▶ Manufacturer: Ilhwa Co., Ltd.
▶ Sold by: Ilhwa Co., Ltd.
▶ Insurance code : 640902590
▶ Storage : Airtight container, store at room temperature (1 to 30℃)
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Capsule with dark blue top cap and white bottom cap filled with white powder
Fluconazole 50mg
ㆍAdults
1. Vaginal candidiasis : Single oral administration of 150mg as fluconazole
2. Mucosal candidiasis
1) Oral pharyngeal candidiasis: Administer 50mg once a day of this drug for 7 to 14 days; extend depending on physician’s judgment.
2) Chronic erythematous candidiasis (oral pain due to dentures): Administer 50mg once a day of this drug for 14 days, with local disinfection of dentures.
3) Other mucosal candidiasis (esophageal candidiasis excluding vaginal candidiasis, non-invasive bronchopulmonary infections, candidiasis, dermatomyositis candidiasis, etc.): Administer 50mg once a day of this drug for 14 to 30 days; for intractable mucosal candidiasis, increase dose to 100mg per day.
3. Systemic candidiasis including candidemia, disseminated candidiasis, and other invasive candida infections (peritoneal, endocardial, pulmonary, urinary, etc.): Administer 400mg of this drug once on the first day, and administer 200mg once a day from the next day; dose may be increased to 400mg per day depending on patient response. Decide duration of treatment depending on clinical response and medical judgment.
4. Cryptococcal meningitis and other cryptococcosis: Administer 400mg of this drug once on the first day, and administer 200 to 400mg once a day from the next day. Duration of treatment is determined by clinical reaction and mycological response, but minimum of 6 to 8 weeks administration is necessary.
5. To prevent recurrence of cryptococcal meningitis in AIDS patients, administer at least 100mg of this drug once a day indefinitely after the patient has received all basic treatment.
6. Preventing fungal infection in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy or radiation therapy: Depending on the degree of the patient’s risk of fungal infection, administer 50 to 400mg per day of this drug. 400mg per day is recommended for patients with extremely high risk of systemic fungal infection, such as patients with severe neutropenia after bone marrow transplantation or expected to be neutropenic for a prolonged period. For these patients, administer 400mg per day starting 5 to 6 days prior to the date neutropenia is expected to begin. Continue administering 400mg per day for 1 week even after neutrocyte count has increased to beyond 1,000cells/mm3.
7. For Onychomycosis, administer 150mg once a week, until full fingernail and toenail growth (until uninfected fingernails and toenails have grown). The duration until full growth of a new fingernail is 3 to 6 months, and 6 to 12 months for toenails, varying individually and according to age. In some cases, fingernails and toenails will remain damaged even after successful treatment through prolonged administration.
Athlete’s foot (tinea pedis), tinea corporis, tinea cruris, cutaneous candidiasis and other skin fungal infections: Administer 50mg once a day of this drug, or 150mg once a week for 2 to 4 weeks. For tinea pedis, 6 weeks administration may be required depending on progression. Administer 50mg once a day for 2 to 4 weeks for leukoderma.
ㆍChildren
Pediatric doses based on adult doses are generally as follow, and shall not exceed 400mg. Safety and efficacy not established for infants less than 6 months old (See Precautions for Use).
1. Oral pharyngeal candidiasis: Administer 6mg per kg weight of this drug on the first day, and administer 3mg per kg weight from the next day. Administer for at least 2 weeks to prevent recurrence.
2. Esophageal candidiasis: Administer 6mg per kg weight of this drug on the first day, and administer 3mg per kg weight from the next day. Dose may be increased to 12mg per day depending on patient response. Administer at least 3 weeks, and 2 weeks after symptoms disappear.
3. Systemic candidiasis including candidemia, disseminated candidiasis, and other invasive candida infections (peritoneal, endocardial, pulmonary, urinary, etc.): Administer 6 to 12mg per kg weight per day. Decide duration of treatment depending on clinical response and medical judgment.
4. Cryptococcal meningitis: Administer 12mg per kg weight of this drug on the first day, and administer 6mg per kg weight from the next day. Dose may be increased to 12mg per kg weight per day depending on patient response. Administer for 10 to 12 weeks after negative results from cerebrospinal fluid cultures.
5. To prevent recurrence of cryptococcal meningitis in AIDS patients, administer 6mg per kg weight once a day after the patient has received all basic treatment.
6. For infants with renal impairment, administration intervals must be increased and doses must be reduced using the same standards as for adult real impairment patients. When administering doses smaller than 10mg, to accurately match doses, oral administration of syrups or intravenous injections may be required depending on the clinical state of the child.
ㆍElderly patients
If renal function is normal, administer the normal adult dose. Reduce dose or increase intervals in case of renal impairment (creatinine clearance 40ml/min or lower)
ㆍRenal impairment patients
This drug is excreted unchanged mainly through urine. Single administration dose does not require dose adjustment, but for multiple administrations, administer the normal dose only on the first day of administration, and adjust doses as follows from the next day.
For patients undergoing regular dialysis, administer 100% of the normal dose after each dialysis session; on days without dialysis, administer a reduced dose depending on creatinine clearance.
