Medication info
Hitoconazole Tablets (Itraconazole Solid Dispersion)

Hitoconazole Tablets (Itraconazole Solid Dispersion)

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

MFDS item code 201500969 · Approved 2015.02.25 · Insurance code 698002700

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
It is advisable to administer this medicine immediately after a meal. 1. Short-term treatment The final clinical and mycological response should preferably be assessed 2~4 weeks after completion of the prescribed treatment. 1) Vulvovaginal candidiasis: 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 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 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 interval; 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. The therapeutic effect continues for 3 months for fingernails and 6 months for toenails after completion of treatment. 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, administer twice the dose. Aspergillosis: 200mg once daily, 2~5 months. For invasive or disseminated disease, increase the dose to 200mg per dose twice daily. Candidiasis: 100~200mg once daily, 3 weeks~7 months Cryptococcal meningitis: 200mg twice daily, 2 months~1 year Maintenance therapy: 200mg once daily Paracoccidioidomycosis: 100mg once daily, 6 months

Ingredients

Manufacturer
Genupharm Co., Ltd.

Efficacy & effects

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

  • Candidiasis vaginitis
  • tinea versicolor
  • body ringworm caused by dermatophytes
  • groin ringworm
  • hand ringworm
  • foot ringworm
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • systemic fungal infections
  • aspergillosis
  • candidiasis
View approved original text

This medication is used for various fungal infections including candidiasis vaginitis, tinea versicolor, and body ringworm caused by dermatophytes, including groin ringworm, hand ringworm, and foot ringworm. It is also effective for oral candidiasis, fungal keratitis, and onychomycosis. Additionally, it is suitable for the treatment of systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis, making it highly versatile. This drug helps to safely and effectively treat various types of fungal infections.

Dosage and Administration

Adult dosage

It is advisable to administer this medicine immediately after a meal. 1. Short-term treatment The final clinical and mycological response should preferably be assessed 2~4 weeks after completion of the prescribed treatment. 1) Vulvovaginal candidiasis: 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 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 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 interval; 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. The therapeutic effect continues for 3 months for fingernails and 6 months for toenails after completion of treatment. 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, administer twice the dose. Aspergillosis: 200mg once daily, 2~5 months. For invasive or disseminated disease, increase the dose to 200mg per dose twice daily. Candidiasis: 100~200mg once daily, 3 weeks~7 months Cryptococcal meningitis: 200mg twice daily, 2 months~1 year Maintenance therapy: 200mg once daily Paracoccidioidomycosis: 100mg once daily, 6 months

Precautions

This medication can be life-threatening for patients with impaired cardiac function, particularly those with congestive heart failure, and should not be administered if the treatment purpose is unclear. If symptoms of heart failure appear during administration, usage should be stopped immediately. Patients who have had allergic reactions to this drug or its components should not take it. This medication has severe interactions with various drugs and should not be used with certain medications; strict adherence to medical advice is necessary when co-administering. Pregnant or potentially pregnant women, and nursing mothers should not use this medication. Patients with hereditary lactose intolerance should not take this drug. Patients with impaired liver function may be affected in terms of the metabolism and excretion of this drug, therefore should regularly undergo liver function tests and should use it cautiously. Patients with decreased kidney function may also need dose adjustment, so caution is advised. For patients with weakened immune function, the drug's effect may vary, necessitating close monitoring of clinical responses. Gastrointestinal symptoms such as headache, nausea, abdominal pain, and diarrhea may occur, as well as skin reactions such as itching and rash; in rare cases, serious allergic reactions or liver toxicity, neuropathy may occur. Dizziness, drowsiness, or visual/auditory disturbances may occur, so care should be taken when driving or operating machinery. In the case of overdose, as there is no specific antidote, immediate medical attention should be received. This medication should be kept out of the reach of children and stored in its original container to prevent misuse or degradation in quality.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disturbance, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, pruritus, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactic reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusional state, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech impairment, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, sweating, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular extrasystole, atrial block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal and low back pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, decreased appetite, malaise, brown 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, thoracic pain, elevated serum triglyceride levels, burning sensation, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremors, visual impairment, transient 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 air or moisture ingress, ideally at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

White or slightly yellow round film-coated tablets

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.