Ketoconazole
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Clinical Pharmacology
Ketoconazole is a synthetic broad-spectrum antifungal agent for topical use.
It has a fungicidal and fungistatic effect on dermatophytes, yeast and yeast-like fungi, dimorphic fungi and eumycetes. Active against staphylococci and streptococci.
Indications
- acute and chronic recurrent vaginal candidiasis;
- prevention of fungal infections of the vagina with low resistance of the body and against the background of treatment with antibacterial agents and other drugs that violate the normal microflora of the vagina.
Composition
Active ingredient: ketoconazole 400 mg
Ketoconazole is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Ketoconazole | Anzhero-Sudzhensky HFZ | Russia | suppositories |
Ketoconazole | Mekofar Kemikal | Vietnam | pills |
Livarol | Nizhpharm | Russia | suppositories |
Mycozoral | Akrikhin | Russia | Other |
Mycozoral | Akrikhin | Russia | pills |
Mycozoral | Akrikhin | Russia | ointment |
Nizoral | Janssen Pharmaceuticals N.V | Belgium | cream |
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Dosage and Administration
Intravaginally. Preliminarily freeing the suppository from the contour packaging, inject it deep into the vagina in a supine position, 1 suppository per day for 3-5 days depending on the course of the disease.
Adverse reactions
From the nervous system and sensory organs: headache, dizziness, drowsiness, paresthesias.
On the part of the digestive tract organs: decreased appetite, nausea, vomiting, diarrhea, abdominal pain, increased levels of hepatic transaminases in the blood, jaundice, hepatitis (high mortality, the risk increases with the use of more than 14 days).
From the urinary system: gynecomastia, decreased libido, impotence, oligospermia, menstrual disorders.
Allergic reactions: urticaria, pruritus.
Other: photophobia, alopecia, arthralgia, fever, thrombocytopenia; local reactions - hyperemia and irritation of the mucous membrane of the vagina, itching of the vagina (suppositories); local skin irritation, burning, rash, contact dermatitis (cream, ointment); irritation, itching and burning of the skin, increased oiliness or dry hair (shampoo)
Contraindications
Hypersensitivity, acute liver disease, pregnancy, breastfeeding.
Drug interactions
With simultaneous use of ketoconazole with rifampicin and isoniazid, there is a decrease in plasma plasma ketoconazole concentration.
With simultaneous use of ketoconazole with cyclosporine, indirect anticoagulants and methylprednisolone may increase their concentrations in the blood plasma.
With simultaneous use of ketoconazole with rifampicin and isoniazid, there is a decrease in plasma plasma ketoconazole concentration.
With simultaneous use of ketoconazole with cyclosporine, indirect anticoagulants and methylprednisolone may increase their concentrations in the blood plasma.
Pregnancy and Lactation
Contraindicated
Special instructions
In oral administration, it is necessary to regularly monitor the picture of peripheral blood, the functional state of the liver and kidneys. If GCS was used for the treatment of skin lesions, then ketoconazole should be prescribed no earlier than 2 weeks later.
Overdosage
Intravaginal overdose unlikely
- Brand name: Ketoconazole
- Active ingredient: Ketoconazole
- Manufacturer: Anzhero-Sudzhensky HFZ
- Country of Origin: Russia
Studies and clinical trials of Ketoconazole (Click to expand)
- Protein-Restricted Diets Plus Keto/Amino Acids - A Valid Therapeutic Approach for Chronic Kidney Disease Patients
- Simultaneous antiandrogen withdrawal and treatment with ketoconazole and hydrocortisone in patients with advanced prostate carcinoma
- Pharmacokinetics and electroencephalographic effects of ketoconazole in the rat
- Electrochemical Behavior and Determination of Ketoconazole from Pharmaceutical Preparations
- The effects of cyclophosphamide, ketoconazole, aclacinomycin-A, methotrexate, and scheduled methotrexate-5-fluorouracil combination chemotherapy on the transplantable R-3327 prostatic adenocarcinoma in the F1 hybrid male rat
- Inhibition of hepatic metastasis from a human pancreatic adenocarcinoma (RWP-2) in the nude mouse by prostacyclin, forskolin, and ketoconazole
- The use of ketoconazole in ectopic adrenocorticotropic hormone syndrome
- Ketoconazole and liarozole in the treatment of advanced prostatic cancer
- Triiodide Ion-Selective Polymeric Membrane Electrode Based on a Ketoconazole-Triiodide Ion Pair
- Antibacterial and Antifungal Agents, XV: Synthesis and Antifungal Activity of Structural Analogues of Bifonazole and Ketoconazole
- Minimal effect of ketoconazole on cyclosporine (SangCyATM) oral absorption and first-pass metabolism in rats: evidence of a significant vehicle effect on SangCyA absorption
- Bioequivalence evaluation of two brands of ketoconazole tablets (Onofin-K® and Nizoral®) in a healthy female Mexican population
- Pharmacokinetic interaction of ketoconazole and itraconazole with ciprofloxacin
- Inhibitory effects of ketoconazole and rifampin on OAT1 and OATP1B1 transport activities: considerations on drug–drug interactions
- A stereospecific high-performance liquid chromatographic assay for the determination of ketoconazole enantiomers in rat plasma
- Identification of 17α, 20α-dihydroxyprogesterone in testicular extracts after incubation with ketoconazole
- ChemInform Abstract: Synthesis of 1,2,4-Triazole and Thiazole Analogues of Ketoconazole.
- ChemInform Abstract: Synthesis of Benzothiophene Analogues of Ketoconazole and Itraconazole.
- Synthesis of Ketoconazole Derivatives.
- Partial Structures of Ketoconazole as Modulators of the Large Conductance Calcium-Activated Potassium Channel (BKCa).
- Enantioselectivity of inhibition of cytochrome P450 3A4 (CYP3A4) by ketoconazole: Testosterone and methadone as substrates
- Determination of the absolute configuration and solution conformation of the antifungal agents ketoconazole, itraconazole, and miconazole with vibrational circular dichroism
- Nonlinear stereoselective pharmacokinetics of ketoconazole in rat after administration of racemate
- Influence of quinidine, cimetidine, and ketoconazole on the enantioselective pharmacokinetics and metabolism of metoprolol in rats
- Study on the Interaction of Ketoconazole with Human and Bovine Serum Albumins by Fluorescence Spectroscopy