Boryeong Itraconazole Tablet (Itraconazole Solid Dispersion)

Adult dosage

(Tablets)(Capsules) It is preferable to administer immediately after meals. 1. Short-term treatment Final clinical and mycological outcomes should preferably be assessed 2～4 weeks after completion of the prescribed treatment. Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Tinea versicolor: Administer 200 mg once daily for 7 days. Tinea corporis and tinea cruris: Administer 100 mg once daily for 15 days. Tinea manuum (interdigital) and tinea pedis (interdigital): Administer 100 mg once daily for 15 days. Tinea manuum (palmar) and tinea pedis (plantar): Administer 100 mg once daily for 30 days or 200 mg twice daily for 7 days. Oropharyngeal candidiasis: Administer 100 mg once daily for 15 days. Fungal keratitis: Administer 200 mg once daily for 21 days. 2. Onychomycosis 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 infection of the toenails. 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 the end of treatment. 3. Systemic fungal infections In immunocompromised patients, 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 drug in the mouth for about 20 seconds to ensure contact with the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the drug remains in the mouth for a longer time. 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 taking it for an 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 effect after 2 weeks, continue taking it for an additional 2 weeks. Do not use 400 mg per day for more than 14 days, even if symptoms have not improved.

Children's dosage

Prevention of fungal infections: Administer 5 mg per kg of body weight per day 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 whose neutrophil count was below 100/μL. Continue treatment until the neutrophil count recovers (1,000/μL).

This medication should not be used in patients with cardiac dysfunction or a history of heart failure. If symptoms of heart failure appear while taking this medication, discontinue use immediately. This medication should not be used if there is an allergy to it or if it is being taken with certain other drugs. Pregnant or potentially pregnant women and breastfeeding women should not take this medication. People with poor liver function should have regular liver function tests when taking this medication, and should avoid use if there is a high risk of liver damage. Patients with impaired kidney function may also require dose adjustments, so caution is needed. Caution should be exercised in patients with weakened immunity or specific systemic fungal infections. This medication can interact with various drugs, so it is important to inform your physician or pharmacist if you are taking any other medications. In particular, combining this medication with heart-related drugs, analgesics, antipsychotics, or anticancer drugs may increase the risk of side effects. Dizziness, vision disturbances, and hearing loss may occur, so caution is advised while driving or operating machinery. This medication can occasionally cause serious liver damage; therefore, if symptoms such as jaundice, abdominal pain, or fatigue occur, consult healthcare professionals immediately. Special care is necessary for children and elderly patients, and the therapeutic effects and side effects should be closely monitored. There are no specific antidotes for overdose, so appropriate treatment should be undertaken based on symptoms. This medication should be kept out of the reach of children and stored in the original container to prevent misuse or quality deterioration.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disturbance, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, pollakiuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, vocal cord dysfunction, 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, transient hearing loss, permanent hearing loss, ventricular premature contraction, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, decreased appetite, fatigue, brown urine, increased liver enzyme levels, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riele 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, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, burning sensation, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, congestive heart failure, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, elevated serum creatine phosphokinase levels

This medication should be stored in a tightly sealed container that is well-ventilated, at room temperature between 1 to 30 degrees Celsius. Storing it this way helps to maintain its effectiveness for a longer duration.

Appearance

White or yellowish circular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle