Itraconazole Tablet (Itraconazole Solid Dispersion)

Adult dose

(Tablets)(Capsules) It is advisable to take this medicine immediately after a meal. 1. Short-term 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), tinea pedis (interdigital): 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 3 weeks without treatment; this constitutes 1 cycle. Administer up to 2 cycles for infection limited to the fingernails 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, AIDS, or organ transplant recipients, the oral bioavailability of this medicine may be reduced; if necessary, increase the dose twofold. 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. (Oral solution) To increase absorption, do not take this medicine with food. Hold this medicine in the mouth for approximately 20 seconds, allowing it to contact the entire mouth, and then swallow. After swallowing, do not rinse the mouth so that the medicine remains in the mouth for an extended period. 1. Oral and esophageal candidiasis Take 200 mg (20 mL) per day in 1～2 divided doses for 1 week. If there is no effect after 1 week, continue for 1 more week. 2. Oral and esophageal candidiasis resistant to fluconazole Take 200～400 mg (20～40 mL) per day in 1～2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue for 2 more weeks. Do not use 400 mg per day for more than 14 days, even if symptoms have not improved.

Child dose

3. Prevention of fungal infections: Administer 5 mg per kg of body weight per day in 2 divided doses. In clinical trials, prophylaxis was started immediately before anticancer treatment and approximately 1 week before bone marrow transplantation. Continue treatment until the neutrophil count recovers to (1,000/μL).

This medication should not be administered to patients with impaired cardiac function or a history of congestive heart failure, and if symptoms of heart failure occur during administration, it should be discontinued immediately. Patients with hypersensitivity to this drug or certain heart diseases should also not use it. Additionally, this drug can interact with several other medications, so it should not be taken in combination with contraindicated medications. Pregnant women or those who may become pregnant, as well as breastfeeding women, should not take this medicine. Patients with impaired liver or kidney function should be cautious when taking this medication and should regularly undergo liver function tests. Patients with weakened immune systems or specific diseases may require dose adjustments. Taking this medication may cause side effects such as headaches, nausea, abdominal pain, and, rarely, severe side effects may occur; thus, if unusual symptoms appear, consult a doctor immediately. Care should be taken when driving or operating machinery as dizziness or visual disturbances may occur. Moreover, this medication may not be absorbed well under low acidity, so it is advisable to take it with acidic beverages. In case of overdose, there is no specific antidote, so you should visit a medical institution immediately for treatment. Finally, keep this medication out of reach of children, and store pharmaceuticals in their original containers to maintain quality.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory decline, sensory abnormality, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, pollakiuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactic-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusional state, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorder, cough, gastrointestinal disturbance, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, increase in alanine aminotransferase, increase in aspartate aminotransferase, increase in serum alkaline phosphatase, increase in serum lactate dehydrogenase, increase in blood urea, increase in gamma-glutamyl transferase, increase in liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular premature contraction, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal pain in the lumbar region, pancreatitis, elevation of serum total protein, elevation of total bilirubin, elevation of LAP, increased serum triglyceride level, decreased appetite, malaise, brown urine, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Rielle syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocyte-destructive vasculitis, acute generalized exanthematous pustulosis, elevation of BUN, positive urinary protein reaction, positive urinary glucose reaction, decreased libido, drowsiness, malaise, shoulder stiffness, insomnia, chest pain, elevation of serum triglyceride levels, flushing, elevation of serum uric acid levels, elevation of serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, increase in serum creatine phosphokinase activity

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness.

Appearance

(Domestic) White or slightly yellow round film-coated tablet (Export) White to off-white egg-shaped film-coated tablet

Package unit

Domestic - 30 tablets/bottle, Domestic - 100 tablets/bottle, Export - 20 tablets/box [10 tablets/PTPX2]