Medication info

Trazone Tablet (Itraconazole)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Itraconazole›100mg / 1 tablet
Manufacturer / importer
Teragen Inc.
Appearance
White to off-white oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201310206 · Approved 2013.11.20

This product's status changed to Approval withdrawn on 2025.04.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of skin and nail fungal infections, vaginal and oral candidiasis, fungal keratitis, and systemic fungal infections
Who uses it
Adults
Adult dosage
This medicine should preferably be administered immediately after meals to increase absorption. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after discontinuation. Therefore, it is advisable to assess the final clinical and mycological response 2~4 weeks after completing the prescribed 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 (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 type), tinea pedis (plantar type): 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 of the fingernails and toenails 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. 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 ends. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplants, the oral bioavailability of this medicine may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily for 2~5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100~200mg once daily for 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily for 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily for 6 months.

Ingredients

Manufacturer
Teragen Inc.

Efficacy & effects

Treatment of skin and nail fungal infections, vaginal and oral candidiasis, fungal keratitis, and systemic fungal infections

  • Candidal vulvovaginitis
  • tinea versicolor
  • dermatophyte infections such as tinea corporis
  • tinea cruris
  • tinea manus
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medication is used to treat various skin fungal infections such as candidal vulvovaginitis, tinea versicolor, and dermatophyte infections like tinea corporis, tinea cruris, tinea manus, and tinea pedis. It is also effective for oral candidiasis and fungal keratitis, as well as onychomycosis. This medication can also be applied to systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis to improve fungal infections.

Dosage and Administration

Adult dosage

This medicine should preferably be administered immediately after meals to increase absorption. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after discontinuation. Therefore, it is advisable to assess the final clinical and mycological response 2~4 weeks after completing the prescribed 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 (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 type), tinea pedis (plantar type): 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 of the fingernails and toenails 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. 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 ends. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplants, the oral bioavailability of this medicine may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily for 2~5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100~200mg once daily for 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily for 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily for 6 months.

Precautions

This medication can be life-threatening to patients with congestive heart failure, so it should not be used unless for the treatment of severe infections. If symptoms of heart failure develop during treatment, usage must be stopped immediately. Patients who are allergic to this medication or who have a history of impaired heart function should not take it. Additionally, serious side effects can occur with certain medications, so it is essential to consult a physician. It is safest for pregnant women or women who might become pregnant and those who are breastfeeding to avoid using this medication. Patients with impaired liver function should have regular liver function tests, as this medication can worsen liver damage, and dosage adjustments may be necessary. Caution is also necessary for patients with impaired kidney function, as dosage adjustments should be considered. This medication has many drug interactions, and concomitant administration may increase side effects or alter therapeutic effects, so all medications being taken should be reported to healthcare professionals. Symptoms such as dizziness, vision disturbances, and hearing loss can occur during administration, so caution is needed when driving or operating machinery. In the event of overdose, there is no specific antidote, so one should seek immediate medical attention for appropriate treatment. This medication should be stored out of the reach of children and kept in its original container to prevent degradation of quality.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory disturbance, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, 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, dysphonia, cough, gastrointestinal disorder, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, kidney impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular premature contractions, atrial block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, anorexia, malaise, brown urine, elevated liver enzyme levels, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Reiel syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, malaise, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, burning sensation, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylactic response, hypertriglyceridemia, tremor, visual impairment, transient or permanent hearing loss, 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 activity

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

Storage

This medication should be stored in a sealed container to prevent air ingress, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy and safety of the medication.

Appearance and packaging

Appearance

White to off-white oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.