Medication info
Icnox 100 mg Tablets (Itraconazole Solid Dispersion)

Icnox 100 mg Tablets (Itraconazole Solid Dispersion)

Prescription medicationTablet
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
Hanpoong Pharmaceutical Co., Ltd.
Appearance
White or yellowish white round film-coated tablet
Packaging
28 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201905813 · Approved 2019.08.19 · Insurance code 658107140

Summary

Main use
Treatment of fungal infections of the skin and nails, fungal infections of the mucous membranes and cornea, and systemic fungal infections
Who uses it
Adults
Adult dosage
For improved absorption, this medicine should preferably be administered 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 completion of 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), tinea pedis (interdigital): 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 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 3 weeks without treatment; this constitutes 1 cycle. Administer up to 2 cycles for infection limited to the fingernails and up to 3 cycles for infection of the toenails. Sites of onychomycosis 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 Or 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 the end of treatment. 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, double the dose. 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: 200mg once daily Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months

Ingredients

Manufacturer
Hanpoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of fungal infections of the skin and nails, fungal infections of the mucous membranes and cornea, and systemic fungal infections

  • Candidiasis
  • tinea versicolor
  • tinea corporis due to dermatophytes
  • tinea cruris
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medication is used for the treatment of fungal diseases such as candidiasis, tinea versicolor, various dermatophyte infections (tinea corporis, tinea cruris, tinea manuum, tinea pedis), oral candidiasis, fungal keratitis, and onychomycosis. It is also effective for systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. This medication treats infections caused by various types of fungi, improving symptoms and aiding in recovery.

Dosage and Administration

Adult dosage

For improved absorption, this medicine should preferably be administered 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 completion of 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), tinea pedis (interdigital): 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 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 3 weeks without treatment; this constitutes 1 cycle. Administer up to 2 cycles for infection limited to the fingernails and up to 3 cycles for infection of the toenails. Sites of onychomycosis 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 Or 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 the end of treatment. 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, double the dose. 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: 200mg once daily Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months

Precautions

This medication should not be used in patients with weakened heart function or a history of congestive heart failure unless the situation is life-threatening. If symptoms of heart failure occur during treatment with this medication, it should be discontinued immediately. Patients who have had allergic reactions to this medication or who are sensitive to its ingredients should not take it. Additionally, this medication may cause serious side effects when taken with certain other drugs, so it is essential to consult with a doctor or pharmacist to check for contraindicated medications. Women who are pregnant, potentially pregnant, or breastfeeding are advised against using this medication. Patients with genetic issues like lactose intolerance should also avoid this medication. Patients with impaired liver or kidney function need monitoring and dose adjustment when taking this medication, and they should carefully observe for side effects. This medication may cause gastrointestinal and neurological side effects like headache, nausea, abdominal pain, and diarrhea, so consult healthcare providers if symptoms are severe. Caution is needed when using this medication in patients allergic to other azole drugs. There is a risk of dizziness or blurred vision when driving or operating machinery, so caution is necessary. This medication is mainly metabolized in the liver; therefore, regular liver function tests are required for patients with liver disease, and it should be taken under physician guidance due to the risk of hepatotoxicity. Additionally, this medication has many drug interactions, which may require dose adjustments or discontinuation based on concomitant medications, so consulting a specialist is crucial. There is no specific antidote for overdose, and treatment should be symptomatic; it should be kept out of reach of children.

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, anaphylactic reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorder, 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, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, 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 lower back pain, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, loss of appetite, malaise, brown urine, elevated liver enzyme levels, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reaction, 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, elevated serum triglycerides, burning sensation, elevated serum uric acid, elevated serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremors, blurred vision, congestive heart failure, dyspnea, severe hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, increased serum creatine phosphokinase

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture exposure. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage ensures the safety of the medication's effectiveness.

Appearance and packaging

Appearance

White or yellowish white round film-coated tablet

Package unit

28 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.