Tablets: white color, round, a flat form with a slanted edge, on one of the parties an engraving of "JANSSEN", on another – "To 200" and dividing risk (on 10 pieces in blisters, in a cardboard pack 1 or 3 blisters);
Cream for external use of 2%: homogeneous structure of white color (on 15 g in aluminum tubas, in a cardboard pack 1 tuba);
Shampoo of 2%: liquid of red-orange color (on 25 ml or 60 ml in bottles from high density polyethylene with the screw-on cover, in a cardboard pack 1 bottle).

Active ingredient of Nizoral – кетоконазол:

1 tablet – 200 mg;
1 g of cream – 20 mg;
1 g of shampoo – 20 mg.

Auxiliary components:

Tablets: lactoses monohydrate, starch corn, magnesium stearate, поливидон K90, silicon dioxide colloid, cellulose microcrystallic, the water purified (in the course of production is removed);
Cream: stearyl alcohol, propylene glycol, cetyl alcohol, polysorbate 60, sorbitan stearate, isopropyl myristate, polysorbate 80, sodium sulfite anhydrous, the water purified;
Shampoo: dinatrium laurylsulphosuccinate, sodium lauryl sulfate, collagen hydrolyzate, Acidum hydrochloricum, methyldextrose macrogoal dioleate, диэтаноламид fatty acids of coconut oil, sodium chloride, sodium hydroxide, imidourea, dye red charming (E129), fragrance, water.

Indications to use

Tablets
Use of drug in the form of tablets is shown for treatment of infectious diseases of skin, mucous membranes, the pilar part of the head caused by barmy mushrooms and/or dermatophytes.

Tablets Nizoral are appointed in case of lack of clinical effect of earlier carried out local therapy, impossibility of use of cream because of the big size of the site of defeat or its considerable depth the patient with intolerance or resistance to therapy with other antifungal means for system use, at the following diseases / states:

Dermatofitiya;
Multi-colored deprive;
The folliculitis caused by sort Malassezia mushrooms;
Candidiasis of skin, mouth and throat;
Chronic form of candidiasis of mucous membranes;
Recurrent form of chronic candidiasis of a vagina.

Besides, tablets are appointed for treatment of system fungal infections: coccidioidosis, paracoccidioidosis, zymonematosis, histoplasmosis.

At fungal meningitis use is inexpedient because of bad penetration through a blood-brain barrier.

Cream for external use of 2%
Nizoral's use in the form of cream is shown for treatment of the fungal infections of skin caused by Trichophyton mentagrophytes, Trichophyton rubrum, Epidermophyton floccosum and Microsporum canis:

Chromophytosis;
Dermatomycosis of smooth skin;
Epidermophitia of feet and brushes;
Inguinal epidermophitia;
Skin candidiasis;
The seborrheal dermatitis which arose against the background of Pityrosporum ovale.

Shampoo of 2%
Use of shampoo is shown for prevention and treatment of a local chromophytosis, seborrheal dermatitis and dandruff.

Contraindications

Nizoral in all forms of release is contraindicated to use at hypersensitivity to its components.

Contraindications to use of tablets:

Acute or chronic form of a disease of a liver;
Simultaneous use with P450 cytochrome CYP3A4 isoenzyme substrates: Disopyramidum, bepridily, astemizoly, tsizapridy, galofantriny, dofetilidy, mizolastiny, levatsetilmetadoly (levometadit), Pimozidum, quinidine, terfenadiny, sertindoly, domperidony as their increased concentration can lead to lengthening of an interval of QT and ventricular arrhythmias on the pirouette type;
The accompanying therapy by GMG-KOA-reduktazy inhibitors CYP3A4, metaboliziruyemy through isoenzymes, including ловастатин, симвастатин;
Combination to a peroral form of midazolam and triazolam;
Use in combination with eplerenony, everolimusy, nisoldipiny, irinotekany;
Simultaneous use with methylergometrine, ergometrine, dihydroergotamine, ergotamine and other alkaloids of an ergot;
Syndrome of glyukozo-galaktozny malabsorption, lactose intolerance, deficit of lactase;
Age up to 3 years;
Breastfeeding period.

