DIFLUCAN® TABLET, SUSPENSION (Fluconazole TABLET, SUSPENSION) DOSAGE AND ADMINISTRATION

(Fluconazole TABLET, SUSPENSION)

Prescribing Information

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DOSAGE AND ADMINISTRATION

Dosage and Administration in Adults:

Single Dose

Vaginal candidiasis:

The recommended dosage of DIFLUCAN for vaginal candidiasis is 150 mg as a single oral dose.

Multiple Dose

SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF DIFLUCAN (FLUCONAZOLE) IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.

The daily dose of DIFLUCAN for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient's response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.

Oropharyngeal candidiasis:

The recommended dosage of DIFLUCAN for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.

Esophageal candidiasis:

The recommended dosage of DIFLUCAN for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient's response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.

Systemic Candida infections:

For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.

Urinary tract infections and peritonitis:

For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50 to 200 mg have been used in open, noncomparative studies of small numbers of patients.

Cryptococcal meningitis:

The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient's response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of DIFLUCAN for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily.

Prophylaxis in patients undergoing bone marrow transplantation:

The recommended DIFLUCAN daily dosage for the prevention of candidiasis in patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils cells/mm3) should start DIFLUCAN prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells/mm3.

Dosage and Administration in Pediatric Patients

Oropharyngeal candidiasis:

The recommended dosage of DIFLUCAN for oropharyngeal candidiasis in pediatric patients 6 months and older is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.

Esophageal candidiasis:

For the treatment of esophageal candidiasis, the recommended dosage of DIFLUCAN in pediatric patients 6 months and older is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used, based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least 2 weeks following the resolution of symptoms.

Systemic Candida infections:

The following dosing regimens in Table 6 are recommended for pediatric patients to achieve systemic exposures similar to adults for the treatment of systemic Candida infections, i.e., to maintain an AUC0-24 between 400-800 mg*h/L.

Table 6: Recommended Dosing Regimens for the Treatment of Systemic Candida Infections in Pediatric Patients

Patient age	Dosing regimen
3 months and older	A loading dose of 25-mg/kg on the first day (not to exceed 800 mg) followed by 12-mg/kg once daily (not to exceed 400 mg).
Birth to 3 months postnatal age and gestational age 30 weeks and above	25-mg/kg on the first day, followed by 12-mg/kg once daily
Birth to 3 months postnatal age and gestational age less than 30 weeks	25-mg/kg on the first day, followed by 9-mg/kg once daily

Patients with systemic candidiasis should be treated for a minimum of 3 weeks and for at least 2 weeks following the resolution of symptoms.

Dosing in Pediatric Patients on ECMO:

The recommended dosage of DIFLUCAN in pediatric patients 3 months and older on ECMO is 35-mg/kg on the first day (not to exceed 800 mg) followed by 12-mg/kg once daily (not to exceed 400 mg).

For patients from birth to 3 months postnatal age, and gestational age less than 30 weeks, a loading dose of 35-mg/kg on the first day followed by 9-mg/kg once daily is recommended. For patients from birth to 3 months postnatal age and gestational age 30 weeks and above, a loading dose of 35-mg/kg on the first day followed by 12-mg/kg once daily is recommended.

Cryptococcal meningitis:

For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient's response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in pediatric patients with AIDS, the recommended dose of DIFLUCAN is 6 mg/kg once daily.

Dosage In Patients With Impaired Renal Function:

Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of DIFLUCAN, an initial loading dose of 50 mg to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following summary:

Creatinine Clearance (mL/min)	Recommended Dose (%)
>50	100
≤50 (no dialysis)	50
Hemodialysis	100% after each hemodialysis

Patients on hemodialysis should receive 100% of the recommended dose after each hemodialysis; on non-dialysis days, patients should receive a reduced dose according to their creatinine clearance.

These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.

When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:

Males:	Weight (kg) × (140 – age)
	72 × serum creatinine (mg/100 mL)

Females: 0.85 × above value

Although the pharmacokinetics of fluconazole has not been studied in pediatric patients with renal insufficiency, dosage reduction in pediatric patients with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in pediatric patients:

K ×	linear length or height (cm)
	serum creatinine (mg/100 mL)

(Where K=0.55 for pediatric patients older than 1 year and 0.45 for infants.)

