Medication info
Tinazol 150 mg (Fluconazole)

Tinazol 150 mg (Fluconazole)

Prescription medicationTabletOral
Ingredient · strength
Fluconazole›150mg / 1 tablet
Manufacturer / importer
Dongkwang Pharmaceutical Co., Ltd.
Appearance
Pink rectangular tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201705156 · Approved 2017.06.30 · Insurance code 645906310

Summary

Main use
Treatment and prevention of fungal infections (including vaginal candidiasis, cryptococcosis, and dermatomycosis)
Who takes it
Adults
Adult dose
The route of administration should be determined according to the patient's clinical condition. Oral preparations are absorbed rapidly and almost completely; therefore, the doses of oral preparations (tablets, capsules, dry syrup) and injectable preparations are the same. ○ Adults 1. Vaginal candidiasis: Administer a single oral dose of 150 mg of fluconazole. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this medicine is 400 mg once on the first day, followed by 200 mg once daily from the next day. The dose may be increased to 400 mg once daily according to the patient's response. The duration of treatment should be determined according to the clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine is 400 mg once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment is determined by the clinical and mycological response, but treatment should usually be given for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed initial treatment. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily, depending on the patient's risk of fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as those with severe or expected prolonged neutropenia, as in the case of bone marrow transplantation. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, and toenails take approximately 6-12 months; growth rates may vary between individuals according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Skin fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this medicine is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment for athlete's foot may be required for 6 weeks, depending on the course of the infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults If renal function is normal, the usual adult dose is administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. ○ Patients with renal impairment This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose. If multiple doses are required, administer the usual dose only on the first day, then adjust the dose from the next day as follows. Creatinine clearance (mL/min) — Recommended dose > 50 — 100 % of the usual dose ≤50 (not on dialysis) — 50% of the usual dose Patients on hemodialysis — 100% of the usual dose after each hemodialysis session For patients receiving hemodialysis, administer 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, administer a reduced dose according to creatinine clearance.

Ingredients

Manufacturer
Dongkwang Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of fungal infections (including vaginal candidiasis, cryptococcosis, and dermatomycosis)

  • Acute vulvovaginal candidiasis
  • recurrent vulvovaginal candidiasis
  • candidemia
  • disseminated candidiasis
  • invasive candidiasis
  • cryptococcal meningitis
  • cryptococcosis
  • fungal infections
  • onychomycosis
  • athlete's foot
  • tinea corporis
  • tinea cruris
View approved original text

This medication is used to treat acute or recurrent vulvovaginal candidiasis, systemic candidiasis (candidemia, disseminated candidiasis, etc.), and cryptococcosis (meningitis, lungs, skin, etc.). It is also effective for maintenance therapy to prevent recurrence of cryptococcosis in AIDS patients. It helps to prevent fungal infections in immunocompromised patients. It is used to treat skin fungal infections such as onychomycosis, athlete's foot, tinea corporis, tinea cruris, tinea versicolor, and cutaneous candidiasis. This drug is widely utilized for the treatment and prevention of various fungal infections.

How to take

Adult dose

The route of administration should be determined according to the patient's clinical condition. Oral preparations are absorbed rapidly and almost completely; therefore, the doses of oral preparations (tablets, capsules, dry syrup) and injectable preparations are the same. ○ Adults 1. Vaginal candidiasis: Administer a single oral dose of 150 mg of fluconazole. 2. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose of this medicine is 400 mg once on the first day, followed by 200 mg once daily from the next day. The dose may be increased to 400 mg once daily according to the patient's response. The duration of treatment should be determined according to the clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose of this medicine is 400 mg once on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment is determined by the clinical and mycological response, but treatment should usually be given for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed initial treatment. 5. Prevention of fungal infections in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily, depending on the patient's risk of fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as those with severe or expected prolonged neutropenia, as in the case of bone marrow transplantation. In these patients, administer 400 mg starting 5-6 days before the anticipated onset of neutropenia and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 6. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until new, uninfected nails have grown). New fingernails usually take 3-6 months to grow, and toenails take approximately 6-12 months; growth rates may vary between individuals according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Skin fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose of this medicine is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment for athlete's foot may be required for 6 weeks, depending on the course of the infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults If renal function is normal, the usual adult dose is administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. ○ Patients with renal impairment This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose. If multiple doses are required, administer the usual dose only on the first day, then adjust the dose from the next day as follows. Creatinine clearance (mL/min) — Recommended dose > 50 — 100 % of the usual dose ≤50 (not on dialysis) — 50% of the usual dose Patients on hemodialysis — 100% of the usual dose after each hemodialysis session For patients receiving hemodialysis, administer 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, administer a reduced dose according to creatinine clearance.

Precautions

This medication should not be administered to certain patients. Women who are allergic to this drug or other azole medications, pregnant, or breastfeeding should not use it. Additionally, serious side effects may occur when taken with certain drugs, so such combinations should be avoided. Patients with lactose intolerance or certain genetic metabolic disorders should also not take this drug. This medication should be used cautiously in patients with impaired kidney or liver function, heart disease, or electrolyte imbalances. Patients taking multiple medications that may alter drug concentrations when combined with this drug should be carefully monitored. This drug is generally safe to use, but abnormalities in blood, liver, and kidney function may occur in some patients. Various side effects, including fatigue, headache, indigestion, skin rashes, have been reported, and in rare cases, severe liver damage or cardiac arrhythmias may occur. Regular blood tests and monitoring of liver and kidney function during the use of this drug are recommended. Particularly, patients with severe illnesses should be closely monitored for potential deterioration of liver function. Women who are pregnant or may become pregnant should use effective contraception during and for a certain period after taking this medication, and it is safest to avoid use in early pregnancy. Breastfeeding women should also avoid taking this drug. This drug interacts with many other medications, requiring dosage adjustments or caution depending on the drugs being taken concurrently. In particular, it is essential to follow a doctor's instructions when taken with drugs affecting the heart, anticoagulants, anticonvulsants, immunosuppressants, or antibiotics. The safety of this drug in children, especially infants under 6 months, has not been sufficiently established, and it should only be used when absolutely necessary. Caution should be taken as this medication may cause dizziness or seizures when driving or operating machinery. Overdose may lead to hallucinations or abnormal behavior, requiring immediate medical assistance. Supportive therapy and, if necessary, gastric lavage or dialysis may be helpful during an overdose.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, increased blood alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage, rash, pruritus, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reaction with eosinophilia and systemic symptoms, myalgia, fatigue, malaise, asthenia, fever, hallucinations, paranoid behavior

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

Storage

This drug should be stored in a tightly closed container to prevent air and moisture from entering, and it should be kept at room temperature between 1°C and 30°C. Storing it this way will help maintain its efficacy for a long time.

Appearance and packaging

Appearance

Pink rectangular tablet

Package unit

30 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.