Itraconazole 200 mg Tablet

Adult dosage

(Tablets)(Capsules) To increase absorption, administration immediately after a meal is preferred. 1. Short-term treatment This medicine continues to have a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, it is preferable to assess the final clinical and mycological response 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 (jock itch): 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) 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 a 3-week drug-free period; this constitutes 1 cycle. Administer up to 2 cycles if only the fingernails are infected, and up to 3 cycles if the toenails are infected. Fingernail infection only: 1 week on treatment, 2 weeks off treatment, 3 weeks on treatment, 4 weeks off treatment Toenail infection: 1 week on treatment, 2 weeks off treatment, 3 weeks on treatment, 4 weeks off treatment, 5 weeks on treatment, 6 weeks off treatment 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 completion of treatment. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, oral bioavailability of this medicine may be reduced; therefore, double the dose if necessary. Aspergillosis: 200mg once daily, average treatment duration 2～5 months. For invasive or disseminated disease, increase the dose to 200mg twice daily. Candidiasis: 100～200mg once daily, average treatment duration 3 weeks～7 months. Cryptococcal meningitis: 200mg twice daily, average treatment duration 2 months～1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months. (Oral solution) To increase absorption, do not take this medicine with food. Hold this medicine in the mouth for approximately 20 seconds to allow it to contact 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 treatment for another 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 treatment for another 2 weeks. Even if symptoms do not improve, do not use 400 mg daily for more than 14 days. 3. Prevention of fungal infections In clinical trials, prophylaxis was started immediately before anticancer therapy and approximately 1 week before bone marrow transplantation. Deep fungal infections were identified in most patients with a neutrophil count 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 damage, patients with diarrhea, and when this medicine is administered for a prolonged period.

Children's dosage

Administer 5 mg/kg of body weight daily in 2 divided doses.

This medication should not be used in patients with impaired cardiac function or a history of heart failure. If symptoms of heart failure occur while taking this medication, it should be discontinued immediately. Patients with an allergic reaction to this medication or a hypersensitivity to its components should not take it. Additionally, this medication can cause serious side effects when taken with certain heart arrhythmia treatments, analgesics, or anticancer agents, so it should not be used together with those. Women who are pregnant or may become pregnant, as well as women who are breastfeeding, should not take this medication. Patients with liver or kidney dysfunction should take this medication with caution, and it is important to undergo regular liver function tests. Caution should also be taken when used in immunocompromised patients or those with specific systemic fungal infections. While taking this medication, side effects such as headaches, nausea, abdominal pain, and diarrhea may occur, and rarely, serious side effects such as liver dysfunction, allergic reactions, heart problems, and hearing loss may happen. If any unusual symptoms occur, consult a healthcare professional immediately. This medication is poorly absorbed in low acidity, so if antacids or acid secretion inhibitors are taken, it is advisable to adjust the timing of administration or take it with acidic beverages. When driving or operating machinery, caution should be exercised as dizziness, visual disturbances, and hearing loss may occur. Pregnant women should avoid this medication as it may affect the fetus, and breastfeeding should be discontinued as the drug can be transferred through breast milk. There is limited information on the safety of this medication in children and the elderly, so consultation with a healthcare professional is necessary before use. In case of overdose, there is no specific antidote, and treatment based on symptoms is necessary. This medication should be stored out of reach of children and kept in its original container to maintain quality.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory decrease, sensory abnormalities, tinnitus, constipation, diarrhea, dyspepsia, abdominal distension, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorder, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, diaphoresis, 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 reactions, diplopia, temporary or permanent hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased bowel movement, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevated total serum protein, elevated total bilirubin, elevated LAP, loss of appetite, fatigue, brown urine, increased liver enzyme levels, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reactions, exfoliative dermatitis, leukocyte destructive vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein reaction, positive urine glucose reaction, 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 reactions, hypertriglyceridemia, tremors, visual disturbances, congestive heart failure, dyspnea, severe hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, desquamative dermatitis, leukocyte destructive vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase levels

This medication should be stored in a tightly closed container to avoid exposure to air and moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

White or pale yellow rectangular tablet

Package unit

Proprietary packaging unit