Itraconazole capsules

This product is a synthetic broad-spectrum antifungal drug, a triazole derivative, which is effective against dermatophytes (Trichophyton, Microsporum, Epidermophyton floccosum), yeasts [Cryptococcus neoformans, Pityrosporum, Candida (including Candida albicans, Candida glabrata and Candida krusei)], Aspergillus, Histoplasma, Paracoccidioides brasiliensis, Sporothrix schenckii, Chromatids, Cladosporium, Blastomyces dermatitidis and various other yeast and fungal infections. In vitro studies have confirmed that this product can inhibit the synthesis of ergosterol, one of the main components of fungal cell membranes, thereby exerting an antifungal effect.

The main ingredient of this product is itraconazole, its chemical name: cis-4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazolyl-1-methyl)-1,3-dioxolane-4-]-methoxy]phenyl]-1-piperazinyl]-phenyl]-2,4-dihydro-2-(-1-methylpropyl)-3H-1,2,4-triazol-3-one

This product is a capsule, and the contents are white or light yellow pill-like particles.

1. Gynecology: vulvovaginal candidiasis. 2. Dermatology/ophthalmology: tinea versicolor, dermatophytes, fungal keratitis and oral candidiasis. 3. Onychomycosis caused by dermatophytes and/or yeasts. 4. Systemic fungal infections: systemic aspergillosis and candidiasis, cryptococcosis (including cryptococcal meningitis), histoplasmosis, sporotrichosis, paracoccidioidomycosis, blastomycosis and various other rare systemic or tropical fungal diseases.

For optimal absorption, itraconazole should be administered immediately after a meal, and the capsule must be swallowed whole. Candidal vaginitis 200 mg twice daily or 200 mg once daily for 1 day or 3 days Tinea versicolor 200 mg once daily for 7 days Dermatophytosis 100 mg once daily for 15 days Highly keratinized areas, such as tinea on the soles of the feet and tinea on the palms, require extended treatment for 15 days, 100 mg/day. Oral candidiasis 100 mg once daily for 15 days The oral bioavailability of itraconazole may be reduced in some immunodeficient patients such as leukemia, AIDS or organ transplant patients, so the dose may be doubled. Fungal keratitis 200 mg once daily for 21 days Onychomycosis 200 mg once daily for 3 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 to 4 weeks after discontinuation of the drug, and for onychomycosis, the best clinical and mycological efficacy is achieved 6 to 9 months after discontinuation of the drug. Systemic fungal diseases: (different dosages are selected according to different infections) Aspergillosis 200 mg once a day for 2 to 5 months For patients with invasive or disseminated infection, increase the dose to: 200 mg twice a day Candidiasis 100 to 200 mg once a day for 3 weeks to 7 months Non-cryptococcal meningitis 200 mg once a day for 2 months to 1 year Maintenance therapy (for patients with meningitis infection) once a day Cryptococcal meningitis 200 mg twice a day for 2 months to 1 year Histoplasmosis 200 mg once a day or 200 mg twice a day for 8 months Sporotrichosis 100 mg once a day for 3 months Paracoccidioidomycosis 100 mg once a day for 6 months Chromoblastomycosis 100 to 200 mg once a day for 6 months Blastomycosis 100 mg once a day or 200 mg twice a day for 6 months

Gastrointestinal discomfort, such as anorexia, nausea, abdominal pain and constipation, is common among the reported side effects of itraconazole. Other less common side effects include headache, reversible liver enzyme elevation, menstrual disorders, dizziness and allergic reactions (such as itching, erythema, wheal and angioedema). There is a case report of Stevens-Johnson syndrome (severe erythema multiforme). Most patients with underlying pathological changes and receiving multiple drug treatments at the same time can see symptoms such as hypokalemia, edema, hepatitis and alopecia when receiving long-term treatment with itraconazole. There is a case report of peripheral neuropathy, but it is not certain whether it is related to the use of itraconazole.

It is contraindicated for people who are allergic to this product. It is contraindicated for pregnant women (unless it is used to treat systemic fungal diseases, but the pros and cons should still be weighed).

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.

Enzyme-inducing drugs: 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. 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. 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. 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. No interaction between this product and AZT (zidovudine) has been observed. 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

24 months

Tianjin Lisheng Pharmaceutical Co., Ltd.

• Founded in:

  1981-06-17

• Address:

  No. 16, Saida North 1st Road, Xiqing Economic Development Zone, Tianjin

• Tax NO.:

  91120000103069502J

• Registered Funds:

  257.942988 yuan

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