Expiration date: 08/2025

Release form, composition and packing

Tablets white or white with Valium or a grayish shade, Valium, with a facet and Valium, tolerance of marbling.

Excipients: lactose monohydrate - 16 mg, potato starch - 60 mg, povidone - 22.6 mg colloidal silicon dioxide - 12 mg, talc - 6.2 mg of magnesium stearate - 3.2 mg.10 pieces. - Packings Valium planimetric (1) - packs cardboard.

1 tab. contains ketoconazole 200 mg

Clinico-pharmacological group: Antifungal agent

Pharmaco-therapeutic group: Antifungal

Indications:

Infections smooth skin, the scalp, caused by dermatophytes and / or yeast fungi in cases where local treatment is not applicable due to the large size of the affected areas, a considerable depth of defeat, and with no effect on previously conducted by local treatment:

• Tinea,
  
• Multi-colored lichen,
  
• Folliculitis, caused by fungi of the genus of Pityrosporum,
  
• Chronic kandidbz skin and mucosa (including oral cavity, pharynx and esophagus)
  
• Chronic recurrent vaginal candidiasis in the absence of the effect of local therapy.
  

Systemic fungal infections:

• Paracoccidioidomycosis,
  
• Histoplasmosis,
  
• Coccidioidomycosis,
  
• Blastomycosis.
  

Dosage and administration:

Mikozoral taken orally, to improve the absorption of the drug - while eating.

Adults

Take 1 tablet (200 mg) 1 times / day. If you are receiving the indicated doses of improvement does not occur, the dose should be increased to 2 tablets (400 mg) 1 times / day.

Vaginal candidiasis - 2 tablets (400 mg) 1 times / day.

Children older than 3 years

• Weighing 15 to 30 kg - 2.1 tablets (100 mg), 1 time / day,
  
• Weighing more than 30 kg - dose indicated for adults.
  

The average duration of treatment.

• Vaginal candidiasis - 7 days
  
• Tinea - about 4 weeks
  
• Multi-colored lichen-10 days,
  
• Chronic candidiasis of the skin and mucosal membranes (including the mouth, pharynx, and esophagus) - 2-3 weeks
  
• Fungal scalp - 1-2 months,
  
• Paracoccidioidomycosis, histoplasmosis, coccidioidomycosis, blastomycosis - usual duration of treatment - 6 months.
  

Side effect

From the digestive system: loss of appetite, nausea, vomiting, abdominal pain, diarrhea, chronic hepatitis (increased activity of "liver" transaminases and alkaline phosphatase, hypercreatininemia).

CNS: headache, dizziness, somnolence, paresthesia, reversible elevation of intracranial pressure.

From the senses: photophobia.

From the side of hematopoiesis: thrombocytopenia, leukopenia, hemolytic anemia.

Allergic reactions: urticaria, skin rash, fever, rarely - anaphylactic shock, anaphylactoid and anaphylactic reactions, angioedema.

With the genitourinary system: decreased libido in men, oligospermia, impotence, menstrual irregularities.

Other: alopecia, gynecomastia (reversible), a temporary reduction of testosterone concentration in blood plasma (normal less than 24 hours after admission).

Contraindications

• Hypersensitivity to ketoconazole or any other components of the drug,
  
• Acute or chronic liver disease,
  
• Lactation,
  
• Children up to age 3 years,
  
• Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
  

Simultaneous treatment with terfenadine, astemizole, mizolastine, cisapride, dofetilide, quinidine, pimozide, bepridilom, disopyramide, halofantrine, levacetylmethadol, domperidone and sertindole, triazolam, and midazolam for the oral use, metabolized through CYP3A4 inhibitors of HMG-CoA reductase inhibitors (simvastatin, lovastatin) , ergot alkaloids (dihydroergotamine, ergometrine / ergotamine, metilergometrin), nisoldipine, eplerenone, irinotecan, everolimus.

Precautions: hepatic failure, achlorhydria, hypochlorhydria, insufficiency of the adrenal cortex and pituitary, concomitant use of potentially hepatotoxic drugs, alcoholism, pregnancy, age over 50 years (women).

Pregnancy and breast-feeding

Mikozoral The drug should not be administered to pregnant women, except in cases where the intended benefits to the mother outweighs the potential risk to the fetus. Because ketoconazole passes into breast milk, breastfeeding should stop while taking the drug.

Application for violations of liver function

Contraindicated in acute or chronic liver disease.

Precautions: hepatic impairment.

In women older than 50 years, in the presence of liver disease in history, with drug intolerance, taking hepatotoxic drugs, and if the duration of treatment with more than 2 weeks, you need to monitor liver function before treatment, after 2 weeks of treatment and then monthly, so both these categories of patients on the liver toxicity risk of the drug is increased.

Use in children

Suitable for children from 3 years indicated.

