Infections smooth skin, scalp, nails, caused by dermatophytes and / or yeast-like fungi (tinea, onychomycosis, paronychia, caused by fungi of the genus Candida, pityriasis versicolor, dandruff, folliculitis caused by fungi of the genus of Pityrosporum, chronic candidiasis skin and mucous membranes) in the when you can masteron enanthate not use the topical treatment of large lesions, significant depth skin lesions, as well as the absence of effect of local treatment carried out previously;
Infections of the gastrointestinal tract caused by yeast fungi.
Chronic recurrent vaginal candidiasis in the absence of the effect of topical therapy.
Systemic fungal infections, such as systemic candidiasis, paracoccidioidomycosis, histoplasmosis, coccidioidomycosis, blastomycosis).
Prophylactic use in patients with a decrease in the body’s defenses (congenital or caused by disease or the influence of drugs).
Acute and chronic liver disease, kidney disease, hypersensitivity to the drug. Precautions – Pregnancy, lactation, age over 50 years, failure of the adrenal cortex and pituitary.
Use during pregnancy and lactation
Studies on the use of ketoconazole in pregnant women are not available, why use the drug during pregnancy is not recommended, except for those cases where the potential benefit of treatment may justify the potential risk to the fetus. Ketoconazole passes into breast milk, breast-feeding while taking the drug is not recommended.
Dosage and administration
of ketoconazole should be taken orally with meals. Treatment of adults and children weighing more than 30 kg:
fungal skin lesions, masteron enanthate gastrointestinal and systemic mycoses:it is recommended to take 1 tablet (200 mg) of ketoconazole per day during meals. If adequate response is observed at this dose, the dose can be increased to two tablets (400mg) once a day.
- Vaginal candidiasis:
2 tablets (400 mg) once a day with meals, for 5 days.
Children with weight og body 15 to 30 kg tablets (100 mg) daily
treatment according to the scheme should be performed at least one week after disappearance of all symptoms as long as no negative microbiological studies are received. Prophylactic immunocompromised patients adults – 2 tablets (400 mg) per day, children – 4.8 mg / kg of body weight per day, but not more than 400 mg. The average duration of treatment is:
- vaginal candidiasis – 5 days;
- cutaneous mycoses caused by dermatophytes – about 4 weeks;
- pityriasis versicolor – 10 days;
- candidiasis of skin and oral cavity – 2-3 weeks;
- fungal scalp – 1 to 2 months;
- fungal nail infections – 6-12 months;
- systemic candidiasis – 1 to 2 months;
- paracoccidioidomycosis, histoplasmosis, coccidioidomycosis, the optimal duration of treatment – 3-6 months.
The most common side effects associated with taking ketoconazole are dysfunction of the gastrointestinal tract, such as dyspepsia, nausea, abdominal pain, diarrhea. Less common – headache, insomnia, arthralgia, fever, reversible increase in the activity of “liver” enzymes, hepatotoxicity, menstrual disorders, dizziness, photophobia, paresthesia, hypercreatininemia, allergic reaction (hives, skin rash, fever), arthralgia, rash. Very rarely – thrombocytopenia, alopecia, impotency and reversible elevation of intracranial pressure (eg, swelling of the optic disc, bulging fontanelle in children), a temporary reduction in the level of testosterone in the blood plasma, reversible gynaecomastia and oligospermia, decreased libido.
supportive measures are recommended in overdose. During the first hour after ingestion, it can be caused by vomiting, gastric lavage performed and appointed activated carbon. Careful monitoring of the patient and symptomatic treatment. There is no specific antidote.
Interactions with other drugs
Drugs affecting the metabolism of ketoconazole:
- rifampicin, rifabutin, carbamazepine, isoniazid and phenytoin significantly reduce the bioavailability of ketoconazole;
- drugs affecting gastric acidity;
- Ritonavir increases the bioavailability of ketoconazole, as a result of this by sharing a need to reduce the dose of ketoconazole.
Ketoconazole may enhance or prolong the action of drugs metabolized by cytochrome P 450, especially from CYP3A group.
Examples of such drugs are:
- Drugs that should not be prescribed during treatment Ketoconazole th: terfenadine, astemizole, cisapride, triazolam, oral midazolam form, quinidine, pimozide, cleaving enzymes of CYP3A4, inhibitors of HMG-CoA reductase such as simvastatin and lovastatin.
- Formulations in which assignment must monitor their levels in plasma, by the action, side effects. Their dosage when co-administered with ketoconazole should be reduced if necessary.
- Oral anticoagulants.
- HIV protease inhibitors such as indinavir, saquinavir.
- Some anti-cancer drugs such as vinca alkaloids, docetaxel.
- CYP3A4 enzyme cleavable calcium channel blockers (including verapamil).
- Certain immunosuppressive agents: cyclosporine.
- Other drugs: digoxin, carbamazepine, buspirone, sildenafil, alprazolam, midazolam, rifabutin, methylprednisolone.
In exceptional cases, the reported occurrence of a disulfiram-like reaction to alcohol, characterized by redness, rash, peripheral edema, nausea and headache. All the symptoms disappear completely within a few hours.
Low acidity: Absorption at this state of the preparation deteriorates. Patients taking antacids such as aluminum hydroxide, you should take them no earlier than 2 hours after administration of ketoconazole.Patients with achlorhydria and patients taking drugs that suppress the secretion of hydrochloric acid in the stomach (eg H2 – histamine receptor inhibitors or “proton pump”), it is desirable to take ketoconazole with acidic drinks.
Ketoconazole attenuates the effect of amphotericin B.
Reduces the stimulating effect on the adrenal corticotropin. It increases the risk of bleeding masteron enanthate “breakthrough” in patients receiving oral contraceptives with a low content of hormones. Increases toxicity of phenytoin.
In some cases, there is a slight, transient asymptomatic increase in activity of “liver” transaminases and alkaline phosphatase. This reaction is not dangerous and does not require discontinuation of treatment, however, such patients should be under special supervision. If the duration of the treatment of ketoconazole than 2 weeks, you need to monitor liver function: before treatment, after two weeks and then monthly. In case of liver dysfunction, treatment should be discontinued.