Oniconazole Tablets 200 mg (Itraconazole Solid Dispersion)

Adult dosage

(Tablets)(Capsules) To improve absorption, this medicine should preferably be taken immediately after meals. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after discontinuation. Therefore, the final clinical and mycological response should preferably be assessed 2～4 weeks after completion of the prescribed course. 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 (jock itch): Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type), tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea manuum (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 3 weeks without treatment; 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. Site of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without concomitant fingernail infection) Treatment No treatment Treatment No treatment Treatment Fingernails Treatment No treatment Treatment Or 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 the end of treatment. 3. Systemic fungal infections 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, increase the dose twofold. Aspergillosis: 200mg once daily; average treatment duration 2～5 months. For invasive or disseminated disease, increase 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) To improve absorption, do not take this medicine with food. Keep this medicine in the mouth for about 20 seconds so that 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) per day in 1～2 divided doses for 1 week. If there is no effect after 1 week, continue for 1 more week. 2. Fluconazole-resistant oral and esophageal candidiasis Take 200～400 mg (20～40 mL) per day in 1～2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue for 2 more weeks. Even if symptoms do not improve, do not use 400 mg daily for more than 14 days. 3. Prevention of fungal infections In clinical trials, prophylactic treatment was initiated immediately before anticancer therapy and approximately 1 week before bone marrow transplant surgery. Deep fungal infections were confirmed in most patients with a neutrophil count below 100/μL. Treatment was continued until the neutrophil count recovered (1,000/μL). Pharmacokinetic values from clinical trials in patients with neutropenia showed considerable interindividual variability. Therefore, monitoring of blood concentrations should be considered, particularly in patients with gastrointestinal damage, patients with diarrhea, and when this medicine is administered for a prolonged period.

Children's dosage

5 mg per kg of body weight per day, administered in 2 divided doses.

Care should be taken when using this drug in patients with weakened cardiac function, as it may worsen cardiac function. It should not be used in patients with a history of congestive heart failure, and if symptoms of heart failure appear during use, administration should be stopped immediately. Patients with allergies to this drug or hypersensitivity to its components should not use it. Serious side effects may occur when taken with certain medications, so it is essential to check and avoid contraindicated drugs. Women who are pregnant or may become pregnant, and nursing mothers should not use this drug. Patients with genetic disorders like lactose intolerance should also avoid taking this drug. Adjustments in dosage may be necessary for patients with reduced liver or kidney function due to its impact on metabolism or excretion, and routine liver function tests should be performed. Patients with weakened immunity or systemic fungal infections also require special caution when using this drug. Side effects such as headache, nausea, abdominal pain, and diarrhea may occur, and rarely liver function abnormalities or skin rashes, neurological symptoms, etc., may arise. If serious allergic reactions or liver damage symptoms occur, medical consultation should be sought immediately. This drug has many drug interactions, so if you are taking other medications, it is crucial to inform your healthcare provider, especially when taken with acid-reducing medications as it may be helpful to take with acidic beverages. Caution is recommended when driving or operating machinery as dizziness or vision disturbances may occur. No specific antidote exists in cases of overdose, so the specified dosage should be strictly adhered to. This drug should be kept out of the reach of children and stored in its original container to maintain quality.

headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, sensory disturbance, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reactions, 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, kidney disorders, urinary 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, temporary or permanent hearing loss, ventricular ectopic beats, atrial block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal flank pain, pancreatitis, increased total serum protein, elevated total bilirubin, increased LAP, loss of appetite, malaise, dark urine, increased 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, positive urine glucose, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, flushing, elevated serum uric acid, increased serum potassium levels, serum sickness, angioedema, anaphylactic reactions, hypertriglyceridemia, visual impairment, congestive heart failure, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, increased serum creatine phosphokinase

This drug should be stored in a tightly closed container to prevent exposure to air or moisture. It is advisable to maintain storage temperature between 1 and 30 degrees Celsius. This will ensure the drug's effectiveness is safely preserved.

Appearance

White or light yellow rectangular film-coated tablets

Package unit

Company packaging unit