Medication info
Econazole Tablets (Itraconazole Solid Dispersion)

Econazole Tablets (Itraconazole Solid Dispersion)

Prescription medicationTablet
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
KooJoo 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 201803802 · Approved 2018.09.27

Summary

Main use
Treatment of fungal infections of the skin and nails, vaginal, oral, and corneal fungal infections, and systemic fungal infections
Who uses it
Adults
Adult dosage
To improve absorption, this drug should preferably be administered immediately after meals. Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Tinea versicolor: Administer 200 mg once daily for 7 days. Tinea corporis, tinea cruris (jock itch): Administer 100 mg once daily for 15 days. Tinea manuum (interdigital type), tinea pedis (interdigital type): 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 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. Pulse therapy: One cycle consists of 200 mg twice daily for 1 week followed by 3 weeks without treatment. 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. In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, the oral bioavailability of this drug may be reduced; if necessary, administer twice 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
KooJoo Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of fungal infections of the skin and nails, vaginal, oral, and corneal fungal infections, and systemic fungal infections

  • Candidiasis
  • tinea
  • body ringworm caused by dermatophytes
  • groin ringworm
  • hand ringworm
  • foot ringworm
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medicine is used to treat fungal infections of the skin and mucous membranes such as candidiasis, tinea, various fungal infections of the skin and nails, oral candidiasis, and fungal keratitis. It is also effective against systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including cryptococcal meningitis), and paracoccidioidomycosis. These conditions are all caused by fungal pathogens, and this medicine improves symptoms by inhibiting or eliminating the fungi. Therefore, it is widely used for the treatment of various fungal infections.

Dosage and Administration

Adult dosage

To improve absorption, this drug should preferably be administered immediately after meals. Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Tinea versicolor: Administer 200 mg once daily for 7 days. Tinea corporis, tinea cruris (jock itch): Administer 100 mg once daily for 15 days. Tinea manuum (interdigital type), tinea pedis (interdigital type): 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 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. Pulse therapy: One cycle consists of 200 mg twice daily for 1 week followed by 3 weeks without treatment. 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. In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, the oral bioavailability of this drug may be reduced; if necessary, administer twice 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 can be life-threatening for patients with compromised cardiac function or a history of heart failure, and should not be used in these cases. If symptoms of heart failure appear while using this medication, it should be discontinued immediately. Patients with allergies to this medication or a history of hypersensitivity to its components should not take it. Additionally, this medication can interact with various other drugs, so it can be dangerous when taken with certain heart disease treatments, some pain relievers, anticoagulants, and anticancer drugs. Pregnant women or those who may become pregnant and nursing mothers should not use this medication, and effective contraception is recommended during treatment. Patients who cannot digest certain sugars for genetic reasons should also avoid this medication. Patients with impaired liver or kidney function may require monitoring of liver function tests or dose adjustments while using this medication, and should be observed closely due to the risk of hepatotoxicity. The effects of this medication may vary in immunocompromised patients, and appropriate dose adjustments should be discussed with healthcare providers. Rare side effects such as headache, dyspepsia, liver function abnormalities, skin rashes, and neurological disorders may occur; if any unusual symptoms arise, contact a healthcare provider immediately. Care should be taken when driving or operating machinery, as dizziness or visual disturbances may occur. This medication may have reduced absorption in a low-acid environment, so patients taking acid-reducing agents are advised to take it with acidic beverages. There is no specific antidote for overdose, and treatment should be based on symptoms, so the prescribed dosage must be strictly adhered to. This medication should be kept out of reach of children and stored in its original container to prevent misuse or degradation of quality.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, sensory abnormality, tinnitus, constipation, diarrhea, indigestion, abdominal distension, vomiting, liver function abnormality, hyperbilirubinemia, itching, rash, urticaria, frequent urination, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorder, 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 blood urea, increased gamma-glutamyl transferase, elevated liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioneurotic edema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal flank pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, anorexia, malaise, brown urine, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riele syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein test, positive urine glucose test, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, burning sensation, elevated serum uric acid, elevated serum potassium, serum sickness, angioneurotic edema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, severe hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, phototoxicity, increased serum creatine phosphokinase

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

Storage

This medication should be stored in a sealed container to prevent air or moisture ingress, and should be kept at room temperature, ideally between 1°C and 30°C. Proper storage helps maintain the medication’s efficacy and prevent degradation.

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.