Oronazole - instructions for use, analogs, reviews and release forms (tablets 200 mg) of the drug for the treatment of skin fungus and systemic mycoses in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Oronazole. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Oronazole 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 Oronazole in the presence of existing structural analogues. Use to treat skin fungus and systemic mycoses in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Oronazole antifungal agent. It has a fungicidal and fungistatic effect. The mechanism of action consists in inhibiting the synthesis of ergosterol and changing the lipid composition of the membrane. Ketoconazole (the active ingredient of the drug Oronazol) is active against the pathogen of the colorful lichen Malassezia furfur, the causative agents of some dermatomycoses (Trichophyton, Epidermophyton floccosum, Microsporum), candida pathogens (Candida), and the causative agents of systemic mycoses (Cryptococcus). It is also active against gram-positive cocci: Staphylococcus spp. (Staphylococcus aureus), Streptococcus spp. (streptococcus).

Composition

Ketoconazole + auxiliary substances.

Pharmacokinetics

Ketoconazole is a weak dibasic compound that dissolves and is absorbed in an acidic medium. Bioavailability of ketoconazole is maximal when taken with food. Absorption of ketoconazole is reduced in patients with reduced acidity of gastric juice, for example, taking antacid and antisecretory drugs, as well as in patients with achlorhydria caused by a particular disease. The binding to plasma proteins, mainly with the albumin fraction, is 99%. Ketoconazole is widely distributed in tissues, but only a small part of the drug penetrates into the cerebrospinal fluid.After absorption from the gastrointestinal tract (GIT), Oronazol is metabolized in the liver with the formation of a large number of inactive metabolites. About 13% is excreted in urine, of which 2-4% is unchanged. It is allocated mainly with bile in the digestive tract and about 57% is excreted with feces.

Indications

• fungus of the skin, including mycosis of the trunk, mycosis of the feet, mycosis of the brushes;
• inguinal epidermophytia;
• coccidioidomycosis (coccidioidosis, coccidiomycosis);
• blastomycosis;
• histoplasmosis;
• Chromomycosis;
• paracoccidioidomycosis (paracoccidioidosis).

Forms of release

Tablets 200 mg.

Medicinal forms of a candle or ointment at the time of publication of the drug in the Directory did not exist.

Instructions for use and dosing regimen

For admission to adults and children with a body weight of more than 30 kg - 200-400 mg per day. Children with a body weight of less than 30 kg - 4-8 mg per 1 kg of body weight per day. Take Oronazole 1 time per day with meals.

Side effect

• headache, dizziness;
• paresthesia (a sensitivity disorder characterized by spontaneous sensations of burning, tingling, crawling);
• drowsiness, insomnia;
• increased excitability;
• anxiety;
• fatigability, general weakness;
• reversible increase in intracranial pressure (for example, edema of the optic discs, swelling of the fontanel in young children);
• nausea, vomiting;
• abdominal pain;
• diarrhea, constipation;
• abnormal liver function;
• dry mouth;
• dysgeusia (a disorder of taste in which taste sensations are partially absent or distorted);
• bloating;
• changing the color of the language;
• toxic hepatitis (increased activity of hepatic transaminases or alkaline phosphatase (AF), jaundice);
• cirrhosis of the liver;
• alcohol intolerance;
• anorexia (a disorder manifested by an obsessive desire to lose weight, fear of obesity);
• hyperlipidemia (elevated levels of lipids and / or lipoproteins in the blood);
• increased appetite;
• Myalgia (pain in the muscles);
• arthralgia (joint pain);
• nose bleed;
• alopecia (baldness);
• dermatitis (inflammatory skin damage);
• erythema (redness of the skin);
• erythema multiforme (characteristic rashes on the skin and mucous membranes);
• itching, rash;
• xeroderma (pigment spots on the skin);
• flushes of blood;
• acute generalized exanthematous pustulosis (pustular eruptions);
• photosensitization (increased sensitivity of the body (often the skin and mucous membranes) to the action of ultraviolet or visible radiation);
• Orthostatic hypotension (a violation of the ability of the body to maintain a normal level of blood pressure in the vertical position);
• gynecomastia (enlargement of the breast with hypertrophy of glands and adipose tissue);
• insufficiency of adrenal function;
• violation of the menstrual cycle;
• possibly a temporary decrease in testosterone in the blood plasma (normalized 24 hours after admission);
• photophobia (photophobia);
• hives;
• anaphylactic shock; anaphylactic reactions;
• angioedema (edema of Quincke);
• pseudo-anaphylactic shock;
• erectile disfunction;
• azoospermia (a pathological condition in which spermatozoa are absent in the ejaculate) at doses exceeding therapeutic;
• a decrease in the number of platelets in the blood;
• fever, chills;
• peripheral edema.

