Daewon Itraconazole Tablets (Itraconazole Solid Dispersion)

Adult dose

(Tablets)(Capsules) It is preferable to administer this medicine immediately after meals. 1. Short-term treatment 1) Candidal vulvovaginitis: Administer itraconazole 200 mg per dose 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 manus (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manus (palmar), tinea pedis (plantar): Administer 100 mg once daily for 30 days, or 200 mg per dose 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 per dose twice daily for 1 week, followed by a 3-week drug-free interval; 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. Toenails (with or without concurrent fingernail infection): 1 week on treatment, 2 weeks off treatment, 3 weeks on treatment, 4 weeks off treatment, 5 weeks on treatment Fingernails: 1 week on treatment, 2 weeks off treatment, 3 weeks on treatment 2) Continuous therapy Administer 200 mg once daily for 3 months. 3. Systemic fungal infections In immunocompromised patients, increase the dose twofold if necessary. Aspergillosis: 200mg once daily for 2～5 months. For invasive or disseminated disease, increase the dose to 200mg per dose 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 (Oral solution) Do not take with food. Hold this medicine in the mouth for approximately 20 seconds to ensure that it contacts the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the medicine remains in the mouth for a longer time. 1. Oral or esophageal candidiasis Take 200 mg (20 mL) daily in 1～2 divided doses for 1 week. If there is no response after 1 week, continue taking it for 1 more week. 2. Oral or esophageal candidiasis resistant to fluconazole Take 200～400 mg (20～40 mL) daily in 1～2 divided doses for 2 weeks. If there is no response after 2 weeks, continue taking it for 2 more weeks. Even if symptoms do not improve, do not use 400 mg daily for more than 14 days.

Child dose

Prevention of fungal infections: Administer 5 mg per kg of body weight daily in 2 divided doses. Continue treatment until the neutrophil count recovers (1,000/μL).

This medication may pose a life-threatening risk to patients with heart issues, particularly those with congestive heart failure, and should not be used if the treatment goal is unclear. If symptoms of heart failure occur, the medication should be stopped immediately. Patients who are allergic to this drug or its components should not take it. This drug can interact with various medications, and taking it with certain drugs may lead to severe side effects; therefore, it is essential to consult with a physician before use. It is safest for pregnant or potentially pregnant women and breastfeeding women not to take this medication. Patients with genetic issues such as lactose intolerance should also avoid this medication. Special caution is necessary for patients with liver or kidney dysfunction, and liver function tests and dosage adjustments may be required. Patients with weakened immune systems or certain neurological disorders should also be cautious while taking this medication. Various side effects such as headaches, nausea, abdominal pain may occur, and if any unusual symptoms arise, medical personnel should be notified immediately. Serious side effects like liver dysfunction, heart problems, skin rashes may require regular check-ups. When driving or operating machinery, the potential for dizziness, visual disturbances, and hearing loss must be considered. This medication can produce complex interactions with multiple drugs; therefore, inform healthcare providers of all medications currently being taken. There is no specific antidote for overdose, so the recommended dosage must be strictly followed. Keep out of the reach of children and store in the original container to prevent misuse.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorders, sensory disturbances, 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, speech disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, diaphoresis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, increased alanine aminotransferase, increased aspartate aminotransferase, increased serum alkaline phosphatase, increased serum lactate dehydrogenase, increased blood urea, increased gamma-glutamyl transferase, 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, atrioventricular block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal flank pain, pancreatitis, increased serum total protein, elevated total bilirubin, elevated LAP, loss of appetite, malaise, dark urine, skin and mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Rielle syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein, positive urine glucose, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increased serum triglyceride levels, flushing, increased serum uric acid levels, increased serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremors, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, severe hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased creatine phosphokinase levels

This medication should be stored in an airtight container that is well-sealed, preferably at temperatures between 1°C and 30°C room temperature. Proper storage will help maintain the drug's effectiveness for a long period.

Appearance

White or slightly yellowish round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle