Medication info
Ciconazole Tablets (Itraconazole)

Ciconazole Tablets (Itraconazole)

Prescription medicationTabletOral
Ingredient · strength
Itraconazole›100mg / 1 tablet
Manufacturer / importer
CMG Pharmaceutical Co., Ltd.
Appearance
White or nearly white oval film-coated tablets
Packaging
Bottle packaging: 30 tablets, 100 tablets
Approval status
Active

MFDS item code 201405281 · Approved 2014.11.12 · Insurance code 648602840

Summary

Main use
Treatment of fungal infections of the skin and nails, fungal infections of the mucous membranes and cornea, and treatment and prevention of systemic fungal infections
Who takes it
Adults · Children
Adult dose
(Tablets)(Capsules) To increase absorption, this medicine should preferably be taken immediately after a meal. 1. Short-term treatment 1) Candidal vaginitis: Administer itraconazole 200 mg 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, tinea cruris: 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 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 1 cycle. Administer up to 2 cycles for infection of the fingernails only and up to 3 cycles for infection of the toenails. 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 or AIDS or those who have undergone organ transplantation, the oral bioavailability of this medicine may be reduced; if necessary, administer twice the dose. Aspergillosis: 200mg once daily; mean treatment duration 2~5 months. For invasive or disseminated disease, increase the dose to 200mg twice daily. Candidiasis: 100~200mg once daily; mean treatment duration 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily; mean treatment duration 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily; mean treatment duration 6 months. (Oral solution) To increase absorption, do not take this medicine with food. Keep this medicine in the mouth for about 20 seconds so that it contacts the entire oral cavity, then swallow. After swallowing, do not rinse the mouth, so that the medicine remains in the mouth for as long as possible. 1. Oral and esophageal candidiasis Take 200 mg (20 mL) daily in 1~2 divided doses for 1 week. If there is no effect after 1 week, continue taking it for 1 more week. 2. Fluconazole-resistant oral and esophageal candidiasis Take 200~400 mg (20~40 mL) daily in 1~2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue taking it for 2 more weeks. Even if symptoms have not improved, do not use 400 mg daily for more than 14 days. 3. Prevention of fungal infections In clinical trials, prophylaxis was started immediately before anticancer treatment and about 1 week before bone marrow transplantation. Deep fungal infections were confirmed in most patients with a neutrophil count of less than 100/μL. Treatment was continued until the neutrophil count recovered (1,000/μL). Pharmacokinetic data from clinical trials in patients with neutropenia showed substantial interindividual variability. Therefore, therapeutic drug monitoring should be considered, particularly in patients with gastrointestinal damage, patients with diarrhea, and when this medicine is administered for a prolonged period.
Child dose
Prevention of fungal infections: Administer 5 mg per kg of body weight daily in 2 divided doses.

Ingredients

Manufacturer
CMG Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of fungal infections of the skin and nails, fungal infections of the mucous membranes and cornea, and treatment and prevention of systemic fungal infections

  • Candidiasis
  • 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 various fungal infections including candidiasis (vulvovaginal candidiasis), tinea versicolor, tinea corporis, tinea capitis, tinea manuum, tinea pedis, oral candidiasis, fungal keratitis, onychomycosis, and others. It is also effective against systemic fungal infections like aspergillosis, candidiasis, cryptococcosis, and paracoccidioidomycosis. The liquid formulation is particularly used for the treatment of oral and esophageal candidiasis in HIV-infected individuals or immunocompromised patients, and for the prevention of invasive fungal infections in patients with anticipated neutropenia such as those with hematological malignancies or undergoing bone marrow transplants. Although clinical data on prevention of aspergillosis is still insufficient, it is generally effective for the treatment and prevention of various fungal infections. This medication is used to improve and treat fungal infections.

