Medication info
Itrawon 100mg (Itraconazole Solid Dispersion)

Itrawon 100mg (Itraconazole Solid Dispersion)

Prescription medicationTablet
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
Optus Pharmaceutical Co., Ltd.
Appearance
Round film-coated tablets that are white or light yellow in color
Packaging
28 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201707371 · Approved 2017.10.11 · Insurance code 674101670

Summary

Main use
Treatment of skin and nail fungal infections, vaginal, oral, and corneal fungal infections, and systemic fungal infections
Who uses it
Adults
Adult dosage
Administration immediately after a meal is recommended. 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) 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 manus (interdigital) and tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manus (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 drug-free interval; 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, such as those with neutropenia, AIDS, or organ transplant recipients, the oral bioavailability of this medicine may be reduced; if necessary, increase the dose 2-fold. 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 for cryptococcal meningitis: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months.

Ingredients

Manufacturer
Optus Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of skin and nail fungal infections, vaginal, oral, and corneal fungal infections, and systemic fungal infections

  • Candidal vaginitis
  • tinea
  • dermatophyte infections such as tinea corporis
  • tinea cruris
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • tinea of the hands
  • onychomycosis
  • aspergillosis
  • candidiasis
View approved original text

This medication is used to treat various fungal infections including candidal vaginitis, tinea, various types of dermatophyte infections, oral candidiasis, fungal keratitis, onychomycosis, and others caused by fungi, such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. Since these infections are all caused by fungi, this drug helps inhibit the growth of the fungi and alleviate the symptoms of infection. Therefore, it is widely used for the treatment of fungal infections of the skin, mucous membranes, and systemic infections.

Dosage and Administration

Adult dosage

Administration immediately after a meal is recommended. 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) 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 manus (interdigital) and tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manus (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 drug-free interval; 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, such as those with neutropenia, AIDS, or organ transplant recipients, the oral bioavailability of this medicine may be reduced; if necessary, increase the dose 2-fold. 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 for cryptococcal meningitis: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months.

Precautions

This medication can pose potentially life-threatening risks to patients with compromised cardiac function or a history of heart failure, and should not be used unless it's for the treatment of serious infections. It should not be administered to patients who have allergic reactions to this drug, have specific heart conditions, or are taking various medications that may interact dangerously with this drug. It is safer not to use this medication in pregnant or potentially pregnant women and nursing mothers. Patients with impaired liver or kidney function, as well as those with weakened immune systems, should be carefully monitored when using this medication, and dosage adjustments may be necessary. This drug can cause various serious side effects; therefore, any symptoms such as headache, nausea, abdominal pain, as well as rare instances of liver dysfunction, heart problems, or allergic reactions should be reported to healthcare professionals immediately. This drug can cause significant drug interactions, so if the patient is taking other medications, they must inform their healthcare provider, especially if the medications include cardiac drugs, anticoagulants, antineoplastics, or sedatives. Regular liver function tests should be conducted during treatment to ensure that no liver issues arise, and if any unusual symptoms occur, the medication should be discontinued immediately and a doctor consulted. This drug is not well absorbed in low acidity conditions, so if the patient is taking medications that reduce stomach acid, it is recommended to take this medication with acidic beverages. Caution is needed when driving or operating machinery, as dizziness, vision impairment, or hearing loss may occur. In case of overdose, there is no specific antidote, so symptomatic treatment is important; this drug is not removed by dialysis. Children and the elderly should use this medication with special care; for children, it should only be used when necessary as the safety has not been established. This drug should be kept out of reach of children and stored in its original container to maintain quality.

Side effects

Decreased myocardial contractility, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, indigestion, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, pollakiuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylaxis-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 disorder, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal dysfunction, 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 serum urea, increased gamma-glutamyl transferase, increased liver enzymes, abnormal urinalysis, increased leukocytes, increased eosinophils, anemia, vascular edema, serum sickness, angioneurotic edema, anaphylaxis, anaphylactic shock, allergic reaction, double vision, visual impairment, hearing loss, ventricular ectopic beats, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, decreased appetite, lethargy, brown urine, increased liver enzyme levels, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein reaction, positive urine sugar reaction, decreased libido, drowsiness, lethargy, shoulder stiffness, insomnia, chest pain, increased serum triglyceride levels, flushing, increased serum uric acid levels, increased serum potassium levels, serum sickness, angioneurotic edema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, temporary hearing loss, permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase levels

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is advisable to maintain storage temperatures between 1°C and 30°C. This helps to retain the medication's effectiveness over time.

Appearance and packaging

Appearance

Round film-coated tablets that are white or light yellow in color

Package unit

28 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.