Traconox 100 mg (Itraconazole Solid Dispersion)

Adult dose

(Tablets) (Capsules) To increase absorption, this drug should preferably be administered immediately after a meal. 1. Short-term treatment 1) Vulvovaginal candidiasis: Administer 200 mg of itraconazole 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), 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 a 3-week drug-free interval; 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 drug may be reduced; therefore, if necessary, double the dose. Aspergillosis: 200mg once daily, 2 to 5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100 to 200mg once daily, 3 weeks to 7 months. Cryptococcal meningitis: 200mg twice daily, 2 months to 1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, 6 months. (Oral solution) To increase absorption, do not take this drug with food. Hold this drug in the mouth for about 20 seconds to ensure contact with the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the drug remains in the mouth for as long as possible. 1. Oral and esophageal candidiasis Take 200 mg (20 mL) daily in 1 to 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 to 400 mg (20 to 40 mL) daily in 1 to 2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue for 2 more weeks. Do not use 400 mg daily for more than 14 days, even if symptoms have not improved. 3. Prevention of fungal infections: In clinical trials, prophylactic therapy was initiated immediately before anticancer treatment and approximately 1 week before bone marrow transplantation. Deep fungal infections were confirmed in most patients with neutrophil counts below 100/μL. Treatment was continued until the neutrophil count recovered (1,000/μL). Pharmacokinetic values obtained in clinical trials in patients with neutropenia showed substantial interindividual variation. Therefore, monitoring of blood levels should be considered, particularly in patients with gastrointestinal damage, patients with diarrhea, and when this drug is administered for a prolonged period.

Child dose

Administer 5 mg per kg of body weight daily in 2 divided doses.

This drug should be used with caution in patients with impaired heart function, particularly those with congestive heart failure, as it can be life-threatening. If symptoms of heart failure occur, administration should be stopped immediately, and it should not be used in combination with medications that can strain the heart. It should not be administered to patients with a history of allergic reactions to this drug or certain cardiac conditions. Additionally, since this drug is primarily metabolized in the liver, patients with impaired liver function should have regular liver function tests and should use this drug cautiously if there is a risk of liver damage. Patients with decreased kidney function may also need dosage adjustments, so caution is required. Pregnant or potentially pregnant women and nursing mothers should not use this drug. This drug has significant interactions with multiple medications, so patients taking other drugs should consult their healthcare provider, particularly when taking medications that affect the heart, nervous system, liver, or kidneys. Dizziness, visual disturbances, hearing loss, and other symptoms can occur during administration, so caution is needed when driving or operating machinery. In the case of overdose, there is no specific antidote, so treatment should be symptomatic, and the drug should be kept out of reach of children.

Decreased cardiac contractility, ventricular arrhythmia, QT prolongation, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorders, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactic reactions, 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, hyperhidrosis, 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 serum urea, increased gamma-glutamyl transferase, liver enzyme elevation, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reactions, diplopia, visual impairment, hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal and lower back pain, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, loss of appetite, listlessness, brown urine, increased liver enzyme levels, mucosal epidermal necrolysis, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increased serum triglyceride level, flushing, increased serum uric acid level, increased serum potassium level, serum sickness, angioedema, anaphylactic reactions, hyperlipidemia, tremors, visual impairment, temporary or permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, severe hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase

This drug should be stored in a tightly sealed container to prevent air exposure, and it is best kept at room temperature between 1°C and 30°C.

Appearance

White or light yellow round film-coated tablet

Package unit

28 tablets/PTP (14 tablets/PTP x 2), 30 tablets/bottle, 100 tablets/bottle