Oniconazole Tablets (Itraconazole Solid Dispersion)

Adult dosage

(Tablets) (Capsules) It is preferable to administer immediately after a meal. 1. Short-term treatment The final clinical and mycological treatment outcomes should preferably be assessed 2～4 weeks after completion of the prescribed treatment. 1) Candida vaginitis: Administer itraconazole 200 mg per dose 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 (jock itch): Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palm), tinea pedis (sole): Administer 100 mg once daily for 30 days or 200 mg per dose 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 per dose twice daily for 1 week, followed by a 3-week drug-free period. This constitutes one cycle. Treat for up to 2 cycles if only the fingernails are infected and up to 3 cycles if the toenails are infected. 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 treatment is completed. 3. Systemic fungal infections The oral bioavailability of this medication may be reduced in patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients; if necessary, double the dose. Aspergillosis: 200mg once daily, average treatment duration 2～5 months. For invasive or disseminated disease, increase to 200mg per dose 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 take with food. Keep this medication in the mouth for approximately 20 seconds so that it contacts the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the medication remains in the mouth for a prolonged period. 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 for 1 additional 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 for 2 additional weeks. Do not use 400 mg daily for more than 14 days, even if symptoms have not improved.

Children's dosage

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

This drug should not be used in patients with weak heart function, particularly those with congestive heart failure. If symptoms of heart failure appear during treatment, administration must be discontinued immediately. This medication may reduce the contractility of the heart muscle and can be dangerous for individuals with heart conditions. Additionally, those allergic to this medication or who have previously experienced hypersensitivity reactions should not take it. Patients with weakened heart function or a history of heart failure should also avoid using this drug for treating onychomycosis. This drug may cause serious side effects when taken with certain other medications, so always check for contraindicated medications and avoid concurrent use. It is safest for pregnant women or those who may become pregnant, as well as nursing mothers, to refrain from taking this medication. Patients with impaired liver function must undergo regular liver function tests while on this drug and should avoid use if there is a determined risk of liver damage. Patients with compromised kidney function may need to adjust their dosage of this drug, so they should follow physician's instructions. This drug should be administered cautiously to patients who are immunocompromised or have certain systemic fungal infections, and monitoring of drug concentrations in the blood may be performed to assess therapeutic effects. During treatment, symptoms such as headache, nausea, abdominal pain, and diarrhea may occur, and rarely, serious liver damage, skin rash, allergic reactions, and hearing loss may arise, so individuals should consult their physician immediately if any abnormal symptoms occur. Dizziness or visual disturbances may occur during treatment, warranting caution when driving or operating machinery. Patients with low gastric acidity may have decreased absorption of this drug, so taking it with acidic beverages may be beneficial. This medication has many interactions with specific drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist, and avoid contraindicated medications. In cases of overdose, as there is no specific antidote, seek medical attention immediately for appropriate treatment, and this drug is not removed by hemodialysis. Lastly, this medication should be stored out of reach of children and kept in its original container to prevent misuse or quality deterioration.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, sensory abnormalities, tinnitus, constipation, diarrhea, indigestion, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, pollakiuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reactions, 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 disorders, 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, visual impairment, temporary or permanent hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, loss of appetite, malaise, brown urine, reversible elevation of liver enzyme levels, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reactions, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein response, positive urine glucose response, decreased libido, drowsiness, shoulder stiffness, insomnia, chest congestion, elevated serum triglycerides, flushing, 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, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase levels

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, at room temperature between 1 and 30 degrees Celsius. Storing it this way can help maintain its effectiveness for a longer period.

Appearance

White or pale yellow circular film-coated tablet

Package unit

Company packaging unit