Itraconazole oral solution

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, Saccharosporium, 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.

The main ingredient of this product is itraconazole. Its chemical name is 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.

This product is a yellow or light yellow viscous clear liquid with a cherry aroma.

-Treatment of oral and/or esophageal candidiasis in HIV-positive or immunocompromised patients. -Prevention of deep fungal infections in patients with hematological malignancies, bone marrow transplants, and patients with expected neutropenia (i.e., 500 cells/μ1). -For patients with neutropenia accompanied by fever, it can be used as a sequential therapy for empirical treatment with itraconazole injection when systemic fungal disease is suspected.

For optimal absorption, this product should not be taken with food. Do not eat for at least 1 hour after taking the medicine. For oral and/or esophageal candidiasis, this oral solution should be gargled in the mouth for about 20 seconds before swallowing. Do not rinse the mouth with other liquids after swallowing. 1. Treatment of oral and/or esophageal candidiasis: Oral 200 mg (2 measuring cups or 20 ml) daily, divided into 1-2 doses, for 1 week. If the medication is ineffective after 1 week, it should be taken for another week. Treatment of oral and/or esophageal candidiasis resistant to fluconazole, oral 100-200 mg (1-2 measuring cups or 10-20 ml) twice a day, for 2 weeks. If the medication is ineffective after 2 weeks, it should be taken for another 2 weeks. For patients taking 400 mg daily, if the symptoms do not improve significantly, the course of treatment should not exceed 14 days. 2. Prevention of fungal infections: 5 mg/kg daily, divided into 2 doses. In clinical trials, preventive treatment began before cytostatic treatment and one week before transplantation, and treatment continued until the neutrophil count returned to normal (i.e., 1000 cells/mu;l). 3. For patients with neutropenia accompanied by fever, empirical treatment for suspected systemic fungal disease should first be given itraconazole injection for treatment, with a recommended dose of 200 mg each time, twice a day. After 4 doses, change to 200 mg each time, once a day. Use for a total of 14 days. The infusion time for each dose should be more than 1 hour. Then use itraconazole oral solution 200 mg each time (2 measuring cups or 20 ml), every 2 times for treatment until clinically significant neutropenia is eliminated. The safety and effectiveness of empirical treatment for patients with fever suspected of systemic fungal disease for more than 28 days has not yet been determined.

Common gastrointestinal discomfort, such as acid vomiting, anorexia, nausea, abdominal pain and constipation. Less common side effects include headache, elevated reversible aminotransferase, 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 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.

It is contraindicated for patients who are known to be allergic to this product or its excipients; 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 take this product should take appropriate contraceptive measures until the next menstrual cycle after the end of treatment. It is contraindicated for use with the following drugs: terfenadine, astemizole, mizolastine, cisapride, triazolam, oral midazolam, dofetilide, quinidine, pimozide, hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors metabolized by CYP3A4 enzymes such as simvastatin and lovastatin.

Precautions for children: There is a lack of sufficient research data on the effects of this product on children. Although a small number of pediatric patients aged 2 weeks to 14 years old have not experienced adverse reactions when treated with a daily dose of 3-6 mg/kg (by body weight), it is still not suitable for children. Precautions for pregnancy and lactation: 1. In animal experiments, when this product is given to animals at high doses, miscarriage, increased stillbirths, rib deformities, cleft palate and other changes in young animals may occur. Although such conditions have not been found in humans, pregnant women should still not use it. 2. There is no data on the concentration of this product in breast milk, so lactating women should use it with caution or suspend breastfeeding when taking this product. Precautions for the elderly: Elderly patients with normal renal function do not need to adjust the dose. Elderly patients with impaired renal function must adjust the dose according to creatinine clearance (see [Usage and Dosage] for details).

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.

150 ml: 1.5 g

24 months