Medication info
Tracon Tablet (Itraconazole Solid Dispersion)

Tracon Tablet (Itraconazole Solid Dispersion)

Prescription medicationTabletOral
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
Daewong Bio Co., Ltd.
Appearance
Round film-coated tablet, white or light yellow
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200713887 · Notified 2007.12.31 · Insurance code 694000420

Summary

Main use
Treatment of skin and nail fungal infections, mucosal and corneal fungal infections, and systemic fungal infections
Who takes it
Adults
Adult dose
For improved absorption, this medicine should preferably be administered immediately after a meal. Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Pityriasis versicolor: Administer 200 mg once daily for 7 days. Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. Tinea manuum (interdigital type), tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. Tinea manuum (palms), tinea pedis (soles): Administer 100 mg once daily for 30 days, or 200 mg twice daily for 7 days. Oral candidiasis: Administer 100 mg once daily for 15 days. Fungal keratitis: Administer 200 mg once daily for 21 days. Intermittent treatment of onychomycosis: Administer 200 mg twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes one cycle. Administer up to 2 cycles if only the fingernails are infected, and up to 3 cycles if the toenails are infected. Continuous treatment of onychomycosis: Administer 200 mg once daily for 3 months. In patients with impaired immune function, such as those with neutropenia, AIDS, or an organ transplant, the oral bioavailability of this medicine may be reduced; if necessary, increase the dose twofold. 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. To improve absorption, do not administer this medicine with food. 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. Oral and esophageal candidiasis resistant to fluconazole: 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. Do not use 400 mg per day for more than 14 days, even if symptoms have not improved. Prevention of fungal infections: Administer 5 mg per kg of body weight per day in 2 divided doses.

Ingredients

Manufacturer
Daewong Bio Co., Ltd.

Efficacy & effects

Treatment of skin and nail fungal infections, mucosal and corneal fungal infections, and systemic fungal infections

  • Candidiasis
  • tinea versicolor
  • tinea corporis
  • tinea capitis
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This drug is used to treat various fungal infections. It is effective for skin mycoses such as candidiasis, tinea versicolor, tinea corporis, tinea manuum, and tinea pedis. It is also used for treating oral candidiasis and fungal keratitis, as well as onychomycosis. For systemic fungal infections, it is applicable for aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. The liquid form is particularly used for treating oral and esophageal candidiasis in HIV-positive patients or immunosuppressed patients, and for preventing deep-seated fungal infections in patients like those with neutropenia. This drug effectively treats and prevents various fungal infections.

How to take

Adult dose

For improved absorption, this medicine should preferably be administered immediately after a meal. Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Pityriasis versicolor: Administer 200 mg once daily for 7 days. Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. Tinea manuum (interdigital type), tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. Tinea manuum (palms), tinea pedis (soles): Administer 100 mg once daily for 30 days, or 200 mg twice daily for 7 days. Oral candidiasis: Administer 100 mg once daily for 15 days. Fungal keratitis: Administer 200 mg once daily for 21 days. Intermittent treatment of onychomycosis: Administer 200 mg twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes one cycle. Administer up to 2 cycles if only the fingernails are infected, and up to 3 cycles if the toenails are infected. Continuous treatment of onychomycosis: Administer 200 mg once daily for 3 months. In patients with impaired immune function, such as those with neutropenia, AIDS, or an organ transplant, the oral bioavailability of this medicine may be reduced; if necessary, increase the dose twofold. 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. To improve absorption, do not administer this medicine with food. 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. Oral and esophageal candidiasis resistant to fluconazole: 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. Do not use 400 mg per day for more than 14 days, even if symptoms have not improved. Prevention of fungal infections: Administer 5 mg per kg of body weight per day in 2 divided doses.

Precautions

This drug can be dangerous for patients with reduced heart function, especially those with congestive heart failure, so it should not be used in these patients. If signs of heart failure appear during treatment with this drug, administration should be stopped immediately and a doctor should be consulted. Patients with allergies to this drug or those who have had hypersensitivity reactions to its components should not use it. Additionally, this drug can cause serious side effects when taken with certain medications, so patients must inform their doctor or pharmacist about all medications they are currently taking. It is safest for women who are pregnant or may become pregnant, and those who are breastfeeding, to avoid this medication. Patients with impaired liver or kidney function should exercise caution when using this drug and regular liver function tests are recommended. This drug can rarely cause severe liver damage, allergic reactions, neurological abnormalities, and hearing loss, so medical consultation should be sought if symptoms appear. Caution is needed when driving or operating machinery, as dizziness, blurred vision, and hearing loss may occur. This drug may not be well absorbed in conditions of low acidity, so if taking medications that reduce acidity, it may help to take it with acidic beverages. In case of overdose, specific antidotes are not available, so immediate medical treatment should be sought. Use in children, the elderly and patients with compromised immune functions should be evaluated after consulting a doctor.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusional state, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorders, cough, gastrointestinal disorders, hepatic failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, kidney 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 blood urea, increased gamma-glutamyl transferase, increased liver enzymes, abnormal urinalysis, increased white blood cell count, increased eosinophils, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, temporary or permanent hearing loss, ventricular ectopic beats, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal lumbar pain, pancreatitis, increase in serum total protein, increase in total bilirubin, increase in LAP, appetite loss, malaise, dark urine, increased liver enzyme levels, mucocutaneous 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 urinary protein test, positive urinary glucose test, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increased serum triglycerides, flushing, increased serum uric acid, increased serum potassium, serum sickness, angioedema, anaphylactic response, hypertriglyceridemia, tremors, 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

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

Storage

This drug should be stored in a tightly sealed container to prevent air and moisture from entering, and should be kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Round film-coated tablet, white or light yellow

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.