[Posted 08/03/2011] ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of fluconazole (Diflucan) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. This risk does not appear to be associated with a single, low dose of fluconazole 150mg to treat vaginal yeast infection (candidiasis). Based on this information, the pregnancy category for fluconazole indications (other than vaginal candidiasis) has been changed from category C to category D. The pregnancy category for a single, low dose of fluconazole has not changed and remains category C.
BACKGROUND: Fluconazole is used to treat yeast infections of the vagina, mouth, throat, esophagus and other organs. It is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before bone marrow transplant. Fluconazole is also used to treat meningitis caused by a certain type of fungus. Pregnancy category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women with serious or life-threatening conditions may be acceptable despite its risks.
RECOMMENDATION: Healthcare professionals should counsel patients if the drug is used during pregnancy or if a patient becomes pregnant while taking the drug. Patients should notify their healthcare professionals if they are or become pregnant while taking fluconazole. If a patient uses fluconazole during pregnancy, the patient should be informed of the potential risk to the fetus. For more information visit the FDA website at: [Web] and [Web].
This medicine is for injection into a vein. It is usually given by a health care professional in a hospital or clinic setting.
If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
This does not apply.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor if your symptoms do not improve. If you are taking this medicine for a long time you may need blood work. Some fungal infections need many weeks or months of treatment to cure completely.
Alcohol can increase possible damage to your liver from this medicine. Avoid alcoholic drinks.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash or itching, hives, swelling of the lips, mouth, tongue, or throat
dark urine
feeling dizzy or faint
irregular heartbeat or chest pain
pain, redness at site of injection
redness, blistering, peeling or loosening of the skin, including inside the mouth
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
