken place. To Spa...