Medication info
Vivozonitraconazole Tablets

Vivozonitraconazole Tablets

Prescription medicationTablet
Ingredient · strength
Itraconazole Solid Dispersions›253mg / 1 tablet
Manufacturer / importer
Vivozon Pharmaceutical Co., Ltd.
Appearance
White or pale yellow round film-coated tablets
Packaging
28 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201603675 · Approved 2016.06.21 · Insurance code 658203220

Summary

Main use
Treatment of skin and nail fungal infections, vaginal, oral, and corneal fungal infections, and systemic fungal infections
Who uses it
Adults
Adult dosage
This medicine should preferably be administered immediately after a meal to increase its absorption. 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 and tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea manus (interdigital) and tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manus (palmar) and tinea pedis (plantar): Administer 100 mg once daily for 30 days or 200 mg twice daily for 7 days. 6) Oropharyngeal 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 limited to the fingernails and up to 3 cycles for toenail infection. 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; therefore, double the dose when necessary. Aspergillosis: 200mg once daily, 2~5 months. For invasive or disseminated disease, increase the dose 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
Vivozon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of skin and nail fungal infections, vaginal, oral, and corneal fungal infections, and systemic fungal infections

  • Candidiasis
  • 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 to treat various skin and mucosal fungal infections caused by Candida, tinea (ringworm), and dermatophytes such as tinea corporis, tinea capitis, tinea manuum, and tinea pedis. It is also effective for oral candidiasis and fungal keratitis, as well as onychomycosis. It is utilized for the treatment of severe systemic fungal infections including aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. This medication is safe and effective for the treatment of various fungal infections.

Dosage and Administration

Adult dosage

This medicine should preferably be administered immediately after a meal to increase its absorption. 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 and tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea manus (interdigital) and tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manus (palmar) and tinea pedis (plantar): Administer 100 mg once daily for 30 days or 200 mg twice daily for 7 days. 6) Oropharyngeal 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 limited to the fingernails and up to 3 cycles for toenail infection. 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; therefore, double the dose when necessary. Aspergillosis: 200mg once daily, 2~5 months. For invasive or disseminated disease, increase the dose 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

It is very important not to administer this drug to patients with impaired cardiac function, particularly those with congestive heart failure. If symptoms of heart failure arise, the medication should be discontinued immediately. Additionally, patients with allergic reactions to this medication or hypersensitivity to its components should not use it. As this drug is mainly metabolized in the liver, patients with poor liver function should undergo regular liver function tests as the risk of liver damage may increase. Patients with impaired renal function also require caution, and dosage adjustment may be necessary. Women who are pregnant, may become pregnant, or are breastfeeding should not use this medication and should employ effective contraception methods afterward. This medication interacts with many other drugs; therefore, if you are currently taking other medications, it is imperative to consult with healthcare professionals, especially if combined with drugs for heart conditions, anticoagulants, antipsychotics, or antivirals, which may present risks. Dizziness, vision impairment, and hearing loss may occur during the course of taking this medication; caution should be exercised while driving or operating machinery. Rarely, serious side effects such as severe liver damage, skin reactions, blood abnormalities, and heart arrhythmias may occur; if any abnormal symptoms arise, notify healthcare professionals immediately and discontinue treatment. In the case of overdose, there is no specific antidote, so treatment should be symptomatic, and it must be stored out of reach of children. Finally, this medication contains lactose, so patients with lactose intolerance should not use it.

Side effects

Decreased myocardial contractility, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, dysgeusia, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, distension, vomiting, hepatic dysfunction, hyperbilirubinemia, pruritus, rash, urticaria, increased urinary frequency, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusional state, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, sweating, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, transient hearing loss, permanent hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, loss of appetite, malaise, dark urine, increased liver enzyme levels, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Rielle syndrome, erythema multiforme, alopecia, photosensitivity, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized pustular rash, elevated BUN, positive urine protein reaction, positive urine sugar reaction, decreased libido, drowsiness, malaise, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, flushing, elevated serum uric acid, elevated serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized pustular rash, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, alopecia, photosensitivity, increased serum creatine phosphokinase levels

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The recommended storage temperature is between 1°C and 30°C at room temperature. Storing it this way will help maintain the drug's efficacy for a longer period.

Appearance and packaging

Appearance

White or pale yellow round film-coated tablets

Package unit

28 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.