Medication info
Spocora Tablets (Itraconazole Solid Dispersion)

Spocora Tablets (Itraconazole Solid Dispersion)

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

MFDS item code 201208655 · Approved 2012.11.23 · Insurance code 657805010

Summary

Main use
Treatment of fungal infections of the skin and nails, mucous membranes and cornea, and systemic fungal infections
Who takes it
Adults
Adult dose
To increase absorption, it is preferable to administer this medicine immediately after a meal. 1. Short-term treatment 1) Candidal vaginitis: 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, tinea cruris: 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 (palmar), 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 period; this constitutes one cycle. Administer up to 2 cycles for infection limited to fingernails and up to 3 cycles for infection involving 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 transplants, 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 to 200mg per dose 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
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of fungal infections of the skin and nails, mucous membranes and cornea, and systemic fungal infections

  • Candidal vulvovaginitis
  • tinea versicolor
  • tinea corporis
  • tinea cruris
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medication is used to treat fungal skin infections such as candidal vulvovaginitis, tinea versicolor, and tinea corporis, tinea cruris, tinea manuum, and tinea pedis caused by dermatophytes. It is also effective for oral candidiasis and fungal keratitis, as well as onychomycosis. Additionally, it is used for the treatment of serious systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including cryptococcal meningitis), and paracoccidioidomycosis. This medication helps improve symptoms and restore normal conditions against various fungal infections, making it very useful in treating various skin and systemic infections caused by fungi.

How to take

Adult dose

To increase absorption, it is preferable to administer this medicine immediately after a meal. 1. Short-term treatment 1) Candidal vaginitis: 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, tinea cruris: 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 (palmar), 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 period; this constitutes one cycle. Administer up to 2 cycles for infection limited to fingernails and up to 3 cycles for infection involving 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 transplants, 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 to 200mg per dose 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 drug may pose risks to patients with weakened heart function, especially those with congestive heart failure, and should not be used unless it is for the treatment of life-threatening infections. If symptoms of heart failure occur during treatment, discontinue use immediately. Patients with known allergies to this drug, a history of decreased heart function, or those who may take certain drugs concomitantly should consult a physician. It is particularly necessary to be cautious due to severe interactions with several medications, which may lead to contraindications with certain drugs. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication and must use effective contraception afterward. Patients with liver dysfunction or reduced kidney function are at a higher risk for side effects from this drug, so regular liver function tests and dosage adjustments are required. During the use of this medication, symptoms such as headaches, nausea, abdominal pain, or diarrhea may occur, and rarely serious side effects such as liver dysfunction, allergic reactions, skin rashes, or hearing loss may happen. This drug has many interactions with other drugs; thus, if you are taking any medications, you must inform your physician or pharmacist. Due to symptoms such as dizziness, blurred vision, and hearing loss, caution should be taken when driving or operating machinery. In case of overdose, as no specific antidote exists, one should visit the hospital immediately for appropriate treatment, and keep this medication out of the reach of children.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylaxis-like reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion state, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorder, cough, gastrointestinal disturbances, hepatic failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioneurotic edema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, transient hearing loss, permanent hearing loss, ventricular extrasystole, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lower back pain, pancreatitis, elevated serum total protein, elevated total bilirubin, elevated LAP, anorexia, 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, positive urine sugar, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, burning sensation, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioneurotic edema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, congestive heart failure, dyspnea, pancreatitis, serious hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased 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 closed container to prevent air from entering, and it is recommended to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature. Storing in this manner will help maintain the medication's efficacy.

Appearance and packaging

Appearance

White or pale yellow round film-coated tablets

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.

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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.