Medication info

Sporanox Solution (Itraconazole)

Prescription medicationSolutionOralApproval withdrawn
Ingredient · strength
Itraconazole›1g / 100mL
Manufacturer / importer
Janssen Korea Ltd.
Appearance
A transparent solution, yellow to light yellow-brown, with a cherry scent
Packaging
150 mL/bottle
Approval status
Approval withdrawn

MFDS item code 199806500 · Notified 1998.01.21 · Insurance code 646900451

This product's status changed to Approval withdrawn on 2025.08.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of oral and esophageal candidiasis in immunocompromised patients; prevention of invasive fungal infections in high-risk patients
Who takes it
Adults · Children
Adult dose
(Tablets)(Capsules) This medication should preferably be taken immediately after a meal to increase absorption. 1. Short-term treatment 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg 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), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palms), 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. 2. Onychomycosis 1) Pulse therapy Administer 200 mg twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles if only the fingernails are infected, and up to 3 cycles if the toenails are infected. 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 or AIDS or those who have undergone organ transplantation, the oral bioavailability of this medication 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. (Oral solution) To increase absorption, do not take this medication with food. Hold this medication in the mouth for approximately 20 seconds, making sure it comes into contact with the entire mouth, then swallow. After swallowing, do not rinse the mouth so that the medication remains in the mouth for as long as possible. 1. Oral and 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 taking it for 1 more week. 2. Oral and 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 taking it for 2 more weeks. Do not use 400 mg daily for more than 14 days, even if symptoms have not improved.
Child dose
Prevention of fungal infections: 5 mg per kg of body weight per day, administered in 2 divided doses.

Ingredients

Importer
Janssen Korea Ltd.

Efficacy & effects

Treatment of oral and esophageal candidiasis in immunocompromised patients; prevention of invasive fungal infections in high-risk patients

  • Candidal vaginitis
  • tinea versicolor
  • body tinea (tinea corporis)
  • groin tinea (tinea cruris)
  • hand tinea (tinea manuum)
  • foot tinea (tinea pedis)
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medication is used to treat various fungal infections on skin and mucosal surfaces, including candidal vaginitis, tinea versicolor, various tinea infections caused by dermatophytes, oral candidiasis, fungal keratitis, and onychomycosis. It is also effective for severe systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis, and paracoccidioidomycosis. It is particularly utilized for the treatment of oral and esophageal candidiasis in HIV-infected and immunocompromised patients, as well as for the prevention of fungal infections in patients with hematologic tumors or those undergoing bone marrow transplants. This drug is available in various forms allowing selection based on the patient's condition. Overall, it helps to improve and treat multiple symptoms caused by fungal infections.

How to take

Adult dose

(Tablets)(Capsules) This medication should preferably be taken immediately after a meal to increase absorption. 1. Short-term treatment 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg 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), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palms), 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. 2. Onychomycosis 1) Pulse therapy Administer 200 mg twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles if only the fingernails are infected, and up to 3 cycles if the toenails are infected. 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 or AIDS or those who have undergone organ transplantation, the oral bioavailability of this medication 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. (Oral solution) To increase absorption, do not take this medication with food. Hold this medication in the mouth for approximately 20 seconds, making sure it comes into contact with the entire mouth, then swallow. After swallowing, do not rinse the mouth so that the medication remains in the mouth for as long as possible. 1. Oral and 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 taking it for 1 more week. 2. Oral and 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 taking it for 2 more weeks. Do not use 400 mg daily for more than 14 days, even if symptoms have not improved.

Child dose

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

Precautions

This drug should be used with caution in patients with impaired cardiac function or a history of congestive heart failure. If symptoms of heart failure appear during treatment, usage should be immediately discontinued. Additionally, individuals who are allergic to this medication or have previously shown hypersensitivity to its components should not use it. Serious side effects can arise when this medication is taken with certain drugs, so it is essential to consult a doctor or pharmacist if taking other medications. Caution is especially required when used with heart medications, anticoagulants, certain antibiotics, antipsychotics, antiviral medications, calcium channel blockers, etc. Pregnant women or those who may become pregnant and breastfeeding women should not use this drug and should ensure effective contraception during treatment. Patients with impaired liver or kidney function may be affected by the metabolism and excretion of this drug, therefore liver and kidney functions should be assessed before administration, and dosage adjustments may be necessary. This drug may cause a variety of side effects, with common symptoms including headache, dizziness, diarrhea, nausea, vomiting, rash, fever, etc. Serious side effects such as hepatotoxicity, heart failure, arrhythmia, and allergic reactions can occur, so any unusual symptoms should be reported immediately to medical personnel. Since this drug is primarily metabolized in the liver, regular liver function tests are necessary, especially for patients with a history of liver disease or those at risk of hepatotoxicity. It is important to exercise caution when driving or operating machinery as side effects such as dizziness, visual disturbances, and hearing loss may occur. In case of overdose, there is no specific antidote, and symptomatic treatment will be given as needed. The drug is not removed by hemodialysis. Keep out of reach of children, and store the medication in its original container to prevent misuse or deterioration in quality.

Side effects

Decreased myocardial contractility, headache, taste disorder, dizziness, cough, diarrhea, nausea, vomiting, abdominal pain, indigestion, rash, fever, leukopenia, thrombocytopenia, hypersensitivity, hypokalemia, sensory impairment, peripheral neuropathy, paresthesia, tinnitus, heart failure, constipation, liver failure, hyperbilirubinemia, itching, urticaria, arthralgia, myalgia, menstrual disorders, edema, sinusitis, upper respiratory infection, rhinitis, agranulocytosis, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypomagnesemia, confusion, drowsiness, tremors, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorders, gastrointestinal disorders, bloating, hepatitis, jaundice, abnormal liver function, erythematous rash, sweating, kidney failure, polyuria, urinary incontinence, erectile dysfunction, systemic edema, facial edema, chest pain, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, double vision, visual impairment, hearing loss, ventricular ectopic beats, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal lumbosacral pain, pancreatitis, elevated total serum protein, increased total bilirubin, elevated LAP, loss of appetite, malaise, brown urine, reversible increase in liver enzyme levels, skin and 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 test, positive urine glucose test, decreased libido, somnolence, malaise, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, flushing, elevated serum uric acid, elevated serum potassium, serum sickness, angioneurotic edema, anaphylactic reaction, pseudoaldosteronism, hypertriglyceridemia, tremors, blurred vision, congestive heart failure, bradycardia, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, elevated serum creatine phosphokinase levels

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, in a cool place below 25 degrees Celsius. This storage method helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

A transparent solution, yellow to light yellow-brown, with a cherry scent

Package unit

150 mL/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.