Medication info
Nakozol 100 mg (Itraconazole)

Nakozol 100 mg (Itraconazole)

Prescription medicationTabletOral
Ingredient · strength
Itraconazole›100mg / 1 tablet
Manufacturer / importer
Withus Pharmaceutical Co., Ltd.
Appearance
White to light white oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201309176 · Approved 2013.09.03 · Insurance code 660702610

Summary

Main use
Treatment of superficial fungal infections (e.g., dermatophytosis, candidiasis), fungal keratitis, and systemic fungal infections
Who takes it
Adults
Adult dose
To increase absorption, this medicine should preferably be administered immediately after a meal. 1. Short-term treatment This medicine continues to have 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) 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: 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 a 3-week drug-free period; this constitutes one cycle. Administer up to 2 cycles for infection limited to the fingernails and up to 3 cycles for toenail infection. Site of onychomycosis Week 1: Treatment Weeks 2, 3, 4: No treatment Week 5: Treatment Weeks 6, 7, 8: No treatment Week 9: Treatment Toenails (with or without concomitant fingernail infection) Treatment No treatment Treatment No treatment Treatment Fingernails Treatment No treatment Treatment Or 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 the end 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; therefore, double the dose if necessary. Aspergillosis: 200mg once daily, 2~5 months. For invasive or disseminated disease, increase 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
Withus Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of superficial fungal infections (e.g., dermatophytosis, candidiasis), fungal keratitis, and systemic fungal infections

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

This medication is used for infections caused by Candida species such as candidal vaginitis and oral candidiasis. It is also effective for skin mycoses such as tinea corporis, tinea capitis, tinea manuum, and tinea pedis caused by dermatophytes. It is used for fungal keratitis and onychomycosis, and it is indicated for the treatment of systemic fungal infections including aspergillosis and cryptococcosis. Therefore, it is a medication that helps improve various fungal infections.

How to take

Adult dose

To increase absorption, this medicine should preferably be administered immediately after a meal. 1. Short-term treatment This medicine continues to have 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) 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: 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 a 3-week drug-free period; this constitutes one cycle. Administer up to 2 cycles for infection limited to the fingernails and up to 3 cycles for toenail infection. Site of onychomycosis Week 1: Treatment Weeks 2, 3, 4: No treatment Week 5: Treatment Weeks 6, 7, 8: No treatment Week 9: Treatment Toenails (with or without concomitant fingernail infection) Treatment No treatment Treatment No treatment Treatment Fingernails Treatment No treatment Treatment Or 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 the end 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; therefore, double the dose if necessary. Aspergillosis: 200mg once daily, 2~5 months. For invasive or disseminated disease, increase 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 medication should not be used in patients with compromised heart function, especially those with congestive heart failure, as it can be life-threatening. If symptoms of heart failure occur while taking this medication, it should be discontinued immediately. It must not be used in individuals with a history of allergy or hypersensitivity to this drug. Additionally, it can interact with several other medications, so it should not be taken together with certain drugs. Women who are pregnant or may become pregnant, as well as nursing mothers, should avoid taking this medication. Patients with lactose intolerance or specific genetic metabolic disorders should also not use this medication. Patients with compromised liver or kidney function, weakened immune systems, or a history of neuropathy due to this medication should use it with caution. This drug may cause gastrointestinal and neurological side effects such as headache, nausea, and abdominal pain, and less commonly, severe side effects such as liver dysfunction, skin rash, and cardiac arrhythmias may occur. Report any abnormal symptoms to a healthcare professional immediately. There are many interactions with other medications, which can increase the risk of side effects when taken together, so inform your healthcare provider about all medications you are taking. Special caution is necessary when used in combination with heart medications, anticoagulants, antipsychotics, anticancer drugs, and other pain relievers. Take it with acidic beverages as low stomach acidity can reduce absorption. Caution is required while driving or operating machinery as side effects like dizziness, visual disturbances, and hearing loss may occur. In case of overdose, there are no specific antidotes, so symptomatic treatment should be taken, and it is not removed by hemodialysis. Keep out of reach of children and store it in its original container to maintain quality.

Side effects

  • Headache
  • nausea
  • abdominal pain
  • rhinitis
  • sinusitis
  • upper respiratory infection
  • leukopenia
  • hypersensitivity
  • taste disorder
  • sensory loss
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  • sensory abnormality
  • tinnitus
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • vomiting
  • liver dysfunction
  • hyperbilirubinemia
  • itching
  • rash
  • urticaria
  • frequent urination
  • 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
  • voice disorder
  • cough
  • gastrointestinal disorder
  • 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 ectopy
  • atrioventricular block
  • palpitations
  • increased bowel motility
  • belching
  • glossitis
  • stomatitis
  • abdominal flank pain
  • pancreatitis
  • increased serum total protein
  • increased total bilirubin
  • increased LAP
  • decreased appetite
  • malaise
  • brown urine
  • mucous membrane syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Rhee syndrome
  • erythema multiforme
  • hair loss
  • photosensitivity reaction
  • exfoliative dermatitis
  • leukocytoclastic vasculitis
  • acute generalized pustular psoriasis
  • 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
  • increased serum potassium
  • serum sickness
  • angioedema
  • anaphylactic reaction
  • hypertriglyceridemia
  • tremors
  • visual impairment
  • temporary or permanent hearing loss
  • congestive heart failure
  • dyspnea
  • pancreatitis
  • significant hepatic toxicity
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • acute generalized pustular psoriasis
  • erythema multiforme
  • exfoliative dermatitis
  • leukocytoclastic vasculitis
  • hair loss
  • photosensitivity
  • increased serum creatine kinase activity

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 ingress, ideally at room temperature between 1 degree and 30 degrees. Storing it this way helps maintain the drug's effectiveness for a long time.

Appearance and packaging

Appearance

White to light white oval 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.

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.