With care appoint tablets at the lowered acidity of a stomach (drug absorption worsens); a concomitant use of antiacid means (including aluminum hydroxide), it is necessary to accept them only in 2 hours after Nizoral; the patient with an achlorhydria or accepting the means suppressing secretion of hydrochloric acid in a stomach (inhibitors of the protonew pump, blockers of H2-histamine receptors), it is desirable to accept drug with the drinks containing Coca; with adrenal insufficiency and with borderline cases, including after extensive surgical intervention; at an alcohol abuse; liver failure (risk of a hepatotoxic); concomitant use of potentially hepatotoxic medicines.

During pregnancy of a tablet and shampoo it is possible to appoint in exceptional cases if the estimated advantage of therapy for mother surpasses potential risk for a fruit.

During breastfeeding shampoo should be applied with care, previously having got advice of the doctor.

Route of administration and dosage

Tablets
Pill is taken orally, during food.

The recommended dosing at system infections and treatment of damages of mucous membranes, skin, the pilar part of the head caused by barmy mushrooms and/or dermatophytes:

Patients weighing more than 30 kg: 1 tablet of 1 times a day, in the absence of clinical effect is recommended to increase a single dose to 2 tablets; at vaginal candidiasis – 2 tablets of 1 times a day;
Children are more senior than 3 years with the body weight of 15-30 kg: ^1/2 tablets of 1 times a day.

The average duration of therapy depending on a disease:

The skin mycoses caused by dermatophytes – about 4 weeks;
Vaginal candidiasis – 1 week;
Candidiasis of an oral cavity and skin – 2-3 weeks;
Multi-colored deprive – 1,5 weeks;
Fungal infections of a pilar part of the head – 1-2 months;
Histoplasmosis, paracoccidioidomycosis, coccidioidomycosis – 6 months.

Continuous use of drug has to be carried out to the eradikation of the activator confirmed with laboratory researches.

At emergence of symptoms of hepatitis (increased fatigue, nausea, vomiting, anorexia, jaundice, an abdominal pain, dark color of urine) it is necessary to cancel drug and to estimate function of a liver.

Cream for external use of 2%
Cream should be applied on the skin affected with a fungus, occupying adjacent healthy sites, 1 time a day.

The average duration of a course depending on a disease:

Dermatomycosis of smooth skin – 3-4 weeks;
Chromophytosis – 2-3 weeks;
Inguinal epidermophitia – 2-4 weeks;
Barmy infections – 2-3 weeks;
Epidermophitia of feet – 4-6 weeks.

At seborrheal dermatitis cream 1 or 2 times a day before total disappearance of all symptoms of a disease are recommended to inflict depending on weight defeats (usually 2-4 weeks).

For prevention of a recurrence, as a maintenance therapy the infected surfaces need to be greased 1-2 times a week. If after use of cream within 4 weeks the clinical effect did not occur, it is necessary to see a doctor for specification of the diagnosis.

Shampoo of 2%
Shampoo is applied outwardly, applying on problem sites of a pilar part of the head and skin for 3-5 minutes and carefully washing out water.

The dosing mode when using in the medical purposes:

Chromophytosis: 1 time a day for 5 days;
Dandruff and seborrheal dermatitis: 2 times a week, a therapy course – 2-4 weeks.

The dosing mode when using in the preventive purposes:

Chromophytosis: carrying out a one-time course before a summer season – 1 time a day within 3 days is recommended;
Seborrheal dermatitis and dandruff: 1 time in 1-2 weeks.

The mode of use of shampoo has no age restrictions.

Side effects

Open clinical trials of use of tablets Nizoral at patients with superficial and deep mycoses noted the following side effects (often – more than 1%, infrequently – with a frequency less than 1%):

Digestive tract: often – an abdominal pain, nausea, diarrhea, functional disorder of a liver; infrequently – dryness in a mouth, vomiting, a lock, dyspepsia, abdominal distention, a dysgeusia, toxic hepatitis (a giperkreatininemiya, increase in activity of liver enzymes, alkaline phosphatases), language discoloration, jaundice;
Nervous system: often – a headache; infrequently – the general weakness, dizziness, drowsiness, paresthesia, sleeplessness, alarm, a hyperexcitability, fatigue;
Cardiovascular system: infrequently – an orthostatic lowering of arterial pressure;
Endocrine system: infrequently – a gynecomastia;
Food and metabolism: infrequently – increase in appetite, intolerance of alcohol, a lipidemia, anorexia;
Sense bodys: infrequently – photophobia;
Immune system: infrequently – pseudoanaphylactic shock;
Respiratory system: infrequently – nasal bleeding;
Musculoskeletal system: infrequently – a mialgiya;
Reproductive system: infrequently – disturbance of a menstrual cycle;
Dermatological reactions: infrequently – an itch, rash, dermatitis, allergic rash, an alopecia, a multiformny erythema, a xeroderma, rushes of blood, an erythema;
Laboratory indicators: infrequently – decrease in level of thrombocytes;
General indicators: infrequently – fever, a fever, peripheral hypostasis.

