Medication info
Itraconax Tablets (Itraconazole Solid Dispersion)

Itraconax Tablets (Itraconazole Solid Dispersion)

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

MFDS item code 201502553 · Approved 2015.04.28 · Insurance code 661904510

Summary

Main use
Treatment of superficial fungal infections (skin, nails, etc.), mucosal fungal infections (vaginal and oral), and systemic fungal infections
Who uses it
Adults
Adult dosage
It is preferable to administer this medicine immediately after a meal to increase absorption. 1. Short-term treatment 1) Candidal vaginitis: Administer itraconazole 200mg twice daily (morning and evening) for 1 day, or 200mg once daily for 3 days. 2) Tinea versicolor: Administer 200mg once daily for 7 days. 3) Tinea corporis, tinea cruris (jock itch): Administer 100mg once daily for 15 days. 4) Tinea manus (interdigital type), tinea pedis (interdigital type): Administer 100mg once daily for 15 days. 5) Tinea manus (palms), tinea pedis (soles): Administer 100mg once daily for 30 days, or 200mg twice daily for 7 days. 6) Oral candidiasis: Administer 100mg once daily for 15 days. 7) Fungal keratitis: Administer 200mg once daily for 21 days. 2. Onychomycosis 1) Pulse therapy One cycle consists of administering 200mg twice daily for 1 week followed by a 3-week drug-free period. 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. 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 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
Youngpoong Pharm. Co., Ltd.

Efficacy & effects

Treatment of superficial fungal infections (skin, nails, etc.), mucosal fungal infections (vaginal and oral), and systemic fungal infections

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

This medication is used effectively for candidal vaginitis, tinea versicolor, various dermatophyte infections (tinea corporis, tinea cruris, tinea manuum, tinea pedis), oropharyngeal candidiasis, and fungal keratitis. It is also beneficial for the treatment of onychomycosis affecting the fingernails and toenails, and is used for the treatment of serious systemic fungal infections like aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. In short, this medication is used to treat fungal infections affecting various skin, mucous membranes, and nails, as well as systemic infections.

Dosage and Administration

Adult dosage

It is preferable to administer this medicine immediately after a meal to increase absorption. 1. Short-term treatment 1) Candidal vaginitis: Administer itraconazole 200mg twice daily (morning and evening) for 1 day, or 200mg once daily for 3 days. 2) Tinea versicolor: Administer 200mg once daily for 7 days. 3) Tinea corporis, tinea cruris (jock itch): Administer 100mg once daily for 15 days. 4) Tinea manus (interdigital type), tinea pedis (interdigital type): Administer 100mg once daily for 15 days. 5) Tinea manus (palms), tinea pedis (soles): Administer 100mg once daily for 30 days, or 200mg twice daily for 7 days. 6) Oral candidiasis: Administer 100mg once daily for 15 days. 7) Fungal keratitis: Administer 200mg once daily for 21 days. 2. Onychomycosis 1) Pulse therapy One cycle consists of administering 200mg twice daily for 1 week followed by a 3-week drug-free period. 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. 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 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 impaired cardiac function or a history of heart failure, and should be used with caution. Patients with allergies to this drug or those with specific heart diseases or who are using multiple drugs should not use it. Pregnant women, women who could become pregnant, and nursing mothers should not take this medication, and thorough contraception is required during treatment. Patients with reduced liver or kidney function may be affected in the metabolism and excretion of this medication, necessitating dosage adjustment and regular monitoring. This drug can interact with various medications, particularly with those affecting the heart, anticancer drugs, anticoagulants, and analgesics, which may increase the risk of side effects, and consultation with healthcare professionals is essential. If symptoms such as headache, nausea, abdominal pain, rash, changes in hearing, or cardiac abnormalities occur during treatment, notify a physician immediately. Absorption may be reduced in low-acid conditions, so it is recommended to take this medication with acidic beverages. Use in children or the elderly should be cautious, with close observation of therapeutic effects and side effects. In the event of overdose, since there is no specific antidote, immediate symptomatic treatment at a hospital is necessary, and this medication is not removed by hemodialysis. Store in a place out of reach of children and in the original container to prevent degradation of quality.

Side effects

headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disturbance, sensory impairment, sensory abnormalities, tinnitus, constipation, diarrhea, indigestion, bloating, vomiting, abnormal liver function, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactic-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confused state, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythema, hyperhidrosis, myalgia, arthralgia, renal impairment, incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, elevation of alanine aminotransferase, elevation of aspartate aminotransferase, increase in serum alkaline phosphatase, increase in serum lactate dehydrogenase, increase in blood urea, elevation of gamma-glutamyl transferase, increased liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, vascular neurogenic edema, anaphylaxis, anaphylactic shock, allergic reaction, double vision, visual impairment, temporary hearing loss, permanent hearing loss, ventricular ectopy, atrioventricular block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, increase in serum total protein, increase in total bilirubin, elevation of LAP, anorexia, malaise, brown urine, skin-mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevation of BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increase in serum triglycerides, burning sensation, elevation of serum uric acid, increase in serum potassium, serum sickness, vascular neurogenic edema, anaphylactic reaction, hypertriglyceridemia, tremor, blurred vision, congestive heart failure, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increase in 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 from entering. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's efficacy for a longer time.

Appearance and packaging

Appearance

White or pale yellow round film-coated tablet

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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.