Itrazole Tablets (Itraconazole Solid Dispersion)

Adult dose

This medicine should preferably be administered immediately after meals to increase absorption. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, it is preferable to assess the final clinical and mycological response 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: 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 interval; this constitutes one cycle. Administer up to 2 cycles for infection limited to the fingernails and up to 3 cycles for toenail infection. 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, oral bioavailability of this medicine may be reduced; therefore, the dose should be doubled if necessary. Aspergillosis: 200mg once daily for 2～5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100～200mg once daily for 3 weeks～7 months. Cryptococcal meningitis: 200mg twice daily for 2 months～1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily for 6 months

This drug should be used with caution in patients with compromised cardiac function, especially those with congestive heart failure, as it may pose a life-threatening risk. If symptoms of heart failure occur during treatment, use should be discontinued immediately. Patients with hypersensitivity to this drug or with a history of certain cardiac diseases should not use it. Additionally, serious side effects may occur when taken with specific medications, so always check the list of contraindicated drugs. Pregnant women, women who may become pregnant, and breastfeeding women should not use this drug, and effective contraception should be employed during treatment. Patients with impaired liver function may be affected by the drug's metabolism, so liver function tests should be conducted regularly, and caution is advised due to the risk of hepatotoxicity. Patients with poor kidney function may also require dosage adjustments, so caution is needed. Patients with weakened immune systems or certain neuropathies should use this drug cautiously. This drug may interact with various medications, so inform your doctor or pharmacist about any other medications you are taking. Low stomach acid may reduce the drug's absorption, so taking it with acidic beverages may aid absorption. Side effects such as dizziness, visual disturbances, hearing loss may occur, requiring caution during driving or operating machinery. Side effects may commonly include headaches, nausea, abdominal pain, and rarely may involve serious liver damage, allergic reactions, or heart problems. In case of overdose, there is no specific antidote, and treatment should be symptomatic, as it is not removed by dialysis. This drug should be kept out of reach of children and stored in its original container to prevent misuse or deterioration of quality.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, abnormal liver function, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorder, edema, granulocytopenia, thrombocytopenia, anaphylaxis-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, altered mental status, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disturbance, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, kidney disorder, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, alanine aminotransferase increase, aspartate aminotransferase increase, serum alkaline phosphatase increase, serum lactate dehydrogenase increase, serum urea increase, gamma-glutamyl transferase increase, increased liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular extrasystole, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lower back pain, pancreatitis, elevated serum total protein, elevated total bilirubin, elevated LAP, decreased appetite, lethargy, dark urine, 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, positive urine glucose, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, burning sensation, elevated serum uric acid, elevated serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase activity

This drug should be stored in a tightly sealed container to prevent air or moisture ingress, with a recommended storage temperature between 1 and 30 degrees Celsius to maintain its efficacy.

Appearance

White or light yellow circular film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle