Medication info

Temazol Tablet 200 mg (Itraconazole)

Prescription medicationExpired
Ingredient · strength
Itraconazole›Strength being verified
Manufacturer / importer
Samchundang Pharmaceutical Co., Ltd.
Appearance
White rectangular film-coated tablets
Packaging
20 tablets (10 tablets/PTP)x2, 30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 200712720 · Approved 2007.11.22

This product's status changed to Expired on 2023.04.01. 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
To increase absorption, it is best to administer immediately after a meal. 1. Short-term treatment Final clinical and mycological response should preferably be assessed 2-4 weeks after completion of the prescribed treatment. Vulvovaginal candidiasis: Take 200mg per dose, 2 times daily (morning and evening) for 1 day, or take 200mg once daily for 3 days Pityriasis versicolor: Take 200mg once daily for 7 days Tinea corporis, tinea cruris (jock itch): Take 100mg once daily for 15 days Tinea manuum (interdigital), tinea pedis (interdigital): Take 100mg once daily for 15 days Tinea manuum (palmar), tinea pedis (plantar): Take 100mg once daily for 30 days Take 200mg per dose, 2 times daily for 7 days Oral candidiasis: Take 100mg once daily for 15 days Fungal keratitis: Take 200mg once daily for 21 days 2. Onychomycosis 1) Pulse therapy Take 200mg per dose, 2 times daily for 1 week, followed by a 3-week treatment-free period. This constitutes 1 cycle. Take up to 2 cycles if only fingernails are infected, and up to 3 cycles if toenails are infected. Toenails (with or without fingernail infection): 1 week of treatment, 2 weeks off, 3 weeks of treatment, 4 weeks off, 5 weeks of treatment Fingernails: 1 week of treatment, 2 weeks off, 3 weeks of treatment 2) Continuous therapy Take 200mg 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. Therefore, 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, 2 times daily Candidiasis: 100mg∼200mg once daily, average treatment duration 3 weeks∼7 months. For invasive or disseminated disease, increase to 200mg per dose, 2 times daily Non-meningeal cryptococcosis: 200mg once daily, average treatment duration 2 months∼1 year Cryptococcal meningitis: 2 times daily, 200mg per dose, average treatment duration 2 months∼1 year. Maintenance therapy: (for meningitis) 200mg once daily Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months

Ingredients

Manufacturer
Samchundang Pharmaceutical 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 infections
  • fungal keratitis
  • oral candidiasis
  • onychomycosis
  • systemic fungal infections
View approved original text

This medication treats fungal infections of the skin and mucous membranes such as candidal vaginitis, tinea versicolor, tinea corporis, tinea cruris, tinea manuum, and tinea pedis. It is also effective against fungal keratitis, oral candidiasis, and onychomycosis. Additionally, it is used for various systemic fungal infections including aspergillosis, candidiasis, cryptococcal disease (including cryptococcal meningitis), and paracoccidioidomycosis. In other words, this medication is utilized for the treatment of various skin and mucosal fungal infections as well as serious systemic fungal infections, thereby improving the patient's condition.

Dosage and Administration

Adult dosage

To increase absorption, it is best to administer immediately after a meal. 1. Short-term treatment Final clinical and mycological response should preferably be assessed 2-4 weeks after completion of the prescribed treatment. Vulvovaginal candidiasis: Take 200mg per dose, 2 times daily (morning and evening) for 1 day, or take 200mg once daily for 3 days Pityriasis versicolor: Take 200mg once daily for 7 days Tinea corporis, tinea cruris (jock itch): Take 100mg once daily for 15 days Tinea manuum (interdigital), tinea pedis (interdigital): Take 100mg once daily for 15 days Tinea manuum (palmar), tinea pedis (plantar): Take 100mg once daily for 30 days Take 200mg per dose, 2 times daily for 7 days Oral candidiasis: Take 100mg once daily for 15 days Fungal keratitis: Take 200mg once daily for 21 days 2. Onychomycosis 1) Pulse therapy Take 200mg per dose, 2 times daily for 1 week, followed by a 3-week treatment-free period. This constitutes 1 cycle. Take up to 2 cycles if only fingernails are infected, and up to 3 cycles if toenails are infected. Toenails (with or without fingernail infection): 1 week of treatment, 2 weeks off, 3 weeks of treatment, 4 weeks off, 5 weeks of treatment Fingernails: 1 week of treatment, 2 weeks off, 3 weeks of treatment 2) Continuous therapy Take 200mg 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. Therefore, 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, 2 times daily Candidiasis: 100mg∼200mg once daily, average treatment duration 3 weeks∼7 months. For invasive or disseminated disease, increase to 200mg per dose, 2 times daily Non-meningeal cryptococcosis: 200mg once daily, average treatment duration 2 months∼1 year Cryptococcal meningitis: 2 times daily, 200mg per dose, average treatment duration 2 months∼1 year. Maintenance therapy: (for meningitis) 200mg once daily Paracoccidioidomycosis: 100mg once daily, average treatment duration 6 months

Precautions

This medicine should not be used in patients with impaired cardiac function, particularly those with congestive heart failure. If symptoms of heart failure appear, treatment should be discontinued immediately. It should not be administered to patients with known allergies to this drug or its components, pregnant women or women who may become pregnant, and nursing mothers. This drug is primarily metabolized in the liver; therefore, it should be used with caution in patients with poor liver function, requiring regular liver function testing. Patients with reduced renal function may require dose adjustments, so caution is needed. This drug may interact with other medications, so patients taking other drugs should consult their physician or pharmacist. In particular, it should not be taken with medications that can cause cardiac arrhythmias. Patients may experience dizziness, visual disturbances, or hearing loss; therefore, caution should be exercised when driving or operating machinery. Pregnant or nursing women should avoid using this medication, and females of childbearing potential should use contraception during treatment. The safety of this drug has not been established in children or the elderly, so it should be administered cautiously. In case of overdose, appropriate treatment should be administered based on symptoms, and caution is required as this drug is not removed by hemodialysis. This medication should be kept out of the reach of children and stored in its original container to maintain quality.

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 disorder, 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, voice disorder, cough, gastrointestinal disturbance, liver failure, hepatitis, jaundice, erythema multiforme rash, hyperhidrosis, muscle pain, joint pain, renal impairment, 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 serum urea, increased gamma-glutamyl transferase, elevated liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, double vision, visual impairment, hearing loss, ventricular ectopy, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal pain lower back pain, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, anorexia, lassitude, dark urine, abdominal pain, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocyte destructive vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein reaction, positive urine sugar reaction, 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, hyperlipidemia, tremor, visual impairment, transient or permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, desquamative dermatitis, leukocyte destructive 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 tightly closed container to prevent exposure to air or moisture. Additionally, it is recommended to keep the drug at room temperature, ideally between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White rectangular film-coated tablets

Package unit

20 tablets (10 tablets/PTP)x2, 30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle

Same-ingredient medicines

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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.