Medication info

Spoconazole Capsule 100 mg (Itraconazole)

Prescription medicationHard capsuleExpired
Ingredient · strength
Itraconazole Pellets›454.55mg / 1 capsule
Manufacturer / importer
Ari Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a blue upper part and a pink lower part filled with white or grayish spherical pellets.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Expired

MFDS item code 202006054 · Approved 2020.08.28

This product's status changed to Expired on 2025.08.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of fungal infections of the skin and nails, fungal infections of the mucosa and cornea, and systemic fungal infections
Who uses it
Adults
Adult dosage
Administration immediately after a meal is preferable. The capsules must be swallowed whole. 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. Oropharyngeal candidiasis: Administer 100 mg once daily for 15 days. Fungal keratitis: Administer 200 mg once daily for 21 days. 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 when only the fingernails are infected and up to 3 cycles when the toenails are infected. Onychomycosis, 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. In patients with impaired immune function, the oral bioavailability of this drug may be reduced; if necessary, administer twice the dose. Aspergillosis: 200mg once daily, average treatment duration 2~5 months. For invasive or disseminated disease, increase the dose to 200mg 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 AIDS patients only): 200mg once daily. Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months. The duration of treatment should be adjusted according to clinical response. The duration of treatment should depend on immune recovery.

Ingredients

Manufacturer
Ari Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of fungal infections of the skin and nails, fungal infections of the mucosa and cornea, and systemic fungal infections

  • Candidal vulvovaginitis
  • tinea versicolor
  • dermatophyte-related tinea corporis
  • tinea cruris
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • paracoccidioidomycosis
View approved original text

This medication is used to treat various fungal infections, including candidal vulvovaginitis, tinea versicolor, and skin ringworm caused by dermatophytes (tinea corporis, tinea cruris, tinea manuum, tinea pedis), as well as oral candidiasis. It is also effective in treating fungal keratitis and onychomycosis. It is applied in the treatment of systemic fungal infections such as aspergillosis, candidiasis, paracoccidioidomycosis, and cryptococcosis, particularly for cryptococcal infections of the central nervous system in immunocompromised patients. However, this drug is to be used only when first-line treatment for cryptococcal meningitis is inappropriate or ineffective. Thus, this medication is widely used in the treatment of various fungal infections.

Dosage and Administration

Adult dosage

Administration immediately after a meal is preferable. The capsules must be swallowed whole. 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. Oropharyngeal candidiasis: Administer 100 mg once daily for 15 days. Fungal keratitis: Administer 200 mg once daily for 21 days. 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 when only the fingernails are infected and up to 3 cycles when the toenails are infected. Onychomycosis, 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. In patients with impaired immune function, the oral bioavailability of this drug may be reduced; if necessary, administer twice the dose. Aspergillosis: 200mg once daily, average treatment duration 2~5 months. For invasive or disseminated disease, increase the dose to 200mg 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 AIDS patients only): 200mg once daily. Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months. The duration of treatment should be adjusted according to clinical response. The duration of treatment should depend on immune recovery.

Precautions

This drug should not be used in patients with impaired cardiac function or a history of congestive heart failure, and should not be used unless the infection is life-threatening. If symptoms of heart failure occur during treatment, use should be discontinued immediately. Patients who are allergic to this drug or have had hypersensitivity reactions to any of its components should not use it. Since it may interact with various medications, caution is needed when taken with treatments for heart disease or certain analgesics, antiarrhythmics, anticoagulants, etc. Pregnant or potentially pregnant women and nursing mothers should not use this drug, and effective contraception is required after use. Patients with impaired liver function may experience slowed metabolism of this drug, so regular liver function tests and dose adjustments under a doctor's guidance are necessary. Patients with reduced kidney function may also require dose adjustments. Patients with weakened immune function should carefully monitor treatment responses, as the effect of the drug may vary. This drug may cause gastrointestinal side effects such as headache, nausea, abdominal pain, diarrhea, liver function abnormalities, skin rashes, etc.; if any unusual symptoms occur, consult a physician. In rare cases, serious side effects such as hearing loss, cardiac arrhythmia, hepatotoxicity, and neuropathy may occur, so immediate notification to a healthcare professional is required if symptoms arise. Caution should also be exercised as dizziness or visual disturbances may occur during driving or operation of machinery while taking this drug. Additionally, as there is a high possibility of interactions with various drugs, patients must consult healthcare providers about any medications taken concurrently, and avoid contraindicated medicines. In case of an overdose, there is no specific antidote; therefore, immediate medical attention is needed.

Side effects

headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory loss, sensory abnormality, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorder, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, state of confusion, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorder, cough, gastrointestinal disorder, 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, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular extrasystole, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal pain in the lumbar region, pancreatitis, elevated serum total protein, elevated total bilirubin, elevated LAP, decreased appetite, lethargy, dark urine, abdominal pain, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein response, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, flushing, elevated serum uric acid, elevated serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremors, visual impairment, transient or permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, significant hepatic toxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase

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

Storage

Store this medication in a tightly sealed container to prevent air intrusion, maintaining a storage temperature between 1 and 30 degrees Celsius (room temperature). Doing so will help preserve the effectiveness of the medication over time.

Appearance and packaging

Appearance

A hard capsule with a blue upper part and a pink lower part filled with white or grayish spherical pellets.

Package unit

30 capsules/bottle, 100 capsules/bottle

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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.