Itraco Tablet (Itraconazole)

Adult dose

(Tablets)(Capsules) It is preferable to administer immediately after a meal. 1. Short-term treatment The final clinical and mycological treatment response should preferably be assessed 2～4 weeks after completion of 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) 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 treatment-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. The treatment effect continues for 3 months for fingernails and 6 months for toenails after treatment is completed. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplants, the oral bioavailability of this medicine may be reduced; if necessary, double the dose. 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 (Oral solution) Do not take with food. Keep this medicine in the mouth for approximately 20 seconds so 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 as long as possible. 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 additional 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 additional weeks. Do not use 400 mg per day for more than 14 days, even if symptoms have not improved. 3. Prevention of fungal infections Administer 5 mg/kg 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. Deep fungal infections were confirmed in most patients with a neutrophil count 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 considerable interindividual variability. Therefore, monitoring of blood concentrations should be considered, particularly in patients with gastrointestinal damage, patients with diarrhea, and when this medicine is administered long term.

This medication is not recommended for patients with impaired cardiac function. Particularly in cases with a history of heart failure, administration of this medication may worsen heart function. It should not be used by patients with hypersensitivity to this drug, or when combined with certain medications. Contraindicated medications include many analgesics, antiarrhythmics, anticoagulants, and antihistamines, and taking them together with this drug may cause serious side effects. Women who are pregnant or may become pregnant, and those who are breastfeeding should not use this medication, as it may be harmful to the fetus or newborn. It should be used cautiously in patients with liver impairment, and regular liver function tests are important. Treatment may need to be discontinued in situations where there is concern about liver damage. Patients with reduced kidney function should also use this drug cautiously, and dosage adjustments may be necessary. This medication has a high potential for interactions with various drugs, so patients taking other medications should consult their healthcare provider. Taking this medication with certain drugs may worsen side effects or alter treatment effectiveness. During treatment with this medication, symptoms such as dizziness, vision impairment, and hearing loss may occur, so caution is required when driving or operating machinery. In cases of overdose, there is no specific antidote, and appropriate treatment should be provided according to symptoms. Finally, this medication should be kept out of the reach of children and stored in its original container to maintain quality.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory disturbance, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, abdominal distension, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylaxis-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorder, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythema multiforme, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased bowel activity, belching, glossitis, stomatitis, abdominal lumbar pain, pancreatitis, elevated serum total protein, increased total bilirubin, increased LAP, loss of appetite, malaise, brown urine, increased liver enzyme levels, 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, sleepiness, 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, shortness of breath, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, elevated serum creatine phosphokinase.

This medication should be kept in a tightly closed container to prevent air or moisture from entering, and should be stored at a temperature between 1°C and 30°C. Proper storage helps maintain the effectiveness and safety of the medication.

Appearance

White or off-white oval film-coated tablets

Package unit

28 tablets/bottle