Description
Fluconazole is used to treat serious fungal or yeast infections, including vaginal candidiasis, oropharyngeal candidiasis (thrush, oral thrush), esophageal candidiasis (candida esophagitis), other candida infections (including urinary tract infections, peritonitis [inflammation of the lining of the stomach], and infections that may occur in different parts of the body), or fungal (cryptococcal) meningitis. It is also used in children on life support called extracorporeal membrane oxygenation (ECMO). This medicine works by killing the fungus or yeast, or preventing its growth.
Fluconazole is also used to prevent candidiasis in patients having bone marrow transplants who receive cancer or radiation treatment.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Powder for Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluconazole for the treatment of oropharyngeal candidiasis in children 6 months to 13 years of age, for the treatment of esophageal candidiasis, other candida infections, or fungal (cryptococcal) meningitis in children, and for children on ECMO. Safety and efficacy have been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluconazole in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving fluconazole.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alfuzosin
- Amiodarone
- Aripiprazole
- Aripiprazole Lauroxil
- Artemether
- Astemizole
- Atazanavir
- Bedaquiline
- Bepridil
- Buprenorphine
- Ceritinib
- Cisapride
- Citalopram
- Clarithromycin
- Clozapine
- Crizotinib
- Dabrafenib
- Dasatinib
- Deuruxolitinib
- Dofetilide
- Domperidone
- Dronedarone
- Encorafenib
- Entrectinib
- Erythromycin
- Escitalopram
- Etrasimod
- Flibanserin
- Glasdegib
- Granisetron
- Halofantrine
- Haloperidol
- Iloperidone
- Itraconazole
- Ivabradine
- Ivosidenib
- Ketoconazole
- Lapatinib
- Lefamulin
- Levoketoconazole
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abrocitinib
- Acalabrutinib
- Acenocoumarol
- Adagrasib
- Alfentanil
- Alprazolam
- Amisulpride
- Amitriptyline
- Anagrelide
- Anisindione
- Apixaban
- Apomorphine
- Aprepitant
- Aprindine
- Arsenic Trioxide
- Asenapine
- Atorvastatin
- Avanafil
- Avapritinib
- Avatrombopag
- Axitinib
- Azathioprine
- Azilsartan
- Azilsartan Medoxomil
- Azithromycin
- Belzutifan
- Benzhydrocodone
- Bosutinib
- Bretylium
- Brexpiprazole
- Brigatinib
- Budesonide
- Buserelin
- Buspirone
- Capivasertib
- Carbamazepine
- Cariprazine
- Carvedilol
- Celecoxib
- Cerivastatin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amlodipine
- Atevirdine
- Cimetidine
- Clopidogrel
- Losartan
- Nicardipine
- Prednisone
- Ramelteon
- Rifapentine
- Rivaroxaban
- Tretinoin
- Trimetrexate
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Electrolyte problems (mineral imbalance) or
- Heart disease—Use with caution. These conditions may increase your risk of having heart rhythm problems and make the effects of this medicine worse.
- Fructose malabsorption (rare hereditary problem) or
- Glucose-galactose malabsorption (rare hereditary problem) or
- Sucrase-isomaltase deficiency (rare hereditary problem)—Should not be used in patients with these conditions. Oral liquid contains sucrose (table sugar).
- Heart rhythm problems (eg, QT prolongation) or
- Liver disease—Use with caution. May make these conditions worse.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
You may take this medicine with or without food.
Shake the oral liquid well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (suspension or tablets):
- For cryptococcal meningitis:
- Adults—400 milligrams (mg) on the first day, followed by 200 mg once a day for at least 10 to 12 weeks. Your doctor may adjust your dose as needed.
- Children 6 months to 13 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 12 milligrams (mg) per kilogram (kg) of body weight on the first day, followed by 6 mg per kg of body weight once a day, for at least 10 to 12 weeks.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- For esophageal candidiasis:
- Adults—200 milligrams (mg) on the first day, followed by 100 mg once a day for at least 3 weeks. Your doctor may increase your dose as needed.
