Medication info

Diflucan Dry Syrup (Fluconazole)

Prescription medication
Ingredient · strength
Fluconazole›1.64g / 100g
Manufacturer / importer
Pfizer Pharmaceuticals Korea Limited
Appearance
White to grayish-white powder
Packaging
22g/bottle X 1 bottle
Approval status
Active

MFDS item code 200511062 · Notified 2005.08.31 · Insurance code 648900181

Summary

Main use
Treatment of candidiasis and dermatomycosis; treatment of cryptococcosis and prevention of recurrence; prevention of fungal infections
Who uses it
Adults · Children
Adult dosage
The route of administration is determined according to the patient's clinical condition. Oral formulations are absorbed rapidly and almost completely; therefore, the doses of oral formulations (capsules, dry syrup) and injections are the same. 1. Adults 1) Vaginal candidiasis: Administer 150 mg of fluconazole as a single oral dose 2) Mucosal candidiasis (1) Oropharyngeal candidiasis Usually administer 50 mg of this drug once daily for 7 - 14 days; treatment may be extended at the physician's discretion. (2) Chronic atrophic oral candidiasis (oral soreness caused by dentures) Usually administer 50 mg of this drug once daily for 14 days, and perform local disinfection of the dentures concurrently. (3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis) Usually administer 50 mg of this drug once daily for 14 - 30 days; for refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 3) Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.) Usually administer 400 mg of this drug once on the first day, followed by 200 mg once daily from the next day; the dose may be increased to up to 400 mg once daily depending on the patient's response. The duration of administration is determined according to clinical response and medical judgment. 4) Cryptococcal meningitis and cryptococcosis at other sites Usually administer 400 mg of this drug 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 responses, but treatment should usually be administered for at least 6 - 8 weeks. 5) To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer at least 200 mg of this drug once daily indefinitely after the patient has completed all initial treatment. 6) Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50 – 400 mg of this drug once daily, depending on the patient's level of risk for fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as those with severe neutropenia or an expected prolonged period of neutropenia, as in the case of bone marrow transplantation. In these patients, administer 400 mg starting 5 - 6 days before the expected onset of neutropenia, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 7) For onychomycosis, administer 150 mg once weekly until the fingernails and 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; the growth rate may vary by individual and age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. For fungal skin infections such as athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: Usually administer 50 mg of this drug once daily or 150 mg once weekly for 2 - 4 weeks. However, athlete's foot may require treatment for 6 weeks, depending on its course. For tinea versicolor, administer 50 mg once daily for 2 - 4 weeks. 3. Elderly patients 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. 4. Patients with renal impairment This drug is excreted mainly in the urine in unchanged form. Dose adjustment is not necessary when administering a single dose. However, if multiple doses are required, administer the usual dose only on the first day of treatment, and adjust the dose from the next day as follows. Creatinine clearance (mL/min) >50: 100% of the usual dose Creatinine clearance (mL/min) ≤50 (not undergoing dialysis): 50% of the usual dose Patients undergoing hemodialysis: 100% of the usual dose after each hemodialysis session Patients undergoing hemodialysis should receive 100% of the usual dose after each hemodialysis session; on days when dialysis is not performed, the dose should be reduced according to creatinine clearance.
Children's dosage
Pediatric doses based on adult doses are generally determined according to the following guidelines and should not exceed 400 mg. Adult dose 100 mg: Pediatric dose 3 mg/kg Adult dose 200 mg: Pediatric dose 6 mg/kg Adult dose 400 mg: Pediatric dose 12 mg/kg However, safety and efficacy have not been established in infants under 6 months of age (see Precautions for Use). 1) Oropharyngeal candidiasis Administer 6 mg/kg on the first day, followed from the next day by 3 mg/kg once daily. Treatment should continue for at least 2 weeks to prevent recurrence. 2) Esophageal candidiasis Administer 6 mg/kg on the first day, followed from the next day by 3 mg/kg once daily. Depending on the patient's response, the dose may be increased to 12 mg/kg once daily. Treatment should continue for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3) Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneum, endocardium, lungs, 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. 4) Cryptococcal meningitis Administer 12 mg/kg on the first day, followed from the next day by 6 mg/kg once daily. Depending on the patient's response, the dose may be increased to 12 mg/kg once daily. Treatment should continue for 10 - 12 weeks after cerebrospinal fluid cultures become negative. 5) To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after completion of initial therapy. 6) In children with renal impairment, the dosing interval should be extended and the dose reduced according to the degree of renal impairment, using the same criteria as for adults with renal impairment. For doses below 10 mg, administer the syrup orally or the injection intravenously, according to the child's clinical condition, to ensure accurate dosing.

