Itraconazole Tablets (Itraconazole Solid Dispersion)

Adult dose

(Tablets)(Capsules) It is preferable to administer immediately after a meal. 1. Short-term treatment 1) Candidal vaginitis: Administer 200 mg of itraconazole 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 and tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea of the hands (interdigital) and tinea of the feet (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea of the hands (palmar) and tinea of the feet (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 a 3-week treatment-free interval; 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. 2) Continuous therapy Administer 200 mg once daily for 3 months. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia or AIDS and organ transplant recipients, the oral bioavailability of this medicine may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily; mean treatment duration 2～5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100～200mg once daily; mean treatment duration 3 weeks～7 months. Cryptococcal meningitis: 200mg twice daily; mean treatment duration 2 months～1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily; mean treatment duration 6 months. (Oral solution) Do not administer with food. Hold this medicine in the mouth for approximately 20 seconds to ensure it contacts the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the medicine remains in the mouth for a longer time. 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 taking it for 1 more 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 taking it for 2 more 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 per kg of body weight per day in 2 divided doses.

This medication should not be used in patients with weakened heart function, particularly in those with congestive heart failure or a history thereof, unless life-threatening circumstances arise. If symptoms of heart failure occur while taking this medication, treatment should be stopped immediately. Patients with a known allergy to this drug or with certain heart conditions should not take it. Additionally, this medication can interact with several other drugs, so concurrent use with specific medications is prohibited. Pregnant women, women who may become pregnant, and breastfeeding women should not take this medication. Patients with metabolic disorders such as lactose intolerance should also avoid this drug. Patients with impaired liver or kidney function should use this medication cautiously and have regular liver function tests. This drug may rarely cause serious side effects such as liver damage, neurological problems, heart issues, and allergic reactions, so if any unusual symptoms occur, consulting a healthcare provider immediately is advised. Caution should be exercised regarding drug interactions during treatment, particularly when used with specific analgesics, antiarrhythmics, anticoagulants, anticancer agents, and psychiatric medications. Dizziness, visual disturbances, or hearing loss may occur while taking this drug, thus caution is advised while driving or operating machinery. This medication is not recommended for pregnant or breastfeeding women, and women planning pregnancy should practice reliable contraception while taking it. The use of this drug in children or elderly patients should be decided carefully according to medical judgment. There is no specific antidote for overdose, and it is not removed by dialysis, so care should be taken not to exceed the recommended dose. Finally, this medication should be stored out of the reach of children, and kept in its original container to maintain its quality.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, pollakiuria, erectile dysfunction, menstrual disorder, edema, neutropenia, thrombocytopenia, anaphylactoid 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, erythematous rash, hyperhidrosis, myalgia, arthralgia, kidney disorders, 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 blood urea, increased gamma-glutamyl transferase, increased liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, angioedema, serum sickness, vasculonervous edema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular premature beats, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal retroperitoneal pain, pancreatitis, increased serum total protein, increased total bilirubin, elevated LAP, decreased appetite, lethargy, brown urine, skin-mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riedel's 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, lethargy, shoulder stiffness, insomnia, chest pain, increased serum triglycerides, burning sensation, increased serum uric acid, increased serum potassium, serum sickness, vasculonervous edema, anaphylactic reaction, hyperlipidemia, tremor, visual impairment, transient or permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase

This medication should be stored in a well-closed container that is not exposed to air, and it is best kept at room temperature between 1°C and 30°C. Storing it this way helps maintain the effectiveness of the drug over time.

Appearance

White or off-white round film-coated tablet

Package unit

28 tablets/bottle, 100 tablets/bottle