Medication info

Itconal Tablets (Itraconazole Solid Dispersion)

Prescription medicationTabletExpired
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
Boryung Biopharma Co., Ltd.
Appearance
White or pale yellow round film-coated tablets
Packaging
28 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201907838 · Approved 2019.11.08

This product's status changed to Expired on 2024.11.08. 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, oral, and corneal fungal infections, 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 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: 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 of the fingernails only, and up to 3 cycles for infection of the toenails. Toenails (with or without concurrent fingernail infection): 1 week on treatment, 2 weeks off treatment, 3 weeks on treatment, 4 weeks off treatment, 5 weeks on treatment Fingernails: 1 week on treatment, 2 weeks off treatment, 3 weeks on treatment 2) Continuous therapy Administer 200 mg once daily for 3 months. 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, mean treatment duration 2~5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100~200mg once daily, mean treatment duration 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily, mean treatment duration 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, mean treatment duration 6 months

Ingredients

Manufacturer
Boryung Biopharma Co., Ltd.

Efficacy & effects

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

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

This medicine is effective against various fungal infections, including candidal vaginitis, tinea versicolor, dermatophytosis caused by Tinea corporis, Tinea capitis, Tinea manuum, and Tinea pedis. It is also used for the treatment of oral candidiasis and fungal keratitis, as well as onychomycosis. Additionally, it can be utilized for the treatment of systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. This medicine helps in treating fungal infections of the skin, mucous membranes, nails, and systemically. Therefore, it is used to improve and treat the symptoms of various fungal infections.

Dosage and Administration

Adult dosage

This medicine should preferably be administered immediately after meals to increase absorption. 1. Short-term 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: 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 of the fingernails only, and up to 3 cycles for infection of the toenails. Toenails (with or without concurrent fingernail infection): 1 week on treatment, 2 weeks off treatment, 3 weeks on treatment, 4 weeks off treatment, 5 weeks on treatment Fingernails: 1 week on treatment, 2 weeks off treatment, 3 weeks on treatment 2) Continuous therapy Administer 200 mg once daily for 3 months. 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, mean treatment duration 2~5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100~200mg once daily, mean treatment duration 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily, mean treatment duration 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, mean treatment duration 6 months

Precautions

This medicine may pose a life-threatening risk to patients with impaired cardiac function or a history of heart failure, and should not be used in such cases. If symptoms of heart failure occur during administration, use should be immediately discontinued. Patients who are allergic to this medicine or have hypersensitivity reactions to its components should not be treated with it. Additionally, serious side effects may occur when used in combination with certain medications, so it should not be used with contraindicated drugs. This medicine should not be used by pregnant or possibly pregnant women, or nursing mothers. Patients with genetic problems such as lactase deficiency or galactose intolerance should also not take this medicine. Patients with reduced liver function are at increased risk of side effects due to the difficulty in metabolizing this medicine, and should have regular liver function tests and use it cautiously. Dosage adjustments may also be necessary for patients with impaired kidney function. In immunocompromised patients or those with specific infections, the effectiveness of the medication may be diminished, so dosage adjustments should be made according to clinical response. This medicine has a high potential for drug interactions, so if other medications are being taken, consultation with a healthcare provider is essential. Symptoms such as dizziness, visual impairment, and hearing loss may occur during treatment, so caution is needed when driving or operating machinery. Patients should inform healthcare providers immediately of any abnormal symptoms such as liver dysfunction, skin rash, swelling, or heart problems during treatment. Children and the elderly may have limited safety data for this medicine, thus requiring special attention. There are no specific antidotes for overdose, so appropriate treatment should be sought promptly at a medical facility.

Side effects

Decreased myocardial contractility, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disturbance, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, neutropenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech difficulties, cough, gastrointestinal disturbance, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, kidney disorder, urinary incontinence, generalized edema, facial swelling, 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, elevated liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular ectopic beats, atrial block, palpitations, increased bowel movement, belching, glossitis, stomatitis, abdominal pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, appetite loss, malaise, brown urine, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, alopecia, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, flushing, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, hearing loss, congestive heart failure, dyspnea, pancreatitis, severe hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, alopecia, photosensitivity, increased serum creatine phosphokinase

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

Storage

This medicine should be stored in a tightly sealed container to prevent air from entering, and it is recommended to keep it at room temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness and safety of the medicine.

Appearance and packaging

Appearance

White or pale yellow round film-coated tablets

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.