Medication info
TinaDerm Capsule (Itraconazole)

TinaDerm Capsule (Itraconazole)

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

MFDS item code 200400129 · Notified 2004.09.21 · Insurance code 645903070

Summary

Main use
Treatment of skin and nail fungal infections, mucosal and corneal fungal infections, and systemic fungal infections
Who takes it
Adults
Adult dose
Administration immediately after a meal is preferable. The capsule must be swallowed whole. Vulvovaginal candidiasis: Administer itraconazole 200 mg per dose twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Pityriasis versicolor: Administer 200 mg once daily for 7 days. Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. Tinea manuum (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. Tinea manuum (palms), tinea pedis (soles): Administer 100 mg once daily for 30 days or 200 mg per dose twice daily for 7 days. Oral candidiasis: Administer 100 mg once daily for 15 days. Fungal keratitis: Administer 200 mg once daily for 21 days. Pulse therapy: Administer 200 mg per dose twice daily for 1 week, followed by a 3-week drug-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. Continuous therapy: Administer 200 mg once daily for 3 months. 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 per dose 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 AIDS patients only): 200mg once daily Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months Treatment duration should be adjusted according to clinical response. Treatment duration should depend on immune recovery.

Ingredients

Manufacturer
Dongkwang Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used for a variety of fungal skin diseases such as candidal vaginitis, tinea versicolor, and tinea corporis, tinea capitis, tinea manuum, tinea pedis caused by dermatophytes. It is also effective for the treatment of oral candidiasis and fungal keratitis, as well as nail and toe fungus. Additionally, it is used for the treatment of systemic fungal infections that occur in immunocompromised patients, such as aspergillosis, candidiasis, paracoccidioidomycosis, cryptococcosis (including meningitis), especially when first-line treatment is ineffective. It can also be used for maintenance therapy of cryptococcal meningitis in AIDS patients. Thus, it is used for the treatment of a wide range of fungal infections to improve symptoms and enhance therapeutic effectiveness.

How to take

Adult dose

Administration immediately after a meal is preferable. The capsule must be swallowed whole. Vulvovaginal candidiasis: Administer itraconazole 200 mg per dose twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. Pityriasis versicolor: Administer 200 mg once daily for 7 days. Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. Tinea manuum (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. Tinea manuum (palms), tinea pedis (soles): Administer 100 mg once daily for 30 days or 200 mg per dose twice daily for 7 days. Oral candidiasis: Administer 100 mg once daily for 15 days. Fungal keratitis: Administer 200 mg once daily for 21 days. Pulse therapy: Administer 200 mg per dose twice daily for 1 week, followed by a 3-week drug-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. Continuous therapy: Administer 200 mg once daily for 3 months. 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 per dose 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 AIDS patients only): 200mg once daily Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months Treatment duration should be adjusted according to clinical response. Treatment duration should depend on immune recovery.

Precautions

This drug should not be administered to patients with compromised heart function, particularly those with congestive heart failure, unless for life-threatening infections. If symptoms of heart failure develop during treatment, use should be discontinued immediately. Patients with a history of allergic reactions to this drug or certain heart conditions should not use it. Additionally, this drug may interact with multiple medications, so caution is advised when taken with heart-related medications, analgesics, antiarrhythmics, anticoagulants, etc. Pregnant women or those who may become pregnant and nursing mothers should not use this drug, and effective contraception should be employed after discontinuation if planning for pregnancy. Patients with weakened liver function or those with a history of hepatotoxicity should have liver function tests regularly while using this drug, and use should be avoided if the risk of liver damage is deemed high. Patients with reduced kidney function should also use with caution as dose adjustment may be necessary. This drug may have reduced plasma concentration in immunocompromised patients, such as AIDS or organ transplant recipients, requiring monitoring of treatment efficacy and dose adjustment. Symptoms such as headache, nausea, abdominal pain and, rarely, abnormal liver function, skin rash, and neurological issues may occur; consult a healthcare provider if abnormal symptoms arise. It may also cause hearing loss; any changes in hearing should be reported immediately. Caution is needed when driving or operating machinery as dizziness or visual disturbances may occur. In case of overdose, there is no specific antidote, and symptomatic treatment should be provided; blood dialysis does not remove this drug. Keep the medication out of the reach of children and store in its original container to prevent quality degradation.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, sensory anomalies, tinnitus, constipation, diarrhea, indigestion, abdominal distension, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, altered mental status, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorder, cough, gastrointestinal disturbance, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, 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 serum urea, increased gamma-glutamyl transferase, increased liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serological disease, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, double vision, visual impairment, hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased bowel activity, belching, glossitis, stomatitis, abdominal flank pain, pancreatitis, elevated serum total protein, elevated total bilirubin, elevated LAP, decreased appetite, malaise, dark urine, increased liver enzyme levels, skin and mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Reiter's syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocyte destructive vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, warmth sensation, elevated serum uric acid, elevated serum potassium, serological disease, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, temporary or permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, increased serum creatine phosphokinase

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

Storage

Store this medication in a tightly sealed container that is air-tight, preferably at room temperature between 1 and 30 degrees Celsius. This helps maintain its efficacy and prevent degradation.

Appearance and packaging

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle

Same-ingredient medicines

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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.