Itraconazole Hydrochloride Capsules

This product is a synthetic triazole derivative with a broad-spectrum antifungal effect. It can inhibit the synthesis of ergosterol in fungal cell membranes, thereby exerting an antifungal effect. This product has an inhibitory effect on 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 yeasts and fungi.

Itraconazole hydrochloride

This product is a capsule preparation

Itraconazole is indicated for the treatment of the following diseases: systemic aspergillosis and candidiasis, cryptococcosis (including cryptococcal meningitis), histoplasmosis, sporotrichosis, Brazilian paracoccidioidomycosis, blastomycosis, and various other rare systemic or tropical fungal diseases.

Oral: For optimal absorption, itraconazole should be administered immediately after a meal and the capsules must be swallowed whole. Indications Dosage Course Remarks Candidal vaginitis 200 mg twice a day for 1 day or 200 mg once a day for 3 days Tinea versicolor 200 mg once a day for 7 days Dermatophytosis 100 mg once a day 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 a day. Oral candidiasis 100 mg once a day for 15 days The oral bioavailability of itraconazole may be reduced in some immunocompromised patients such as leukemia, AIDS or organ transplant patients, so the dose may be doubled. Fungal keratitis 200 mg once a day for 21 days Onychomycosis 200 mg once a day for 3 months This product is cleared from the skin and nail tissue

Gastrointestinal discomfort is common, such as anorexia, nausea, abdominal pain and constipation. Less common side effects include headache, elevated reversible aminotransferase, menstrual disorders, dizziness and severe 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 may experience 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.

1. Those who are allergic to this product are prohibited from using it. 2. Pregnant women are prohibited from using it. Unless it is used to treat systemic fungal diseases, the potential harm to the fetus should still be considered.

Precautions for children: Since the clinical data of itraconazole for children are limited, it is recommended not to use itraconazole in children unless the potential benefits outweigh the possible harm. Precautions for pregnancy and lactation: It is contraindicated for pregnant women. Unless it is used for systemic fungal treatment, the potential harm to the fetus should still be weighed. It is not beneficial for breastfeeding women. Precautions for the elderly: It is not clear yet.

1. Enzyme-inducing drugs: such as rifampicin and phenytoin can significantly reduce the oral bioavailability of this product, so 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. Itraconazole can inhibit drug metabolism catalyzed by cytochrome 3A enzyme, resulting in increased and/or prolonged drug effects including side effects. Therefore: ① During the treatment with itraconazole capsules, terfenadine, astemizole, cisapride, oral midazolam and triazolam should not be taken. If midazolam is injected intravenously, it should be used with extra caution because its sedative effect will be prolonged; ② If oral anticoagulants, digoxin, cyclosporine A, systemic methylprednisolone, vinca alkaloids and tacrolimus need to be taken simultaneously with itraconazole, the dose of these drugs should be reduced; ③ Patients taking dihydropyridine calcium channel blockers and quinidine should be monitored for side effects such as edema and tinnitus/hearing loss. The dose of these drugs can be reduced if necessary; ④ There are rare reports of rhabdomyolysis in transplant patients who receive itraconazole capsules, cyclosporine and hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors such as simvastatin at the same time, but the causal relationship between itraconazole and rhabdomyolysis has not been established. 4. This product has been reported to interact with warfarin and digoxin. Therefore, if these drugs are taken together with this product, the dose should be reduced. 5. The interaction between this product and AZT (zidovudine) has not 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 (calculated as C35H38Cl2N8O4)

24 months

Shanghai Modern Hasen (Shangqiu) Pharmaceutical Co., Ltd.

• Founded in:

  1999-11-12

• Address:

  No. 166, North side of Xinxing Road, west side of Zhenxing Road, Liangyuan District, Shangqiu City

• Tax NO.:

  91411400716735619N

• Registered Funds:

  83.29 million yuan

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