Medication info
Sporanox Capsules (Itraconazole)

Sporanox Capsules (Itraconazole)

Prescription medicationHard capsule
Ingredient · strength
Itraconazole›100mg / 1 capsule
Manufacturer / importer
Janssen Korea Ltd.
Appearance
A capsule with a blue opaque upper part and a pink lower part filled with granules that are white to light yellow.
Packaging
56 capsules/box [(14 capsules * 4 PTP)]
Approval status
Active

MFDS item code 202105228 · Approved 2021.07.09 · Insurance code 646902560

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
To increase absorption, this medicine should preferably be administered immediately after a meal. The capsules must be swallowed whole. 1. Short-term treatment Since the therapeutic effect in skin tissue continues even after treatment is discontinued, the final clinical and mycological response should preferably be assessed 2~4 weeks after completion of the prescribed treatment. Vulvovaginal candidiasis: Administer itraconazole 200 mg per dose twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Pityriasis versicolor: Administer 200 mg once daily for 7 days. Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. Tinea manuum (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. Tinea manuum (palmar), tinea pedis (plantar): Administer 100 mg once daily for 30 days, or 200 mg per dose twice daily for 7 days. Oral candidiasis: Administer 100 mg once daily for 15 days. Fungal keratitis: Administer 200 mg once daily for 21 days. 2. Onychomycosis 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 of the fingernails only, and up to 3 cycles for infection of the toenails. 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 organ transplant recipients, oral bioavailability of this medicine may be reduced; adjust the dose according to clinical response. 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 for cryptococcal meningitis (AIDS patients only): 200mg once daily. Duration of treatment should be based on immune recovery. Paracoccidioidomycosis: 100mg once daily; average treatment duration 6 months. There are no efficacy data for this dosage regimen in the treatment of paracoccidioidomycosis in patients with AIDS. Treatment duration should be adjusted according to clinical response.

Ingredients

Importer
Janssen Korea Ltd.

Efficacy & effects

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

  • Candidal vaginitis
  • tinea versicolor
  • tinea corporis caused by dermatophytes
  • tinea capitis
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • paracoccidioidomycosis
View approved original text

This medication is used for the treatment of various fungal infections of the skin and mucous membranes, such as candidal vaginitis, tinea versicolor, tinea corporis caused by dermatophytes, tinea capitis, tinea manuum, and tinea pedis. It is also effective for oral candidiasis and fungal keratitis, as well as onychomycosis. Additionally, it is used for the treatment of systemic fungal infections such as aspergillosis, candidiasis, paracoccidioidomycosis, and cryptococcal infections (especially cryptococcal meningitis) that may occur in immunocompromised patients. In particular, for cryptococcal meningitis, it is used as maintenance therapy when initial treatment is inappropriate or ineffective. It helps effectively treat various fungal infections and supports healthy living.

Dosage and Administration

Adult dosage

To increase absorption, this medicine should preferably be administered immediately after a meal. The capsules must be swallowed whole. 1. Short-term treatment Since the therapeutic effect in skin tissue continues even after treatment is discontinued, the final clinical and mycological response should preferably be assessed 2~4 weeks after completion of the prescribed treatment. Vulvovaginal candidiasis: Administer itraconazole 200 mg per dose twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Pityriasis versicolor: Administer 200 mg once daily for 7 days. Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. Tinea manuum (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. Tinea manuum (palmar), tinea pedis (plantar): Administer 100 mg once daily for 30 days, or 200 mg per dose twice daily for 7 days. Oral candidiasis: Administer 100 mg once daily for 15 days. Fungal keratitis: Administer 200 mg once daily for 21 days. 2. Onychomycosis 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 of the fingernails only, and up to 3 cycles for infection of the toenails. 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 organ transplant recipients, oral bioavailability of this medicine may be reduced; adjust the dose according to clinical response. 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 for cryptococcal meningitis (AIDS patients only): 200mg once daily. Duration of treatment should be based on immune recovery. Paracoccidioidomycosis: 100mg once daily; average treatment duration 6 months. There are no efficacy data for this dosage regimen in the treatment of paracoccidioidomycosis in patients with AIDS. Treatment duration should be adjusted according to clinical response.

Precautions

This medication must be used with caution in patients with impaired cardiac function, especially those with congestive heart failure, as it can be life-threatening. Patients with hypersensitivity to this medication or those with poor cardiac function should consult a physician, especially when using certain medications that may pose risks. Dose adjustment is necessary for patients with poor liver function or impaired kidney function, and liver and kidney status should be monitored regularly. This medication has many drug interactions; therefore, if you are taking other medications, you must inform your healthcare provider, and some drugs may be contraindicated for use together. It is recommended that women who are pregnant or may become pregnant, as well as nursing mothers, refrain from using this medication, and strict contraception should be followed during treatment. Serious side effects such as severe liver damage, heart problems, allergic reactions, and hearing loss may occur, so if any unusual symptoms appear, you should immediately consult a healthcare provider. Dizziness, visual disturbances, or drowsiness may also occur, so caution is advised when driving or operating machinery. Particular care should be taken when administering this medication to children or the elderly, and it should only be used if the benefits outweigh the risks. In case of overdose, since there is no specific antidote, you should visit a medical facility immediately for appropriate treatment. This medication should be kept out of reach of children, and stored in its original container to prevent degradation.

Side effects

Decreased myocardial contractility, ventricular arrhythmia, QT prolongation, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, dysesthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, impaired liver function, hyperbilirubinemia, pruritus, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, agranulocytosis, thrombocytopenia, anaphylactoid reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusional state, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice 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, increased white blood cells, increased eosinophils, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reactions, diplopia, visual impairment, hearing loss, ventricular extrasystoles, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal low back pain, pancreatitis, increased total serum protein, increased total bilirubin, increased LAP, loss of appetite, lethargy, dark urine, increased liver enzyme levels, Stevens-Johnson syndrome, toxic epidermal necrolysis, Reiter's syndrome, erythema multiforme, hair loss, photosensitivity reactions, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urinalysis for protein, positive urinalysis for glucose, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increased serum triglycerides, flushing, increased serum uric acid, increased serum potassium, serum sickness, angioedema, anaphylactic reactions, pseudohyperaldosteronism, hypertriglyceridemia, tremors, blurred vision, congestive heart failure, bradycardia, dyspnea, 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 an air-tight container and kept in a dry place at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

A capsule with a blue opaque upper part and a pink lower part filled with granules that are white to light yellow.

Package unit

56 capsules/box [(14 capsules * 4 PTP)]

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.