Sebozol - instructions for use, analogs, reviews and release forms (shampoo, ointment or cream) of the drug for the treatment of seborrhea or dandruff of the scalp, fungus, multicolored lichen in adults, children and pregnancy. Composition and alcohol

In this article, you can read the instructions for using the drug Sebosol. The reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Sebozol in their practice are presented. 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 Sebozol in the presence of existing structural analogues.Use to treat seborrhea or dandruff scalp, fungus, colorful lichen in adults, children, as well as during pregnancy and lactation. Composition and interaction of the drug with alcohol.

Sebosol 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. It is active against the pathogen of multi-colored lichen Malassezia furfur, the causative agents of some dermatomycoses (Trichophyton, Epidermophyton floccosum, Microsporum), pathogens of candidiasis or thrush (Candida), as well as pathogens 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 a decreased acidity of gastric juice, for example, taking antacid preparations such as aluminum hydroxide, and antisecretory drugs,such as histamine H2 receptor blockers and proton pump inhibitors, 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, ketoconazole 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

For external use:

• treatment and prevention of fungal skin lesions of the scalp;
• smooth skin dermatomycosis;
• inguinal epidermophytia;
• epidermophytosis of hands and feet;
• candidiasis of the skin.

For topical application:

• treatment of acute and chronic recurrent vaginal candidiasis;
• prevention of fungal infections of the vagina with reduced resistance of the body and against treatment with antibacterial agents and other drugs that disrupt the normal microflora of the vagina.

Forms of release

Shampoo.

Ointment for external use (sometimes mistakenly called cream or gel).

Instructions for use and how to use them

For external and local administration, the dosing regimen depends on the indications and the dosage form used.

Shampoo

On the affected areas apply Sebozol shampoo for 3-5 minutes, then rinse with water.

Ointment

Candidiasis of the skin, smooth skin ringworm, jock itch, athlete's foot and toes, pityriasis versicolor: it is recommended to apply Sebozol ointment 1 time per day to the affected skin and immediately adjacent areas.

Seborrheic dermatitis: Sebozole ointment 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 ointment applied 1 or 2 times a week.

Side effect

• headache;
• dizziness;
• paresthesia;
• drowsiness;
• increased excitability;
• insomnia;
• anxiety;
• fatigue;
• 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;
• dyspepsia;
• dry mouth;
• dysgeusia;
• bloating;
• changing the color of the language;
• jaundice;
• cirrhosis of the liver;
• hepatic insufficiency (including cases of transplantation and death);
• alcohol intolerance;
• anorexia;
• hyperlipidemia;
• increased appetite;
• myalgia;
• arthralgia;
• nose bleed;
• alopecia;
• dermatitis;
• erythema;
• erythema multiforme;
• itching;
• rash;
• xeroderma;
• flushes of blood;
• acute generalized exanthematous pustulosis;
• photosensitization;
• orthostatic hypotension;
• gynecomastia;
• insufficiency of adrenal function;
• violation of the menstrual cycle;
• possibly a temporary decrease in the concentration of testosterone in the blood plasma (normalized 24 hours after admission);
• photophobia;
• rash;
• hives;
• anaphylactic shock;
• anaphylactic reactions;
• angioedema;
• pseudo-anaphylactic shock;
• erectile disfunction;
• azoospermia (at doses exceeding therapeutic - 200-400 mg per day);
• a decrease in the number of thrombocytopenia;
• fever;
• peripheral edema;
• chills.

Contraindications

• acute and chronic liver disease;
• pregnancy, lactation;
• children under 3 years;
• hypersensitivity to ketoconazole;
• simultaneous administration with the following substrates of the isoenzyme CYP3A4 (an increase in the concentration of these drugs in plasma caused by a joint intake with ketoconazole may lead to an increase or prolongation of both the therapeutic and side effects and the development of potentially dangerous effects, including the prolongation of the QT interval and development of ventricular arrhythmia such as "pirouette"): analgesics (levacetylmetadol, methadone); antiarrhythmics (disopyramide, dofetilide, dronedarone, quinidine); anthelmintic and antiprotozoal drugs (halofantrine); antihistamines (astemizole, misolastine,terfenadine); preparations for the treatment of migraine (dihydroergotamine, ergometrine, ergotamine, methylergometrine); antitumor drugs (irinotecan); antipsychotic drugs, anxiolytics and hypnotics (lurasidone, midazolam orally, pimozide, sertindole, triazolam); calcium channel blockers (beprideal, felodipine, lercanidipine, nisoldipine); cardiovascular drugs of different groups (ivabradine, ranolazine); diuretics (eplerenone); immunosuppressants (everolimus); gastrointestinal drugs (cisapride, domperidone); lipid-lowering drugs (lovastatin, simvastatin); Other (colchicine in the treatment of patients with impaired liver and kidney function).

Application in pregnancy and lactation

Sebozol is contraindicated in pregnancy and lactation (breastfeeding).

Use in children

Contraindicated in children under 3 years.

special instructions

Use in fungal meningitis is impractical, because Ketoconazole poorly penetrates the blood-brain barrier (GEB).

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

Patients with elevated liver enzymes or migrated toxic liver injury due to administration of other drugs should not use ketoconazole, except in those cases where the expected benefits justify 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.

Patients with adrenal insufficiency or borderline states against the background of stress (including extensive surgery, intensive care) in patients with a prolonged course of therapy with suspected adrenal insufficiency should be monitored adrenal function, asin volunteers, ketoconazole at a daily dose of 400 mg or more caused a decrease in the "cortisol response" to stimulation of ACTH.

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

The use of acidic drinks increases the absorption of ketoconazole.

Drug Interactions

With the simultaneous use of sebozol with antacids (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 (for example, antiviral drugs, including ritonavir, ritonavir-boosted darunavir, and ritonavir-boosted fosamprenavir), an increase in the bioavailability of ketoconazole is possible. 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 sebosol 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 is advisable to use 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, brotisolam, 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 (oral dosage form), zincalcet, 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 Sebozol.

Analogues of the drug Sebosol

Structural analogs for the active substance:

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

Analogues for the pharmacological group (antifungal agents):

• Ambiz;
• Ampholip;
• Amphotericin B;
• Batrafen;
• Bifonazole;
• Bifosin;
• Butoconazole nitrate;
• Vagiphereon;
• Vfend;
• VORICOSE;
• Voriconazole;
• Gainomax;
• Ginezole 7;
• Griseofulvin;
• Dermazol;
• Diflucan;
• Zalain;
• Irunin;
• Itraconazole;
• Candide;
• Canison;
• Keto plus;
• Clindacine B prolong;
• Clion D 100;
• Clotrimazole;
• Lamisyl;
• Lamizil Dermgel;
• Levorin;
• Loceril;
• Metronikon Neo;
• Mikoderil;
• Mikozolone;
• Miconazole;
• Myconorm;
• Mycosyst;
• Mycospores;
• Natamycin;
• Neo Penotran;
• Neo Piotrand Forte;
• Nizoral;
• Nystatin;
• Nitrofungin;
• Onihon;
• Orungal;
• Orunite;
• Offlomil Luck;
• Pimafucin;
• Rumikoz;
• Sertaconazole;
• Terbisyl;
• Terbinafine;
• Fluconazole;
• Flucostat;
• Fukortsin;
• Fungoterbine;
• Ciscan;
• Exifin;
• Exoderyl;
• Ecofuqin;
• Eraksis.

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