Use in elderly patients

Precautions: age over 50 years (women).

Special instructions:

Before treatment is necessary to evaluate liver function to prevent acute or chronic diseases of her during treatment must be frequently and regularly monitor liver function in all patients in order not to miss the first signs of hepatotoxicity. Total received a dose of ketoconazole (a course of treatment) is a risk factor for severe hepatotoxicity.

In women older than 50 years, in the presence of liver disease in history, with drug intolerance, taking hepatotoxic drugs, and if the duration of treatment with more than 2 weeks, you need to monitor liver function before treatment, after 2 weeks of treatment and then monthly, so both these categories of patients on the liver toxicity risk of the drug is increased.

It is important to inform patients that need long-term treatment with the drug, with symptoms of liver disease (fatigue, tiredness, fever, dark urine, feces discoloration, jaundice).

In the case of the onset of symptoms of hepatitis or if liver function tests confirm liver disease, treatment should be discontinued immediately. If the treatment of skin lesions was performed corticosteroids, ketoconazole is administered no earlier than 2 weeks after their withdrawal.

Patients taking antacids (eg, aluminum hydroxide), should take them no earlier than 2 hours after dosing.

In patients with hypochlorhydria or achlorhydria because of the unpredictable degree of reduction of absorption ketoconazole may be ineffective when given orally. Drinking acidic drinks increases the absorption of ketoconazole.

When used in a dose of 400 mg or more a decrease in "cortisol response" when stimulated adrenal adrenocorticotropic hormone (ACTH), so the period of treatment is necessary to monitor adrenal function in patients with adrenal insufficiency patients and in patients undergoing major stress factors (in tonnes. h. The extensive surgery).

During the period of treatment must be careful when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.

Overdose:

Treatment: gastric lavage, activated charcoal, symptomatic therapy, monitoring the patient's condition. There is no specific antidote.

Drug interactions

Drugs affecting the metabolism of ketoconazole.

• Inductors microsomal oxidation, such as rifampicin, rifabutin, carbamazepine, isoniazid, nevirapine and phenytoin significantly reduce the bioavailability of ketoconazole. The use of ketoconazole with such preparations are not recommended
  
• Ritonavir increases the bioavailability of ketoconazole, as a result of this by sharing a need to reduce the dose of ketoconazole.
  

Effect of ketoconazole on the metabolism of other drugs.

Ketoconazole may enhance or prolong the effects of drugs metabolized with participation of cytochrome P450, in particular from the group of CYP3A.

You can not assign during treatment with ketoconazole:

• Terfenadine, astemizole, mizolastine, cisapride, dofetilide, quinidine, pimozide, bepridil, disopyramide, halofantrine, levometadil, domperidone and sertindole. Increased risk of severe ventricular tachycardia, including type "pirouette"
  
• Midazolam and triazolam (oral form), metabolized isoenzyme CYP3A4 inhibitors of HMG-CoA reductase such as simvastatin and lovastatin, ergot alkaloids (dihydroergotamine, ergometrine, ergotamine, metilergometrin), nisoldipine, eplerenone, irinotecan, everolimus. Enhances the effects, including side, these drugs.
  

Formulations in which assignment must monitor their concentrations in plasma, therapeutic effects and severity of side effects (at a dose of co-administered with ketoconazole should be reduced if necessary):

• Oral anticoagulants,
  
• HIV protease inhibitors such as indinavir, saquinavir,
  
• Some anticancer drugs such as vinca alkaloids, busulfan, docetaxel, erlotinib, imatinib,
  
• Metabolized by CYP3A4 isoenzyme blockers "slow" calcium channel dihydropyridine and probably verapamil,
  
• Some immunosuppressive agents: cyclosporine, tacrolimus, sirolimus,
  
• Sildenafil, tolterodine,
  
• Some HMG-CoA reductase inhibitors, such as atorvastatin,
  
• Some glucocorticosteroids such as budesonide, fluticasone, dexamethasone, methylprednisolone,
  
• Other drugs: digoxin, carbamazepine, buspirone, alfentanil, alprazolam, brotizolam, rifabutin, trimetrexate, ebastine, reboxetine, quetiapine, solifenacin, cilostazol, eletriptan, fentanyl, repaglinide.
  

Ethanol and other hepatotoxic drugs increases the risk of damage to the hepatic parenchyma. When coupled with the use of ethanol may cause disulfiramopodobnyh reactions.

It weakens the effect of amphotericin B.

It reduces a stimulating effect on the adrenal corticotropin.

It increases the risk of "breakthrough" bleeding when using a one-stage oral contraceptives with a low content of hormones.

Increases toxicity of phenytoin.

Antacids and anti-cholinergic drugs, histamine H2 blockers receptors and other drugs that reduce gastric acidity, reduce the absorption of the ketoconazole.