Itraconazole capsules

1. Pharmacotherapeutic classification: J02AC02 (systemic antifungal drugs, triazole derivatives). Itraconazole is a triazole derivative with broad-spectrum antifungal activity. 2. In vitro tests have shown that itraconazole can inhibit the growth of a variety of human pathogenic fungi within the conventional concentration range (≤0.025μg/ml to 0.8μg/ml), including: dermatophytes (Trichophyton, Microsporum, Epidermophyton floccosum), yeasts (Candida including Candida albicans, Candida glabrata and Candida krusei; Cryptococcus neoformans; Malassezia; Trichosporon; Geotrichum), Aspergillus, Histoplasma, Paracoccidioides brasiliensis, Sporothrix schenckii, Chromosporium, Cladosporium, Blastomyces dermatitidis, Pseudomonas boydii, Penicillium marneffei and many other yeasts and fungi. Candida krusei, Candida glabrata and Candida tropicalis are usually the least sensitive Candida strains. In in vitro tests, individual tests showed that it had obvious resistance to itraconazole. The main fungi that were not inhibited by itraconazole were Zygomycetes (Rhizopus, Rhizomucor, Mucor and Absidia), Fusarium, Scedosporium and Scopulariopsis. 3. The results of in vitro tests showed that itraconazole could disrupt the synthesis of ergosterol in the fungal cell membrane. Ergosterol is an important component of the fungal cell membrane, and interfering with its synthesis will ultimately produce an antifungal effect.

Itraconazole.

This product is a powder, blue capsule, the contents are white pill-like particles.

1. Gynecology: vulvovaginal candidiasis. 2. Dermatology/Ophthalmology: (1) Tinea versicolor, dermatophytes, fungal keratitis and oral candidiasis. (2) Onychomycosis caused by dermatophytes and/or yeasts. 3. Systemic fungal infections: systemic aspergillosis and candidiasis, cryptococcosis (including cryptococcal meningitis), histoplasmosis, sporotrichosis, paracoccidioidomycosis, blastomycosis and various other rare systemic or tropical fungal diseases. Note: For immunocompromised patients with cryptococcosis and all patients with central nervous system cryptococcosis, this product can only be used for treatment when first-line drugs are not applicable or ineffective.

For optimal absorption, itraconazole capsules should be administered immediately after meals and the capsules must be swallowed whole. 1. Candidal vaginitis: 200 mg each time, twice a day, for a course of 1 day or 200 mg each time, once a day, for a course of 3 days; 2. Tinea versicolor: 200 mg each time, once a day, for a course of 7 days; 3. Dermatophyte disease: 100 mg each time, once a day, for a course of 15 days; Highly keratinized areas (such as sole tinea, palm tinea) require: Extended treatment for 15 days, 100 mg each time, once a day, for a program of 15 days; 4. Oral candidiasis: 100 mg each time, once a day, for a course of 15 days; 5. Fungal keratitis: 200 mg each time, once a day, for a course of 21 days; (Keratitis is divided into ulcerative keratitis, also known as corneal ulcer There are two types of ulcers: ulcers and non-ulcerative keratitis, i.e. deep keratitis. They are caused by different factors, internal and external. Inflammation caused by corneal trauma, bacteria and viruses invading the cornea. The affected eye has a foreign body sensation, stinging or even burning sensation. Mixed congestion on the surface of the bulbar conjunctiva, accompanied by symptoms such as photophobia, tearing, visual impairment and increased secretions. The surface of the cornea is infiltrated with ulcers. Ulcerative keratitis, also known as corneal ulcer, is mostly caused by exogenous factors, that is, inflammation caused by infectious pathogens invading the corneal epithelial cell layer from the outside. )6. For some immunodeficient patients, such as leukemia, AIDS or organ transplant patients, when using itraconazole capsules to treat fungal infections, the oral bioavailability of itraconazole may be reduced, and the dose can be doubled. 7. Onychomycosis: 1) Shock treatment: 200 mg each time, twice a day, for one week as a shock course. For nail infection, two shock courses are recommended, with a 3-week interval between each course; for toenail infection, three shock courses are recommended. Each course of treatment is separated by 3 weeks. 2) Alternatively, continuous treatment is used: 200 mg each time, once a day, for three consecutive months. This product is cleared from the skin and nail tissue more slowly than plasma. Therefore, for skin infections, the best clinical and mycological efficacy is achieved 2-4 weeks after discontinuation of the drug, and for onychomycosis, the best clinical and mycological efficacy is achieved 6-9 months after discontinuation of the drug.

