Itraconazole Tablets (Itraconazole Solid Dispersion)

Adult dosage

To increase the absorption rate, this medicine should preferably be taken immediately after a meal. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological response should preferably be assessed 2～4 weeks after completing the prescribed course of treatment. 1) Candidal vaginitis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. 2) Tinea versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type), tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palmar), tinea pedis (plantar): Administer 100 mg once daily for 30 days or 200 mg twice daily for 7 days. 6) Oral candidiasis: Administer 100 mg once daily for 15 days. 7) Fungal keratitis: Administer 200 mg once daily for 21 days. 2. Onychomycosis 1) Pulse therapy Administer 200 mg twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles for infection limited to the fingernails and up to 3 cycles for toenail infection. Toenails (with or without concurrent fingernail infection) Week 1: Treatment Week 2: No treatment Week 3: Treatment Week 4: No treatment Week 5: Treatment Fingernails Week 1: Treatment Week 2: No treatment Week 3: Treatment or 2) Continuous therapy Administer 200 mg once daily for 3 months. The therapeutic effect continues for 3 months for fingernails and 6 months for toenails after treatment is completed. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, the oral bioavailability of this medicine may be reduced; therefore, increase the dose twofold if necessary. Aspergillosis: 200mg once daily; average treatment duration, 2～5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100～200mg once daily; average treatment duration, 3 weeks～7 months. Cryptococcal meningitis: 200mg twice daily; average treatment duration, 2 months～1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily; average treatment duration, 6 months.

This drug should not be used in patients with compromised cardiac function, especially those with heart failure or a history thereof, unless for serious infection treatment, as it may pose a life-threatening risk. If symptoms of heart failure occur during administration, discontinue use immediately. It should not be used in patients with hypersensitivity to this drug, those with certain cardiac diseases, and in combination with specific medications. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not use this drug. Special caution is required in patients with impaired liver function or renal function, and regular liver function tests are recommended. This drug has many drug interactions; therefore, consult with a physician or pharmacist if taking other medications. When taking this medication, absorption may be lower in a low-acid state, so taking it with acidic beverages may help. Side effects such as dizziness, headache, nausea, and abdominal pain may occur, and rarely, severe hepatotoxicity or allergic reactions may develop, so any unusual symptoms should be reported to healthcare professionals immediately. Special consideration must be given when using this drug in children or the elderly, and dose adjustments may be necessary. In cases of overdose, there are no specific antidotes; treatment should be based on symptoms, and it should be stored out of reach of children.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disturbance, sensory decrease, paresthesia, tinnitus, constipation, diarrhea, indigestion, bloating, vomiting, liver dysfunction, hyperbilirubinemia, pruritus, rash, urticaria, polyuria, erectile dysfunction, menstrual disorder, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorder, cough, gastrointestinal disorder, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioneurotic edema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular ectopic contractions, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, decreased appetite, malaise, brown urine, increased liver enzyme levels, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein test, positive urine glucose test, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, burning sensation, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioneurotic edema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, hearing loss, congestive heart failure, dyspnea, pancreatitis, severe hepatic toxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase levels

This medication should be stored in a tightly sealed container that is resistant to air, at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness for a longer duration.

Appearance

White or pale yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle