Daewoong Itraconazole Tablet 100mg (Itraconazole Solid Dispersion)

Adult dosage

1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after discontinuation. Therefore, it is preferable to assess the final clinical and mycological response 2–4 weeks after completion of the prescribed treatment. 1) Candidal vaginitis: Administer itraconazole 200 mg per dose 2 times 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 and tinea cruris (jock itch): Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type) and tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palms) and tinea pedis (soles): Administer 100 mg once daily for 30 days, or 200 mg per dose 2 times 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 2 times daily for 1 week, followed by a 3-week drug-free interval; this constitutes one cycle. Administer up to 2 cycles for infection of the fingernails only and up to 3 cycles for infection of the toenails. Toenails (with or without concurrent fingernail infection): 1 week of treatment, 2 weeks off treatment, 3 weeks of treatment, 4 weeks off treatment, 5 weeks of treatment Fingernails: 1 week of treatment, 2 weeks off treatment, 3 weeks of treatment 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; therefore, if necessary, increase the dose twofold. Aspergillosis: 200 mg once daily; average treatment duration 2–5 months. For invasive or disseminated disease, increase to 200 mg per dose 2 times daily. Candidiasis: 100–200 mg once daily; average treatment duration 3 weeks–7 months. Cryptococcal meningitis: 200 mg 2 times daily; average treatment duration 2 months–1 year. Maintenance therapy: 200 mg once daily. Paracoccidioidomycosis: 100 mg once daily; average treatment duration 6 months

This medication should not be administered to patients with impaired cardiac function, especially those with congestive heart failure. If symptoms of heart failure occur, its use should be discontinued immediately, as this medication may reduce myocardial contractility. It should not be used by those who have hypersensitivity to this drug or are taking specific drugs that interact with it. It is not to be administered to pregnant women or women who may become pregnant, as well as nursing mothers. Use cautiously in patients with impaired liver function, and it is crucial to regularly perform liver function tests during treatment. Patients with reduced renal function should also exercise caution, and dosage adjustments may be necessary as required. This medication can interact with various drugs, so it is essential to inform healthcare professionals if using other medications. Particular caution should be taken when used in combination with certain cardiac drugs, analgesics, antibiotics, and antineoplastic agents, as risks may be increased. During treatment with this medication, side effects such as dizziness, headaches, indigestion, and skin rashes may occur, and if any unusual symptoms are experienced, a healthcare professional should be consulted immediately. Caution is necessary during driving or operation of machinery, as dizziness or visual disturbances may occur. Safety has not been sufficiently established for children; therefore, use only when necessary and under the guidance of a specialist. There is no specific antidote for overdose; therefore, strict adherence to dosages is required, and it should be stored out of reach of children.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disturbance, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, agranulocytosis, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusional state, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, 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 serum urea, increased gamma-glutamyl transferase, elevated liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioneurotic edema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, transient hearing loss, permanent hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, increased total serum protein, increased total bilirubin, increased LAP, decreased appetite, lethargy, brown urine, mucocutaneous syndrome, 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, angioneurotic edema, anaphylaxis reaction, hypertriglyceridemia, tremor, blurred vision, congestive heart failure, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, Steven-Johnson syndrome, acute generalized exanthematous pustulosis, increased serum creatine phosphokinase

Store this medication in a tightly sealed container to prevent air ingress, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy well.

Appearance

White to pale yellow oval film-coated tablet

Package unit

Company packaging unit