Itraconazole Tablets (Itraconazole Solid Dispersion)

Adult dose

(Tablets)(Capsules) It is preferable to administer this medicine immediately after a meal. 1. Short-term treatment The final clinical and mycological response should preferably be assessed 2～4 weeks after completion of the prescribed treatment. 1) Vulvovaginal candidiasis: 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 (palms), tinea pedis (soles): Administer 100 mg once daily for 30 days, or 200 mg twice daily for 7 days. 6) Oropharyngeal 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 one cycle. Administer up to 2 cycles for infection limited to the fingernails, and up to 3 cycles for infection of the toenails. Toenails (with or without concurrent fingernail infection): Treatment in week 1, no treatment in week 2, treatment in week 3, no treatment in week 4, treatment in week 5. Fingernails: Treatment in week 1, no treatment in week 2, treatment in week 3. 2) Continuous therapy Administer 200 mg once daily for 3 months. The therapeutic effect continues for 3 months for fingernails and 6 months for toenails after the end of treatment. 3. Systemic fungal infections In patients with impaired immune function, double the dose if necessary. 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. Hold this medicine in the mouth for approximately 20 seconds, allowing it to contact the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the medicine remains in contact 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 response after 1 week, continue for 1 additional week. 2. Fluconazole-resistant oral and esophageal candidiasis Take 200～400 mg (20～40 mL) per day in 1～2 divided doses for 2 weeks. If there is no response after 2 weeks, continue for 2 additional weeks. Even if symptoms do not improve, do not use 400 mg per day for more than 14 days.

Child dose

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

This drug can be life-threatening for patients with decreased cardiac function or a history of congestive heart failure; therefore, it should not be administered unless for serious infection treatment. If symptoms of heart failure occur during administration, the use should be immediately discontinued. Patients who have had an allergic reaction to this drug should not take it. As this medication is primarily metabolized in the liver, patients with impaired liver function should use it cautiously and regular liver function tests should be conducted. Patients with reduced kidney function may also require dose adjustments. It is advisable for pregnant women, those who may become pregnant, and lactating women to avoid this medication. This drug has a significant potential for interactions with various medications, particularly with certain cardiac drugs, analgesics, antipsychotics, and anticoagulants; consultation with a physician or pharmacist is essential. Patients may experience side effects such as dizziness, headache, dyspepsia, liver dysfunction, skin rashes, and should report any unusual symptoms immediately to seek treatment. This medication requires caution when driving or operating machinery, and rare side effects such as hearing loss have also been reported. There is no specific antidote for overdose; immediate medical attention is necessary. This medication should be stored out of the reach of children and kept in its original container to prevent misuse or quality degradation.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disturbance, sensory impairment, sensory abnormality, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactic 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 disorder, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal 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 nitrogen, increased gamma-glutamyl transferase, increased liver enzymes, abnormal urinalysis, increased white blood cells, increased eosinophils, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, double vision, visual impairment, hearing loss, ventricular ectopic beats, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lower back pain, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, loss of appetite, malaise, brown urine, increased liver enzyme levels, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel 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 triglycerides, flushing, increased serum uric acid, increased serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, transient or permanent hearing loss, congestive heart failure, shortness of breath, pancreatitis, severe hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase activity

This medication should be stored in a tightly sealed container to prevent air or moisture ingress, preferably at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy.

Appearance

White or light yellow round film-coated tablets

Package unit

30 tablets/bottle