Ingredients

Importer
Pfizer Pharmaceuticals Korea Limited

Efficacy & effects

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

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

This medication is used for the treatment of acute or recurrent vulvovaginal candidiasis. It is also effective for treating various fungal infections such as oropharyngeal, pharyngeal, esophageal, and mucosal candidiasis in both immunocompetent and immunocompromised patients. It is effective for systemic Candida infections such as candidemia and disseminated candidiasis. It helps treat and prevent cryptococcal symptoms that may occur in AIDS patients or organ transplant recipients. It is also used to prevent the risk of fungal infections in patients undergoing cytotoxic chemotherapy or radiation therapy. It is effective against a variety of skin fungal infections, including dermatophyte infections of the skin and nails. Thus, it is widely used for the treatment and prevention of fungal infections.

Dosage and Administration

Adult dosage

The route of administration is determined according to the patient's clinical condition. Oral formulations are absorbed rapidly and almost completely; therefore, the doses of oral formulations (capsules, dry syrup) and injections are the same. 1. Adults 1) Vaginal candidiasis: Administer 150 mg of fluconazole as a single oral dose 2) Mucosal candidiasis (1) Oropharyngeal candidiasis Usually administer 50 mg of this drug once daily for 7 - 14 days; treatment may be extended at the physician's discretion. (2) Chronic atrophic oral candidiasis (oral soreness caused by dentures) Usually administer 50 mg of this drug once daily for 14 days, and perform local disinfection of the dentures concurrently. (3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis) Usually administer 50 mg of this drug once daily for 14 - 30 days; for refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 3) Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.) Usually administer 400 mg of this drug once on the first day, followed by 200 mg once daily from the next day; the dose may be increased to up to 400 mg once daily depending on the patient's response. The duration of administration is determined according to clinical response and medical judgment. 4) Cryptococcal meningitis and cryptococcosis at other sites Usually administer 400 mg of this drug 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 responses, but treatment should usually be administered for at least 6 - 8 weeks. 5) To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer at least 200 mg of this drug once daily indefinitely after the patient has completed all initial treatment. 6) Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50 – 400 mg of this drug once daily, depending on the patient's level of risk for fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infections, such as those with severe neutropenia or an expected prolonged period of neutropenia, as in the case of bone marrow transplantation. In these patients, administer 400 mg starting 5 - 6 days before the expected onset of neutropenia, and continue administering 400 mg for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or higher. 7) For onychomycosis, administer 150 mg once weekly until the fingernails and 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; the growth rate may vary by individual and age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. For fungal skin infections such as athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: Usually administer 50 mg of this drug once daily or 150 mg once weekly for 2 - 4 weeks. However, athlete's foot may require treatment for 6 weeks, depending on its course. For tinea versicolor, administer 50 mg once daily for 2 - 4 weeks. 3. Elderly patients 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. 4. Patients with renal impairment This drug is excreted mainly in the urine in unchanged form. Dose adjustment is not necessary when administering a single dose. However, if multiple doses are required, administer the usual dose only on the first day of treatment, and adjust the dose from the next day as follows. Creatinine clearance (mL/min) >50: 100% of the usual dose Creatinine clearance (mL/min) ≤50 (not undergoing dialysis): 50% of the usual dose Patients undergoing hemodialysis: 100% of the usual dose after each hemodialysis session Patients undergoing hemodialysis should receive 100% of the usual dose after each hemodialysis session; on days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Children's dosage

