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Fluconazole, Sodium Chloride Solution for injection

It is used to treat or prevent certain kinds of fungal or yeast infections

Generic Name: fluconazole

Brand Names: Diflucan

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[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].

What is this medicine?

FLUCONAZOLE (floo KON na zole) is an antifungal medicine. It is used to treat or prevent certain kinds of fungal or yeast infections.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • history of irregular heart beat
  • kidney disease
  • an unusual or allergic reaction to fluconazole, other antifungal medicines, foods, dyes or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

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.

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:
  • cisapride
  • pimozide
  • red yeast rice

This medicine may also interact with the following medications:

  • birth control pills
  • cyclosporine
  • diuretics like hydrochlorothiazide
  • medicines for diabetes that are taken by mouth
  • medicines for high cholesterol like atorvastatin, lovastatin or simvastatin
  • phenytoin
  • ramelteon
  • rifabutin
  • rifampin
  • some medicines for anxiety or sleep
  • tacrolimus
  • terfenadine
  • theophylline
  • warfarin

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
  • stomach pain
  • trouble breathing
  • unusual bruising or bleeding
  • vomiting
  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • changes in how food tastes
  • diarrhea
  • headache
  • stomach upset, nausea

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.

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.


Last Updated: April 22, 2009
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