Administration

DIFLUCAN is administered orally. DIFLUCAN can be taken with or without food.

Directions for Mixing the Oral Suspension

Prepare a suspension at time of dispensing as follows: tap bottle until all the powder flows freely. To reconstitute, add 24 mL of distilled water or Purified Water (USP) to fluconazole bottle and shake vigorously to suspend powder. Each bottle will deliver 35 mL of suspension. The concentrations of the reconstituted suspensions are as follows:

Fluconazole Content per Bottle	Concentration of Reconstituted Suspension
350 mg	10 mg/mL
1400 mg	40 mg/mL

Note: Shake oral suspension well before using. Store reconstituted suspension between 30°C (86°F) and 5°C (41°F) and discard unused portion after 2 weeks. Protect from freezing.

Medication Guide

MEDICATION GUIDE

PATIENT INFORMATION DIFLUCAN® (dye-FLEW-kan) (fluconazole) Tablets
This leaflet contains important information about DIFLUCAN. It is not meant to take the place of your healthcare provider's instructions. Read this information carefully before you take DIFLUCAN. Ask your healthcare provider if you do not understand any of this information or if you want to know more about DIFLUCAN.
What is DIFLUCAN? DIFLUCAN is a prescription medicine used to treat vaginal yeast infections caused by a yeast called Candida. DIFLUCAN helps stop too much yeast from growing in the vagina so the yeast infection goes away. DIFLUCAN is different from other treatments for vaginal yeast infections because it is a tablet taken by mouth. DIFLUCAN is also used for other conditions. However, this leaflet is only about using DIFLUCAN for vaginal yeast infections. For information about using DIFLUCAN for other reasons, ask your healthcare provider. See the section of this leaflet for information about vaginal yeast infections.
What is a vaginal yeast infection? It is normal for a certain amount of yeast to be found in the vagina. Sometimes too much yeast starts to grow in the vagina and this can cause a yeast infection. Vaginal yeast infections are common. About three out of every four adult women will have at least one vaginal yeast infection during their life. Some medicines and medical conditions can increase your chance of getting a yeast infection. If you are pregnant, have diabetes, use birth control pills, or take antibiotics you may get yeast infections more often than other women. Personal hygiene and certain types of clothing may increase your chances of getting a yeast infection. Ask your healthcare provider for tips on what you can do to help prevent vaginal yeast infections. If you get a vaginal yeast infection, you may have any of the following symptoms: • itching • a burning feeling when you urinate • redness • soreness • a thick white vaginal discharge that looks like cottage cheese
Do not take DIFLUCAN if you. • take the following medicines: o quinidine o erythromycin o pimozide o are allergic to fluconazole, the active ingredient in DIFLUCAN, or any of the ingredients in DIFLUCAN. See the end of this Patient Information leaflet for a complete list of ingredients in DIFLUCAN.
Before you take DIFLUCAN, tell your healthcare provider about all of your medical conditions, if you: • have liver problems • have kidney problems • have heart problems including heart arrythmias • have hypokalemia (low potassium) • are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking DIFLUCAN. You and your healthcare provider will decide if DIFLUCAN is right for you. If you may become pregnant you should use a birth-control (contraceptive) method while taking DIFLUCAN and for 1 week after your final dose. • are breastfeeding or plan to breastfeed. DIFLUCAN can pass into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while you are taking DIFLUCAN. Before you start taking DIFLUCAN, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: • diabetes medicines such as glyburide, tolbutamide, glipizide • blood pressure medicines like hydrochlorothiazide, losartan, amlodipine, verapamil, nifedipine or felodipine • blood thinners such as warfarin • cyclosporine, tacrolimus or sirolimus (used to prevent rejection of organ transplants) • rifampin or rifabutin for tuberculosis • phenytoin or carbamazepine to control seizures • theophylline to control asthma • quinidine (used to correct disturbances in heart rhythm) • amiodarone (used for treating uneven heartbeats 'arrhythmias') • amitriptyline or nortriptyline for depression • pimozide for psychiatric illness • amphotericin