NIZORAL

Active material: Ketoconazole
When ATH: J02AB02
CCF: Antifungal agent
When CSF: 08.01.01
Manufacturer: JOHNSON & JOHNSON LTD (Russia)

Pharmaceutical form, composition and packaging

Pills white, round, flat, beveled, with a notch on one side, with an inscription “JANSSEN” on one side and “C / 200” – another.

1 tab.
ketoconazole200 mg

[Ring] corn starch, lactose monohydrate, polyvidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.

Pharmacological action

Antifungal, It has activity against dermatophytes, yeasts, dimorphic fungi and eumitsetov. It is also active against staphylococci and streptococci. The mechanism of action is to inhibit ergosterol synthesis of membrane fungi and violating cell wall permeability. Ineffective against Aspergillus, Zygomycetes. It reduces the formation of androgens.

 

Testimony

Fungal infections, caused by susceptible pathogens: gastrointestinal mycosis, eye, genital, chronic recurrent vaginal candidiasis, ringworm (incl. beard and mustache area, scalp, hands), onychomycosis, thrush, folliculitis, ringworm, Systemic fungal infections (blastomycosis, kandidamikoz, parakokcidioidoz, kokcidioidoz, kryptokokkoz, histoplasmosis, xromomikoz, sporotrichosis, paronixij, hrybkovыy sepsis, fungal pneumonia); leishmaniasis (cutaneous and visceral); chromophytosis, prevention of fungal infections in patients with an increased risk of development; prostate cancer (at high doses as an auxiliary ADT), Kashin-Beck syndrome (endemic deforming osteoarthritis), girsutizm (treatment as PM 3 or 4 lines).

 

Contraindications

Hypersensitivity, pregnancy, laktatsiya.C caution. Hepatic and / or renal failure, concomitant use of potentially hepatotoxic drugs, alcoholism, axlorgidrija, hypacidity, pregnancy, lactation, childhood (to 2 years) (Safety and efficacy have not been established).

 

Side effects

From the digestive system: decreased appetite, nausea, vomiting, abdominal pain, constipation or diarrhea, toxic hepatitis (activity increase “Hepatic” transaminases, giperkreatininemiя). From the nervous system: headache, dizziness, drowsiness, paresthesia. With the genitourinary system: gynecomastia, decreased libido in men, oligospermatism, impotence, dysmenorrhoea, azoospermia. From the side of hematopoiesis: thrombocytopenia, leukopenia, gemoliticheskaya anemia. Allergic reactions: hives, skin rash, fever, rash, photophobia. Other: alopecia.

 

Dosing and Administration

Inside, for 1 reception, while eating. When ringworm and multicolored shingles appoint 200-400 mg / day for 1-8 Sun. In onihomikozah – 200-400 mg / day for 3-12 months to recover, including the normalization of laboratory values. In systemic mycosis – by 200-400 mg / day for 2 Sun, then – by 200 mg for 4-6 Sun, until complete recovery. When vulvovaginal candidiasis – by 200-400 mg for 3-5 days. If paronychia – by 200-400 mg / day; fungal pneumonia, sepsis – by 0.4-1 g / day; the syndrome of Kashin-Beck – by 600-1200 mg / day; at others. fungal diseases – by 200-400 mg. The maximum daily dose for adults – 1 g in systemic mycosis and 1.2 g prostate cancer (by 400 mg 3 once a day). The duration of treatment with systemic mycosis – from 6 months or more; when paracoccidioidomycosis – 3-12 Months. Children from 2 or older at the vulvovaginal candidiasis, when paronychia, fungal pneumonia, sepsis – 5-10 mg / kg once daily for 5 days.

 

Cautions

During treatment should regularly monitor the pattern of peripheral blood, the functional state of the liver and kidneys. If the treatment of skin lesions was performed SCS, ketoconazole is administered no earlier than 2 Weeks after their withdrawal. In patients with hypochlorhydria or achlorhydria because of the unpredictable degree of reduction of absorption ketoconazole may be ineffective when administered orally. Drinking acidic drinks increases the absorption of ketoconazole.

 

Cooperation

Ethanol and other. hepatotoxic drugs increase the risk of liver damage parenehimy. When combined use of ethanol may cause reactions disulfiramopodobnyh. Increasing the concentration of sulfonylurea derivatives and increases the risk of hypoglycemia. Rifampicin and isoniazid reduce the concentration of ketoconazole in the plasma. It weakens the effect of amphotericin B. Increases in plasma concentration of cyclosporin, anticoagulants, digoksina, midazolama, triazolam and methylprednisolone. Increases bioavailable indinavir. It reduces the stimulating effect on the adrenal corticotropin. When combined with terfenadine, astemizole, and cisapride increases the risk of severe ventricular tachycardia, incl. type “pirouette”. It increases the risk of bleeding “Breakthrough” while single-step using oral contraceptives with low hormone. Increases toxicity of phenytoin. Antacids and anticholinergic drugs, H2-blockers of histamine receptors, etc.. PM, lowering gastric acidity, reduce the absorption of ketoconazole.

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