Medication info

Leadnox Tablet (Itraconazole)

Prescription medicationTabletApproval withdrawn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Approval withdrawn

MFDS item code 201605793 · Approved 2016.09.30

This product's status changed to Approval withdrawn on 2024.01.23. 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
This medicine should preferably be administered immediately after a meal to increase absorption. 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) Tinea 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) and tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palmar) and tinea pedis (plantar): Administer 100 mg once daily for 30 days, or 200 mg twice daily for 7 days. 6) Oropharyngeal 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 for infection limited to the fingernails, and up to 3 cycles for infection involving the toenails. 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 is completed. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia or AIDS or those who have undergone organ transplantation, the oral bioavailability of this medicine may be reduced. If necessary, double the dose. Aspergillosis: 200mg once daily for 2~5 months. For invasive or disseminated disease, increase the dose 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: 200mg once daily. Paracoccidioidomycosis: 100mg once daily for 6 months

Ingredients

Manufacturer
Hanwha Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Candidiasis
  • tinea corporis
  • tinea capitis
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
  • cryptococcal meningitis
  • paracoccidioidomycosis
View approved original text

This drug is used to treat various fungal infections including candidiasis, tinea corporis, tinea capitis, tinea pedis, and other dermatophyte infections. It is also effective for the treatment of oral candidiasis and fungal keratitis, and onychomycosis. Additionally, it is utilized for systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. It is used to improve various types and locations of fungal infections.

Dosage and Administration

Adult dosage

This medicine should preferably be administered immediately after a meal to increase absorption. 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) Tinea 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) and tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palmar) and tinea pedis (plantar): Administer 100 mg once daily for 30 days, or 200 mg twice daily for 7 days. 6) Oropharyngeal 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 for infection limited to the fingernails, and up to 3 cycles for infection involving the toenails. 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 is completed. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia or AIDS or those who have undergone organ transplantation, the oral bioavailability of this medicine may be reduced. If necessary, double the dose. Aspergillosis: 200mg once daily for 2~5 months. For invasive or disseminated disease, increase the dose 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: 200mg once daily. Paracoccidioidomycosis: 100mg once daily for 6 months

Precautions

This medication may pose a life-threatening risk to patients with heart dysfunction or a history of heart failure, and should not be used unless for the treatment of serious infections. If symptoms of heart failure appear during treatment, administration should be discontinued immediately. Patients allergic to this medication, those with heart dysfunction, or those taking certain medications should consult their doctor. Women who are pregnant, potentially pregnant, or breastfeeding should not take this medication and should use contraception if necessary. Patients with impaired liver or kidney function may be affected in drug metabolism and excretion, so liver and kidney function tests should be performed before use, and dosage adjustments may be required. Caution is necessary for patients with weakened immunity or certain neuropathies, and if abnormal symptoms appear during treatment, medical personnel should be notified immediately. This medication has many drug interactions, so if other medications are being taken, it is essential to inform the doctor or pharmacist, as some drugs are contraindicated for co-administration. Symptoms such as dizziness, vision impairment, and hearing loss may occur during use, so caution is needed when driving or operating machinery. Occasionally, severe liver damage, allergic reactions, skin rashes, and blood abnormalities may appear, so if symptoms are suspected, treatment should be stopped immediately and medical attention sought. There are no specific antidotes for overdose, so the recommended dosage should be strictly adhered to, and should be stored out of reach of children. This medication should be stored in its original container, and transferring it to another container may pose a risk of misuse or quality degradation.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, dysgeusia, sensory perception decrease, sensory perception abnormality, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, 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 disorder, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal disorder, 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 disease, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual disturbances, hearing loss, ventricular ectopic beats, atrioventricular block, palpitations, increased bowel movements, belching, glossitis, stomatitis, abdominal flank pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, poor appetite, malaise, brown urine, increased liver enzyme levels, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leucocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, malaise, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, warmth sensation, elevated serum uric acid, elevated serum potassium, serum disease, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, shortness of breath, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leucocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase

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

Storage

This medication should be stored in a sealed container to prevent air exposure, and a temperature between 1 to 30 degrees Celsius is recommended for storage. Proper storage helps maintain efficacy and prevent deterioration.

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.