Itraconazole 100 mg Tablet (Itraconazole Solid Dispersion)

Adult dose

(Tablets)(Capsules) For better absorption, this medicine should preferably be taken immediately after a meal. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological response should preferably be assessed 2～4 weeks after completing the prescribed course of 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) 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 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 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 treatment-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. Site of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without concurrent fingernail infection) Treatment No treatment Treatment No treatment Treatment Fingernails Treatment No treatment Treatment or 2) Continuous therapy Administer 200 mg once daily for 3 months. After treatment ends, the therapeutic effect continues for 3 months in fingernails and 6 months in toenails. 3. Systemic fungal infections Oral bioavailability of this medicine may be reduced in patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients. If necessary, double the dose. Indication Dose Average treatment duration Remarks Aspergillosis 200mg once daily 2～5 months For invasive or disseminated disease, increase 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 therapy: 200mg once daily Paracoccidioidomycosis 100mg once daily 6 months (Oral solution) For better absorption, do not take this medicine with food. Hold this medicine in the mouth for approximately 20 seconds to ensure contact with 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) daily in 1～2 divided doses for 1 week. If there is no effect after 1 week, continue for 1 additional week. 2. Fluconazole-resistant oral and esophageal candidiasis 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 additional weeks. Do not use 400 mg daily for more than 14 days, even if symptoms have not improved. 3. Prevention of fungal infections Administer 5 mg/kg body weight daily in 2 divided doses. In clinical trials, prophylaxis was initiated immediately before chemotherapy 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 considerable interindividual variability. Therefore, monitoring of blood concentrations should be considered, particularly in patients with gastrointestinal injury, patients with diarrhea, and when this medicine is administered long term.

This medication should not be administered to patients with compromised cardiac function, especially those with congestive heart failure, unless for the treatment of life-threatening situations or serious infections. If symptoms of heart failure appear during treatment, the medication should be stopped immediately. Care should be taken as serious adverse reactions can occur in patients with hypersensitivity to this drug or with impaired cardiac function, particularly due to the strong potential for drug interactions. Thus, if there are any concomitant medications, it is essential to consult a doctor or pharmacist. Pregnant women, women who may become pregnant, and nursing mothers should not use this medication, and patients with genetic issues such as lactose intolerance should also avoid it. Patients with compromised liver or kidney function may be affected in terms of the drug’s metabolism and excretion, thus requiring dosage adjustment and careful observation. Additionally, patients with weakened immune systems or specific neuropathies should use this drug cautiously. This medication carries risks of common side effects such as headache, nausea, and abdominal pain, and less commonly severe liver toxicity, cardiac arrhythmias, allergic reactions, and hearing loss. Therefore, if any unusual symptoms occur, immediate consultation with healthcare personnel is advised. Patients with heart failure should be particularly cautious as this drug may reduce myocardial contractility. It should only be used when the benefits of treatment outweigh the risks, and symptoms of heart failure should be carefully monitored during treatment. Since this medication is primarily metabolized in the liver, regular liver function tests should be performed, and it should be administered more cautiously to patients with liver disease or a history of liver toxicity. Additionally, due to the strong potential for drug interactions, dosage adjustments or prohibitions on concurrent use may be necessary with various medications, especially those related to heart diseases, anticoagulants, antineoplastics, analgesics, and antipsychotics. Patients with low acid production may have reduced absorption of this medication, so taking it with acidic beverages is recommended. The use of this medication during pregnancy is limited due to potential effects on the fetus, and it should not be used during this period. Furthermore, breastfeeding should be discontinued if the medication is needed. There is limited safety data regarding its use in children and the elderly, so it should only be administered if the benefits of treatment outweigh the risks. There is no specific antidote for overdose; therefore, symptomatic treatment should be provided as needed, as blood dialysis does not remove the medication. This medication should be kept out of reach of children and stored in its original container to prevent misuse or deterioration in quality.

Decreased myocardial contractility, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disturbances, sensory impairment, sensory abnormalities, tinnitus, constipation, diarrhea, dyspepsia, abdominal distention, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylaxis-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, altered mental status, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech impairment, 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, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, temporary hearing loss, permanent hearing loss, ventricular ectopic contractions, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lower back pain, pancreatitis, serum total protein elevation, total bilirubin elevation, LAP elevation, loss of appetite, fatigue, 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, leukocyte destructive vasculitis, acute generalized exanthematous pustulosis, BUN elevation, positive urine protein test, positive urine glucose test, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, flushing, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, allergic reaction to anaphylaxis, hypertriglyceridemia, tremors, visual impairment, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, exfoliative dermatitis, increased serum creatine phosphokinase enzyme levels

This drug should be stored in a tightly sealed container that prevents air from entering, and it should be kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage ensures that the medication's effectiveness and safety are maintained for a long time.

Appearance

White or pale yellow round film-coated tablet

Package unit

28 tablets/bottle, 100 tablets/bottle