Pediatric doses based on adult doses are generally determined according to the following guidelines and should not exceed 400 mg. Adult dose 100 mg: Pediatric dose 3 mg/kg Adult dose 200 mg: Pediatric dose 6 mg/kg Adult dose 400 mg: Pediatric dose 12 mg/kg However, safety and efficacy have not been established in infants under 6 months of age (see Precautions for Use). 1) Oropharyngeal candidiasis Administer 6 mg/kg on the first day, followed from the next day by 3 mg/kg once daily. Treatment should continue for at least 2 weeks to prevent recurrence. 2) Esophageal candidiasis Administer 6 mg/kg on the first day, followed from the next day by 3 mg/kg once daily. Depending on the patient's response, the dose may be increased to 12 mg/kg once daily. Treatment should continue for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3) Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneum, endocardium, lungs, 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. 4) Cryptococcal meningitis Administer 12 mg/kg on the first day, followed from the next day by 6 mg/kg once daily. Depending on the patient's response, the dose may be increased to 12 mg/kg once daily. Treatment should continue for 10 - 12 weeks after cerebrospinal fluid cultures become negative. 5) To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after completion of initial therapy. 6) In children with renal impairment, the dosing interval should be extended and the dose reduced according to the degree of renal impairment, using the same criteria as for adults with renal impairment. For doses below 10 mg, administer the syrup orally or the injection 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 allergic to this medication, its components, or similar class of drugs should not use it. Pregnant women or those who may become pregnant, as well as breastfeeding women, should also avoid using this medication. Additionally, patients taking certain heart-related medications or some other drugs may be at risk when using this medication together, so caution is advised. This medication contains sugar, and patients with genetic problems such as sugar enzymopathy or fructose and glucose-galactose malabsorption should not use it. When administering this medication, careful consideration should be given to allergy history, kidney and liver function status, and the presence of heart disease. Patients with reduced liver function should be cautious as there is a risk of liver function deterioration. Patients with heart disease or electrolyte imbalances may be at risk for cardiac issues such as arrhythmias, so caution is necessary. This medication may interact with other medications by inhibiting certain enzymes, so it is essential to consult with a physician or pharmacist regarding any concurrent medications. While this medication is generally safe, serious allergic reactions, skin rashes, or liver function abnormalities may rarely occur. Symptoms such as headaches, indigestion, diarrhea, vomiting may appear, and if severe symptoms occur, consult medical personnel. Using this medication during pregnancy may harm the fetus, so its use should be avoided, and effective contraception is needed during and for a period after treatment. Breastfeeding women should also avoid using this medication since it can be transmitted in breast milk. Safety in children, especially infants under six months old, has not been established, so it should only be used when absolutely necessary. Dizziness or seizures may occur while taking this medication, so caution is advised when driving or operating machinery. Excessive dosing may lead to hallucinations or abnormal behavior, and in such cases, medical facilities should be visited immediately. When using in syrup form, the exact dosage should be measured and not diluted. It is recommended to undergo blood tests, kidney and liver function tests, and electrolyte tests before taking this medication. When combining this medication with others, interactions may occur, so it is essential to consult healthcare professionals.

Side effects

Eosinophilia, Drug Reaction (DRESS), Agranulocytosis, Leukopenia, Neutropenia, Thrombocytopenia, Anaphylaxis, Angioedema, Hypertriglyceridemia, Hypercholesterolemia, Hypokalemia, Insomnia, Drowsiness, Headache, Seizure, Dizziness, Paresthesia, Dysgeusia, Tremor, Vertigo, Torsade 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, Hepatocyte Necrosis, Hepatitis, Hepatocyte Damage, Rash, Itching, Urticaria, Increased Sweating, Drug Rash, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, Acute Generalized Exanthematous Pustulosis, Exfoliative Dermatitis, Facial Edema, Hair Loss, Fatigue, Lethargy, Weakness, Fever, Adrenal Insufficiency, Hallucinations, Paranoid Behavior

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

Storage

This medication should be stored in a tightly sealed container to protect it from air or moisture, and the storage temperature should ideally be maintained between approximately 15 and 25 degrees Celsius, which is the usual room temperature. Therefore, care should be taken to close the container properly when using the medication to prevent moisture or air from entering.

Appearance and packaging

Appearance

White to grayish-white powder

Package unit

22g/bottle X 1 bottle

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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.