1. Common gastrointestinal discomfort, such as anorexia, nausea, abdominal pain and constipation. 2. Less common side effects include headache, elevated reversible aminotransferase, menstrual disorders, dizziness and allergic reactions (such as itching, erythema, wheals and angioedema). 3. There have been case reports of Stevens-Johnson syndrome (severe erythema multiforme). Most patients with underlying pathological changes who are receiving multiple drug treatments at the same time may experience symptoms such as hypokalemia, edema, hepatitis and alopecia when receiving long-term itraconazole treatment. There have been case reports of peripheral neuropathy, but it is not certain whether it is related to the use of itraconazole.

1. It is contraindicated for patients who are known to be allergic to any of the ingredients of this product. 2. It is contraindicated to be used in combination with the following drugs: 2.1 CYP3A4 metabolites that can cause QT interval prolongation, such as astemizole, bepridil, cisapride, dofetilide, levomethadone, mizolastine, pimozide, quinidine, sertindole, and terfenadine. When the above drugs are used in combination with this product, the plasma concentration of these substrates may increase, leading to QT interval prolongation and the rare occurrence of torsade de pointes. 2.2 HMG-CoA reductase inhibitors metabolized by CYP3A4, such as lovastatin or simvastatin. 2.3 Triazolam and oral midazolam. 2.4 Ergot alkaloids, such as dihydroergotamine, ergonovine, ergotamine, and methylergonovine. 2.5 Nisoldipine. 3. Except for the treatment of life-threatening or serious infections, it is contraindicated in patients with ventricular dysfunction who have or have had a history of congestive heart failure (CHF). 4. Except for life-threatening cases, it is contraindicated in pregnant women. 5. When women of childbearing age use this product, they should take appropriate contraceptive measures until the next menstrual cycle after discontinuation of the drug.

Precautions for children: There are limited clinical data on the use of this product in children. It can only be used in children when the benefits outweigh the risks. Or follow the doctor's advice. Precautions for pregnancy and lactation: 1. For pregnant women, this product can only be used when the disease is life-threatening and the potential benefits outweigh the potential harm to the fetus. Women of childbearing age who use this product should take appropriate contraceptive measures until the next menstrual cycle after the end of treatment. 2. Animal studies have shown that itraconazole is reproductively toxic. 3. There are limited data on the use of this product by pregnant women. According to post-marketing experience, there are case reports of congenital malformations, including skeletal, urogenital, cardiovascular and ocular malformations, as well as chromosomal abnormalities and multiple malformations. The relevance of these cases to this product has not been established. 4. According to epidemiological data on the use of itraconazole within three months of pregnancy (mostly for short-term treatment of vulvovaginal candidiasis), this product has not shown to increase teratogenicity compared with the control group that did not use any known teratogens. 5. Only a small amount of itraconazole is secreted into breast milk. Therefore, breastfeeding women should weigh the pros and cons when using this product. Only when the potential benefits outweigh the possible harm to breastfeeding can itraconazole be used. If in doubt, the patient should stop breastfeeding. Elderly precautions: There is limited clinical data on the use of this product in the elderly. Therefore, it can only be used in elderly patients when the benefits outweigh the risks. Or follow the doctor's advice.

1. Enzyme-inducing drugs: such as rifampicin and phenytoin can significantly reduce the oral bioavailability of this product. Therefore, the plasma concentration of this product should be monitored when taken together with enzyme-inducing drugs. 2. In vitro studies have shown that there is no interaction between this product and imipramine, propranolol, diazepam, cimetidine, indomethacin, tolbutrin and sulfadimethoxine in terms of plasma protein binding. 3. It has been reported that when this product is used in excess of the recommended dose, it interacts with cyclosporine A, astemizole and terfenadine. If these drugs are taken with this product, the dose should be reduced. 4. It has been reported that this product interacts with warfarin and digoxin. Therefore, if these drugs are taken with this product, the dose should be reduced. 5. No interaction between this product and AZT (zidovudine) has been observed. 6. The induction effect of this product on the metabolism of ethinyl estradiol and norethindrone has not been observed.

Sealed, store in a cool, dry place.

0.1g/tablet

24 months

Xian Janssen Pharmaceutical Ltd.

• Founded in:

  1985-10-22

• Address:

  No. 19, Caotang 4th Road, Caotang Science and Technology Industrial Base, High-tech Zone, Xi'an, Shaanxi Province, 17F, Huicheng International, No. 4, Gaoxin 5th Road, High-tech Zone, Xi'an, Shaanxi Province

• Tax NO.:

  91610000623100825C

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  284.317164 yuan

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