Medication info
Ditra Tablet (Itraconazole Solid Dispersion)

Ditra Tablet (Itraconazole Solid Dispersion)

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

MFDS item code 201502419 · Approved 2015.04.23 · Insurance code 693901460

Summary

Main use
Treatment of skin and nail fungal infections, mucosal and corneal fungal infections, and systemic fungal infections
Who uses it
Adults
Adult dosage
It is preferable to administer immediately after a meal. 1. Short-term 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) Pityriasis versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis, tinea cruris (jock itch): Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type), tinea pedis (interdigital type): 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 for fingernail infections only and up to 3 cycles for toenail infections. 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 treatment ends. 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; average treatment duration 2~5 months. For invasive or disseminated disease, increase 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: 200mg once daily. Paracoccidioidomycosis: 100mg once daily; average treatment duration 6 months.

Ingredients

Manufacturer
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of skin and nail fungal infections, mucosal and corneal fungal infections, and systemic fungal infections

  • Candidiasis
  • tinea
  • dermatophyte infections such as tinea corporis
  • tinea capitis
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medicine is used to treat various fungal diseases, such as candidiasis, tinea, and fungal infections of the skin and nails. It is also effective against oral candidiasis and fungal keratitis. Additionally, it is used for the treatment of systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis, and paracoccidioidomycosis. This drug helps to improve various fungal infections affecting the skin, mucous membranes, and systemic areas.

Dosage and Administration

Adult dosage

It is preferable to administer immediately after a meal. 1. Short-term 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) Pityriasis versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis, tinea cruris (jock itch): Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type), tinea pedis (interdigital type): 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 for fingernail infections only and up to 3 cycles for toenail infections. 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 treatment ends. 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; average treatment duration 2~5 months. For invasive or disseminated disease, increase 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: 200mg once daily. Paracoccidioidomycosis: 100mg once daily; average treatment duration 6 months.

Precautions

This drug may pose a risk to patients with impaired cardiac function or a history of heart failure, and should not be administered unless for life-threatening infections. Treatment should be discontinued immediately if signs of congestive heart failure appear. Patients with hypersensitivity to this drug, those with specific cardiac, renal, or liver diseases, pregnant or breastfeeding women should not take this medication. Additionally, this drug has significant interactions with various medications, so consultation with a doctor or pharmacist is essential if taken with specific drugs. Patients with reduced liver function may be affected by the metabolism of this drug and should undergo regular liver function tests, with dosage adjustments if necessary. Caution is also advised when administering to patients with reduced kidney function, considering dosage adjustments. Rarely, serious side effects such as liver damage, allergic reactions, neurological abnormalities, and hearing loss may occur, and any unusual symptoms should be reported to medical professionals immediately. Dizziness, vision impairment, and hearing loss may occur, and caution is advised when driving or operating machinery. Women who are pregnant or may become pregnant should not take this medication, and effective contraceptive measures must be used after taking the drug. Breastfeeding women should also discontinue nursing if taking this drug. Caution is advised when administering to children or the elderly, only using when the benefits outweigh the risks. In cases of overdose, as there is no specific antidote, treatment should be symptomatic, and this drug is not removed by hemodialysis. Keep this medicine out of reach of children and store in the original container to prevent misuse or deterioration of quality.

Side effects

  • Headache
  • nausea
  • abdominal pain
  • rhinitis
  • sinusitis
  • upper respiratory infection
  • leukopenia
  • hypersensitivity
  • taste disorder
  • sensory impairment
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  • sensory anomaly
  • 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
  • confusional state
  • peripheral neuropathy
  • dizziness
  • drowsiness
  • tremor
  • heart failure
  • left ventricular failure
  • tachycardia
  • hypertension
  • hypotension
  • pulmonary edema
  • voice 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
  • leukocytosis
  • eosinophilia
  • anemia
  • vascular edema
  • serum sickness
  • angioedema
  • anaphylaxis
  • anaphylactic shock
  • allergy reaction
  • diplopia
  • hearing loss
  • ventricular extrasystoles
  • atrial block
  • palpitations
  • increased bowel motility
  • belching
  • glossitis
  • stomatitis
  • abdominal and lumbar pain
  • pancreatitis
  • increased serum total protein
  • increased total bilirubin
  • increased LAP
  • loss of appetite
  • malaise
  • brown urine
  • increased liver enzyme levels
  • mucocutaneous syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Riel syndrome
  • erythema multiforme
  • hair loss
  • photosensitivity reaction
  • exfoliative dermatitis
  • leukotoxic vasculitis
  • acute generalized pustular dermatitis
  • increased BUN
  • positive urine protein test
  • positive urine glucose test
  • decreased libido
  • somnolence
  • shoulder stiffness
  • insomnia
  • chest pain
  • elevated serum triglycerides
  • burning sensation
  • elevated serum uric acid
  • elevated serum potassium
  • serum sickness
  • angioedema
  • anaphylactic reaction
  • hyperlipidemia
  • tremor
  • visual impairment
  • temporary or permanent hearing loss
  • congestive heart failure
  • dyspnea
  • pancreatitis
  • serious hepatotoxicity
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • acute generalized pustular dermatitis
  • erythema multiforme
  • exfoliative dermatitis
  • leukotoxic vasculitis
  • hair loss
  • photosensitivity
  • increased serum creatine phosphokinase

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

Storage

This drug should be stored in a tightly sealed container to prevent air exposure and at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness and prevent deterioration of the drug.

Appearance and packaging

Appearance

White or yellowish 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.

Questions about this medicine

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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.