Medication info
Itranox Tablet 100 mg (Itraconazole Solid Dispersion)

Itranox Tablet 100 mg (Itraconazole Solid Dispersion)

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

MFDS item code 201502332 · Approved 2015.04.16 · Insurance code 647203920

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
To increase absorption, this medicine should preferably be taken immediately after a meal. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological response should preferably be assessed 2~4 weeks after completing the prescribed course of treatment. 1) Candidal vaginitis: Administer itraconazole 200 mg per dose 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, 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 per dose 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 per dose twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles for infection limited to the fingernails, and up to 3 cycles for toenail infection. Toenails (with or without concomitant fingernail infection): 1 week of treatment, 2 weeks off treatment, 3 weeks of treatment, 4 weeks off treatment, 5 weeks of treatment Fingernails: 1 week of treatment, 2 weeks off treatment, 3 weeks of treatment 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 Oral bioavailability of this medicine may be reduced in patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients; 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
Korea Chorus Co., Ltd.

Efficacy & effects

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

  • Candidiasis
  • tinea
  • dermatophyte-caused tinea corporis
  • tinea cruris
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medication is used to treat fungal infections such as candidiasis and oral candidiasis, as well as tinea and dermatophyte infections including tinea corporis, tinea cruris, tinea manuum, and tinea pedis. It is also effective against various fungal infections such as fungal keratitis and onychomycosis. It can be used for systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. In summary, this drug treats a wide range of fungal diseases from skin and mucosal fungal infections to systemic fungal infections.

Dosage and Administration

Adult dosage

To increase absorption, this medicine should preferably be taken immediately after a meal. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological response should preferably be assessed 2~4 weeks after completing the prescribed course of treatment. 1) Candidal vaginitis: Administer itraconazole 200 mg per dose 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, 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 per dose 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 per dose twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles for infection limited to the fingernails, and up to 3 cycles for toenail infection. Toenails (with or without concomitant fingernail infection): 1 week of treatment, 2 weeks off treatment, 3 weeks of treatment, 4 weeks off treatment, 5 weeks of treatment Fingernails: 1 week of treatment, 2 weeks off treatment, 3 weeks of treatment 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 Oral bioavailability of this medicine may be reduced in patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients; 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 in patients with impaired cardiac function, especially those with congestive heart failure, and should not be used unless for the treatment of serious infections. If symptoms of heart failure occur during treatment with this medication, discontinue use immediately. Patients who are allergic to this medication or have a history of hypersensitivity to its components should not use it. Furthermore, this medication has a high potential for drug interactions and may be contraindicated or require caution when used with certain medications. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication, and effective contraceptive methods should be used after taking it if there is a possibility of pregnancy. Patients with hereditary lactose intolerance should also not take this medication. Patients with reduced liver function may have difficulty metabolizing this medication, increasing the risk of side effects, and should undergo regular liver function tests and carefully follow physician's directions. Patients with weakened kidney function should also be cautious when taking this medication and may require dose adjustments. Immunocompromised patients, such as those with AIDS or organ transplant patients, may have altered responses to this medication, necessitating dose adjustments based on clinical responses. This medication can rarely cause severe liver damage, allergic reactions, neurological issues, heart problems, and hearing loss, so consult a physician immediately if any unusual symptoms occur. Additionally, this medication may not be absorbed well under low acidity conditions, so it is advisable to take it with acidic beverages when taking medications that suppress gastric acid secretion. Caution is needed while driving or operating machinery as dizziness, visual disturbances, and hearing loss may occur. Lastly, this medication must be taken as prescribed by a physician, and potential drug interactions should always be checked if taken with other medications.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disturbance, sensory distortion, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, hives, pollakiuria, erectile dysfunction, menstrual disorders, edema, agranulocytosis, thrombocytopenia, anaphylactoid reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorders, cough, gastrointestinal disturbance, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, increase in alanine aminotransferase, increase in aspartate aminotransferase, increase in serum alkaline phosphatase, increase in lactate dehydrogenase, increase in blood urea, increase in gamma-glutamyl transferase, increase in liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reactions, diplopia, visual impairment, transient hearing loss, permanent hearing loss, ventricular ectopic beats, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, increase in serum total protein, increase in total bilirubin, increase in LAP, decreased appetite, malaise, 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, increase in BUN, positive urine protein test, positive urine glucose test, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increase in serum triglyceride levels, flushing, increase in serum uric acid levels, increase in serum potassium levels, serum sickness, angioedema, anaphylactic response, hypertriglyceridemia, tremor, blurred vision, congestive heart failure, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, increase in serum creatine phosphokinase

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

Storage

This medication should be stored in a tightly sealed container that is air-tight, and it is recommended to keep it at a temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and prevents degradation.

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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.