Medication info

Itraconazole Tablets 100 Milligrams (Itraconazole)

Prescription medicationTablet
Ingredient · strength
Itraconazole›100mg / 1 tablet
Manufacturer / importer
White Life Sciences Co., Ltd.
Appearance
White to off-white oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201603413 · Approved 2016.06.14

Summary

Main use
Treatment of skin and nail fungal infections, vaginal, oral, and corneal fungal infections, and systemic fungal infections
Who uses it
Adults
Adult dosage
This medicine should preferably be administered immediately after a meal to increase absorption. 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 one cycle. Treat for up to 2 cycles if only the fingernails are infected and up to 3 cycles if the toenails are infected. Toenails (with or without concomitant fingernail infection): 1 week of treatment, 2 weeks off, 3 weeks of treatment, 4 weeks off, 5 weeks of treatment Fingernails: 1 week of treatment, 2 weeks off, 3 weeks of treatment 2) Continuous therapy Administer 200 mg once daily for 3 months. The treatment effect continues for 3 months for fingernails and 6 months for toenails after treatment ends. 3. Systemic fungal infections Oral bioavailability of this medicine may be reduced in patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients. If necessary, double the dose. Aspergillosis: 200mg once daily; average treatment duration 2~5 months. For invasive or disseminated disease, increase 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
White Life Sciences Co., Ltd.

Efficacy & effects

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

  • Candidiasis
  • 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 effectively used for treating fungal infections of the skin and mucous membranes such as candidiasis and tinea versicolor. It is also helpful for infections caused by dermatophytes like tinea corporis, tinea capitis, tinea manuum, and tinea pedis. It can be applied to treat oral candidiasis and fungal keratitis and is effective for fungal infections occurring in the nails of the hands and feet. It is also used for systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. It assists in the recovery of patients' health by treating various fungal diseases.

Dosage and Administration

Adult dosage

This medicine should preferably be administered immediately after a meal to increase absorption. 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 one cycle. Treat for up to 2 cycles if only the fingernails are infected and up to 3 cycles if the toenails are infected. Toenails (with or without concomitant fingernail infection): 1 week of treatment, 2 weeks off, 3 weeks of treatment, 4 weeks off, 5 weeks of treatment Fingernails: 1 week of treatment, 2 weeks off, 3 weeks of treatment 2) Continuous therapy Administer 200 mg once daily for 3 months. The treatment effect continues for 3 months for fingernails and 6 months for toenails after treatment ends. 3. Systemic fungal infections Oral bioavailability of this medicine may be reduced in patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients. If necessary, double the dose. Aspergillosis: 200mg once daily; average treatment duration 2~5 months. For invasive or disseminated disease, increase 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

This medication should not be used in patients with impaired heart function, especially those with congestive heart failure, unless in exceptional cases. If symptoms of heart failure develop during treatment, use should be immediately discontinued. Patients with allergic reactions to this medication or sensitivity to any component should not use it. Additionally, this medication may cause serious side effects when taken with certain drugs, thus it should not be taken with contraindicated medications. It is also safer for pregnant women, those who may become pregnant, and women who are breastfeeding not to use this medication. Patients with reduced liver or kidney function should use this medication with caution and should regularly undergo liver function tests during treatment. Adjustments to drug concentration may be needed for patients with weakened immune systems or organ transplant recipients. Side effects such as headaches, nausea, and abdominal pain may occur, and in rare cases, severe liver damage, skin rashes, and neurological abnormalities may arise. As this medication interacts with many other drugs, it is essential to consult a physician or pharmacist if taking other medications. Particularly when taken with drugs that lower stomach acidity, the absorption of this medication may decrease, so it is preferable to take it with acidic beverages. Avoid using this medication during pregnancy or breastfeeding, and women of childbearing age should use effective contraception during and after use. There is no specific antidote for overdose, so appropriate treatment should be received according to symptoms, and it should be kept out of reach of children. This medication should be used carefully depending on the patient's condition and other concurrent medications, so it is important to consult with an expert before taking it.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disturbance, perceptual decline, perceptual abnormality, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, abnormal liver function, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactic-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorder, cough, gastrointestinal disorder, liver 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, elevated liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular ectopic beats, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal flank pain, pancreatitis, elevated serum total protein, elevated total bilirubin, elevated LAP, loss of appetite, malaise, jaundice, abdominal pain, brown urine, increased liver enzyme levels, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lião syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein, positive urine glucose, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides level, flushing, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, serious liver toxicity, 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 best kept at room temperature between 1 and 30 degrees Celsius. Proper storage retains the drug's effectiveness and prevents degradation.

Appearance and packaging

Appearance

White to off-white oval film-coated tablet

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.