Nizoral - instructions for use, analogs, reviews and release forms (cream or ointment 2%, shampoo 2%, tablets 200 mg) drugs for the treatment of dandruff, seborrheic dermatitis and candidiasis in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Nizoral. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Nizoral 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 Nizoral in the presence of existing structural analogues. Use for the treatment of dandruff, seborrheic dermatitis and candidiasis (fungus) in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Nizoral - Synthetic derivative of imidazole-dioxolane with fungicidal or mycostatic action against dermatophytes, yeast (Candida, Malassezia, Torulopsis, Cryptococcus), dimorphic fungi and higher fungi (eumycetes). Less sensitive to the action of Ketoconazole (the active substance of the drug Nizoral): Aspergillus spp., Sporothrix schenckii, some Dermatiaceae, Mucor spp. and other fikomycetes, with the exception of Enomophthorales. Ketoconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in membranes. Data from clinical studies and study of drug interactions showed that when taking the drug at a dose of 200 mg 2 times a day for 3-7 days, there may be a slight increase in the QT interval: the average maximum increase in the QT interval to 6-12 msec was observed after 1-4 hour after taking the drug Nizoral, when the concentration of ketoconazole in the blood plasma reached the maximum values. However, such an increase in the QT interval is considered clinically insignificant.

At a therapeutic dose of 200 mg once a day, there may be a transient decrease in testosterone concentration in the plasma. The testosterone concentration returns to the initial value within 24 hours after the administration of ketoconazole.During prolonged therapy with this dosage, the testosterone concentration usually differs slightly from the control.

Nizoral in a daily dose of 400 mg and above caused a decrease in the "cortisol response" to ACTH stimulation in volunteers.

Composition

Ketoconazole + auxiliary substances.

Pharmacokinetics

Ketoconazole is a weak dibasic substance that dissolves and is absorbed in an acidic medium. After absorption from the gastrointestinal tract, ketoconazole is metabolized in the liver with the formation of a large number of inactive metabolites. About 13% of the dose is excreted in the urine, of which 2 to 4% is unchanged drug substance. The drug is excreted mainly with bile in the digestive tract.

Indications

Infections of the skin, scalp and mucous membranes 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 or in the absence of the effect of previous local treatment, as well as for the treatment of patients with persistent or with intolerance to therapy with other antifungal drugs for systemic use:

• dermatophytosis;
• colored lichen;
• Folliculitis caused by fungi of the genus Malassezia;
• chronic candidiasis of the mucous membranes and candidiasis of the skin;
• Candidiasis of the mouth and pharynx;
• chronic recurrent candidiasis of the vagina;
• treatment and prevention of infections caused by yeast Malassezia spp. (Pityrosporum spp.), Such as pityriasis lichen (local), seborrheic dermatitis and dandruff (shampoo).

Systemic fungal infections:

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

The use of Nizoral in fungal meningitis is impractical, since the drug penetrates poorly through the blood-brain barrier.

Forms of release

Tablets 200 mg.

Cream for external use 2% (sometimes mistakenly called ointment or gel).

Shampoo 2% (sometimes mistakenly called a spray).

Instructions for use and how to use them

Pills

The drug Nizoral is taken orally, during meals to improve absorption.

With infections of the skin, scalp and mucous membranes caused by dermatophytes and / or yeast fungi and systemic infections:

Adults: 1 tablet (200 mg) 1 time per day with meals. If at reception, the specified dose does not improve, the dose should be doubled (400 mg once a day).With vaginal candidiasis, 2 tablets (400 mg) are prescribed 1 time per day with meals.

Children older than 3 years with a body weight of 15 to 30 kg: 1/2 tablet (100 mg) once a day (since the experience of using the drug for children weighing less than 15 kg is limited, it is not recommended to prescribe the drug to children weighing less than 15 kg ); with a body weight of more than 30 kg: the doses indicated for adults.

Average duration of treatment:

• vaginal candidiasis - 7 days;
• skin mycoses caused by dermatophytes - about 4 weeks;
• multi-colored lichen - 10 days;
• Candidiasis of the skin and oral cavity - 2-3 weeks;
• fungal lesions of the scalp - 1-2 months;
• paracoccidioidomycosis, histoplasmosis, coccidioidomycosis - usually the duration of treatment is 6 months.

For all indications, treatment should be continuous until clinical parameters and laboratory indicators indicate eradication of the pathogen. Inadequate duration of treatment can lead to a relapse of infection. However, if signs and symptoms of hepatitis such as anorexia, nausea, vomiting, fatigue, jaundice, abdominal pain and dark urine occur, the treatment should be immediately discontinued and the liver function evaluated.

Cream

Candidiasis of the skin, dermatomycosis of smooth skin, inguinal epidermophytia, epidermophytia of hands and feet, pityriasis: it is recommended to apply Nizoral cream once a day to the affected skin and the area immediately adjacent to it.

Seborrheic dermatitis: Nizoral cream is applied to the affected area 1 or 2 times a day, depending on the severity of the lesion.

Continue treatment for a sufficient period of time, at least for several days after the disappearance of all symptoms of the disease. The diagnosis should be reviewed if there is no clinical improvement after 4 weeks of treatment. General hygiene measures should be observed to control sources of infection and reinfection.

The usual duration of treatment is as follows: chromophytosis - 2-3 weeks, yeast infections - 2-3 weeks, jock itch - 2-4 weeks, tinea smooth skin - 3-4 weeks, athlete's foot - 4-6 weeks.

