Medication info
Cannazole Capsule 50 mg (Fluconazole)

Cannazole Capsule 50 mg (Fluconazole)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Fluconazole›50mg / 1 capsule
Manufacturer / importer
IQUR Co., Ltd.
Appearance
Capsule filled with white powder, light blue on the upper part and white on the lower part
Packaging
30 capsules, 100 capsules
Approval status
Active

MFDS item code 201505830 · Approved 2015.08.20 · Insurance code 674400540

Summary

Main use
Treatment of candidiasis and cutaneous fungal infections; treatment and prevention of recurrence of cryptococcosis; prevention of fungal infections
Who uses it
Adults · Children
Adult dosage
The route of administration should be determined according to the patient's clinical condition. Since oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. Vulvovaginal candidiasis: A single oral dose of 150 mg fluconazole Oropharyngeal candidiasis: The usual dose is 50 mg of this medicine once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose is 50 mg of this medicine once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal candidiasis): The usual dose is 50 mg of this medicine once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg of this medicine as a single dose 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. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this medicine as a single dose 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 generally continue for at least 6 ~ 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed primary treatment. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily according to the patient's risk of developing a 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, or those expected to have severe or prolonged neutropenia. 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 more. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until uninfected new nails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rates may vary by age and individual. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this medicine 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. In patients with normal renal function, the usual adult dose is generally administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose. When multiple doses are required, administer the usual dose only on the first day, then adjust the dose from the following day as follows. Creatinine clearance (mL/min) > 50: 100% of the usual dose Creatinine clearance (mL/min) ≤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 when dialysis is not performed, administer a reduced dose according to creatinine clearance.
Children's dosage
Pediatric dose corresponding to an adult dose of 100 mg: 3 mg/kg Pediatric dose corresponding to an adult dose of 200 mg: 6 mg/kg Pediatric dose corresponding to an adult dose of 400 mg: 12 mg/kg Do not exceed 400 mg. The safety and efficacy of this medicine in infants younger than 6 months have not been established (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily according to the patient's response. Treat for at least 3 weeks and for at least 2 weeks after symptoms resolve. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg once daily. The duration of treatment should be determined according to the clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this medicine on the first day, followed by 6 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily according to the patient's response. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed primary treatment. In children with renal impairment, the dosing interval should be extended and the dose reduced according to the same criteria as for adults with renal impairment, based on the degree of renal impairment. When administering doses below 10 mg, administer the syrup orally or inject the injectable formulation intravenously, according to the child's clinical condition, to ensure accurate dosing.

Ingredients

Manufacturer
IQUR Co., Ltd.

Efficacy & effects

Treatment of candidiasis and cutaneous fungal infections; treatment and prevention of recurrence of cryptococcosis; prevention of fungal infections

  • Acute vaginal candidiasis
  • recurrent vaginal candidiasis
  • oral pharyngeal infection
  • esophageal infection
  • non-invasive bronchopulmonary infection
  • candiduria
  • skin mucosal candidiasis
  • chronic atrophic oral candidiasis
  • oral pain due to dentures
  • candidemia
  • disseminated candidiasis
  • peritoneal infection
View approved original text

This medication is used to treat acute or recurrent vaginal candidiasis. It is effective for various mucosal and skin candidiasis including oral cavity, pharynx, esophagus, respiratory system, urinary tract, and skin mucosal candidiasis. Additionally, it helps in treating systemic candidiasis such as candidemia. It is also used for the treatment and prevention of cryptococcal meningitis and other cryptococcal infections in immunocompromised patients. It prevents fungal infections in patients with neutropenia due to cytotoxic chemotherapy and radiation therapy. It is effective for various skin fungal infections such as onychomycosis, tinea pedis, and tinea corporis. Overall, this medication is used for the treatment and prevention of various fungal infections.