B or voriconazole for fungal infections • erythromycin for bacterial infections • olaparib, cyclophosphamide or vinca alkaloids such as vincristine or vinblastine for treatment of cancer • fentanyl, alfentanil or methadone for chronic pain • ibrutinib used for treating blood cancer • ivacaftor or ivacaftor combinations, such as tezacaftor/ivacaftor and ivacaftor/tezacaftor/elexacaftor, used to treat cystic fibrosis • lurasidone used to treat schizophrenia or depression • lemborexant, used for the treatment of insomnia • lipid lowering drugs such as atorvastatin, simvastatin, and fluvastatin • non-steroidal anti-inflammatory drugs including celecoxib, ibuprofen, and naproxen • prednisone, a steroid used to treat skin, gastrointestinal, hematological or respiratory disorders • antiviral medications used to treat HIV like saquinavir or zidovudine • tofacitinib for rheumatoid arthritis • abrocitinib (used to treat atopic dermatitis, also known as eczema) • vitamin A nutritional supplement • tolvaptan used to treat hyponatremia (low levels of sodium in your blood) or to slow kidney function decline Since there are many brand names for these medicines, check with your healthcare provider or pharmacist if you have any questions.
How should I take DIFLUCAN? • Take DIFLUCAN exactly as your healthcare provider tells you to. • Take DIFLUCAN by mouth with or without food. • If you take too much DIFLUCAN, call your healthcare provider or go to the nearest emergency room right away.
What should I avoid while taking DIFLUCAN? DIFLUCAN can cause dizziness and seizures. Do not drive or operate machinery until you know how DIFLUCAN affects you.
What are the possible side effects of DIFLUCAN? DIFLUCAN may cause serious side effects including: • serious liver problems. Some people with serious medical problems have developed serious liver problems that became life-threatening or caused death while taking DIFLUCAN. Sometimes these liver problems can be reversed when you stop taking DIFLUCAN. Tell your healthcare provider right away if you have symptoms of serious liver problems including:
	• dark colored urine • severe skin itching • yellowing of the skin and eyes (jaundice)	• light-colored stools • tiredness	• vomiting • loss of appetite
• serious allergic reactions: Serious allergic reactions (anaphylaxis) have happened while taking DIFLUCAN. Stop taking DIFLUCAN, call your healthcare provider or go to the nearest hospital emergency room right away if you get any signs or symptoms of an allergic reaction including:
	• shortness of breath • fever • swelling of the eyelids	• coughing • skin rash, hives, blisters or skin peeling • face, mouth, neck, or any other part of the body	• wheezing • throbbing of the heart or ears • chills
• serious skin problems. Some people with serious medical problems have developed serious skin problems that have caused death while taking DIFLUCAN. Tell your healthcare provider right away if you develop a rash while taking DIFLUCAN. The most common side effects of DIFLUCAN include:
	• headache • dizziness	• diarrhea • stomach pain	• nausea or upset stomach • changes in the way food tastes
Other side effects include: • adrenal insufficiency: Some people who have taken DIFLUCAN developed adrenal insufficiency that was reversible. Tell your healthcare provider right away if you have symptoms of adrenal insufficiency including:
	• long lasting fatigue	• muscle weakness	• loss of appetite
	• weight loss	• stomach pain	• dizziness
	• nausea	• vomiting
• dizziness or seizures.
These are not all the possible side effects of DIFLUCAN. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store DIFLUCAN? Store DIFLUCAN tablets below 86°F (30°C). Keep DIFLUCAN and all medicines out of the reach of children.
General information about the safe and effective use of DIFLUCAN. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DIFLUCAN for a condition for which it was not prescribed. Do not give DIFLUCAN to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider for information about DIFLUCAN that is written for health professionals.
What are the ingredients in DIFLUCAN? Active ingredient: fluconazole Inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate.
For Medical Information about DIFLUCAN, please visit www.pfizermedinfo.com or call 1-800-438-1985.
This Patient Information has been approved by the U.S. Food and Drug Administration				Revised: 3/2025

LAB-0380-16.0

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