The usual duration of treatment for seborrheic dermatitis is 2-4 weeks. For maintenance therapy with seborrheic dermatitis, the cream is applied once or twice a week.

Shampoo

Children from infancy, adolescents and adults: apply Nizoral shampoo 2% on 3-5 minutes for affected areas, then rinse with water.

Treatment:

• pityriasis lichen: 1 times a day for 5 days;
• seborrheic dermatitis and dandruff: 2 times a week for 2-4 weeks.

Prevention:

• pityriasis lichen: 1 time a day for 3 days (one-time course of treatment before the onset of summer).
• seborrheic dermatitis and dandruff: weekly or 1 time in two weeks.

Features of use in children is not available.

Side effect

• headache;
• nausea, vomiting;
• abdominal pain;
• diarrhea;
• gynecomastia;
• photophobia;
• dyspepsia;
• constipation;
• dry mouth;
• bloating;
• changing the color of the language;
• pseudo-anaphylactic shock;
• dizziness;
• paresthesia;
• drowsiness;
• increased excitability;
• insomnia;
• anxiety;
• fatigue;
• general weakness;
• alcohol intolerance;
• anorexia;
• increased appetite;
• myalgia;
• violation of the menstrual cycle;
• nose bleed;
• alopecia;
• dermatitis;
• erythema;
• erythema multiforme;
• itching;
• rash;
• an allergic rash;
• Orthostatic lowering of arterial pressure;
• fever;
• chills;
• reversible increase in intracranial pressure (for example, edema of the optic discs, swelling of the fontanel in young children);
• erectile disfunction;
• a temporary decrease in the concentration of testosterone in the blood plasma (normalized 24 hours after admission).

Contraindications

• acute or chronic liver disease;
• deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;
• simultaneous reception with substrates of isoenzyme 3A4 cytochrome P450 (CYP3A4): astemizole, bepridilom, halofantrine, disopyramide, cisapride, dofetilide, levacetylmetadol (levometadil), misolastine, pimozide | quinidine, sertindole, terfenadine and domperidone, since elevated concentrations of these drugs in plasma can lead to prolongation of the QT interval and ventricular arrhythmias of the torsades de pointes type;
• simultaneous administration with triazolam and midazolam for oral administration;
• simultaneous administration with CYP3A4 isozymes metabolized by HMG-CoA reductase inhibitors such as simvastatin and lovastatin;
• simultaneous reception with ergot alkaloids, eg dihydroergotamine, ergometrine, ergotamine, methylergometrin;
• simultaneous reception with nisoldipine, eplerenone, irinotecan, everolimus;
• children under 3 years;
• hypersensitivity to ketoconazole or any of the components of the drug.

Nizoral uses caution to prescribe alcohol abusers.while taking the drug with alcohol may occur disulfiramopodobnyh reactions, characterized by redness, rash, edema, nausea and headache.

Because of the risk of hepatotoxicity in patients with hepatic insufficiency and in patients receiving potentially hepatotoxic drugs, Nizoral should be used with caution and only in cases where the potential benefit outweighs the potential possible taking into account the availability of other effective antifungal agents.

Application in pregnancy and lactation

At the moment, there is limited information on the use of tablets Nizoral during pregnancy.

In animal studies, reproductive toxicity of ketoconazole was found. The degree of potential risk to a person is unknown.

Thus, tablets Nizoral should not be given to pregnant women except in cases where the potential benefit to the mother outweighs the potential risk for the fetus.

Since ketoconazole is excreted in breast milk, breast-feeding is not recommended while taking the drug.

special instructions

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

To prevent withdrawal syndrome with prolonged local treatment with corticosteroids, it is recommended to continue local use of corticosteroids in combination with Nizoral shampoo 2% followed by a gradual corticosteroid withdrawal within 2-3 weeks.

If the medicine has become unusable or the expiration date has expired, do not throw it into the waste water and throw it out! Place the drug in a bag and put it in the trash. These measures will help protect the environment!

Cream Nizoral can not be used in ophthalmic practice.

In order to prevent withdrawal syndrome after cessation of long-term treatment with local corticosteroids, it is recommended to continue the use of local corticosteroids in the morning and Nizoral cream in the evening, and then gradually, within 2-3 weeks, to cancel steroids.

Impact on the ability to drive and work with machinery

Nizoral shampoo 2% does not affect the ability to drive and work with machinery.

Drug Interactions

Drugs that reduce the acidity of gastric juice reduce the absorption of Nizoral.

The simultaneous use of the drug Nizoral with the following drugs is contraindicated:

• astemizole, bepridil, halofantrine, disopyramide, cisapride, dofetilide, levacetylmethadol (levometadil), misolastine, pimozide, quinidine, sertindole, terfenadine and domperidone, since elevated concentrations of these drugs in plasma can lead to prolongation of the QT interval and ventricular arrhythmias of the torsades type pointes;
• triazolam and midazolam for oral administration;
• metabolized CYP3A4 HMG-CoA reductase inhibitors such as simvastatin and lovastatin;
• ergot alkaloids, for example dihydroergotamine, ergometrine, ergotamine, methylergometrine;
• nisoldipine;
• eplerenone;
• irinotecan;
• everolimus.

Analogues of the drug Nizoral

Structural analogs for the active substance:

• Dermazol;
• Ketoconazole;
• Ketoconazole DS;
• Ketoconazole Altpharm;
• Livarol;
• Mikanisal;
• Mycosorrhal;
• Mikoket;
• Oronazole;
• Perch;
• Sebosol;
• Fungin;
• Fungistab.

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