Altrazole Tablet (Itraconazole Solid Dispersion)

Adult dose

(Tablets)(Capsules) It is preferable to administer immediately after meals. 1. Short-term 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) Tinea 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 manuum (interdigital) and tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palmar) and tinea pedis (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 period; this constitutes 1 cycle. Administer up to 2 cycles for infection limited to the fingernails and up to 3 cycles for infection involving the toenails. 2) Continuous therapy: Administer 200 mg once daily for 3 months. 3. Systemic fungal infections In patients with impaired immune function, the dose may be doubled 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) Do not administer with food. Hold this medicine in the mouth for approximately 20 seconds to ensure contact with 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 response after 1 week, continue for 1 additional week. 2. Oral and esophageal candidiasis resistant to fluconazole Take 200～400 mg (20～40 mL) daily in 1～2 divided doses for 2 weeks. If there is no response after 2 weeks, continue for 2 additional weeks. Even if symptoms do not improve, do not use 400 mg daily for more than 14 days. 3. Prevention of fungal infections Administer 5 mg/kg body weight daily in 2 divided doses. Prophylaxis was started immediately before chemotherapy and approximately 1 week before bone marrow transplantation. Treatment was continued until the neutrophil count recovered (1,000/μL).

This medication can be life-threatening for patients with impaired heart function, especially those with congestive heart failure. It should not be administered unless for the treatment of serious infections. If symptoms of heart failure develop while taking this medication, it should be discontinued immediately. This medication can cause serious side effects when taken with certain drugs, so it should not be used in conjunction with contraindicated medications. Patients with allergic reactions to this medication or hypersensitivity to its components should not use it. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication, and women of childbearing potential should use effective contraception after taking it. Patients with impaired liver function or a history of hepatotoxicity should undergo regular liver function tests while on this medication, and treatment should be avoided if there is a high risk of liver damage. Patients with reduced kidney function also need dose adjustments, so they should follow their physician's instructions. Due to numerous interactions with various drugs, it is essential to inform healthcare professionals if other medications are being taken, especially heart medications, anticoagulants, analgesics, anticancer drugs, and antipsychotics. This medication may not be absorbed well in a low-acid environment, so it is advisable to take it with acidic beverages if gastrointestinal acid-reducing medications are being used. If headaches, nausea, abdominal pain, rash, swelling, hearing difficulties, or heart abnormalities occur, consult a healthcare professional immediately. Caution should be taken when driving or operating machinery due to possible dizziness, vision impairment, or hearing loss as side effects. In case of overdose, there is no specific antidote, and symptomatic treatment should be sought immediately at a medical facility. This medication should be kept out of reach of children and stored in its original packaging to prevent deterioration and misuse.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disturbance, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, abnormal liver function, hyperbilirubinemia, itching, rash, urticaria, frequent urination, erectile dysfunction, menstrual disorders, edema, agranulocytosis, thrombocytopenia, anaphylaxis-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, 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, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, elevated alanine aminotransferase, elevated aspartate aminotransferase, increased serum alkaline phosphatase, increased serum lactate dehydrogenase, increased serum urea, elevated gamma-glutamyl transferase, increased liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioneurotic edema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular ectopic beats, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and flank pain, pancreatitis, elevated serum total protein, elevated total bilirubin, increased LAP, anorexia, malaise, brown urine, increased liver enzyme levels, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel 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, insomnia, shoulder stiffness, chest pain, elevated serum triglycerides, burning sensation, elevated serum uric acid, elevated serum potassium, serum sickness, angioneurotic edema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, dyspnea, severe hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, increased serum creatine phosphokinase

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1°C and 30°C. This helps to preserve the efficacy and safety of the medication for an extended period.

Appearance

White or yellowish round film-coated tablet

Package unit

30 tablets/bottle