Medication info
Itraconazole Tablet (Itraconazole Solid Dispersion)

Itraconazole Tablet (Itraconazole Solid Dispersion)

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

MFDS item code 202003512 · Approved 2020.05.15 · Insurance code 059000910

Summary

Main use
Treatment of fungal infections of the skin and nails, mucosal and corneal fungal infections, and systemic fungal infections
Who uses it
Adults
Adult dosage
It is preferable to take this medicine immediately after a meal. Vulvovaginal candidiasis: Take itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Tinea versicolor: Take 200 mg once daily for 7 days. Tinea corporis and tinea cruris: Take 100 mg once daily for 15 days. Tinea manuum (interdigital) and tinea pedis (interdigital): Take 100 mg once daily for 15 days. Tinea manuum (palmar) and tinea pedis (plantar): Take 100 mg once daily for 30 days or 200 mg twice daily for 7 days. Oral candidiasis: Take 100 mg once daily for 15 days. Fungal keratitis: Take 200 mg once daily for 21 days. Onychomycosis, pulse therapy: Take 200 mg twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles for fingernail infection only, and up to 3 cycles for toenail infection. Onychomycosis, continuous therapy: Take 200 mg once daily for 3 months. In patients with reduced immune function, such as those with neutropenia or AIDS or those who have undergone organ transplantation, 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.

Ingredients

Manufacturer
KS Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of fungal infections of the skin and nails, mucosal and corneal fungal infections, and systemic fungal infections

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

This medication is used for various skin and mucosal fungal infections, including candidal vaginitis, tinea versicolor, and dermatophyte infections such as tinea corporis, tinea capitis, tinea manuum, and tinea pedis. It is also effective for oropharyngeal candidiasis, fungal keratitis, and onychomycosis. Additionally, it is used in the treatment of systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. This medication helps improve and treat symptoms caused by various forms of fungal infections.

Dosage and Administration

Adult dosage

It is preferable to take this medicine immediately after a meal. Vulvovaginal candidiasis: Take itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Tinea versicolor: Take 200 mg once daily for 7 days. Tinea corporis and tinea cruris: Take 100 mg once daily for 15 days. Tinea manuum (interdigital) and tinea pedis (interdigital): Take 100 mg once daily for 15 days. Tinea manuum (palmar) and tinea pedis (plantar): Take 100 mg once daily for 30 days or 200 mg twice daily for 7 days. Oral candidiasis: Take 100 mg once daily for 15 days. Fungal keratitis: Take 200 mg once daily for 21 days. Onychomycosis, pulse therapy: Take 200 mg twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles for fingernail infection only, and up to 3 cycles for toenail infection. Onychomycosis, continuous therapy: Take 200 mg once daily for 3 months. In patients with reduced immune function, such as those with neutropenia or AIDS or those who have undergone organ transplantation, 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.

Precautions

This medication should be used with caution in patients with poor heart function, especially those with a history of congestive heart failure or impaired ventricular function as it may pose life-threatening risks. Patients with allergic reactions to this medication or hypersensitivity to its components should not use it. Severe side effects may occur when taken with certain specific medications, so it should not be combined with cardiac medications, certain analgesics, antiarrhythmics, anticancer drugs, or antipsychotics. Women who are pregnant, possibly pregnant, or breastfeeding should not take this medication, and if there is a chance of pregnancy, effective contraceptive measures should be taken after discontinuation of the drug until the next menstrual period. Patients with liver dysfunction should have regular liver function tests when using this medication, and it is advisable to avoid its use if there is a high risk of liver damage. Patients with decreased kidney function may also require careful dose adjustment. This medication may rarely cause side effects such as headache, nausea, abdominal pain, liver function abnormalities, skin rash, etc., and immediate consultation with medical personnel is necessary if there are any abnormal symptoms. Dizziness, vision or hearing disturbances may occur during treatment, so caution is needed when driving or operating machinery. This medication may not be well-absorbed in low acidity states, so patients taking acid-reducing medications may benefit from taking it with acidic beverages. There is no specific antidote in cases of overdose, so it is important to adhere to recommended dosages and avoid excess. Care should be taken when administering this medication to children or the elderly, especially the elderly, to consider potential liver, kidney, and heart function impairments for dose adjustments. This medication should be stored out of reach of children, and kept in its original container to prevent degradation or misuse.

Side effects

Decreased myocardial contractility, ventricular arrhythmia, QT prolongation, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory disturbance, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, abdominal distension, vomiting, abnormal liver function, hyperbilirubinemia, itching, rash, urticaria, pollakiuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, 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 blood urea, increased gamma-glutamyl transferase, elevated liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, vasogenic edema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular extrasystole, atrial block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, loss of appetite, malaise, dark urine, mucosal membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, phototoxic reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein reaction, positive urine sugar reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increased serum triglyceride levels, flushing, increased serum uric acid levels, elevated serum potassium levels, transient asymptomatic decrease in left ventricular ejection fraction, heart failure, decreased cardiac output, deep vein thrombosis, difficulty breathing, acute liver failure, 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 sealed container that does not allow air to pass through, and it is recommended to be kept at a temperature between 1 and 30 degrees Celsius. This will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

White or pale yellow 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.

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.