Itraconazole Tablets (Itraconazole Solid Dispersion)

Adult dose

This medicine should preferably be administered immediately after a meal to increase absorption. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissues even after treatment is discontinued. Therefore, the final clinical and mycological therapeutic effects should preferably be assessed 2～4 weeks after completing the prescribed 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 (jock itch): 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 of the fingernails only and up to 3 cycles for infection of the toenails. Affected area of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without fingernail infection) Treatment Treatment-free Treatment Treatment-free Treatment Fingernails Treatment Treatment-free 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 ends. 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; if necessary, double the dose. 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 treatment: 200mg once daily Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months

This medication should not be administered to patients with impaired cardiac function, especially in cases of congestive heart failure unless it is life-threatening. If heart failure symptoms occur during treatment, discontinue use immediately. This medication contains lactose and should not be used by patients with lactose intolerance or certain genetic metabolic disorders. Patients with a history of hypersensitivity reactions should also avoid this medication. This drug can interact with several medications, hence care should be taken when combined with cardiac medications, anticoagulants, or chemotherapeutics. Pregnant or potentially pregnant women and nursing mothers should avoid using this drug and effective contraception should be ensured during treatment. Patients with liver or kidney impairment may be affected in the metabolism and excretion of this drug, requiring dose adjustment and liver function tests. This drug may rarely cause serious hepatic toxicity, allergic reactions, neuropathy, and hearing loss; if any abnormal symptoms occur, consult a physician immediately. Dizziness and visual disturbances may occur during treatment, necessitating caution while driving or operating machinery. If other medications are being taken, be sure to inform healthcare providers to check for interaction risks, as some medications may be contraindicated. This drug should be administered with increased caution to children and the elderly, and adverse effects should be carefully monitored in these populations. There are no specific antidotes in case of overdose, thus immediate medical attention is required. Store in a safe place out of the reach of children, preferably in the original container.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory disturbance, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, pruritus, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactic reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, dysphonia, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythema multiforme, hyperhidrosis, myalgia, arthralgia, kidney dysfunction, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular extrasystole, atrial block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevation of total serum protein, elevation of total bilirubin, elevation of LAP, loss of 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 reaction, positive urine sugar reaction, decreased libido, drowsiness, malaise, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, flushing, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremors, visual impairment, hearing loss, congestive heart failure, shortness of breath, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, Steven-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase activity

This medication should be stored in a tightly sealed container to prevent air ingress, and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain drug efficacy and prevent degradation.

Appearance

White or pale yellow round film-coated tablets

Package unit

28 tablets/bottle, 100 tablets/bottle