ㆍAdults
1) The following fungal skin infections due to dermatophytes : tinea pedis, tinea corporis, tinea cruris
2) Onychomycosis
ㆍChildren
Tinea capitisCapsule with dark blue top cap and white bottom cap filled with white powder
Fluconazole 50mg
ㆍAdults
1. Vaginal candidiasis : Single oral administration of 150mg as fluconazole
2. Mucosal candidiasis
1) Oral pharyngeal candidiasis: Administer 50mg once a day of this drug for 7 to 14 days; extend depending on physician’s judgment.
2) Chronic erythematous candidiasis (oral pain due to dentures): Administer 50mg once a day of this drug for 14 days, with local disinfection of dentures.
3) Other mucosal candidiasis (esophageal candidiasis excluding vaginal candidiasis, non-invasive bronchopulmonary infections, candidiasis, dermatomyositis candidiasis, etc.): Administer 50mg once a day of this drug for 14 to 30 days; for intractable mucosal candidiasis, increase dose to 100mg per day.
3. Systemic candidiasis including candidemia, disseminated candidiasis, and other invasive candida infections (peritoneal, endocardial, pulmonary, urinary, etc.): Administer 400mg of this drug once on the first day, and administer 200mg once a day from the next day; dose may be increased to 400mg per day depending on patient response. Decide duration of treatment depending on clinical response and medical judgment.
4. Cryptococcal meningitis and other cryptococcosis: Administer 400mg of this drug once on the first day, and administer 200 to 400mg once a day from the next day. Duration of treatment is determined by clinical reaction and mycological response, but minimum of 6 to 8 weeks administration is necessary.
5. To prevent recurrence of cryptococcal meningitis in AIDS patients, administer at least 100mg of this drug once a day indefinitely after the patient has received all basic treatment.
6. Preventing fungal infection in immunocompromised patients at risk of fungal infection due to neutropenia caused by cytotoxic chemotherapy or radiation therapy: Depending on the degree of the patient’s risk of fungal infection, administer 50 to 400mg per day of this drug. 400mg per day is recommended for patients with extremely high risk of systemic fungal infection, such as patients with severe neutropenia after bone marrow transplantation or expected to be neutropenic for a prolonged period. For these patients, administer 400mg per day starting 5 to 6 days prior to the date neutropenia is expected to begin. Continue administering 400mg per day for 1 week even after neutrocyte count has increased to beyond 1,000cells/mm3.
7. For Onychomycosis, administer 150mg once a week, until full fingernail and toenail growth (until uninfected fingernails and toenails have grown). The duration until full growth of a new fingernail is 3 to 6 months, and 6 to 12 months for toenails, varying individually and according to age. In some cases, fingernails and toenails will remain damaged even after successful treatment through prolonged administration.
Athlete’s foot (tinea pedis), tinea corporis, tinea cruris, cutaneous candidiasis and other skin fungal infections: Administer 50mg once a day of this drug, or 150mg once a week for 2 to 4 weeks. For tinea pedis, 6 weeks administration may be required depending on progression. Administer 50mg once a day for 2 to 4 weeks for leukoderma.
ㆍChildren
Pediatric doses based on adult doses are generally as follow, and shall not exceed 400mg. Safety and efficacy not established for infants less than 6 months old (See Precautions for Use).
1. Oral pharyngeal candidiasis: Administer 6mg per kg weight of this drug on the first day, and administer 3mg per kg weight from the next day. Administer for at least 2 weeks to prevent recurrence.
2. Esophageal candidiasis: Administer 6mg per kg weight of this drug on the first day, and administer 3mg per kg weight from the next day. Dose may be increased to 12mg per day depending on patient response. Administer at least 3 weeks, and 2 weeks after symptoms disappear.
3. Systemic candidiasis including candidemia, disseminated candidiasis, and other invasive candida infections (peritoneal, endocardial, pulmonary, urinary, etc.): Administer 6 to 12mg per kg weight per day. Decide duration of treatment depending on clinical response and medical judgment.
4. Cryptococcal meningitis: Administer 12mg per kg weight of this drug on the first day, and administer 6mg per kg weight from the next day. Dose may be increased to 12mg per kg weight per day depending on patient response. Administer for 10 to 12 weeks after negative results from cerebrospinal fluid cultures.
5. To prevent recurrence of cryptococcal meningitis in AIDS patients, administer 6mg per kg weight once a day after the patient has received all basic treatment.
6. For infants with renal impairment, administration intervals must be increased and doses must be reduced using the same standards as for adult real impairment patients. When administering doses smaller than 10mg, to accurately match doses, oral administration of syrups or intravenous injections may be required depending on the clinical state of the child.
ㆍElderly patients
If renal function is normal, administer the normal adult dose. Reduce dose or increase intervals in case of renal impairment (creatinine clearance 40ml/min or lower)
ㆍRenal impairment patients
This drug is excreted unchanged mainly through urine. Single administration dose does not require dose adjustment, but for multiple administrations, administer the normal dose only on the first day of administration, and adjust doses as follows from the next day.
For patients undergoing regular dialysis, administer 100% of the normal dose after each dialysis session; on days without dialysis, administer a reduced dose depending on creatinine clearance.
ㆍAdults
1) The following fungal skin infections due to dermatophytes : tinea pedis, tinea corporis, tinea cruris
2) Onychomycosis
ㆍChildren
Tinea capitis