- Children 6 months to 13 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 6 milligrams (mg) per kilogram (kg) of body weight on the first day, followed by 3 mg per kg of body weight once a day, for at least 3 weeks.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- For oropharyngeal candidiasis:
- Adults—200 milligrams (mg) on the first day, followed by 100 mg once a day for at least 2 weeks.
- Children 6 months to 13 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 6 milligrams (mg) per kilogram (kg) of body weight on the first day, followed by 3 mg per kg of body weight once a day, for at least 2 weeks.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- For other infections that may occur in different parts of the body:
- Adults—Doses of up to 400 milligrams (mg) per day.
- Children 3 months of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 25 milligrams (mg) per kilogram (kg) of body weight on the first day, followed by 12 mg per kg of body weight once a day.
- Children from birth to 3 months postnatal and 30 weeks gestational age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 25 mg per kg of body weight on the first day, followed by 12 mg per kg of body weight once a day, for at least 3 weeks.
- Children from birth to 3 months postnatal and younger than 30 weeks gestational age—Dose is based on body weight and must be determined by your doctor. The dose is usually 25 mg per kg of body weight on the first day, followed by 9 mg per kg of body weight once a day, for at least 3 weeks.
- For prevention of candidiasis during bone marrow transplantation:
- Adults—400 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For urinary tract infections or peritonitis:
- Adults—50 to 200 milligrams (mg) per day.
- Children—Use and dose must be determined by your doctor.
- For vaginal candidiasis:
- Adults—150 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For cryptococcal meningitis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
The mixed oral liquid should be kept in the refrigerator or at room temperature and used within 14 days. Do not freeze.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
If your or your child's symptoms do not improve, or if they become worse, check with your doctor. Continue to take this medicine as directed.
You or your child should not use erythromycin (Ery-Tab®), pimozide (Orap®), or quinidine (Cardioquin®) while using this medicine because of the risk of unwanted side effects.
Using this medicine for a long time or using it too much while you are pregnant (especially during the first trimester) can harm your unborn baby. Use an effective form of birth control during treatment with this medicine and for at least 1 week after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may rarely cause serious liver problems. Check with your doctor right away if you or your child have stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.
This medicine may rarely cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hives, hoarseness, trouble with breathing, trouble with swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Serious skin reactions can occur in certain people during treatment with this medicine. Check with your doctor right away if you or your child start having a skin rash, itching, or any other skin changes while using this medicine.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem including QT prolongation.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Rare
- Chest tightness
- chills
- clay-colored stools
- cough
- dark urine
- diarrhea
- difficulty with swallowing
- dizziness
- fast heartbeat
- fever
- headache
- hives, itching, or skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- light-colored stools
- loss of appetite
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach pain, continuing
- unpleasant breath odor
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- vomiting
- vomiting of blood
- yellow eyes and skin
Incidence not known
- Black, tarry stools
- blistering, peeling, or loosening of the skin
- chest pain or discomfort
- decreased urine
- dry mouth
- fainting
- hoarseness
- increased thirst
- irregular or slow heart rate
- joint or muscle pain
- loss of bladder control
- lower back or side pain
- mood changes
- muscle pain or cramps
- muscle spasm or jerking of the arms and legs
- numbness or tingling in the hands, feet, or lips
- painful or difficult urination
- pale skin
- red skin lesions, often with a purple center
- red, irritated eyes
- seizures
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- sudden loss of consciousness
- swollen glands
- unusual bleeding or bruising
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Fearfulness, suspiciousness, or other mental changes
- seeing, hearing, or feeling things that are not there
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Belching
- change in taste or bad, unusual, or unpleasant (after) taste
- heartburn
- indigestion
- stomach discomfort or upset
Incidence not known
- Hair loss or thinning of the hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20071428
