Medication info

Daewoong Itraconazole Capsule (Itraconazole Solid Dispersion)

Prescription medicationApproval withdrawn
Ingredient · strength
Itraconazole Solid Dispersions›Strength being verified
Manufacturer / importer
Daewoong Pharmaceutical Co., Ltd.
Appearance
An orange hard capsule with a beige upper part containing grayish-white granules in the lower part.
Packaging
Company packaging unit
Approval status
Approval withdrawn

MFDS item code 200400467 · Approved 2004.09.06

This product's status changed to Approval withdrawn on 2023.03.30. 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, mucosal 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 1) Candidal vaginitis: Administer itraconazole 200 mg per dose 2 times 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 and tinea cruris (jock itch): Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type) and tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palms) and tinea pedis (soles): Administer 100 mg once daily for 30 days, or 200 mg per dose 2 times 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 2 times daily for 1 week, followed by a 3-week drug-free interval; this constitutes one 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, such as those with neutropenia, AIDS, or organ transplant recipients, the oral bioavailability of this medicine may be reduced; therefore, if necessary, increase the dose twofold. Aspergillosis: 200 mg once daily; average treatment duration 2–5 months. For invasive or disseminated disease, increase to 200 mg per dose 2 times daily. Candidiasis: 100–200 mg once daily; average treatment duration 3 weeks–7 months. Cryptococcal meningitis: 200 mg 2 times daily; average treatment duration 2 months–1 year. Maintenance therapy: 200 mg once daily. Paracoccidioidomycosis: 100 mg once daily; average treatment duration 6 months

Ingredients

Manufacturer
Daewoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of skin and nail fungal infections, mucosal and corneal fungal infections, and systemic fungal infections

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

This medication is effective against various skin fungal infections such as candidal vaginitis, tinea versicolor, tinea corporis due to dermatophytes, tinea capitis, tinea manuum, and tinea pedis. It is also used for treating oral candidiasis and fungal keratitis, as well as onychomycosis. For systemic fungal infections, it is indicated for aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis, helping to improve systemic fungal infections. Thus, it is utilized in treating diverse skin and systemic fungal diseases, effectively alleviating infection symptoms and supporting health recovery.

Dosage and Administration

Adult dosage

To increase absorption, this medicine should preferably be taken immediately after a meal. 1. Short-term treatment 1) Candidal vaginitis: Administer itraconazole 200 mg per dose 2 times 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 and tinea cruris (jock itch): Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type) and tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palms) and tinea pedis (soles): Administer 100 mg once daily for 30 days, or 200 mg per dose 2 times 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 2 times daily for 1 week, followed by a 3-week drug-free interval; this constitutes one 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, such as those with neutropenia, AIDS, or organ transplant recipients, the oral bioavailability of this medicine may be reduced; therefore, if necessary, increase the dose twofold. Aspergillosis: 200 mg once daily; average treatment duration 2–5 months. For invasive or disseminated disease, increase to 200 mg per dose 2 times daily. Candidiasis: 100–200 mg once daily; average treatment duration 3 weeks–7 months. Cryptococcal meningitis: 200 mg 2 times daily; average treatment duration 2 months–1 year. Maintenance therapy: 200 mg once daily. Paracoccidioidomycosis: 100 mg once daily; average treatment duration 6 months

Precautions

This medication should not be used in patients with compromised heart function or a history of heart failure. If symptoms of heart failure occur during treatment, use should be discontinued immediately. Patients with allergies to this medication or its components, those with reduced heart function, and those taking certain drugs concurrently should avoid use. Caution is especially warranted due to the potential for significant drug interactions. Women who are pregnant, may become pregnant, or are nursing should not use this medication. Patients with impaired liver function or a history of liver toxicity should use this medication with caution and have regular liver function tests. Patients with reduced kidney function may also require dosage adjustments when using this medication. Patients with weakened immune systems, such as those with AIDS or organ transplant recipients, may require dosage adjustments due to lower absorption rates of this medication. This medication can cause gastrointestinal symptoms such as headache, nausea, abdominal pain, as well as skin reactions like itching and rash. Rarely, serious side effects may include liver dysfunction, heart issues, and neurological problems; thus, if any unusual symptoms occur, consult a physician immediately. This medication has many potential interactions with other drugs, and caution should be exercised during combined use. Specifically, consult a healthcare professional if using with drugs that may affect the heart or are metabolized in the liver. There may be dizziness or visual disturbances when driving or operating machinery, so caution is advised. This medication is not recommended for pregnant or breastfeeding women, and women of childbearing age should take appropriate contraceptive measures after using this medication. Use with caution in children or the elderly, and dose adjustments may be necessary based on individual conditions. In the case of overdose, there is no specific antidote, so seek immediate medical attention for appropriate treatment. This medication should be stored out of reach of children and kept in its original container to maintain quality.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, sensory abnormality, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, pollakiuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, trembling, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, kidney disorders, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioneurotic edema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, transient hearing loss, permanent hearing loss, ventricular premature contraction, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lower back pain, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, anorexia, malaise, brown urine, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urinary protein, positive urinary glucose, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, flushing, elevated serum uric acid, elevated serum potassium, serum sickness, angioneurotic edema, anaphylactic reaction, hypertriglyceridemia, trembling, blurred vision, congestive heart failure, dyspnea, severe hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, increased serum creatine phosphokinase

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

Storage

Store this medication at room temperature between 1°C and 30°C, and it is important to keep it in a tightly sealed container to prevent air exposure. This will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

An orange hard capsule with a beige upper part containing grayish-white granules in the lower part.

Package unit

Company packaging unit

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.