Medication info
Itraconazole Tablet (Itraconazole Solid Dispersion)

Itraconazole Tablet (Itraconazole Solid Dispersion)

Prescription medicationTabletOral
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
Ilhwa Co., Ltd.
Appearance
Round film-coated tablets that are white or light yellow in color
Packaging
28 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200500815 · Notified 2005.05.19 · Insurance code 640900820

Summary

Main use
Treatment and prevention of fungal infections of the skin and nails, mucosal and corneal fungal infections, and systemic fungal infections
Who takes it
Adults · Children
Adult dose
(Tablets) (Capsules) It is preferable to administer immediately after meals. 1. Short-term 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) 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 of the hands (interdigital type), tinea of the feet (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea of the hands (palms), tinea of the feet (soles): 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 of the fingernails only, and up to 3 cycles for infection of the toenails. 2) Continuous therapy Administer 200 mg once daily for 3 months. 3. Systemic fungal infections In patients with impaired immune function, double the dose if necessary. Aspergillosis: 200mg once daily, 2~5 months. For invasive or disseminated disease, increase to 200mg per dose twice daily. Candidiasis: 100~200mg once daily, 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily, 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, 6 months. (Oral solution) Do not administer with food. Keep this drug in the mouth for about 20 seconds, allowing it to contact the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the drug remains in the mouth for a longer time. 1. Oral and esophageal candidiasis Take 200 mg (20 mL) daily in 1~2 divided doses for 1 week. If there is no effect after 1 week, continue for 1 more week. 2. Oral and esophageal candidiasis resistant to fluconazole Take 200~400 mg (20~40 mL) daily in 1~2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue for 2 more weeks. Even if symptoms do not improve, do not use 400 mg daily for more than 14 days.
Child dose
Prevention of fungal infections: 5 mg/kg per day, divided into 2 doses.

Ingredients

Manufacturer
Ilhwa Co., Ltd.

Efficacy & effects

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

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

This medication is used to treat localized fungal infections such as candidal vulvovaginitis, tinea versicolor, various tinea infections caused by dermatophytes, oral candidiasis, fungal keratitis, and onychomycosis. It is also effective against systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. The liquid formulation is particularly suitable for treating oral and esophageal candidiasis in HIV-positive individuals or immunocompromised patients and for preventing invasive fungal infections in patients with hematologic malignancies or those undergoing bone marrow transplants. However, please note that there is insufficient clinical efficacy data regarding the prevention of aspergillosis. This medication is used for the treatment and prevention of various fungal infections.

How to take

Adult dose

(Tablets) (Capsules) It is preferable to administer immediately after meals. 1. Short-term 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) 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 of the hands (interdigital type), tinea of the feet (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea of the hands (palms), tinea of the feet (soles): 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 of the fingernails only, and up to 3 cycles for infection of the toenails. 2) Continuous therapy Administer 200 mg once daily for 3 months. 3. Systemic fungal infections In patients with impaired immune function, double the dose if necessary. Aspergillosis: 200mg once daily, 2~5 months. For invasive or disseminated disease, increase to 200mg per dose twice daily. Candidiasis: 100~200mg once daily, 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily, 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, 6 months. (Oral solution) Do not administer with food. Keep this drug in the mouth for about 20 seconds, allowing it to contact the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the drug remains in the mouth for a longer time. 1. Oral and esophageal candidiasis Take 200 mg (20 mL) daily in 1~2 divided doses for 1 week. If there is no effect after 1 week, continue for 1 more week. 2. Oral and esophageal candidiasis resistant to fluconazole Take 200~400 mg (20~40 mL) daily in 1~2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue for 2 more weeks. Even if symptoms do not improve, do not use 400 mg daily for more than 14 days.

Child dose

Prevention of fungal infections: 5 mg/kg per day, divided into 2 doses.

Precautions

This medication may be dangerous for patients with weakened cardiac function, particularly those with congestive heart failure, and it is advisable not to use it in such cases. If signs of heart failure occur while using this medication, administration should be stopped immediately. Patients allergic to this medication or its components should not take it. Moreover, this medication can interact with several other drugs, so care should be taken, especially when taken with certain analgesics, antiarrhythmics, anticoagulants, antihistamines, antineoplastics, antipsychotics, and calcium channel blockers. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication, and if planning to become pregnant, effective contraceptive methods should be used after administration. Patients with impaired liver or kidney function, those with weakened immune systems, and individuals who have previously experienced hepatotoxicity or neuropathy should take special precautions when using this drug and require regular liver function tests and monitoring. Absorption of this medication may be reduced in conditions of low acidity in the stomach; therefore, if taking medications that suppress gastric acid secretion, it is recommended to take it with acidic beverages. Caution is also needed when using this medication in children and the elderly, and dosage adjustments may be necessary. In the case of overdose, there is no specific antidote, so immediate consultation with medical personnel is required, and treatment should be provided according to the symptoms. This medication should be stored out of reach of children and should be kept in its original container for safety.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory 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, anaphylactoid reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, dysphonia, cough, gastrointestinal disorders, hepatic failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, 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 reactions, diplopia, visual impairment, transient hearing loss, permanent hearing loss, ventricular premature contractions, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal flank pain, pancreatitis, elevated serum total protein, elevated total bilirubin, elevated LAP, decreased appetite, malaise, brown urine, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Rielle syndrome, erythema multiforme, hair loss, photosensitivity reactions, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urinalysis for protein, positive urinalysis for glucose, decreased libido, drowsiness, shoulder stiffness, insomnia, chest discomfort, elevated serum triglycerides, warmth, elevated serum uric acid, elevated serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase activity

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

Storage

This medication should be stored in a sealed container that does not allow air intake, and it is recommended to be kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Round film-coated tablets that are white or light yellow in color

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.