Fluconazole 150 mg Tablets

Adult dose

The route of administration should be determined according to the patient's clinical condition. Since oral formulations are rapidly and almost completely absorbed, the doses of oral formulations (tablets, capsules, dry syrup) and injectable formulations 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, and urinary tract infections, etc.): The usual dose 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 is determined according to clinical response and medical judgment. 3. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose 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 clinical and mycological response, but treatment should generally continue for at least 6 ~ 8 weeks. 4. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg once daily indefinitely after the patient has completed primary treatment. 5. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia resulting from cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg once daily according to 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 undergoing bone marrow transplantation, who are expected to have severe or prolonged neutropenia. In these patients, administer 400 mg beginning 5-6 days before the expected onset of neutropenia and continue 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 6. For onychomycosis, administer 150 mg once weekly until the fingernails and toenails have regrown (until new, uninfected nails have grown). New fingernails generally take 3-6 months to grow, and toenails take 6-12 months; growth rates may vary among individuals and with age. In some cases, fingernails or toenails may remain damaged after successful treatment with long-term therapy. Dermal fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg once daily or 150 mg once weekly for 2-4 weeks. However, treatment for athlete's foot may need to continue for 6 weeks, depending on the course of the disease. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults Use the usual adult dose if renal function is normal. If renal impairment is present (creatinine clearance 50 mL/min or less), reduce the dose or extend the dosing interval. ○ Patients with renal impairment This medicine is excreted mainly in the urine unchanged. No dosage adjustment is required for a single dose; however, if multiple doses are required, administer the usual dose only on the first day and 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 Patients on hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days without dialysis, reduce the dose according to creatinine clearance.

This drug should not be used in certain patients. First, patients who have had allergic reactions to this drug or other azole medications, pregnant women or women who may become pregnant, and nursing mothers should not take this medication. Additionally, patients who are currently taking certain heart-related medications or some other drugs should avoid using this drug. This medication contains lactose and should not be given to patients with lactose intolerance or specific genetic metabolic disorders. Patients with kidney or liver problems, a history of drug allergies, or heart disease or electrolyte imbalance should use this drug with caution. Moreover, co-administration with certain drugs may increase the risk of side effects, and it should be administered under a doctor's supervision. This drug is generally safe; however, in rare cases, abnormalities in the blood, liver, or kidneys may occur, and allergic reactions such as skin rashes or itching may appear. Common gastrointestinal symptoms include abdominal pain, diarrhea, nausea, and vomiting. Regular monitoring of liver and kidney function, blood tests, and electrolyte status is important while taking this medication. In particular, patients with severe diseases or those on long-term treatment need to be closely monitored for potential liver function abnormalities. This drug may affect heart rhythm, so patients with heart disease or electrolyte imbalances should be more cautious. Additionally, this drug may have limited effectiveness against certain fungal infections, and switching to other antifungals may be necessary in case of treatment failure. This drug interacts with multiple medications, necessitating dose adjustments or additional testing based on the other medications being taken. Women who are pregnant or planning to become pregnant should consult a physician before taking this drug and should use effective contraception during and for a period after treatment. Nursing mothers should avoid using this drug as it is excreted in breast milk. Safety in infants under 6 months has not been established, so it should only be used when absolutely necessary. Caution is advised when driving or operating machinery as dizziness or seizures may occur. In case of overdose, hallucinations or unusual behavior may present, and immediate medical attention should be sought. This medication is primarily excreted in urine, thus adequate fluid intake is important, and if necessary, blood dialysis can be used to remove the drug.

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

This drug should be stored in a closed container to prevent exposure to air and moisture. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. Proper storage preserves the drug's efficacy and safety.

Appearance

Pink rectangular tablet

Package unit

30 tablets/bottle