Itrozole Tablets (Itraconazole Solid Dispersion)

Adult dose

This medicine should preferably be administered immediately after a meal to increase absorption. Vulvovaginal candidiasis: Administer itraconazole 200 mg per dose, 2 times daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Pityriasis versicolor: Administer 200 mg once daily for 7 days. Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. Tinea manuum (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. Tinea manuum (palmar), tinea pedis (plantar): Administer 100 mg once daily for 30 days or 200 mg per dose, 2 times daily for 7 days. Oropharyngeal candidiasis: Administer 100 mg once daily for 15 days. Fungal keratitis: Administer 200 mg once daily for 21 days. Onychomycosis Pulse therapy: Administer 200 mg per dose, 2 times daily for 1 week, followed by a 3-week drug-free period; this constitutes 1 cycle. Administer up to 2 cycles for infection of the fingernails only and up to 3 cycles for infection of the toenails. Continuous therapy: Administer 200 mg once daily for 3 months. 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, 2～5 months. For invasive or disseminated disease, increase the dose to 200mg per dose, 2 times daily. Candidiasis: 100～200mg once daily, 3 weeks～7 months. Cryptococcal meningitis: 200mg 2 times daily, 2 months～1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, 6 months. To increase absorption, do not administer 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. 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 taking it for an additional 1 week. 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 taking it for an additional 2 weeks. Do not use 400 mg daily for more than 14 days, even if symptoms have not improved.

Child dose

Prevention of fungal infections: Administer 5 mg/kg of body weight per day in 2 divided doses.

This medication can be life-threatening in patients with compromised heart function or a history of heart failure, and should not be administered unless for the treatment of serious infections. If symptoms of congestive heart failure appear, treatment should be stopped immediately. Patients with hypersensitivity to this drug or allergies to its ingredients should not take it. Additionally, this drug should be avoided in conjunction with certain medications, as they can dangerously increase blood concentration or worsen side effects. It is safest not to use this drug during pregnancy or if there is a possibility of pregnancy, as well as for nursing mothers. Patients with genetic metabolic disorders such as lactose intolerance should not take this drug. Patients with impaired liver or kidney function should use this drug with caution and should have liver function tests conducted regularly. Dose adjustment may be necessary in immunocompromised patients or those with specific diseases. This drug can rarely cause severe liver damage, heart problems, allergic reactions, neurological abnormalities, hearing loss, among other side effects, so if any abnormal symptoms arise, consult a healthcare provider immediately. Furthermore, since this drug interacts with many other drugs, it is essential to inform healthcare providers of any other medications being taken. Caution is needed while driving or operating machinery as dizziness or visual disturbances may occur. In case of overdose, there is no specific antidote, and proper treatment must be received immediately at a hospital, as this drug is not removed by hemodialysis. 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 disorders, sensory loss, sensory abnormalities, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremors, 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 dysfunction, 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, visual impairment, hearing loss, ventricular extrasystole, atrial block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal and lower back pain, pancreatitis, elevated serum total protein, elevated total bilirubin, increased LAP, loss of appetite, lethargy, brown urine, increased liver enzyme levels, Stevens-Johnson syndrome, toxic epidermal necrolysis, Reye's syndrome, erythema multiforme, hair loss, photosensitivity, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, flushing, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremors, blurred vision, congestive heart failure, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, increased serum creatine phosphokinase

This medication must be stored in a sealed container to prevent air exposure. Additionally, it is advisable to keep the drug in a cool place at room temperature between 1 to 30 degrees Celsius.

Appearance

Round film-coated tablet, white or light yellow in color

Package unit

28 tablets/bottle, 100 tablets/bottle