Medication info
Hitrazol Tablets 100 mg (Itraconazole Solid Dispersion)

Hitrazol Tablets 100 mg (Itraconazole Solid Dispersion)

Prescription medicationTablet
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
LightPharmTech Co., Ltd.
Appearance
Round film-coated tablets that are white or off-white in color
Packaging
28 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201905404 · Approved 2019.07.31 · Insurance code 690301490

Summary

Main use
Treatment of fungal infections of the skin and nails, vaginal, oral, and corneal fungal infections, and systemic fungal infections
Who uses it
Adults
Adult dosage
This medicine should preferably be taken immediately after a meal to increase absorption. 1. Short-term treatment 1) Candidal vaginitis: Administer itraconazole 200 mg 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: 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 treatment-free period; this constitutes one 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. The treatment effect continues for 3 months for fingernails and 6 months for toenails after treatment ends. 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; 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
LightPharmTech Co., Ltd.

Efficacy & effects

Treatment of fungal infections of the skin and nails, vaginal, oral, and corneal fungal infections, and systemic fungal infections

  • Vulvovaginal candidiasis
  • tinea
  • tinea corporis due to dermatophytes
  • tinea cruris
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • systemic fungal infections
  • aspergillosis
  • candidiasis
View approved original text

This medication is effective against fungal infections such as vulvovaginal candidiasis and oral thrush. It is also used for the treatment of tinea, which can occur on various areas such as the body (tinea corporis), groin (tinea cruris), hands (tinea manuum), and feet (tinea pedis). It can also be applied to fungal keratitis and onychomycosis. Furthermore, it aids in the treatment of systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. In conclusion, this drug effectively improves various types of fungal infections.

Dosage and Administration

Adult dosage

This medicine should preferably be taken immediately after a meal to increase absorption. 1. Short-term treatment 1) Candidal vaginitis: Administer itraconazole 200 mg 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: 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 treatment-free period; this constitutes one 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. The treatment effect continues for 3 months for fingernails and 6 months for toenails after treatment ends. 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; 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

It is very important that this medication is not used in patients with impaired cardiac function. Specifically, it should not be administered to patients with a history of congestive heart failure or decreased ventricular function, and if symptoms of heart failure arise during treatment, the medication must be discontinued immediately. Patients with a history of allergy to this medication or hypersensitivity to any of its components should not take it. Furthermore, it is crucial to avoid concurrent use of this medication with certain drugs, particularly those that may affect cardiac rhythm. Pregnant women, women who may become pregnant, and nursing mothers should not take this medication, and if it is necessary to take it, a doctor should be consulted. Patients with impaired liver or kidney function may be affected in their metabolism and excretion of this medication, thus liver and kidney function tests should be conducted prior to administration and dose adjustment may be necessary. This medication has a high potential for drug interactions, so patients should inform their healthcare provider of any other medications they are taking. Notably, taking this medication with acid-reducing drugs may decrease its absorption, so taking it with acidic drinks may be helpful. While taking this medication, symptoms such as headache, nausea, and abdominal pain may occur, and rarely, liver dysfunction, skin rashes, cardiac problems, and hearing loss may happen. Therefore, if any unusual symptoms appear, consultation with a healthcare provider is necessary. Caution is needed when driving or operating machinery, as dizziness or visual disturbances may occur. Finally, special caution is required when administering this medication to children and the elderly, and should only be used when the benefits of treatment outweigh the risks. In case of overdose, there is no specific antidote, so immediate medical attention should be sought for appropriate treatment.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, dysgeusia, hypoaesthesia, paresthesia, tinnitus, constipation, diarrhea, indigestion, bloating, vomiting, liver dysfunction, hyperbilirubinemia, pruritus, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, neutropenia, thrombocytopenia, anaphylaxis-like reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, vocal disturbance, cough, gastrointestinal disturbances, 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 blood urea, increased gamma-glutamyl transferase, elevated liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, angioedema, serum sickness, angioneurotic edema, anaphylaxis, anaphylactic shock, allergic reactions, diplopia, visual impairment, hearing loss, ventricular premature contractions, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal pain in the lumbar region, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, decreased appetite, malaise, brown urine, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, alopecia, photosensitivity reactions, exfoliative dermatitis, leukocyte destructive vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increased serum triglycerides, flushing, increased serum uric acid, increased serum potassium, serum sickness, angioneurotic edema, anaphylactic reactions, hypertriglyceridemia, tremors, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocyte destructive vasculitis, alopecia, 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 tightly sealed container to prevent air ingress, and it should be kept at a temperature between 1 and 30 degrees Celsius. This will help maintain the efficacy of the drug and prevent deterioration.

Appearance and packaging

Appearance

Round film-coated tablets that are white or off-white in color

Package unit

28 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.