Shinshin Itraconazole Tablets 100 mg (Itraconazole Solid Dispersion)

Adult dosage

To improve absorption, this medicine should preferably be administered immediately after a meal. 1. Short-term treatment 1) Candidal vaginitis: 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, tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea manus (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manus (palmar), 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 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. Toenails (with or without concomitant fingernail infection): 1 week of treatment, 2 weeks off, 3 weeks of treatment, 4 weeks off, 5 weeks of treatment Fingernails: 1 week of treatment, 2 weeks off, 3 weeks of treatment Or 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, AIDS, or organ transplantation, 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 to 200mg twice daily. Candidiasis: 100～200mg once daily, 3 weeks～7 months. Cryptococcal meningitis: 200mg twice daily, 2 months～1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, 6 months.

This medication may pose a life-threatening risk to patients with compromised heart function or a history of heart failure, so it should be used cautiously only when necessary. Patients who have had allergic reactions to this medication or are taking specific heart-related drugs should not use this medication. Patients with impaired liver function or kidney function issues should have their liver and kidney functions closely monitored while receiving this medication, and dosage adjustments may be necessary. This medication can interact with various other drugs, so it is crucial to inform healthcare providers if any other medications are being taken, especially when used in conjunction with heart, anticoagulant, anticancer, or antipsychotic medications. Women who are pregnant or may become pregnant, as well as nursing mothers, should not use this medication, and effective contraceptive measures should be utilized after discontinuation if pregnancy is possible. Since this medication is primarily metabolized in the liver, patients with liver dysfunction should undergo regular liver function tests, and immediate discontinuation is necessary if any signs of liver toxicity appear. Dizziness, vision disturbances, or hearing loss may occur during the use of this medication, so caution is needed when driving or operating machinery. It should be given cautiously to children and the elderly, particularly elderly patients considering potential impairments in liver, kidney, and heart functions and any accompanying diseases for dosage adjustments. There is no specific antidote for overdose, so symptomatic treatment appropriate to the symptoms is essential. This medication should be stored out of the reach of children, and it is safer not to transfer it to another container from the original packaging.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, sensory abnormality, tinnitus, constipation, diarrhea, indigestion, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorder, edema, granulocytopenia, thrombocytopenia, anaphylactic-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorder, cough, gastrointestinal disturbance, 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, elevated blood urea, increased gamma-glutamyl transferase, elevated liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, transient hearing loss, permanent hearing loss, ventricular premature contraction, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, increased serum total protein, elevated total bilirubin, elevated LAP, loss of appetite, lethargy, brown urine, mucosal membrane 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 proteinuria, positive glucosuria, decreased libido, sleepiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, burning sensation, elevated serum uric acid, elevated serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, Steven-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase activity

This medication should be stored in a tightly sealed container to prevent air ingress, and it is best kept at room temperature between 1 to 30 degrees Celsius. This will help maintain the drug's effectiveness for a longer period.

Appearance

White or yellowish round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle