Medication info
Megatrak Capsule (Itraconazole)

Megatrak Capsule (Itraconazole)

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

MFDS item code 202003621 · Approved 2020.05.18 · Insurance code 060500160

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 increase absorption, this medicine should preferably be administered immediately after a meal. The capsule must be swallowed whole. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological response should preferably be assessed 2~4 weeks after completion of the prescribed treatment. 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. 2) Tinea 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 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 twice daily for 1 week, followed by 3 weeks without treatment; this constitutes 1 cycle. Administer up to 2 cycles if only fingernails are infected, and up to 3 cycles if toenails are infected. Site of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without concomitant fingernail infection) Treatment No treatment Treatment No treatment Treatment Fingernails Treatment No treatment Treatment \ 2) 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 completion of treatment. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia or AIDS or those who have undergone organ transplantation, the oral bioavailability of this medicine may be reduced; if necessary, increase the dose twofold. 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 patients with AIDS only): 200mg once daily2 Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months. There are no efficacy data for this dosage regimen for the treatment of paracoccidioidomycosis in patients with AIDS. 1 The duration of treatment should be adjusted according to clinical response. 2 The duration of treatment should depend on immune recovery.

Ingredients

Manufacturer
L&C Bio Co., Ltd.

Efficacy & effects

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

  • Vulvovaginal candidiasis
  • tinea
  • 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 vulvovaginal candidiasis and tinea, as well as various fungal infections affecting the skin and nails. It is also effective for oral candidiasis and fungal keratitis. It is used to treat systemic fungal infections such as aspergillosis, candidiasis, paracoccidioidomycosis, and cryptococcosis occurring in immunocompromised patients, particularly when cryptococcal meningitis is present, it is prescribed after failure of first-line treatment. This drug helps effectively improve and treat fungal infections.

Dosage and Administration

Adult dosage

To increase absorption, this medicine should preferably be administered immediately after a meal. The capsule must be swallowed whole. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological response should preferably be assessed 2~4 weeks after completion of the prescribed treatment. 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. 2) Tinea 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 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 twice daily for 1 week, followed by 3 weeks without treatment; this constitutes 1 cycle. Administer up to 2 cycles if only fingernails are infected, and up to 3 cycles if toenails are infected. Site of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without concomitant fingernail infection) Treatment No treatment Treatment No treatment Treatment Fingernails Treatment No treatment Treatment \ 2) 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 completion of treatment. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia or AIDS or those who have undergone organ transplantation, the oral bioavailability of this medicine may be reduced; if necessary, increase the dose twofold. 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 patients with AIDS only): 200mg once daily2 Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months. There are no efficacy data for this dosage regimen for the treatment of paracoccidioidomycosis in patients with AIDS. 1 The duration of treatment should be adjusted according to clinical response. 2 The duration of treatment should depend on immune recovery.

Precautions

This medication should be used with caution in patients with weak heart function or a history of heart failure as life-threatening situations may arise. This medication should not be administered if allergic to it or when taking certain medications, and should not be used by pregnant or potentially pregnant women, or nursing mothers. Patients with impaired liver or kidney function may be affected by the metabolism and excretion of this medication, so careful dosing is necessary and regular liver function tests are important. This medication may interact with various drugs; therefore, it is essential to consult a doctor or pharmacist if taking other medications, especially those affecting the heart, nervous system, liver, or kidneys. Symptoms such as headache, nausea, abdominal pain, and diarrhea may occur. Rarely, serious side effects such as liver function abnormalities, rash, neuropathy, and hearing loss can occur and any unusual symptoms should be reported to healthcare professionals immediately. This medication may be absorbed less effectively in a low-acidity state; therefore, if taking acid-reducing medications, it is recommended to take them with acidic beverages. Caution should be taken while driving or operating machinery as side effects such as dizziness, visual disturbances, and hearing loss may occur. In cases of overdose, there is no specific antidote, so immediate medical attention should be sought. Children and the elderly should use this medication more cautiously, with dosing adjusted particularly for the elderly considering potential impairments in liver, kidney, and heart function. This medication must be kept out of reach of children and stored in its original container to prevent deterioration or misuse.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory decrease, sensory abnormality, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, vocal cord dysfunction, cough, gastrointestinal disorder, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, kidney disorder, urinary incontinence, systemic 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 reaction, diplopia, vision impairment, transient hearing loss, permanent hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal pain in the lower back, pancreatitis, elevated serum total protein, elevated total bilirubin, elevated LAP, decreased appetite, lethargy, brown urine, increased liver enzyme levels, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Rielle syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urinary protein reaction, positive urinary glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, flushing, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylactic reactions, hypertriglyceridemia, tremors, vision impairment, congestive heart failure, dyspnea, pancreatitis, severe hepatotoxicity, toxic epidermal necrolysis, 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

This medication should be stored in a tightly sealed container to prevent air and moisture exposure, ideally at room temperature between 1 to 30 degrees Celsius. This helps maintain the medication's effectiveness and prevents degradation.

Appearance and packaging

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/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.