Medication info

Megatra Tablet (Itraconazole Solid Dispersion)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
L&C Bio Co., Ltd.
Appearance
White or off-white round film-coated tablet
Packaging
28 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001047 · Approved 2020.02.17

This product's status changed to Approval withdrawn on 2024.07.02. 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, vagina, mouth, and cornea, and systemic fungal infections
Who uses it
Adults
Adult dosage
It is preferable to take this medicine immediately after a meal. 1. Short-term treatment The final clinical and mycological treatment response should preferably be assessed 2~4 weeks after completing the prescribed treatment. 1) Candidal vaginitis: Administer 200 mg of itraconazole 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 and tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea of the hands (interdigital) and tinea of the feet (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea of the hands (palms) and tinea of the feet (soles): 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 treatment-free period; this constitutes one cycle. Treat for up to 2 cycles when only the fingernails are infected, and up to 3 cycles when the toenails are infected. Toenails (with or without concomitant fingernail infection): 1 week of treatment, 2 weeks off treatment, 3 weeks of treatment, 4 weeks off treatment, 5 weeks of treatment Fingernails: 1 week of treatment, 2 weeks off treatment, 3 weeks of treatment 2) Continuous therapy Administer 200 mg once daily for 3 months. The treatment 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 or AIDS and organ transplant recipients, the oral bioavailability of this medicine may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily, 2~5 months. For invasive or disseminated disease, increase the dose to 200mg twice daily. Candidiasis: 100~200mg once daily, 3 weeks~7 months Cryptococcal meningitis: 200mg twice daily, 2 months~1 year. Maintenance therapy: 200mg once daily Paracoccidioidomycosis: 100mg once daily, 6 months

Ingredients

Manufacturer
L&C Bio Co., Ltd.

Efficacy & effects

Treatment of fungal infections of the skin and nails, vagina, mouth, and cornea, 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 medication is effective for skin and mucosal fungal infections caused by candidiasis, tinea, and various types of ringworm (including body, groin, hand, foot ringworm), oral candidiasis, fungal keratitis, and onychomycosis. It is also used for severe systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (especially including meningitis), and paracoccidioidomycosis. This drug is effective in treating multiple fungal infections and helps improve the symptoms of patients. It is widely used for those with fungal diseases, and it can be used with confidence for treatment.

Dosage and Administration

Adult dosage

It is preferable to take this medicine immediately after a meal. 1. Short-term treatment The final clinical and mycological treatment response should preferably be assessed 2~4 weeks after completing the prescribed treatment. 1) Candidal vaginitis: Administer 200 mg of itraconazole 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 and tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea of the hands (interdigital) and tinea of the feet (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea of the hands (palms) and tinea of the feet (soles): 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 treatment-free period; this constitutes one cycle. Treat for up to 2 cycles when only the fingernails are infected, and up to 3 cycles when the toenails are infected. Toenails (with or without concomitant fingernail infection): 1 week of treatment, 2 weeks off treatment, 3 weeks of treatment, 4 weeks off treatment, 5 weeks of treatment Fingernails: 1 week of treatment, 2 weeks off treatment, 3 weeks of treatment 2) Continuous therapy Administer 200 mg once daily for 3 months. The treatment 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 or AIDS and organ transplant recipients, the oral bioavailability of this medicine may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily, 2~5 months. For invasive or disseminated disease, increase the dose to 200mg twice daily. Candidiasis: 100~200mg once daily, 3 weeks~7 months Cryptococcal meningitis: 200mg twice daily, 2 months~1 year. Maintenance therapy: 200mg once daily Paracoccidioidomycosis: 100mg once daily, 6 months

Precautions

This drug may pose risks for patients with compromised heart function, especially those with congestive heart failure, and should be used with caution. Patients with allergic reactions to this medication or impaired heart function should not use it. Furthermore, this medication may interact with various other drugs, so it is essential to consult with a physician or pharmacist about any medications being taken concurrently. It is recommended that pregnant or potentially pregnant women and nursing mothers avoid taking this medication. Patients with liver or kidney dysfunction should consult with healthcare professionals before using this medication, as dosage adjustments may be necessary. While taking this medication, regular liver function tests should be conducted, and if any unusual symptoms arise, healthcare professionals should be notified immediately. This drug may not be well absorbed in low acidity conditions, so taking it with acidic beverages may be beneficial when taking medications that lower stomach acidity. Side effects such as dizziness, headache, indigestion, rash, etc., may occur, and patients should consult with healthcare professionals if symptoms are severe. Caution is needed while driving or operating machinery as dizziness or visual disturbances may occur. In case of overdose, there is no specific antidote, so immediate medical attention is required for appropriate treatment. Lastly, 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 infection, leukopenia, hypersensitivity, dysgeusia, hypoesthesia, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, agranulocytosis, thrombocytopenia, anaphylactoid reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech 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 blood urea, increased gamma-glutamyl transferase, increased liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reactions, diplopia, visual impairment, temporary hearing loss, permanent hearing loss, ventricular premature contractions, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, anorexia, malaise, brown urine, skin and mucosal syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reactions, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein, positive urine glucose, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increased serum triglycerides, burning sensation, increased serum uric acid levels, increased serum potassium levels, serum sickness, angioedema, anaphylaxis reaction, hypertriglyceridemia, tremors, visual impairment, congestive heart failure, dyspnea, severe 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 a sealed container to prevent air from entering, and it is advisable to store it at room temperature between 1 °C and 30 °C. Storing it this way helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

White or off-white round film-coated tablet

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.