Medication info
Itraconazole Capsule (Itraconazole)

Itraconazole Capsule (Itraconazole)

Prescription medicationHard capsule
Ingredient · strength
Itraconazole Pellets›454.55mg / 1 capsule
Manufacturer / importer
White Life Science Co., Ltd.
Appearance
A hard capsule with a blue upper part and a pink lower part filled with white or grayish spherical pellets.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 202002094 · Approved 2020.03.25 · Insurance code 625201980

Summary

Main use
Treatment of fungal infections of the skin and nails, mucous membranes and cornea, and systemic fungal infections
Who uses it
Adults
Adult dosage
To increase absorption, it is preferable to administer this medicine immediately after a meal. The capsules must be swallowed whole. 1. Short-term treatment 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg 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 and tinea cruris: 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 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 twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes one cycle. Administer up to 2 cycles if only the fingernails are infected and up to 3 cycles if the toenails are infected. Site of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without fingernail infection) Treatment Treatment-free Treatment Treatment-free Treatment Fingernails Treatment Treatment-free Treatment 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, the dose may be doubled. 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 (for AIDS patients only): 200mg once daily. Paracoccidioidomycosis: 100mg once daily for 6 months. There are no efficacy data for this dosage regimen for the treatment of paracoccidioidomycosis in ADIS patients. 1 The duration of treatment should be adjusted according to clinical response. 2 The duration of treatment should depend on immune recovery.

Ingredients

Manufacturer
White Life Science Co., Ltd.

Efficacy & effects

Treatment of fungal infections of the skin and nails, mucous membranes and cornea, and systemic fungal infections

  • Candidiasis
  • tinea
  • body tinea caused by dermatophytes
  • groin tinea
  • hand tinea
  • foot tinea
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • paracoccidioidomycosis
View approved original text

This medication is used for various fungal infections including candidiasis, tinea, skin infections due to dermatophytes, oral candidiasis, fungal keratitis, and onychomycosis. It is also applicable for the treatment of severe infections such as aspergillosis, candidiasis, paracoccidioidomycosis, and cryptococcosis. Especially in immunocompromised patients or those with central nervous system infections, it is used when first-line treatments are ineffective, and it is also utilized for maintaining cryptococcal meningitis in AIDS patients. This drug effectively treats a variety of fungal infections, helping to improve the patient's condition.

Dosage and Administration

Adult dosage

To increase absorption, it is preferable to administer this medicine immediately after a meal. The capsules must be swallowed whole. 1. Short-term treatment 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg 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 and tinea cruris: 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 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 twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes one cycle. Administer up to 2 cycles if only the fingernails are infected and up to 3 cycles if the toenails are infected. Site of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without fingernail infection) Treatment Treatment-free Treatment Treatment-free Treatment Fingernails Treatment Treatment-free Treatment 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, the dose may be doubled. 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 (for AIDS patients only): 200mg once daily. Paracoccidioidomycosis: 100mg once daily for 6 months. There are no efficacy data for this dosage regimen for the treatment of paracoccidioidomycosis in ADIS patients. 1 The duration of treatment should be adjusted according to clinical response. 2 The duration of treatment should depend on immune recovery.

Precautions

This drug is not recommended for patients with decreased heart function, particularly those with congestive heart failure. If symptoms of heart failure occur, administration should be discontinued immediately. It should not be taken by individuals with a history of allergy to this medication or those who have had hypersensitivity reactions to its components. Additionally, taking this drug with certain medications may result in severe side effects, so it is essential to check the list of contraindicated medications. Women who are pregnant or may become pregnant, as well as those who are nursing, should avoid using this medication. Patients with impaired liver or kidney function should use this medication with caution, and dosage adjustments may be necessary. During treatment, regular liver function tests should be conducted to monitor for potential liver toxicity. Patients with weakened immune systems should closely monitor the drug's effectiveness and side effects, and dosage adjustments may be needed. This drug has many interactions with various medications, so individuals taking other drugs should consult a healthcare professional. Dizziness, visual and auditory disturbances may occur; caution is needed when driving or operating machinery. There is no specific antidote for overdose, and symptomatic treatment should be administered, as it is not removed by dialysis. Keep out of reach of children and store in the original container to prevent misuse or degradation of quality.

Side effects

Decreased myocardial contractility, heart failure, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disturbance, sensory impairment, sensation abnormalities, tinnitus, constipation, diarrhea, indigestion, abdominal distension, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocyte deficiency, thrombocytopenia, anaphylactic-like reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal disorders, urinary incontinence, systemic edema, facial edema, chest pain, fever, pain, fatigue, chills, elevated alanine aminotransferase, elevated aspartate aminotransferase, increased serum alkaline phosphatase, increased serum lactate dehydrogenase, elevated blood 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, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal lumbar pain, pancreatitis, elevated serum total protein, elevated total bilirubin, increased LAP, loss of appetite, fatigue, brown urine, skin and mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Rielle syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, burning sensation, elevated serum uric acid, elevated serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, temporary 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 well-sealed container that is airtight, at room temperature between 1 and 30 degrees Celsius. This storage method will help maintain the effectiveness of the drug and prevent degradation.

Appearance and packaging

Appearance

A hard capsule with a blue upper part and a pink lower part filled with white or grayish spherical pellets.

Package unit

30 capsules/bottle, 100 capsules/bottle

Same-ingredient medicines

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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.