IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
FLUCONAZOLE – ORAL
COMMON BRAND NAME(S): Diflucan
USES: Fluconazole is used to prevent and treat a variety of fungal and yeast infections. It belongs to a class of drugs called azole antifungals. It works by stopping the growth of certain types of fungus.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking fluconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily.
If you are taking the liquid suspension form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
Dosage is based on your medical condition and response to treatment. For children, dosage is also based on weight. Generally in children, the dose should not exceed 600 milligrams daily unless directed by the doctor.
This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take it at the same time each day as directed.
Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow the fungus to continue to grow, which may result in a return of the infection.
Tell your doctor if your condition persists or if it worsens.
SIDE EFFECTS: Nausea, vomiting, diarrhea, stomach upset/pain, headache, dizziness, or hair loss may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.
This drug may rarely cause serious liver disease. Get medical help right away if you develop any signs of liver disease, including: severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, unusual tiredness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking fluconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal drugs (such as ketoconazole, itraconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease.
Fluconazole may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using fluconazole, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using fluconazole safely.
Although uncommon, this drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the effects of this drug, especially rash, vomiting, and diarrhea.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby if taken in high doses daily during the first 3 months of pregnancy. Discuss the risks and benefits with your doctor.
Fluconazole passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Products that may interact with this drug include: clopidogrel.
Many drugs besides fluconazole may affect the heart rhythm (QT prolongation), including pimozide, quinidine, macrolide antibiotics (such as erythromycin), among others.
Fluconazole can slow down the removal of other medications from your body, which can affect how they work. An example of the affected drugs is cisapride, among others.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: hallucinations, mental/mood changes.
NOTES: Do not share this medication with others.
This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.
Laboratory and/or medical tests (such as liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store the tablets at room temperature away from light and moisture. Do not store in the bathroom.
Store the liquid suspension at room temperature or in the refrigerator. Do not freeze. Discard any unused medication after 14 days.
Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2010. Copyright(c) 2010 First Databank, Inc.