Medication info
Itraconazole Tablets (Itraconazole Solid Dispersion)

Itraconazole Tablets (Itraconazole Solid Dispersion)

Prescription medicationTabletOral
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
Sungwon Adcock Pharma Co., Ltd.
Appearance
White or off-white round film-coated tablets
Packaging
28 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201500626 · Approved 2015.02.05 · Insurance code 664901080

Summary

Main use
Treatment of skin and nail fungal infections, vaginal, oral, and corneal fungal infections, and systemic fungal infections
Who takes it
Adults
Adult dose
It is preferable to take this medicine immediately after a meal. 1. Short-term treatment 1) Candidal vaginitis: Administer 200 mg of itraconazole 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 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 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 drug-free period; this constitutes 1 cycle. Administer up to 2 cycles for fingernail infections and up to 3 cycles for toenail infections. 2) Continuous therapy Administer 200 mg once daily for 3 months. 3. Systemic fungal infections In patients with impaired immune function, increase the dose twofold if necessary. Aspergillosis: 200mg once daily, for 2~5 months. For invasive or disseminated disease, increase to 200mg per dose 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
Sungwon Adcock Pharma Co., Ltd.

Efficacy & effects

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

  • Candidal vulvovaginitis
  • tinea versicolor
  • body ringworm caused by dermatophytes
  • groin ringworm
  • hand ringworm
  • foot ringworm
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medication is effective against various fungal infections such as candidal vulvovaginitis, tinea versicolor, body ringworm caused by dermatophytes, groin ringworm, hand ringworm, and foot ringworm. It is also used to treat oral candidiasis and fungal keratitis, as well as onychomycosis. In severe cases, it may be used to treat systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. Overall, it helps improve fungal infections affecting the skin, mucous membranes, and systemic conditions.

How to take

Adult dose

It is preferable to take this medicine immediately after a meal. 1. Short-term treatment 1) Candidal vaginitis: Administer 200 mg of itraconazole 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 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 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 drug-free period; this constitutes 1 cycle. Administer up to 2 cycles for fingernail infections and up to 3 cycles for toenail infections. 2) Continuous therapy Administer 200 mg once daily for 3 months. 3. Systemic fungal infections In patients with impaired immune function, increase the dose twofold if necessary. Aspergillosis: 200mg once daily, for 2~5 months. For invasive or disseminated disease, increase to 200mg per dose 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 is not safe for patients with impaired heart function. Caution is required as administering this medicine to patients with weak hearts may worsen cardiac function. Patients who are allergic to this medication or have experienced hypersensitivity reactions in the past should not take it. Additionally, patients with liver or kidney dysfunction should be particularly cautious while using this medication. This medication may interact with various other drugs, so it is crucial to consult with a physician or pharmacist when taking it alongside heart-related medications, analgesics, antibiotics, anticoagulants, or anticancer drugs. Serious side effects may occur when taken with certain drugs. Women who are pregnant or may become pregnant and those who are breastfeeding should not take this medication and should use contraception diligently while taking it. This medication is primarily metabolized in the liver; therefore, patients with impaired liver function should undergo regular liver function tests, and dose adjustments may be necessary if required. During treatment, side effects such as headache, dyspepsia, nausea, abdominal pain, rash, and edema may occur, and in rare cases, severe liver damage or heart problems, allergic reactions may arise, so immediate consultation with a healthcare provider is recommended in case of unusual symptoms. This medication may not be well absorbed in a low stomach acidity environment, hence it is recommended to take it with acidic beverages if taking medications that lower stomach acidity. Dizziness, drowsiness, and visual disturbances may occur, so caution is needed when driving or operating machinery. There are no specific antidotes for overdose, thus it is essential to adhere to the recommended dosage and keep it out of reach of children.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory reduction, sensory abnormalities, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, abnormal liver function, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, altered mental status, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorder, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, systemic 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 nitrogen, 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, hearing loss, ventricular extrasystole, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal flank pain, pancreatitis, elevated serum total protein, increased total bilirubin, increased LAP, decreased appetite, lethargy, brown urine, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein test, positive urine glucose test, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increased serum triglycerides, flushing, increased serum uric acid, increased serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, serious hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase

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

Storage

Store this medication in a tightly closed container to prevent exposure to air or moisture, and keep it at room temperature between 1°C and 30°C. By storing it this way, the efficacy of the medication can be maintained for a long time.

Appearance and packaging

Appearance

White or off-white 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.