Artzol Tablets (Itraconazole Solid Dispersion)

Adult dosage

This medicine should preferably be administered immediately after a meal to increase absorption. 1. Short-term treatment This medicine continues to have a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological therapeutic effect should preferably be assessed 2～4 weeks after completion of the prescribed treatment. 1) Candida vaginitis: Administer itraconazole 200 mg 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), 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 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 concomitant fingernail infection): treatment in week 1, no treatment in weeks 3, treatment in week 5, no treatment in weeks 7, treatment in week 9 Fingernails: treatment in week 1, no treatment in weeks 3, treatment in week 5 Or 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, such as those with neutropenia, AIDS, or organ transplant recipients, 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 the dose 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.

This drug can be life-threatening for patients with decreased heart function, especially those with congestive heart failure, and should not be used unless for infection treatment. If symptoms of heart failure appear during treatment, the medication should be discontinued immediately. Patients with allergies to this drug or those with certain heart diseases, liver, or kidney dysfunction should not take it. Additionally, this drug may cause severe side effects due to interactions with multiple medications, so contraindicated drugs should not be taken concurrently. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this drug, and effective contraceptive methods should be used after administration. Since this drug is primarily metabolized in the liver, patients with liver impairment should undergo regular liver function tests during treatment. Patients with renal dysfunction may also require dose adjustment, so caution is needed. Side effects such as dizziness, headache, dyspepsia, skin rash, and abnormal liver function may occur, so if unusual symptoms appear, medical consultation is necessary. Rare side effects such as hearing loss have also been reported; if any change in hearing is noticed, it should be reported immediately. Caution is warranted as dizziness or visual disturbances may occur while driving or operating machinery. If other medications are taken during the course of this drug, it is essential to inform healthcare providers and to be vigilant for the potential of side effects due to drug interactions. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and this drug is not removed by hemodialysis. Lastly, this medication should be kept out of reach of children, and it should be stored in its original container for safe and effective use.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory perception decrease, sensory perception abnormality, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactic-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice 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, increased alanine aminotransferase, increased aspartate aminotransferase, increased serum alkaline phosphatase, increased serum lactate dehydrogenase, increased urea in blood, increased gamma-glutamyl transferase, elevated liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, transient or permanent hearing loss, ventricular ectopic beats, atrioventricular block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevated serum total protein, elevated total bilirubin, increased LAP, decreased appetite, malaise, brown urine, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Reiter's syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increased serum triglyceride levels, flushing, elevated serum uric acid levels, increased serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, transient or permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, severe hepatotoxicity, toxic epidermal necrolysis, Steven-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased creatine phosphokinase in blood

This medication should be stored in a tightly sealed container that is well-ventilated, at room temperature between 1 to 30 degrees Celsius. Storing in this manner helps maintain the efficacy and safety of the drug.

Appearance

White or yellowish round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle