Ketoconazole

1. Pharmacology: This product belongs to the azole antifungal drug, which has antibacterial effects on deep infection fungi such as Candida, Chromatiaceae, Coccidioides, Histoplasma, Sporothrix, etc., and also has antibacterial activity against Trichophyton, etc. This product has poor effects on Aspergillus, Sporothrix schenckii, certain dark spores, Mucor, etc. This product inhibits the biosynthesis of ergosterol, the main steroid in the fungal cell membrane, by interfering with the activity of cytochrome P-450, damaging the fungal cell membrane and changing its permeability, resulting in the leakage of important intracellular substances. This product can inhibit the biosynthesis of triglycerides and phospholipids in fungi, inhibit the activity of oxidases and peroxidases, cause the accumulation of hydrogen peroxide in cells, leading to cell submicrostructure degeneration and cell necrosis.

This product is suitable for the treatment of the following systemic fungal infections: 1. Candidiasis, chronic skin and mucosal candidiasis, oral candidiasis, urinary tract candidiasis, chronic and recurrent vaginal candidiasis that is ineffective with local treatment. 2. Dermatitis blastomycosis. 3. Coccidioidomycosis. 4. Histoplasmosis. 5. Chromomycosis. 6. Paracoccidioidomycosis. This product can be used to treat skin fungal infections, tinea versicolor and tinea caused by skin fungi and yeasts, when local treatment or oral griseofulvin is ineffective, or when it is difficult to accept griseofulvin treatment for severe and stubborn skin fungal infections.

Oral administration: Adults: 0.2-0.4 g per day, taken at once or divided into 2 doses. Children over 2 years old: 3.3-6.6 mg/kg per day, taken at once or divided into 2 doses.

1. Hepatotoxicity: This product can cause an increase in serum aminotransferase, which is reversible. Severe hepatotoxicity occasionally occurs, mainly hepatocellular type, with an incidence of about 0.01%. Clinical manifestations include jaundice, dark urine, abnormal fatigue, etc., which usually recover after discontinuation of the drug, but there are also reports of deaths, and hepatitis-like cases have also occurred in children. 2. Gastrointestinal reactions, such as nausea, vomiting, poor appetite, etc.; 3. Male breast development and lack of semen, which is related to the inhibition of testosterone and adrenal cortex hormone synthesis by this product. 4. Other adverse reactions include rash, dizziness, drowsiness, photophobia, etc.

It is contraindicated for patients who are allergic to this product or those with acute or chronic liver disease.

Precautions for children: There is a lack of systematic research data on the use of this product in children, and there is a lack of data on the use of infants under 2 years old. Therefore, this product should not be used in children under 2 years old. It is also not suitable for children over 2 years old. If there is an indication for its use, it is necessary to weigh the pros and cons before deciding whether to use it. Precautions for pregnancy and lactation: This product can pass through the blood-placental barrier. Animal experiments have shown that this product can cause teratogenesis, such as syndactyly, oligodactyly, and dystocia in rats. Data from the US FDA shows that the use of this drug in pregnant women is Class C, which means that it is toxic in animal experimental studies and there is a lack of sufficient data on human studies. Therefore, pregnant women should avoid using it. This product can be secreted into breast milk. There has been no confirmed problem with the use of this product in humans, but this product can increase the possibility of kernicterus in newborns. When there is an indication for its use in lactating women, they should weigh the pros and cons before deciding whether to use it. Precautions for the elderly:

1. When alcohol and hepatotoxic drugs are used together with this product, the chance of hepatotoxicity increases. 2. The simultaneous use of this product with anticoagulants such as warfarin, coumarin, and indandione derivatives can enhance their effects, leading to a prolonged prothrombin time. Patients should be closely observed, prothrombin time should be monitored, and the dose of anticoagulants should be adjusted. 3. The simultaneous use of cyclosporine and this product will increase the blood concentration of the former and may increase the risk of nephrotoxicity. When the two drugs are used at the same time, the blood concentration of cyclosporine should be monitored. 4. The simultaneous use of antacids, anticholinergics, antispasmodics, histamine H2 receptor blockers, omeprazole, sucralfate, etc. can significantly reduce the absorption of this product. Therefore, such drugs should be used 2 hours after taking this product.

Keep away from light and store in sealed container.

Di'ao Group Chengdu Pharmaceutical Co., Ltd.

• Founded in:

  1997-07-31

• Address:

  No. 518, Herui Road, Chengdu Hi-tech Zone

• Tax NO.:

  91510100201913965Q

• Registered Funds:

  71.01 million yuan

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