Itraconazole Tablets (Itraconazole Solid Dispersion)

Adult dosage

To increase absorption, this medicine should preferably be administered immediately after a meal. 1. Short-term treatment 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. 2) Pityriasis 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 type), tinea pedis (plantar type): 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 drug-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. 2) Continuous therapy Administer 200 mg once daily for 3 months. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia or AIDS or those who have undergone organ transplantation, the oral bioavailability of this medicine may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily, 2～5 months. For invasive or disseminated disease, increase the dose to 200mg twice daily. Candidiasis: 100～200mg once daily, 3 weeks～7 months Cryptococcal meningitis: 200mg twice daily, 2 months～1 year. Maintenance therapy: 200mg once daily Paracoccidioidomycosis: 100mg once daily, 6 months

This medication may be hazardous to patients with impaired heart function, particularly those with congestive heart failure, and should not be administered unless for life-threatening infections. Patients with hypersensitivity to this drug or those with a history of certain heart diseases, as well as those taking multiple medications, must avoid contraindicated drugs due to the possibility of severe adverse reactions. Women who are pregnant or may become pregnant, as well as nursing mothers, should not use this medication, and individuals with lactose intolerance should not be treated with it. Patients with reduced liver function or a history of liver toxicity should undergo regular liver function tests when receiving this medication. Patients with reduced kidney function may also require dose adjustments, so caution is advised. This medication has a strong interaction with various drugs; therefore, patients taking other medications should consult their physician or pharmacist. During treatment, neurological symptoms such as dizziness, vision disturbances, and hearing loss may occur, and caution should be taken if these symptoms manifest. This medication can occasionally cause severe skin reactions, hepatotoxicity, cardiac irregularities, and blood disorders; any unusual symptoms should be reported to healthcare personnel immediately. There are no specific antidotes for overdose, and symptomatic treatment should be provided; the drug is not removed by hemodialysis. It should be used cautiously in children and the elderly, only when the benefits of treatment outweigh the risks. This medication should be kept out of the reach of children and stored in its original container to prevent deterioration of quality.

Decreased myocardial contractility, ventricular arrhythmia, QT prolongation, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory reduction, sensory disturbance, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, altered mental status, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorder, cough, gastrointestinal disturbance, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, systemic edema, facial edema, chest pain, fever, pain, fatigue, chills, increased alanine aminotransferase, increased aspartate aminotransferase, increased serum alkaline phosphatase, increased serum lactate dehydrogenase, increased serum urea, increased gamma-glutamyl transferase, liver enzyme elevation, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, vasogenic edema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular ectopic beats, atrioventricular block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal flank pain, pancreatitis, elevated serum total protein, elevated total bilirubin, elevated LAP, decreased appetite, malaise, dark urine, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukoclastogenic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein, positive urine glucose, decreased libido, drowsiness, malaise, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, flushing, elevated serum uric acid, elevated serum potassium, serum sickness, vasogenic edema, anaphylactic response, hypertriglyceridemia, tremors, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, severe hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, increased serum creatine phosphokinase

This medication should be stored in a tightly closed container to prevent exposure to air or humidity. It is advisable to maintain a storage temperature between 1°C and 30°C.

Appearance

White or pale yellow round film-coated tablets

Package unit

28 tablets/bottle, 100 tablets/bottle