Medication info
Hitzol Tablet (Itraconazole Solid Dispersion)

Hitzol Tablet (Itraconazole Solid Dispersion)

Prescription medicationTablet
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
The U Pharmaceutical Co., Ltd.
Appearance
White or pale yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202003790 · Approved 2020.05.25 · Insurance code 057001160

Summary

Main use
Treatment of systemic fungal infections, skin and nail fungal infections, and mucosal and corneal fungal infections
Who uses it
Adults
Adult dosage
To improve absorption, this medicine should preferably be administered immediately after meals. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological treatment outcomes should preferably be assessed 2~4 weeks after completing the prescribed course of treatment. 1) Candida 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) Pityriasis versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis, tinea cruris (jock itch): 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 drug-free period; this constitutes 1 cycle. Administer up to 2 cycles for infection limited to the fingernails and up to 3 cycles for infection of the toenails. Toenails (with or without concomitant fingernail infection): 1 week on treatment, 2 weeks off treatment, 3 weeks on treatment, 4 weeks off treatment, 5 weeks on treatment Fingernails: 1 week on treatment, 2 weeks off treatment, 3 weeks on 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 the end of treatment. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or an organ transplant, the oral bioavailability of this medicine may be reduced; if necessary, increase the dose twofold. 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
The U Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Candida vaginitis
  • tinea versicolor
  • tinea corporis
  • tinea cruris
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medication is effectively used for various fungal infections including candida vaginitis, tinea versicolor, dermatophytosis (tinea corporis, tinea cruris, tinea manuum, tinea pedis), oral candidiasis, fungal keratitis, and onychomycosis. It is also utilized in the treatment of systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. Thus, this medication helps in improving local and systemic fungal infections, contributing to the alleviation of symptoms and recovery of patients.

Dosage and Administration

Adult dosage

To improve absorption, this medicine should preferably be administered immediately after meals. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological treatment outcomes should preferably be assessed 2~4 weeks after completing the prescribed course of treatment. 1) Candida 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) Pityriasis versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis, tinea cruris (jock itch): 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 drug-free period; this constitutes 1 cycle. Administer up to 2 cycles for infection limited to the fingernails and up to 3 cycles for infection of the toenails. Toenails (with or without concomitant fingernail infection): 1 week on treatment, 2 weeks off treatment, 3 weeks on treatment, 4 weeks off treatment, 5 weeks on treatment Fingernails: 1 week on treatment, 2 weeks off treatment, 3 weeks on 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 the end of treatment. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or an organ transplant, the oral bioavailability of this medicine may be reduced; if necessary, increase the dose twofold. 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

This medication may pose life-threatening risks to patients with compromised cardiac function, especially those with congestive heart failure, and should only be used cautiously when necessary. Treatment should be discontinued immediately if symptoms of heart failure appear. Individuals who have allergies to this medication or have had hypersensitive reactions to its components should not use it. This medication can interact with various drugs, and serious side effects may occur when taken with certain medications, so contraindicated drugs must be checked. Pregnant or potentially pregnant women, as well as nursing mothers, are advised not to use this medication. Patients with lactose intolerance or specific genetic metabolic disorders should not take this medication. Patients with impaired liver or kidney function may be affected by the metabolism and excretion of this medication, necessitating dosage adjustments and regular function tests. Patients with weakened immune systems or certain neuropathies should be more cautious when using this medication, and seek immediate consultation from a doctor if abnormal symptoms occur. This medication can cause various side effects such as headaches, dyspepsia, liver function abnormalities, skin rashes, and patients should inform medical personnel if symptoms worsen or unusual reactions are suspected. Dizziness, visual disturbances, and hearing loss may occur during treatment, and caution is advised when driving or operating machinery. This medication may not be well absorbed in low-acid conditions, so taking it with acidic drinks may be helpful. There is no specific antidote for overdose, so hospital care should be sought immediately for appropriate treatment. Keep this medication out of the reach of children and maintain its quality by storing it in its original container.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory decline, sensory disturbance, tinnitus, constipation, diarrhea, indigestion, abdominal distension, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, 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 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, increased liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reactions, diplopia, visual disturbances, transient hearing loss, permanent hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal pain in the flank, pancreatitis, increased total serum protein, elevated total bilirubin, elevated LAP, anorexia, malaise, jaundice, abdominal pain, brown urine, elevated liver enzyme levels, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitive reaction, exfoliative dermatitis, leukocyte destructive 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, flushing, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual disturbances, congestive heart failure, dyspnea, pancreatitis, serious 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 or moisture, preferably at temperatures between 1 to 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness and prevents degradation.

Appearance and packaging

Appearance

White or pale yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/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.