Medication info
Itraconazole Tablets (Itraconazole Solid Dispersion)

Itraconazole Tablets (Itraconazole Solid Dispersion)

Prescription medicationTabletOral
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
Celix Co., Ltd.
Appearance
White or yellowish round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201404497 · Approved 2014.09.30 · Insurance code 646203760

Summary

Main use
Treatment of skin and nail fungal infections, mucosal and corneal fungal infections, and systemic fungal infections
Who takes it
Adults
Adult dose
To increase absorption, it is preferable to administer this medicine immediately after meals. 1. Short-term treatment This medicine continues to have a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological treatment effects should preferably be assessed 2 ~ 4 weeks after completing the prescribed 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) Pityriasis 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 type), tinea pedis (interdigital type): 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 treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles when only the fingernails are infected, and up to 3 cycles when the toenails are infected. Affected area of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without concomitant fingernail infection) Treatment Treatment-free period Treatment Treatment-free period Treatment Fingernails Treatment Treatment-free period Treatment or 2) Continuous therapy Administer 200 mg once daily for 3 months. The therapeutic effect continues for 3 months for fingernails and 6 months for toenails after treatment ends. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia or AIDS and organ transplant recipients, the oral bioavailability of this medicine may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily, average treatment duration 2~5 months. For invasive or disseminated disease, increase the dose to 200mg per dose twice daily. Candidiasis: 100~200mg once daily, average treatment duration 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily, average treatment duration 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months

Ingredients

Manufacturer
Celix Co., Ltd.

Efficacy & effects

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

  • Candidal vulvovaginitis
  • tinea versicolor
  • dermatophytosis including tinea corporis
  • tinea cruris
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis of hands and feet
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medication is used to treat fungal infections such as candidal vulvovaginitis, tinea versicolor, and various forms of dermatophytosis (including tinea corporis, tinea cruris, tinea manuum, tinea pedis). It is also effective against oral candidiasis and fungal keratitis, as well as onychomycosis affecting fingers and toes. Additionally, it is used in the treatment of systemic fungal infections, including aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. This medication effectively improves a wide range of fungal infections.

How to take

Adult dose

To increase absorption, it is preferable to administer this medicine immediately after meals. 1. Short-term treatment This medicine continues to have a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological treatment effects should preferably be assessed 2 ~ 4 weeks after completing the prescribed 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) Pityriasis 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 type), tinea pedis (interdigital type): 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 treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles when only the fingernails are infected, and up to 3 cycles when the toenails are infected. Affected area of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without concomitant fingernail infection) Treatment Treatment-free period Treatment Treatment-free period Treatment Fingernails Treatment Treatment-free period Treatment or 2) Continuous therapy Administer 200 mg once daily for 3 months. The therapeutic effect continues for 3 months for fingernails and 6 months for toenails after treatment ends. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia or AIDS and organ transplant recipients, the oral bioavailability of this medicine may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily, average treatment duration 2~5 months. For invasive or disseminated disease, increase the dose to 200mg per dose twice daily. Candidiasis: 100~200mg once daily, average treatment duration 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily, average treatment duration 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months

Precautions

It is very important not to use this medication in patients with impaired cardiac function. Particularly, patients with congestive heart failure or a history of impaired cardiac function should be cautious as this medication may exacerbate their heart condition. Patients with an allergy to this medication should not take it, and serious side effects may occur if taken with certain other medications, so it is essential to consult a physician. For example, it may be risky when used concurrently with some analgesics, antiarrhythmics, and anticoagulants. Women who are pregnant or may become pregnant, as well as women who are breastfeeding, should avoid taking this medication. Additionally, patients with certain genetic disorders such as lactose intolerance should not use this medication. Patients with impaired liver or kidney function may be affected by the metabolism and excretion of this medication, so liver and kidney function tests should be done before administration, and dosage adjustment may be necessary if needed. This medication may have various side effects, with common symptoms including headache, nausea, and abdominal pain. Rarely, serious liver damage, allergic reactions, and heart problems may occur. If any abnormal symptoms appear, immediate medical attention should be sought. Moreover, this medication has many drug interactions; if taking any other medications, it is crucial to inform the healthcare provider, especially when taking it alongside medications that reduce stomach acid, as taking them with acidic beverages may aid in absorption. Caution is needed while driving or operating machinery, as dizziness or visual disturbances may occur. Finally, there is no specific antidote in case of overdose, so it is important to adhere to the recommended dosage and avoid overdose. Keep out of reach of children, and store the medication in its original container to maintain its quality.

Side effects

Decreased myocardial contractility, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disturbance, decreased sensation, abnormal sensation, tinnitus, constipation, diarrhea, dyspepsia, abdominal distension, vomiting, liver function abnormalities, hyperbilirubinemia, itching, rash, urticaria, pollakiuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorder, 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, 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 reaction, diplopia, visual impairment, hearing loss, ventricular ectopy, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, decreased appetite, malaise, brown urine, skin and mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reaction, 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, burning sensation, 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, significant hepatotoxicity, 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 to prevent air exposure, and it is advisable to store it at room temperature between 1 and 30 degrees Celsius. By storing it this way, the efficacy of the medication can be well preserved.

Appearance and packaging

Appearance

White or yellowish round film-coated tablets

Package unit

30 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.