Medication info
Hanol Itraconazole Tablets

Hanol Itraconazole Tablets

Prescription medicationTabletOral
Ingredient · strength
Itraconazole›100mg / 1 tablet
Manufacturer / importer
Hanol Bio Pharma Co., Ltd.
Appearance
White to off-white oval film-coated tablets
Packaging
28 tablets/bottle
Approval status
Active

MFDS item code 200400354 · Notified 2004.10.13 · Insurance code 655603040

Summary

Main use
Treatment and prevention of superficial fungal infections (including tinea and candidiasis) and deep fungal infections
Who takes it
Adults · Children
Adult dose
(Tablets)(Capsules) 1) Candidal vaginitis: 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 (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. Onychomycosis 1) Pulse therapy: Administer 200 mg twice daily for 1 week, followed by a 3-week drug-free period; this constitutes 1 cycle. Administer up to 2 cycles for infection of the fingernails only, and up to 3 cycles for infection of the toenails. 2) Continuous therapy: Administer 200 mg once daily for 3 months. Systemic fungal infections: In patients with impaired immune function, such as those with neutropenia or AIDS or those who have undergone organ transplantation, the dose may be doubled if necessary. Aspergillosis: 200 mg once daily for 2–5 months. For invasive or disseminated disease, increase the dose to 200 mg twice daily. Candidiasis: 100–200 mg once daily for 3 weeks–7 months. Cryptococcal meningitis: 200 mg twice daily for 2 months–1 year. Maintenance therapy: 200 mg once daily. Paracoccidioidomycosis: 100 mg once daily for 6 months. (Oral solution) Oral or esophageal candidiasis: Take 200 mg (20 mL) daily in 1–2 divided doses for 1 week. If there is no effect after 1 week, continue for 1 additional week. Oral or esophageal candidiasis resistant to fluconazole: Take 200–400 mg (20–40 mL) daily in 1–2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue for 2 additional weeks. Do not use 400 mg per day for more than 14 days, even if symptoms have not improved.
Child dose
Prevention of fungal infections: Administer 5 mg/kg body weight per day in 2 divided doses.

Ingredients

Manufacturer
Hanol Bio Pharma Co., Ltd.

Efficacy & effects

Treatment and prevention of superficial fungal infections (including tinea and candidiasis) and deep fungal infections

  • Candidal vaginitis
  • tinea
  • dermatophyte-induced tinea corporis
  • tinea capitis
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medicine is used to treat various fungal infections. In the form of tablets or capsules, it is used for skin and mucosal fungal infections such as candidal vaginitis, tinea, dermatophyte infections leading to tinea corporis, oral candidiasis, fungal keratitis, and onychomycosis, as well as systemic fungal infections like aspergillosis, candidiasis, and cryptococcosis. The liquid form is particularly used for treating oral and esophageal candidiasis in HIV-positive individuals or immunosuppressed patients, as well as for preventing deep-seated fungal infections in patients with hematological malignancies and other immunocompromised conditions. This medication helps effectively treat and prevent various types and locations of fungal infections.

How to take

Adult dose

(Tablets)(Capsules) 1) Candidal vaginitis: 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 (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. Onychomycosis 1) Pulse therapy: Administer 200 mg twice daily for 1 week, followed by a 3-week drug-free period; this constitutes 1 cycle. Administer up to 2 cycles for infection of the fingernails only, and up to 3 cycles for infection of the toenails. 2) Continuous therapy: Administer 200 mg once daily for 3 months. Systemic fungal infections: In patients with impaired immune function, such as those with neutropenia or AIDS or those who have undergone organ transplantation, the dose may be doubled if necessary. Aspergillosis: 200 mg once daily for 2–5 months. For invasive or disseminated disease, increase the dose to 200 mg twice daily. Candidiasis: 100–200 mg once daily for 3 weeks–7 months. Cryptococcal meningitis: 200 mg twice daily for 2 months–1 year. Maintenance therapy: 200 mg once daily. Paracoccidioidomycosis: 100 mg once daily for 6 months. (Oral solution) Oral or esophageal candidiasis: Take 200 mg (20 mL) daily in 1–2 divided doses for 1 week. If there is no effect after 1 week, continue for 1 additional week. Oral or esophageal candidiasis resistant to fluconazole: Take 200–400 mg (20–40 mL) daily in 1–2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue for 2 additional weeks. Do not use 400 mg per day for more than 14 days, even if symptoms have not improved.

Child dose

Prevention of fungal infections: Administer 5 mg/kg body weight per day in 2 divided doses.

Precautions

This medicine should not be given to patients with impaired heart function. Special caution should be taken in patients with congestive heart failure or reduced ventricular function, as severe side effects can occur. Patients genetically unable to digest certain sugars or those allergic to this medication should not take it. Additionally, there are various drugs that may be dangerous when taken with this medication, so it is essential to consult a doctor or pharmacist. Women who are pregnant or may become pregnant, as well as nursing mothers, should not use this medication, and if there is a possibility of pregnancy, effective contraception should be employed during and after medication. Patients with impaired liver or kidney function should consult a physician before taking this medication, and those with liver dysfunction should regularly undergo liver function tests. Caution is required due to the risk of liver toxicity. This medication can interact with various drugs, so anyone taking other medications should inform their healthcare providers, and some medications may need adjustment or avoidance when taken together. Symptoms such as dizziness, visual disturbances, and hearing loss may occur during treatment, so caution is needed when driving or operating machinery. There is no specific antidote for overdose; immediate medical attention should be sought for appropriate care. Finally, this medication should be stored out of reach of children and kept in its original container to prevent misuse or quality deterioration.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory reduction, sensory disturbance, tinnitus, constipation, diarrhea, indigestion, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, frequent urination, 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, vocal disturbance, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial swelling, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, macular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, double vision, visual impairment, hearing loss, ventricular ectopic contractions, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lower back pain, pancreatitis, elevated total serum protein, elevated total bilirubin, increased LAP, anorexia, lethargy, dark urine, increased liver enzyme levels, 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, elevated BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, burning sensation, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, temporary hearing loss, permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, 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 exposure to air, ideally at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's efficacy and prevent degradation.

Appearance and packaging

Appearance

White to off-white oval film-coated tablets

Package unit

28 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.