Contraindications

• acute and chronic liver disease;
• pregnancy;
• lactation (breastfeeding);
• children under 3 years;
• hypersensitivity to ketoconazole.

Contraindicated simultaneous reception of Oronazole with the following drugs:

• analgesics (levacetylmethadol, methadone);
• antiarrhythmics (disopyramide, dofetilide, dronedarone, quinidine);
• anthelmintic and antiprotozoal drugs (halofantrine);
• antihistamine drugs (astemizole, misolastine, terfenadine);
• preparations for the treatment of migraine (dihydroergotamine, ergometrine, ergotamine, methylergometrin);
• antitumor drugs (irinotecan);
• antipsychotic drugs, anxiolytics and hypnotics (lurasidone, midazolam orally, pimozide, sertindole, triazolam);
• calcium channel blockers (bepiride, felodipine, lercanidipine, nisoldipine);
• cardiovascular drugs of different groups (ivabradine, ranolazine);
• diuretics (eplerenone);
• immunosuppressants (everolimus);
• gastrointestinal drugs (cisapride, domperidone);
• lipid-lowering drugs (lovastatin, simvastatin);
• colchicine (in the treatment of patients with impaired liver and kidney function).

Application in pregnancy and lactation

Oronazole is contraindicated in pregnancy and lactation (breastfeeding).

Use in children

Contraindicated in children under 3 years of age and children weighing less than 15 kg.

special instructions

The use of fungal meningitis is not advisable, since ketoconazole poorly penetrates the blood-brain barrier (GEB).

Because of the risk of hepatotoxicity, ketoconazole should be used only in cases where the potential benefit exceeds the possible risk.

In patients with increased hepatic enzyme activity or with transferred toxic liver damage due to the use of other drugs, do not use Oronazole, unless the expected benefit justifies the risk of liver damage.

Before the beginning of treatment it is necessary to evaluate the function of the liver in order to avoid acute or chronic diseases. During treatment, it is necessary to regularly monitor the picture of peripheral blood, the functional state of the liver and kidneys in patients in order not to miss the first symptoms of hepatotoxicity. It is impossible to exclude the development of hepatotoxicity during the first month, and even during the first week of therapy.The total dose of ketoconazole is a risk factor for severe hepatotoxicity. Therefore, during the treatment period it is recommended to regularly monitor liver function in patients receiving ketoconazole therapy.

In patients with adrenal insufficiency or borderline conditions against a background of stressful effects (including after extensive surgical interventions or in intensive care settings), patients with a prolonged course of therapy should be monitored for adrenal insufficiency if an adrenal insufficiency is suspected.

If glucocorticosteroids (SCS) were used to treat skin diseases, then ketoconazole is prescribed no earlier than 2 weeks after their withdrawal.

The use of acidic drinks increases the absorption of ketoconazole.

Drug Interactions

With simultaneous use of ketoconazole with antacid agents (aluminum hydroxide), histamine H2 receptor blockers, proton pump inhibitors, absorption of ketoconazole from the digestive tract decreases. With these combinations, the antifungal activity of ketoconazole should be monitored and, if necessary, corrected for its dose.

With the simultaneous use of ketoconazole with powerful inducers of the CYP3A4 isoenzyme, a decrease in the bioavailability of ketoconazole is possible, which may cause a significant decrease in its effectiveness. These drugs include isoniazid, rifabutin, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine. If these combinations can not be avoided, then the antifungal activity of ketoconazole should be monitored and, if necessary, increased its dose.

With the simultaneous use of ketoconazole with potent inhibitors of the CYP3A4 isoenzyme (eg, antiviral drugs, including ritonavir, ritonavir-boosted darunavir, and ritonavir-boosted fosamprenavir), the bioavailability of ketoconazole may be increased. With these combinations, the patient should be monitored for symptoms of increased intensity and duration of action of ketoconazole, ketoconazole concentration in the blood plasma and, if necessary, reduce its dose.

