Itraconazole 100 mg Tablet

Adult dose

(Tablets)(Capsules) It is preferable to administer immediately after meals. 1. Short-term treatment The final clinical and mycological therapeutic effect should preferably be assessed 2～4 weeks after completion of the prescribed treatment. 1) Candidal vaginitis: 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 (jock itch): 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 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 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 toenail infection. 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 patients with impaired immune function, 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 per dose twice daily Candidiasis: 100～200mg once daily, 3 weeks～7 months Cryptococcal meningitis: 200mg twice daily, 2 months～1 year Maintenance treatment for cryptococcal meningitis: 200mg once daily Paracoccidioidomycosis: 100mg once daily, 6 months (Oral solution) Do not take with food. Hold this medicine in the mouth for about 20 seconds so that it comes into contact with 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 and esophageal candidiasis Take 200 mg (20 mL) daily 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) daily in 1～2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue for 2 more weeks. Even if symptoms do not improve, do not use 400 mg daily for more than 14 days. 3. Prevention of fungal infections Administer 5 mg/kg body weight daily in 2 divided doses. In clinical trials, prophylaxis 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. Continue treatment until the neutrophil count recovers (1,000/μL). Pharmacokinetic values obtained in clinical trials in patients with neutropenia showed considerable interindividual variability. Therefore, therapeutic drug monitoring should be considered, especially in patients with gastrointestinal damage, patients with diarrhea, and when this medicine is administered for a prolonged period.

This drug should not be used in patients with impaired cardiac function or a history of congestive heart failure unless for life-threatening infections. If symptoms of heart failure occur during treatment, discontinue use immediately. This medication may reduce cardiac contractility; caution is necessary in patients with heart disease. Patients with hypersensitivity to this drug or those with specific cardiac diseases, liver disorders, or kidney issues should avoid use. Furthermore, many dangerous drug interactions occur with this medication, so consultation with a doctor or pharmacist is essential. Pregnant women, those who may become pregnant, and nursing mothers should not use this drug, and patients with hereditary issues such as lactose intolerance should also avoid it. Patients with impaired liver function should undergo regular liver function tests when using this drug, and dosage adjustments may be necessary. This drug has numerous drug interactions that may cause side effects or changes in efficacy when taken concomitantly, so consultation with a healthcare professional is required if other medications are being taken. During treatment, various adverse reactions such as headache, nausea, abdominal pain, diarrhea, liver dysfunction, rash, swelling, etc., may occur, and in serious cases, healthcare providers must be notified immediately. Rare side effects such as hearing loss, neuropathy, liver toxicity, and cardiac side effects have also been reported, requiring prompt action for any symptoms. Caution is advised when driving or operating machinery, as dizziness or visual impairment may occur. There is no specific antidote for overdose, so it is important to strictly adhere to the recommended dosage and keep it out of reach of children.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, sensory abnormalities, tinnitus, constipation, diarrhea, indigestion, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, kidney dysfunction, 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, elevated liver enzymes, abnormal urinalysis, increased leukocytes, increased eosinophils, anemia, vascular edema, serum sickness, angioneurotic edema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, transient hearing loss, permanent hearing loss, ventricular ectopia, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal flank pain, pancreatitis, elevated total serum protein, increased total bilirubin, elevated LAP, decreased appetite, malaise, brown urine, sicca 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 test, positive urine glucose test, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, burning sensation, elevated serum uric acid, elevated serum potassium, serum sickness, angioneurotic edema, anaphylactic reaction, hypertriglyceridemia, tremors, visual impairment, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase

Store this medication in a tightly closed container to prevent air intrusion, and keep it at a temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will maintain the drug's efficacy and prevent degradation.

Appearance

White or off-white rectangular film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle