Medication info
Triazole Tablets (Itraconazole Solid Dispersion)

Triazole Tablets (Itraconazole Solid Dispersion)

Prescription medicationTablet
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
Teragen Etex Co., Ltd.
Appearance
White or pale yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201504954 · Approved 2015.07.20 · Insurance code 698505080

Summary

Main use
Treatment of fungal infections of the skin and nails, vaginal, oral, and corneal fungal infections, and systemic fungal infections
Who uses it
Adults
Adult dosage
It is preferable to administer immediately after a meal. Candidal vaginitis: Administer itraconazole 200 mg per dose twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Tinea versicolor: Administer 200 mg once daily for 7 days. Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. Tinea manuum (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. Tinea manuum (palmar), tinea pedis (plantar): Administer 100 mg once daily for 30 days or 200 mg per dose 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. Administer 200 mg per dose twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles if only the fingernails are infected and up to 3 cycles if the toenails are infected. Administer 200 mg once daily for 3 months. The therapeutic effect continues for 3 months after the end of treatment for fingernails and 6 months for toenails. In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, 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 the dose 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 Etex Co., Ltd.

Efficacy & effects

Treatment of fungal infections of the skin and nails, vaginal, oral, and corneal fungal infections, and systemic fungal infections

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

This medicine treats fungal infections such as candidal vaginitis and oral candidiasis. It is also effective for various skin mycoses caused by tinea, including tinea corporis, tinea capitis, tinea manuum, and tinea pedis. It is used in the treatment of onychomycosis and fungal keratitis, and assists in the treatment of systemic fungal infections like aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. This drug is widely used in the treatment of various fungal infection diseases.

Dosage and Administration

Adult dosage

It is preferable to administer immediately after a meal. Candidal vaginitis: Administer itraconazole 200 mg per dose twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Tinea versicolor: Administer 200 mg once daily for 7 days. Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. Tinea manuum (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. Tinea manuum (palmar), tinea pedis (plantar): Administer 100 mg once daily for 30 days or 200 mg per dose 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. Administer 200 mg per dose twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles if only the fingernails are infected and up to 3 cycles if the toenails are infected. Administer 200 mg once daily for 3 months. The therapeutic effect continues for 3 months after the end of treatment for fingernails and 6 months for toenails. In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, 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 the dose 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 drug should be used with caution in patients with diminished cardiac function, especially those with congestive heart failure, as it may be life-threatening. Patients with allergic reactions to this drug or hypersensitivity to its components should not use it. This drug has significant interactions with several other medications, and concomitant use with certain drugs may intensify side effects or diminish efficacy, hence there are many contraindicated medications. Pregnant women, women who may become pregnant, or nursing mothers should not use this drug, and effective contraception should be ensured after taking the drug if pregnancy is planned. Patients with genetic issues such as lactose intolerance should not take this drug. Patients with poor liver function or those at risk for hepatotoxicity should regularly undergo liver function tests while taking this drug, and dose adjustment may be necessary as required. Patients with impaired kidney function may also require caution regarding dose adjustment. Patients with weakened immune systems, such as AIDS patients or organ transplant recipients, may experience reduced effectiveness of the drug, necessitating dose adjustments based on treatment response. This drug can rarely cause severe liver damage, cardiac problems, neuropathy, allergic reactions, hearing loss, and other side effects, and any unusual symptoms should prompt immediate consultation with a physician. Dizziness, visual disturbances, drowsiness, among other symptoms, may occur during treatment with this drug, necessitating caution when driving or operating machinery. This drug is poorly absorbed in lower acidity; therefore, taking it with acidic beverages is recommended when used with antacids that reduce stomach acidity. In case of overdose, there is no specific antidote, and treatment should be symptomatic as it is not removed by hemodialysis. This drug should be kept out of reach of children and stored in its original container to maintain quality.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, dysesthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, hives, polyuria, erectile dysfunction, menstrual disorders, edema, agranulocytosis, thrombocytopenia, anaphylaxis-like reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, altered mental status, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice impairment, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, excessive sweating, myalgia, arthralgia, renal impairment, 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, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, anorexia, malaise, brown urine, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity, exfoliative dermatitis, leukocyte destructive vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein test, positive urine glucose test, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increased serum triglycerides, flushing, increased serum uric acid, increased serum potassium, serum sickness, angioedema, anaphylaxis reaction, hypertriglyceridemia, tremors, visual impairment, temporary 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, leukocyte destructive 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 or moisture from entering. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. Proper storage will help retain the drug's effectiveness for a long time.

Appearance and packaging

Appearance

White or pale yellow round 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.