With simultaneous use, ketoconazole is able to inhibit CYP3A4-mediated drug metabolism, as well as transport of active substances due to P-glycoprotein.This can lead to an increase in the concentrations of these drugs in plasma and / or from active metabolites, which causes an increase in the intensity and duration of the therapeutic or side effects of concomitant medications.

It is not recommended to use the following drugs with ketoconazole simultaneously: tamsulosin, fentanyl, rifabutin, rivaroxaban, carbamazepine, dasatinib, nilotinib, trabectidine, salmeterol. If these combinations can not be avoided, clinical monitoring of the patient's condition should be provided to detect symptoms of an increase in intensity or duration of therapeutic and / or side effects, monitor the concentration of the drug in the blood plasma and, if necessary, reduce the dose of the drug or suspend its use.

Caution should be applied to ketoconazole simultaneously with the following drugs: alfentanil, buprenorphine (intravenously and sublingually), oxycodone, digoxin, coumarins, cilostazol, repaglinide, saxagliptin, praziquantel, ebastin, eletriptan, bortezomib, busulfan,docetaxel, erlotinib, imatinib, Ixabepilone, lapatinib, trimetrexate, vinca alkaloids, alprazolam, aripiprazole, brothisolam, buspirone, haloperidol, midazolam (intravenously), perosporone, quetiapine, ramelteron, risperidone, maraviroc, indinavir, saquinavir, nadolol, verapamil, aliskiren, aprepitant, budesonide, ciclesonide, cyclosporine, dexamethasone, fluticasone, methylprednisolone, sirolimus, tacrolimus, tamsirolimus, atorvastatin, reboxetine, fesoterodine, imidafenacin, sildenafil, solifenacin, tadalphil, tolterodine, alitretinoin for pharmaceuticals form), cinacalcet, mozavaptan, tolvaptan. When combined, careful monitoring of the clinical condition of the patient is recommended, if necessary - monitoring the concentration of the drug in the blood plasma and, if necessary, reducing its dose.

In isolated cases, a disulfiram-like reaction is possible when alcohol is consumed during the administration of ketoconazole.

Analogues of the drug Oronazole

Structural analogs for the active substance:

• Dermazol;
• Ketoconazole;
• Livarol;
• Mikanisal;
• Mycosorrhal;
• Mikoket;
• Nizoral;
• Perch;
• Sebosol;
• Fungavis;
• Fungin.

Analogues of the drug Oronazole by the pharmacological group (antifungal agents):

• Ambiz;
• Amicon;
• Antifungole;
• Atitis;
• Batrafen;
• Binafin;
• Bifosin;
• Vfend;
• VORICOSE;
• Gynofort;
• Griseofulvin;
• Dactanol;
• Diflason;
• Diflucan;
• Zalain;
• Imidil;
• Itraconazole;
• Iphenec;
• Kandibene;
• Candide;
• Ketoconazole;
• Clotrimazole;
• Lamisyl;
• Levorin;
• Livarol;
• Lomexin;
• Loceril;
• Mikonil;
• Mikogal;
• Mikoderil;
• Mycosorrhal;
• Mycospores;
• Nizoral;
• Nystatin;
• Nitrofungin;
• Noxafil;
• Onihon;
• Orunite;
• Pimafucin;
• Procanazole;
• Rumikoz;
• Sebosol;
• Sertamicol;
• Tebicur;
• Terbiks;
• Terbinafine;
• Flucosan;
• Flukoside;
• Flukoreem;
• Flucostat;
• Fongial;
• Fungoterbine;
• Cidokan;
• Cyclopolis;
• Ciscan;
• Ekalin;
• Exeter;
• Exifin;
• Exoderyl;
• Exorolphinolac;
• Exostat;
• Ecodax;
• Ecofuqin;
• Eraksis.

A doctor's opinion of a dermatologist

It is never easy to treat systemic fungal infections. Patient requires patience and accurate performance of medical appointments. That and good drug Oronazol, that the entire daily dose of it is taken at a time. Therefore, it rarely happens that the patient misses the medication.Based on my experience, I can say that can respond well to Oranazole coccidiomycosis and blastomycosis. But not all patients easily tolerate therapy with this drug. Often they complain of abdominal pain, stool disorders, insomnia, general weakness. There were no serious side effects during treatment with Oranazole in my practice. And all the patients brought the treatment to an end.

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