Besides, use of tablets in the post-registration period caused such undesirable actions:

Immune system: very seldom – a small tortoiseshell, a Quincke's disease, an acute anaphylaxis, anaphylactic reactions and other allergic states;
Nervous system: very seldom – reversible increase in intracranial pressure in the form of hypostasis of disks of optic nerves, at children is swellings of a fontanel and other signs;
Endocrine system: very seldom – insufficiency of function of adrenal glands;
Musculoskeletal system: very seldom – an arthralgia;
Digestive tract: very seldom – a severe form of a hepatotoxic (a liver failure, cholestatic hepatitis, cirrhosis, гепатонекроз (biopsy), including cases of a lethal outcome and transplantation);
Urinogenital system: very seldom – erectile dysfunction, an azoospermism against the background of exceeding of the recommended doses;
Dermatological reactions: very seldom – photosensitivity;
Laboratory indicators: very seldom – thrombocytopenia;
Others: perhaps – decrease in level of testosterone in a blood plasma (it is recovered in 24 hours after reception).

When drawing cream Nizoral can cause a burning sensation and irritation of skin, is rare – local reactions of allergic character (in the form of contact dermatitis).

Treat the side effects revealed during post-market researches:

Immune system: very seldom – a small tortoiseshell, hypersensitivity;
Skin and hypodermic fabrics: very seldom – an itch, rash, an erythema.

Use of shampoo can cause infrequent undesirable reactions:

System and local disturbances: a skin itch, an erythema, irritation in a site of application, pustules, hypersensitivity, skin reactions;
Organ of sight: the raised dacryagogue, irritation of eyes;
Immune system: hypersensitivity reactions;
Nervous system: disturbance of flavoring feelings;
Invasions and infections: folliculitis;
Dermatological reactions: xeroderma, skin rash, burning sensation, skin peeling, acne rash, contact dermatitis, alopecia, disturbance of texture of hair; very seldom – urticaria, hypostasis, discoloration of hair.

Special instructions

In view of risk of a hepatotoxic of a tablet Nizoral it is necessary to use only in case of excess of advantage of therapy over potential threat, considering existence of other types of effective antifungal remedies.

Treatment by tablets should be begun after preliminary estimate of function of a liver, having excluded acute or chronic pathologies. Drug use inside should be accompanied with regular control of a picture of peripheral blood, a functional condition of kidneys and a liver as it is important not to pass the first signs of a hepatotoxic which can arise at patients without obvious risk factors. The received total dose of a ketokonazol poses a threat for development of a heavy hepatotoxic. The patient has to be informed that at nausea, vomiting, anorexia, weakness, darkening of urine, an abdominal pain and jaundice it is necessary to stop use of tablets and to see urgently a doctor.

Patients with a superactivity of liver enzymes or the postponed toxic damage of a liver against the background of reception of other means Nizoral can appoint only in the most acute cases, having provided control of level of liver enzymes.

At a daily dose 2 tablets are possible above decrease in the kortizolovy response to stimulation of adrenocorticotropic hormone therefore it is necessary to exercise control of function of adrenal glands at adrenal insufficiency or borderline cases at the patients experiencing considerable stressful influences (conditions of an intensive care, extensive surgical interventions, etc.), and also at patients with a long course of treatment at suspicion on adrenocortical insufficiency.

At decrease in acidity of a gastric juice absorption of a ketokonazol worsens.

Ketokonazol it is possible to appoint not earlier than in 2 weeks after cancellation of the previous glucocorticosteroid therapy.

Acid drinks increase absorbability of a ketokonazol.

Nizoral's use does not exert impact on ability of the patient to control of vehicles and mechanisms.

Cream should be applied only outwardly, use in ophthalmology is contraindicated.

Not to allow development of a withdrawal after long therapy by local corticosteroids, their use is recommended to be stopped gradually, having continued use within 2-3 weeks. At a combination to cream local corticosteroids should be used during cancellation only in the morning, and cream – in the evening.