How to take

Adult dose

(Tablets)(Capsules) To increase absorption, this medicine should preferably be taken immediately after a meal. 1. Short-term treatment 1) Candidal vaginitis: Administer itraconazole 200 mg 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, tinea cruris: 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 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 1 cycle. Administer up to 2 cycles for infection of the fingernails only and up to 3 cycles for infection of the toenails. 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 or AIDS or those who have undergone organ transplantation, the oral bioavailability of this medicine may be reduced; if necessary, administer twice the dose. Aspergillosis: 200mg once daily; mean treatment duration 2~5 months. For invasive or disseminated disease, increase the dose to 200mg twice daily. Candidiasis: 100~200mg once daily; mean treatment duration 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily; mean treatment duration 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily; mean treatment duration 6 months. (Oral solution) To increase absorption, do not take this medicine with food. Keep this medicine in the mouth for about 20 seconds so that it contacts the entire oral cavity, then swallow. After swallowing, do not rinse the mouth, so that the medicine remains in the mouth for as long as possible. 1. Oral and esophageal candidiasis Take 200 mg (20 mL) daily in 1~2 divided doses for 1 week. If there is no effect after 1 week, continue taking it for 1 more week. 2. Fluconazole-resistant oral and esophageal candidiasis Take 200~400 mg (20~40 mL) daily in 1~2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue taking it for 2 more weeks. Even if symptoms have not improved, do not use 400 mg daily for more than 14 days. 3. Prevention of fungal infections In clinical trials, prophylaxis was started immediately before anticancer treatment and about 1 week before bone marrow transplantation. Deep fungal infections were confirmed in most patients with a neutrophil count of less than 100/μL. Treatment was continued until the neutrophil count recovered (1,000/μL). Pharmacokinetic data from clinical trials in patients with neutropenia showed substantial interindividual variability. Therefore, therapeutic drug monitoring should be considered, particularly in patients with gastrointestinal damage, patients with diarrhea, and when this medicine is administered for a prolonged period.

Child dose

Prevention of fungal infections: Administer 5 mg per kg of body weight daily in 2 divided doses.

Precautions

This medication should not be used in patients with weakened heart function. Patients with congestive heart failure or impaired ventricular function must consult a doctor before administration. Patients with a history of allergic reactions to this medication should avoid using it. Caution is also needed in patients with certain heart diseases, liver diseases, or kidney diseases. It is advisable for pregnant or potentially pregnant women, as well as breastfeeding women, not to use this medication. Since this medication is primarily metabolized in the liver, patients with poor liver function should undergo liver function tests before administration, and periodic liver function tests are necessary during treatment. Due to numerous drug interactions, serious side effects may occur depending on co-administered medications, thus, patients must inform their doctor or pharmacist about all medications they are taking. Special caution is necessary when co-administering with certain analgesics, antiarrhythmics, antibiotics, anticoagulants, anticancer drugs, antipsychotics, calcium channel blockers, etc. This medication may not absorb well in low acidity states, so when taking acid-reducing medications, it may be helpful to take this medication with acidic drinks (e.g., regular cola). During administration, gastrointestinal symptoms such as headache, nausea, abdominal pain, diarrhea, as well as liver function abnormalities, skin rash, and neurological symptoms may occur, and if any of these abnormal symptoms arise, immediate consultation with medical personnel is required. In addition, this medication has rarely been reported to cause ear-related adverse reactions such as hearing loss; thus, if there are any changes in hearing, immediate notification is necessary. In case of overdose, as there is no specific antidote, immediate hospital visit for appropriate treatment is needed. Lastly, this medication should be stored out of reach of children, and kept in its original container to prevent misuse or quality degradation.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disturbance, sensory decline, sensory abnormality, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorder, edema, granulocytopenia, thrombocytopenia, anaphylaxis-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorder, cough, gastrointestinal disorder, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, incontinence, generalized edema, facial swelling, chest pain, fever, pain, fatigue, chills, increased alanine aminotransferase, increased aspartate aminotransferase, increased serum alkaline phosphatase, increased serum lactate dehydrogenase, increased serum urea, increased gamma-glutamyl transferase, increased liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, double vision, visual impairment, hearing loss, ventricular ectopic beats, atrial block, palpitations, increased bowel activity, belching, glossitis, stomatitis, abdominal pain in the lumbar region, pancreatitis, elevated serum total protein, elevated total bilirubin, increased LAP, decreased appetite, malaise, jaundice, dark urine, increased liver enzyme levels, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein, positive urine glucose, decreased libido, drowsiness, malaise, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides levels, burning sensation, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylaxis reaction, hypertriglyceridemia, tremors, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, dyspnea, significant hepatic toxicity, toxic epidermal necrolysis, 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

This medication should be stored in a tightly sealed container to prevent exposure to air and should be kept at room temperature between 1°C and 30°C. This way, the effectiveness of the medication can be maintained, and deterioration can be prevented.

Appearance and packaging

Appearance

White or nearly white oval film-coated tablets

Package unit

Bottle packaging: 30 tablets, 100 tablets

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.