Medication info

Nutraconazole 100 mg (Itaconazole)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
Ahn-Guk Newpharm Co., Ltd.
Appearance
White or yellowish round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201603336 · Approved 2016.06.10

This product's status changed to Approval withdrawn on 2024.03.06. 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, vaginal, oral, and corneal fungal infections, and systemic fungal infections
Who uses it
Adults
Adult dosage
It is preferable to administer this medicine immediately after a meal. 1. Short-term treatment 1) Candidal vaginitis: 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 (palms), tinea pedis (soles): 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 a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles if only the fingernails are infected and up to 3 cycles if the toenails are infected. 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 transplant recipients, 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
Ahn-Guk Newpharm Co., Ltd.

Efficacy & effects

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

  • Candidal vaginitis
  • tinea versicolor
  • tinea corporis due to dermatophytes
  • tinea capitis
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medication is used to treat fungal infections of the skin and mucous membranes, such as candidal vaginitis, tinea versicolor, various dermatophyte infections (tinea corporis, tinea capitis, tinea manuum, tinea pedis), oral candidiasis, fungal keratitis, and onychomycosis. It is also effective against systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. These fungal infections can be difficult to treat, but this drug helps improve various locations and types of fungal infections. Patients should use it as prescribed for significant relief from symptoms and effective treatment of infections. Since it plays a critical role in the treatment of fungal infections, consistent use can lead to favorable results. This medication is used for treating various fungal infections.

Dosage and Administration

Adult dosage

It is preferable to administer this medicine immediately after a meal. 1. Short-term treatment 1) Candidal vaginitis: 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 (palms), tinea pedis (soles): 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 a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles if only the fingernails are infected and up to 3 cycles if the toenails are infected. 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 transplant recipients, 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

It is important not to administer this drug to patients with compromised heart function, especially those with congestive heart failure. If symptoms of heart failure appear, discontinue use immediately. Those who have allergic reactions or hypersensitivity to this medication should not use it. Additionally, it may be dangerous to take this drug with certain heart-related medications or various other drugs, so consultation with a doctor or pharmacist is essential. Women who are pregnant or may become pregnant, as well as those who are breastfeeding, should not take this medication and should implement effective contraception after use. Patients with impaired liver or kidney function may face an increased risk of side effects from this drug, requiring careful monitoring and possibly dosage adjustments. Since this drug is primarily metabolized in the liver, regular liver function tests should be conducted, and treatment should be discontinued immediately if signs of liver damage occur. Side effects such as headaches, nausea, abdominal pain, and skin rashes or itching may occur, so caution is warranted. Dizziness or visual and auditory disturbances can occur, necessitating caution while driving or operating machinery. This drug interacts with many other medications, with some being contraindicated for concurrent use; therefore, inform healthcare providers of any other medications being taken. There is no specific antidote for overdose, so immediate medical attention is required, and it is not removed by hemodialysis. Keep out of reach of children and store in the original container to prevent misuse or quality deterioration.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, 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 state, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disturbance, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, kidney disorder, 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 reaction, diplopia, visual impairment, hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal pain in the lower back, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, decreased appetite, malaise, brown urine, sicca syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive proteinuria, positive glucosuria, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, increased serum triglyceride level, burning sensation, increased serum uric acid level, increased serum potassium level, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, transient or permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, Steven-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase activity

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

Storage

Store this medication in a sealed container to prevent air or moisture ingress, and it is advisable to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the drug's efficacy.

Appearance and packaging

Appearance

White or yellowish round film-coated tablet

Package unit

30 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.