Dosage and Administration

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Since oral formulations are absorbed rapidly and almost completely, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. Vulvovaginal candidiasis: A single oral dose of 150 mg fluconazole Oropharyngeal candidiasis: The usual dose is 50 mg of this medicine once daily for 7-14 days; treatment may be extended at the physician's discretion. Chronic atrophic oral candidiasis (oral soreness due to dentures): The usual dose is 50 mg of this medicine once daily for 14 days, together with local disinfection of the dentures. Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infection, candiduria, mucocutaneous candidiasis, etc., excluding vulvovaginal candidiasis): The usual dose is 50 mg of this medicine once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg of this medicine as a single dose 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. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this medicine as a single dose 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 generally continue for at least 6 ~ 8 weeks. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this medicine once daily indefinitely after the patient has completed primary treatment. Prevention of fungal infections in immunocompromised patients at risk due to neutropenia caused by cytotoxic chemotherapy, radiotherapy, or bone marrow transplantation: Administer 50-400 mg of this medicine once daily according to the patient's risk of developing a 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, or those expected to have severe or prolonged neutropenia. 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 more. For onychomycosis, administer 150 mg once weekly until the fingernails or toenails have regrown (until uninfected new nails have grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rates may vary by age and individual. Even after successful treatment with long-term administration, the fingernails or toenails may sometimes remain damaged. Dermatophyte infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this medicine 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. In patients with normal renal function, the usual adult dose is generally administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. This medicine is excreted mainly in the urine unchanged. No dose adjustment is necessary for a single dose. When multiple doses are required, administer the usual dose only on the first day, then adjust the dose from the following day as follows. Creatinine clearance (mL/min) > 50: 100% of the usual dose Creatinine clearance (mL/min) ≤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 when dialysis is not performed, administer a reduced dose according to creatinine clearance.

Children's dosage

Pediatric dose corresponding to an adult dose of 100 mg: 3 mg/kg Pediatric dose corresponding to an adult dose of 200 mg: 6 mg/kg Pediatric dose corresponding to an adult dose of 400 mg: 12 mg/kg Do not exceed 400 mg. The safety and efficacy of this medicine in infants younger than 6 months have not been established (see Precautions for Use). Oropharyngeal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. Treatment should continue for at least 2 weeks to prevent recurrence. Esophageal candidiasis: Administer 6 mg/kg of this medicine on the first day, followed by 3 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily according to the patient's response. Treat for at least 3 weeks and for at least 2 weeks after symptoms resolve. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg once daily. The duration of treatment should be determined according to the clinical response and medical judgment. Cryptococcal meningitis: Administer 12 mg/kg of this medicine on the first day, followed by 6 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily according to the patient's response. Treatment should continue for 10-12 weeks after cerebrospinal fluid cultures become negative. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed primary treatment. In children with renal impairment, the dosing interval should be extended and the dose reduced according to the same criteria as for adults with renal impairment, based on the degree of renal impairment. When administering doses below 10 mg, administer the syrup orally or inject the injectable formulation intravenously, according to the child's clinical condition, to ensure accurate dosing.

Precautions

This medication should not be administered to certain patients. For example, patients with allergies to this medicine or similar drugs, pregnant or potentially pregnant women, and breastfeeding mothers should not use this medication. Also, significant side effects may occur when taken with certain drugs, so patients currently on those medications should avoid this drug. For instance, it can be dangerous when taken along with drugs that affect heart rhythms, certain antibiotics, or antihistamines. This drug contains lactose and should not be used in patients with lactose intolerance or certain genetic metabolic disorders. Patients with kidney or liver function issues should use this drug with caution, and those with heart disease or electrolyte imbalances should be closely monitored while taking it due to the potential risk of side effects. Generally, this drug has good tolerability, but in rare cases, adverse effects on blood or liver function may occur, and skin rashes or allergic reactions can emerge. Commonly reported symptoms include headaches, dizziness, and gastrointestinal disturbances. During treatment with this drug, regular blood tests, liver function tests, and kidney function tests should be performed, especially for patients with existing liver or kidney issues. This drug can affect heart electrical signals, so patients with heart conditions should have their status monitored through ECG during use. Additionally, due to numerous drug interactions, patients taking other medications must inform their doctor or pharmacist, as dosage adjustments or monitoring may be necessary. Using this medication during pregnancy can be harmful to the fetus, so those who are planning to become pregnant or are pregnant should consult with a physician. Breastfeeding mothers should also avoid using this medication. Safety has not been established in infants under 6 months of age, therefore it should be used cautiously and only when necessary. There is a risk of dizziness or seizures while driving or operating machinery during treatment, so caution is needed. In case of overdose, symptoms such as hallucinations or abnormal behavior may occur, and immediate medical attention should be sought. This medication is primarily excreted through urine, so adequate hydration and dialysis treatment when necessary may be helpful.

Side effects

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, dysgeusia, 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, liver 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, alopecia, drug reaction with eosinophilia and systemic symptoms (DRESS), myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucinations, psychotic behavior

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and it is safe to store at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Capsule filled with white powder, light blue on the upper part and white on the lower part

Package unit

30 capsules, 100 capsules

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.